[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"tnbc---triple-negative-breast-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:tnbc---triple-negative-breast-cancer":29},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,39,0,25,[9,58,86,118,153,177,205,232,276,295,321,345,367,393,420,442,470,493,512,539,564,589,611,642,666],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":32,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":46,"lastUpdatePostDateStruct":47,"startDateStruct":50,"completionDateStruct":52,"leadSponsor":54,"locationsCount":57},"100644477","early-phase-1-imaging-study-of-a-trop2-binder-in-metastatic-uc-hr-and-her2--breast-cancer-tnbc-and-nsclc-100644477",false,"NCT07671092","Imaging Study of a TROP2 Binder in Metastatic UC, HR+ and HER2- Breast Cancer, TNBC, and NSCLC","A Phase 0 Imaging Study to Assess the Feasibility, Biodistribution, and Dosimetry of a Trophoblast Cell Surface Antigen 2 (TROP2) Binder in Metastatic Urothelial Cancer (UC), Hormone Receptor-Positive (HR+) and Human Epidermal Growth Factor Receptor 2-Negative (HER2-) Breast Cancer, Triple-Negative Breast Cancer (TNBC), and Non-Small-Cell Lung Cancer (NSCLC)","Inclusion Criteria:\n\n* Are at least 18 years old at the time of signing the informed consent form (ICF)\n* Have biopsy proven metastatic UC, HR+ and HER2- breast cancer, TNBC, or NSCLC\n\nExclusion Criteria:\n\n* TROP2-targeting antibody-drug conjugates (ADCs) such as sacituzumab govitecan or datopotamab deruxtecan, should be discontinued at least 90 days prior to administration of RYZ211 and RYZ212\n* For Women of Childbearing Potential: Are pregnant or breastfeeding\n\nNote: Additional criteria may apply and will be assessed by the study site","ALL","18 Years",{"count":20,"type":21},40,"ESTIMATED","INTERVENTIONAL",[24],"EARLY_PHASE1","This imaging study aims to assess the feasibility, biodistribution, and dosimetry of a TROP2 binder in subjects with metastatic UC, HR+ and HER2- breast cancer, TNBC, or NSCLC.",[27,28,29,30,31],"Metastatic Urothelial Carcinoma","Breast Cancer","TNBC - Triple-Negative Breast Cancer","Hormone Receptor Positive HER-2 Negative Breast Cancer","NSCLC",[33,34,28,35,36,37,38,39,40,41,42,43,44],"HR+","HER2-","Non Small Cell Lung Cancer","Triple Negative Breast Cancer","Trop2","TNBC","RayzeBio","Rayze","BMS","Bristol Myers Squibb","RPT","Imaging Agent","NOT_YET_RECRUITING","2026-06-22",{"date":48,"type":49},"2026-06-26","ACTUAL",{"date":51,"type":21},"2026-06",{"date":53,"type":21},"2027-10",{"name":55,"class":56},"RayzeBio, Inc.","INDUSTRY",1,{"id":59,"slug":60,"hasResults":12,"nctId":61,"briefTitle":62,"officialTitle":62,"acronym":4,"eligibilityCriteria":63,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":64,"targetDuration":4,"studyType":22,"phases":66,"briefSummary":68,"conditions":69,"keywords":71,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":85},"100635399","phase-2-phase-ii-trial-of-pembrolizumabchemotherapy-with-live-biotherapeutic-product-mo-03-in-patients-with-early-stage-triple-negative-breast-cancer-100635399","NCT07552181","Phase II Trial of Pembrolizumab\u002FChemotherapy With Live Biotherapeutic Product MO-03 in Patients With Early Stage Triple Negative Breast Cancer","Inclusion Criteria:\n\n* Female or male age ≥ 18 years of age.\n* Patients with high-risk early stage triple negative breast cancer. Triple negative status will be defined as ER≤10%, PR≤10%, HER2 negative (by FISH) per ASCO-CAP guidelines.\n* Clinically staging T1c any N M0 or any T N1-3 M0.\n* Willing to provide FFPE from baseline standard of care biopsy and post-treatment residual tumor at the time of surgery.\n* ECOG 0-1\n* Patients must have adequate organ function as defined in the following. Specimens must be collected within 28 days prior to the start of study treatment.\n* For patients who will receive regimen 1 only: Participants must have adequate cardiac function. Participants must have left ventricular ejection fraction ≥ 50% as assessed by either ECHO or MUGA within 28 days prior to the start of treatment. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification and must be class 2B or better.\n* Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test within 28 days of the start of treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n* Male participants: A male participant must agree to use a contraception as detailed in Appendix B of this protocol during the treatment period and for at least 120 days after the last dose of MO-03 and refrain from donating sperm during this period.\n* Female participants: A female participant is eligible to participate if she is not pregnant (see Appendix B), not breastfeeding, and at least one of the following conditions applies:\n\n  i. Not a woman of childbearing potential (WOCBP) as defined in Appendix B OR ii. Females of child-bearing potential must be willing to use effective contraception during study and for 120 days after the last dose of MO-03.\n* Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.\n\nExclusion Criteria:\n\n* Participants with known human immunodeficiency virus (HIV) infection must be on effective anti-retroviral therapy at registration and have undetectable viral load test on the most recent test results obtained within 6 months prior to registration.\n* Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within 6 months prior to registration, if indicated.\n\nNote: No testing for Hepatitis B is required unless mandated by local health authority.\n\n* Participant must not have uncontrolled diabetes or hypertension in the opinion of treating investigator.\n* Participant must not have had a major surgery within 14 days prior to screening.\n* Participant must not have severe infection within 14 days prior to enrollment.\n* Prohibited Treatments and\u002For Therapies:\n\n  * Any prior chemotherapy, biological therapy, immunotherapy for the current breast cancer diagnosis prior to start of study intervention\n  * Prior use of immune checkpoint inhibitor is prohibited\n  * Prior breast surgery or radiation therapy for current invasive breast cancer\n  * Participants must not have a diagnosis of immunodeficiency and be receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to enrollment.\n  * Participants must not have active autoimmune disease that has required systemic treatment in 2 years prior to enrollment (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroidreplacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment.\n  * Participants must not have a history of (non-infectious) pneumonitis that required steroids or has current (non-infectious) pneumonitis.\n  * Any live vaccine within 30 days prior to the first dose of study drug and for 3 months after chemo-immunotherapy. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.\n  * Participants on any dose of warfarin. Use of low molecular weight heparin, antithrombin agents, anti-platelet agents or factor Xa inhibitors is allowed\n  * Participants may not use any other live biotherapeutic products (LBP) or supplementary use of probiotics in pill form during their participation in the study (e.g., Ferring's Rebyota, Vowst)\n* Participants may not be currently participating in or participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention.\n* Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.\n* Known allergy to any of the components within the study agents and\u002For their excipients (i.e., corn starch, lactose, microcrystalline cellulose, croscarmellose sodium or magnesium stearate).\n* Medical history and concurrent diseases:\n\n  * Any prior malignancy except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for at least five years\n  * Known active CNS metastases and\u002For carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (Note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention\n  * History of (non-infectious) pneumonitis that required steroids or has current pneumonitis\n  * Known history of active TB (Mycobacterium tuberculosis)\n* Intercurrent or historic medical condition that increases subject risk in the opinion of the Investigator. Eligibility may be revisited for intercurrent medical conditions once resolution\u002Frecovery is deemed adequate by the investigator (e.g., recovery from major surgery, completion of treatment for severe infection).\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n* Has had an allogenic tissue\u002Fsolid organ transplant.",{"count":65,"type":21},50,[67],"PHASE2","This is a single-arm and single site phase II trial combination of chemotherapy and pembrolizumab with LBP MO-03 in 50 trial participants with early triple negative breast cancer. MO-03 will be given at a dose of 4 x 10e9 CFU per capsule, 1 capsule taken orally twice daily. Patients will receive standard of care pembrolizumab 200 mg every 3 weeks in concurrent with a regimen of chemotherapy. Please refer to Table 2 for a summary of the chemo-immunotherapy with pembrolizumab containing regimens. Patients will continue to take MO-03 up until the day prior to surgery (lumpectomy or mastectomy). Post-surgery, patients will come in for a 2-week follow-up and then enter survival follow-up annually for 5 years.",[29,38,70],"Early Stage Triple-Negative Breast Carcinoma",[72,73,38,74],"Pembrolizumab","Neoadjuvant Chemo-Immunotherapy","High-risk early stage TNBC","2026-06-19",{"date":77,"type":49},"2026-06-24",{"date":79,"type":21},"2026-09",{"date":81,"type":21},"2035-09",{"name":83,"class":84},"Yuan Yuan","OTHER",3,{"id":87,"slug":88,"hasResults":12,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":4,"eligibilityCriteria":92,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":93,"targetDuration":4,"studyType":22,"phases":95,"briefSummary":97,"conditions":98,"keywords":102,"overallStatus":107,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":117},"100498336","phase-1-bal0891-in-patients-with-advanced-solid-tumors-or-relapsed-or-refractory-acute-myeloid-leukemia-100498336","NCT05768932","BAL0891 in Patients With Advanced Solid Tumors or Relapsed or Refractory Acute Myeloid Leukemia","A Phase 1 Study of BAL0891 as Monotherapy and in Combination With Chemotherapy or Tislelizumab in Patients With Advanced Solid Tumors or Relapsed or Refractory Acute Myeloid Leukemia","1.1. Inclusion criteria: Substudy 1, 2, 3 and Dose expansion Each patient must meet all the following inclusion criteria.\n\n1. Informed consent signed by the patient prior to any study-related procedure indicating that they understand the purpose of, and procedures required for, the study, and are willing to participate in the study.\n2. Male or female aged ≥18 years (or ≥ 19 years according to local regulatory guidelines) at the time of screening.\n3. Patients with incurable advanced\u002Fmetastatic solid tumor disease refractory to or intolerant of existing therapy known to provide clinical benefit for their condition.\n\n   Note: Patients with non-CNS tumors participating during dose escalation may have inactive CNS metastasis, defined as 4 weeks after either brain metastasis resection or radiation, and a) all residual neurological symptoms resolved to grade ≤ 2; b) on stable doses of dexamethasone, if applicable; and c) follow-up imaging shows no new lesions appearing.\n4. Patients enrolled in Dose Expansion only\n\n   • TNBC cohorts i. Must have histologically confirmed breast adenocarcinoma that is unresectable, loco-regional, or metastatic.\n\n   ii. Must have source data documented pathologically confirmed triple negative breast cancer, defined as both of the following.\n   1. Estrogen receptor (ER) and progesterone receptor (PgR) negative: \\\u003C1% of tumor cell nuclei are immunoreactive in the presence of evidence that the sample can express ER or PgR (positive intrinsic controls)\n   2. Human epidermal growth factor receptor 2 (HER2) negative as per American Society of Clinical Oncology\u002FCollege of American Pathologists guidelines\n\n      * IHC 0 or 1 fluorescence in situ hybridization (FISH) negative (or equivalent negative test)\n      * Patients with IHC 2 must have a negative by FISH (or equivalent negative test) iii. Patients with a history of different breast cancer phenotypes (i.e., ER\u002FPgR\u002FHER2 Positive) must obtain pathological confirmation of triple-negative disease in at least one of the current sites of metastasis.\n\n   iv. Must have progression on or after therapy containing anthracycline and\u002For a taxane. Subjects must have received anthracycline and\u002For a taxane based regimen or other chemotherapy \u002F targeted therapy regimen if anthracycline or taxane was contraindicated or another available approved targeted agent was contraindicated. At time of enrolment, patients must have progressed on, be intolerant of, or be ineligible for, all available standard of care therapies with proven benefit.\n\n   • GC cohort i. Must have a histologically or cytologically confirmed diagnosis of gastric or gastroesophageal junction adenocarcinoma.\n\n   ii. Must have progression on or after therapy containing platinum\u002Ffluoropyrimidine. Subjects must have received platinum-based chemotherapy or other chemotherapy regimen if platinum-based chemotherapy was contraindicated or another available approved targeted agent unless the targeted agent was contraindicated. At time of enrolment, patients must have progressed on, be intolerant of, or be ineligible for, all available standard of care therapies with proven benefit.\n\n   iii. Documentation of HER2\u002Fneu status. Patients who are HER2\u002Fneu-positive must be treated with a HER2\u002Fneu inhibitor, and subjects should have progressed on or be intolerant to the targeted therapy or subjects must have received other chemotherapy regimen if HER2\u002Fneu inhibitor was contraindicated or another available approved targeted agent unless the targeted agent was contraindicated. At time of enrolment, patients must have progressed on, be intolerant of, or be ineligible for, all available standard of care therapies with proven benefit.\n\n   iv. Subjects must\u002Fshould have received no more than 3 lines of prior therapy for the advanced disease (if a subject progressed within 6 months of completing adjuvant therapy, this would count as a prior line of therapy).\n5. For patients enrolled in Substudy 3 or cohort 3 and 4, if a taxane (i.e., paclitaxel or docetaxel) was administered as part of the previous regimen, PD must have occurred \\> 12 months from the end of the previous treatment. (Patients who received a taxane in previous treatments without reaching PD may enroll without the 12-month waiting period.)\n6. Patients enrolled in Dose Expansion only, patient must have undergone a minimum of 1 prior systemic regimen for advanced or metastatic disease. (Korea only, patients must have received the second line standard of care treatment as per the regulations of the respective country. Patients who are unsuitable to receive the standard of care second line treatment will be eligible for enrollment)\n7. Eastern Cooperative Oncology Group performance status (ECOG PS) 0or-1\n8. For patients enrolled from DL1.4 of Substudy 1 onwards and for all patients in Substudies 2 and 3 and all four dose expansion cohorts, measurable tumor disease per Response Evaluation Criteria in Solid Tumors 1.1 criteria (RECIST 1.1), i.e., a minimum of one target lesion.\n9. Adequate organ functions as indicated by the following Screening visit local laboratory values:\n\n   1. Hemoglobin ≥ 9 g\u002FdL (criterion must be met without erythropoietin dependency and without packed red blood cell transfusion within the last 4 weeks)\n   2. ANC ≥ 2.0 × 109\u002FL; criterion must be met without growth factor (e.g., G-CSF, GM CSF, etc.) administration within the last 2 weeks\n   3. Platelets ≥ 100 × 109\u002FL\n   4. Total bilirubin ≤ 1.5 × ULN\n   5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) baseline levels ≤ 1.5 × ULN, with the option for AST\u002FALT ≤ 3.0 × ULN, or ≤ 5.0 × ULN for patients with liver metastasis, upon accumulating evidence for the absence of liver toxicity in biologically active DLs\n   6. Albumin ≥ 2.8 g\u002FdL\n   7. CLCR ≥ 50 mL\u002Fmin (as calculated by the Cockcroft-Gault formula), or eGFR ≥ 50 mL\u002Fmin\u002F1.73 m² (MDRD equation or CKD-EPI equation)\n   8. For women of childbearing potential, negative serum human chorionic gonadotropin (hCG)\n10. Men\u002Fwomen of child-producing\u002Fbearing potential must agree to: avoid impregnating a partner or becoming pregnant, respectively, during the study, and for at least 6 months after the last dose of either investigational drug, and comply with the contraception requirements.\n\n1.2. Inclusion criteria: Substudy 4 Each patient must meet all the following inclusion criteria.\n\n1. Informed consent signed by the patient prior to any study-related procedure indicating that they understand the purpose of, and procedures required for, the study, and are willing to participate in the study.\n2. Male or female aged ≥18 years (or ≥ 19 years according to local regulatory guidelines) at the time of screening.\n3. Eastern Cooperative Oncology Group performance status (ECOG PS) 0-2.\n4. Estimated life expectancy of at least 8 weeks\n5. AML either de novo or secondary as any subtype diagnosed according to the WHO 2022 classification system \\[except acute promyelocytic leukemia (APL)\\] who either:\n\n   Relapse\u002Frefractory (R\u002FR) acute myeloid leukemia (AML) defined as those who have also failed or are not appropriate for any approved standard-of-care (SOC) therapies, or hematopoietic stem cell transplant (HSCT) with reappearance of ≥ 5% blasts in the bone marrow.\n6. Relapsed AML is defined as having 5% or more leukemic blasts in the bone marrow, reappearance of leukemic blasts in peripheral blood (in at least two peripheral blood samples taken at least one week apart), or the development of new extramedullary disease.\n7. WBC, peripheral blood leukocyte count≤ 25,000\u002FµL and blast count ≤ 25,000\u002FµL prior to initiation of therapy\n\n   1. Hydroxyurea is allowed during screening and prior to day 1 of study treatment to keep the blast count ≤25,000\u002FµL; hydroxyurea is to be ceased 24 hours prior to study therapy.\n   2. Hydroxyurea may be used for up to 28 days in the initial treatment cycle if needed, to keep the white blood cell (WBC) count ≤25,000\u002FµL. However, no other anti-leukemic treatments, apart from the study drug, are allowed during this period.\n   3. Leukapheresis is allowed to maintain blast count ≤25,000\u002FµL\n8. Adequate organ functions as indicated by the following Screening visit local laboratory values:\n\n   1. CLCR ≥ 60 mL\u002Fmin (as calculated by the Cockcroft-Gault formula), or eGFR ≥ 60 mL\u002Fmin\u002F1.73 m² (MDRD equation or CKD-EPI equation)\n   2. Total bilirubin ≤ 1.5 × ULN (unless considered due to leukemic organ involvement), or, Direct bilirubin ≤ ULN for subjects with total bilirubin levels \\> 1.5 ULN\n   3. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) baseline levels ≤ 3.0 × ULN\n   4. Albumin ≥ 2.5 g\u002FdL\n   5. International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants\n   6. Activated Partial Thromboplastin Time (aPTT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants\n9. Men\u002Fwomen of child-producing\u002Fbearing potential must agree to: avoid impregnating a partner or becoming pregnant, respectively, during the study, and for at least 6 months after the last dose of either investigational drug, and comply with the contraception requirements.",{"count":94,"type":21},260,[96],"PHASE1","This study is a multiple cohort, multicenter, open-label Phase 1 study with dose-escalation substudies investigating intravenous (IV) BAL0891 as monotherapy, and in combination with tislelizumab or paclitaxel, to determine the safety and tolerability of increasing doses of BAL0891 in patients with advanced solid tumors or relapsed or refractory acute myeloid leukemia. An adaptive model-based design will be used to guide the dose escalation. Subject assignment to Substudy 1, 2, 3 and 4 will be finalized following approval from the investigator and sponsor.\n\nThe dose-expansion stage will be conducted with the RP2D to further evaluate the preliminary anti-tumor activity, safety, and tolerability in metastatic TNBC and GC.",[99,29,100,101],"Advanced Solid Tumor","Gastric Cancer","Leukemia Acute Myeloid Leukemia (AML)",[103,104,105,106],"carcinoma","paclitaxel","BAL0891","tislelizumab","RECRUITING","2026-06-11",{"date":110,"type":49},"2026-06-15",{"date":112,"type":49},"2022-12-14",{"date":114,"type":21},"2026-12-24",{"name":116,"class":56},"SillaJen, Inc.",17,{"id":119,"slug":120,"hasResults":12,"nctId":121,"briefTitle":122,"officialTitle":122,"acronym":123,"eligibilityCriteria":124,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":125,"enrollmentInfo":126,"targetDuration":4,"studyType":128,"phases":4,"briefSummary":129,"conditions":130,"keywords":134,"overallStatus":107,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":152},"100609178","evaluating-minimal-residual-disease-mrd-through-longitudinal-circulating-tumor-dna-ctdna-profiling-in-breast-malignancies-100609178","NCT07211178","Evaluating Minimal Residual Disease (MRD) Through Longitudinal Circulating Tumor DNA (ctDNA) Profiling in Breast Malignancies","GEMINI Breast","Inclusion Criteria:\n\nAll Cohorts:\n\n1. Willing and able to participate in the research and provide biospecimens\n2. Willing and able to provide informed consent\n3. Must be diagnosed with breast cancer\n\nCohort 1: Neoadjuvant Treatment Cohort 1A: Newly Diagnosed, High Risk HR+,HER2-\n\n1. A known or suspected HR+, HER2- breast cancer treated with curative intent (Stage II to III disease)\n2. Patients are considered at high risk of recurrence, defined as 4 or more positive axillary lymph nodes (ALNs), or between 1-3 positive ALNs and either grade 3 disease or tumor size of 5 cm or larger.\n\nCohort 1B: HER2+ 1. A known or suspected HER2+ breast cancer treated with curative intent (Stage II to III disease). Inclusive of HR+ or HR- patients.\n\nCohort 1C: Triple Negative Breast Cancer\n\n1\\. A known or suspected triple negative breast cancer treated with curative intent (Stage I to III disease).\n\nCohort 2: Adjuvant Therapy \u002F Surveillance Cohort 2A: Newly Diagnosed HR+,HER2-\n\n1. A known or suspected HR+, HER2- breast cancer treated with curative intent (Stage II to III disease)\n2. Patients are considered at high risk of recurrence, defined as 4 or more positive axillary lymph nodes (ALNs), or between 1-3 positive ALNs and either grade 3 disease or tumor size of 5 cm or larger.\n3. Have undergone curative intent surgery with no clinical evidence of disease.\n\nCohort 2B: HER2+\n\n1. A known or suspected HER2+ breast cancer treated with curative intent (Stage II to III disease)\n2. Have undergone curative intent surgery with no clinical evidence of disease.\n\nCohort 2C: Triple Negative Breast Cancer\n\n1. A known or suspected triple negative breast cancer treated with curative intent (Stage I to III disease)\n2. Have undergone curative intent surgery with no clinical evidence of disease.\n\nCohort 3: 5-Years Post-Diagnosis Surveillance (NED)\n\n1. A known HR+, HER2- breast cancer treated with curative intent (Stage II to III disease).\n2. No Evidence of Disease (NED) ≥ 5 years from initial diagnosis.\n3. Patients are considered at high risk of recurrence, defined as 4 or more positive axillary lymph nodes (ALNs), or between 1-3 positive ALNs and either grade 3 disease or tumor size of 5 cm or larger.\n\nExclusion Criteria:\n\n1. Not willing or able to adhere with the study procedures\n2. Active secondary malignancy\n3. Diagnosis of a malignancy within 3 years of breast cancer diagnosis Note: Ductal carcinoma in situ (DCIS, ipsilateral or contralateral) within 3 years is not excluded.","99 Years",{"count":127,"type":21},900,"OBSERVATIONAL","For patients with breast cancer, it's important to find any remaining cancer cells after they've had their main treatment. Even a few cells, called minimal residual disease (MRD), can lead to the cancer coming back later.\n\nA way to find these cells is by looking for tiny bits of cancer DNA that are shed into the blood. This is called circulating tumor DNA (ctDNA). A simple blood test, often called a liquid biopsy, can detect this ctDNA. This research aims to see if finding this cancer DNA in the blood can help predict if a patient's cancer will return. It also may help find out if the treatment is working.\n\nUltimately, the results of this research may help doctors better manage breast cancer and develop new and improved tests and treatments.",[28,29,131,132,133],"HR Positive\u002FHER-2 Negative Breast Cancer","HER2 + Breast Cancer","Early Stage Breast Cancer",[135,136,137,138,139,133,140,141,142],"Minimal Residual Disease","MRD","Next generation sequencing","NGS","ctDNA","TNBC - Triple Negative Breast Cancer","HR positive \u002F HER-2 negative breast cancer","HER2+ breast cancer","2026-06-10",{"date":145,"type":49},"2026-06-12",{"date":147,"type":49},"2025-10-27",{"date":149,"type":21},"2033-12",{"name":151,"class":56},"Tempus AI",14,{"id":154,"slug":155,"hasResults":12,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":4,"eligibilityCriteria":159,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":160,"targetDuration":4,"studyType":22,"phases":162,"briefSummary":163,"conditions":164,"keywords":4,"overallStatus":107,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":85},"100489973","phase-2-alpelisibinos-inhibitornab-paclitaxel-in-patients-with-her2-negative-metaplastic-breast-cancer-mpbc-100489973","NCT05660083","Alpelisib\u002FiNOS Inhibitor\u002FNab-paclitaxel in Patients With HER2 Negative Metaplastic Breast Cancer (MpBC)","Phase II Trial of Alpelisib With iNOS Inhibitor and Nab-paclitaxel in Patients With HER2 Negative Metastatic or Locally Advanced Metaplastic Breast Cancer (MpBC)","Inclusion Criteria:\n\n1. The patient (or legally acceptable representative if applicable) provides written informed consent for the study.\n2. At least 18 years of age on the day of informed consent signing.\n3. Histologically confirmed HER2 negative MpBC and\u002For Triple Negative Breast Cancer (TNBC) with squamous and\u002For sarcomatoid elements, including osseous, chondroid, and spindle morphology.\n4. HER2 negative status as defined by the current American Society of Clinical Oncology and College of American Pathologists guidelines at time of study entry.\n5. Locally advanced inoperable or metastatic MpBC with measurable disease by RECIST 1.1 Both first- and second-line patients will be eligible for this trial. Patients may have received prior immunotherapy, per standard of care.\n6. Eastern Cooperative Oncology Group performance status of 0 or 1.\n7. Adequate organ and marrow function as defined below:\n\n   * Hemoglobin ≥9.0 g\u002Fdl (without blood transfusion within 2 weeks of laboratory test used to determine eligibility)\n   * Absolute neutrophil count ≥1000\u002FμL (without granulocyte colony stimulating factor support within 2 weeks of laboratory test used to determine eligibility)\n   * Platelet count ≥100,000\u002FμL (without transfusion within 2 weeks of laboratory test used to determine eligibility)\n   * Serum total bilirubin (TB) ≤1.5 x institutional upper limit of normal (ULN; In the case of known Gilbert's syndrome, a higher serum TB \\[\\>1.5 x ULN\\] is allowed),\n   * Aspartate transaminase\u002Falanine transaminase ≤5 x institutional ULN\n   * Creatinine ≤1.5X the ULN or measured creatinine clearance ≥ 60 mL\u002Fmin\u002F1.\n8. Fasting blood glucose of ≤140 mg\u002Fdl and HgbA1c ≤7.0.\n9. Ability to swallow oral medication.\n10. Ability to take aspirin.\n11. Women of childbearing potential must agree to use contraception for the duration of the study through 90 days after the last dose of study treatment. A condom is required for all sexually active male participants to prevent them from fathering a child AND to prevent delivery of study treatment via seminal fluid to their partner. In addition, male participants must not donate sperm during the study and up to the time period as specified in labels of study drugs.\n12. If patient received major surgery, they must have recovered adequately from the toxicity and\u002For complications from the intervention prior to starting the study treatment.\n13. Willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations.\n\nExclusion Criteria:\n\n1. Concomitant use of strong inhibitors or strong inducers of cytochrome P450 (CYP)3A4. The patient must have discontinued strong CYP3A4 inhibitors or strong CYP3A4 inducers for at least 1 week prior to study treatment initiation (Examples included in Appendix 2).\n2. Currently receiving warfarin or other coumarin-derived anticoagulant for treatment, prophylaxis, or otherwise. Therapy with DOACs, heparin, low molecular weight heparin, direct oral anticoagulants or fondaparinux is allowed.\n3. Concurrent use of medications that interact with nitrate\u002Fnitrite levels (Examples included in Appendix 3).\n4. Received previous treatment with nab-paclitaxel, Pl3K inhibitor, AKT inhibitor, or mTOR inhibitor.\n5. Known history of Steven Johnson's syndrome or toxic epidermal necrolysis.\n6. Since HAART agents are metabolized by CYP3A4, HIV positive patients will be excluded from this trial.\n7. Poorly controlled hypertension at baseline (defined as systolic blood pressure \\>150 mm Hg). Isolated, unconfirmed systolic BP elevations will NOT exclude participation. Patients with medication-controlled hypertension are allowed provided they have been on their current medications for at least 4 weeks prior to Cycle 1, Day 1.\n8. Has any of the following cardiac abnormalities:\n\n   * Symptomatic congestive heart failure\n   * History of documented congestive heart failure (New York Heart Association functional classification III-IV)\n   * Documented cardiomyopathy\n   * Left ventricular ejection fraction \\\u003C50% as determined by multigated acquisition scan or echocardiogram\n   * Myocardial infarction \\~6 months prior to enrollment\n   * Unstable angina pectoris\n   * Serious uncontrolled cardiac arrhythmia\n   * Symptomatic pericarditis\n   * History of congenital QT prolongation\n   * Absolute corrected QT interval of \\>480 msec in the presence of potassium \\>4.0 mEq\u002FL and magnesium \\>1.8 mg\u002Fdl.\n9. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 3 weeks prior to study treatment administration. NOTE: Patients who have entered the follow-up phase of an investigational study may participate as long as it has been 3 weeks after the last dose of the previous investigational agent.\n10. Known or suspected hypersensitivity to any component or excipient of the proposed regimen (nab-paclitaxel, alpelisib, iNOS inhibitor, aspirin).\n11. Known additional malignancy that requires active treatment.\n12. Pneumonitis\u002F interstitial lung disease on baseline CT scan of the chest or moderate to severe chronic lung disease\n13. Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.\n14. Manifestations of malabsorption due to prior gastrointestinal surgery, gastrointestinal surgery disease, or an unknown reason.\n15. Symptomatic\u002Funtreated metastatic central nervous system disease.\n16. Type I diabetes mellitus irrespective of Hgb A1c OR uncontrolled type II diabetes mellitus defined as hemoglobin A1c \\>7%.\n17. Uncontrolled gastric ulcer\n18. ≥ Grade 2 sensory neuropathy\n19. Osteonecrosis of jaw\n20. Pancreatitis\n21. Pregnant, breastfeeding or expecting to conceive children within the projected duration of the study, starting with the prescreening or screening visit through 30 days after the last dose of study treatment.",{"count":161,"type":21},36,[67],"This is a research study to test the safety and effectiveness of using the drug alpelisib together with chemotherapy (nab-paclitaxel) and a drug called L-NMMA in patients with HER2 negative metastatic or locally advanced metaplastic breast cancer, who have not responded to previous treatments.\n\nParticipants in this study in addition to the standard care chemotherapy will also receive the drug alpelisib and L-NMMA. The therapies will be administered every 3 weeks (1 cycle) until disease progression, toxicity or until the participant withdraws from the study. The nab-paclitaxel chemotherapy will be administered intravenously on Day 1 of the 3 week cycles. Participants will take the drug alpelisib by mouth once daily at a dose determined by a safety study and the drug L-NMMA will be given intravenously on days 1 to 5 of the 3 week cycles.",[165,166,167,29],"HER2-negative Breast Cancer","Metastatic Breast Cancer","Metaplastic Breast Carcinoma","2026-06-03",{"date":170,"type":49},"2026-06-04",{"date":172,"type":49},"2023-01-12",{"date":174,"type":21},"2028-12-02",{"name":176,"class":84},"The Methodist Hospital Research Institute",{"id":178,"slug":179,"hasResults":12,"nctId":180,"briefTitle":181,"officialTitle":182,"acronym":4,"eligibilityCriteria":183,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":184,"targetDuration":4,"studyType":22,"phases":186,"briefSummary":187,"conditions":188,"keywords":193,"overallStatus":107,"whyStopped":4,"lastUpdateSubmitDate":195,"lastUpdatePostDateStruct":196,"startDateStruct":198,"completionDateStruct":200,"leadSponsor":202,"locationsCount":204},"100566595","phase-1-first-in-human-study-of-tub-030-in-patients-with-advanced-solid-tumors-100566595","NCT06657222","First in Human Study of TUB-030 in Patients With Advanced Solid Tumors","A Multicenter FIH Dose Escalation and Optimization Phase I\u002FIIa Trial to Investigate Safety, Tolerability, PK, and Efficacy of the 5T4 ADC TUB-030 in Patients With Advanced Solid Tumors (5-STAR 1-01)","Inclusion Criteria:\n\n1. Male or non-pregnant, non-breastfeeding female aged 18 years or older\n2. Adequate organ function\n3. Patients who received anti-cancer treatment including chemotherapy, biological therapy, endocrine therapy, PARP inhibitor, or other oral or investigational drugs must have had their last dose at least 4 weeks (6 weeks for nitrosourea, mitomycin-C) or 5 half-lives, whichever is shorter, before C1D1\n4. AEs related to prior therapy, radiotherapy or surgical procedures must resolve to ≤grade 1.\n5. For patients with known brain metastases, evidence of clinically stable disease post radiation therapy is required prior to enrollment.\n6. For patients who underwent radiotherapy (≥ 30% of the bone marrow or wide field) to sites outside the brain, the final dose of radiation must have been administered ≥ 28 days prior to C1D1. For patients who underwent palliative radiotherapy (≤ 30% of the bone marrow or wide field) the final dose of radiation must have been administered ≥14 days prior to C1D1.\n7. Radiologically measurable disease by RECIST v1.1, 4 weeks before C1D1, that can include a lesion in an irradiated field that shows progression according to RECIST v1.1 after irradiation.\n8. Eastern Cooperative Oncology Group (ECOG) 0-1.\n9. Have a life expectancy of \\>12 weeks for disease-related mortality, as evaluated by the INV.\n10. In the opinion of the INV, the patient must be able and willing to understand and give signed informed consent\n11. Women of childbearing potential (WOCBP) who are sexually active with a non-sterilized partner must use at least 1 highly effective method of contraception (with a failure rate of 1% per year) from the time of screening and must agree to continue using such precautions until the end of exposure, plus 5 half-lives and 6 months add-on in the case of patients of childbearing potential Patients must agree to continue a highly effective contraceptive method, refrain from egg cell donation and breastfeeding while on study treatment and for 5 half-lives plus 6 months after the last dose of study treatment.\n12. Males must use an effective barrier method of contraception without interruption if the patient is sexually active with an WOCBP until the end of exposure, 5 half-lives plus 6 months add-on after the end of treatment. In addition, their female partners who are WOCBP should agree to use 1 highly effective barrier method of contraception at the same time. Male patients should refrain from donating sperm during study participation and for 6 months after the last dose of the study drug.\n\nExclusion Criteria:\n\n\\-",{"count":185,"type":21},250,[96,67],"The goal of this clinical trial is to learn if the drug TUB-030 works to treat solid cancer in adults. The study will also explore the safety of TUB-030. The main questions it aims to answer are:\n\nTo determine the safety and tolerability of TUB-030 To determine the maximum tolerated dose of TUB-030 as a single drug given to patients with solid cancer Researchers will also compare doses of TUB-030 in two specific cancer types, in patients with head and neck cancer and patients with non-small cell lung cancer, to see if TUB-030 works to treat these two solid cancer types and to determine the best dose.\n\nParticipants will:\n\nReceive drug TUB-030 every 3 weeks Visit the clinic once every 3 weeks for checkups and tests Answer patient reported outcome questionnaires about their symptoms",[189,190,191,31,29,192],"Advanced Solid Tumors","HNSCC","SCLC","CRC",[189,31,194],"Head and Neck Cancer","2026-05-22",{"date":197,"type":49},"2026-05-27",{"date":199,"type":49},"2024-12-13",{"date":201,"type":21},"2028-12",{"name":203,"class":56},"Tubulis GmbH",16,{"id":206,"slug":207,"hasResults":12,"nctId":208,"briefTitle":209,"officialTitle":210,"acronym":4,"eligibilityCriteria":211,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":212,"targetDuration":4,"studyType":22,"phases":214,"briefSummary":215,"conditions":216,"keywords":218,"overallStatus":107,"whyStopped":4,"lastUpdateSubmitDate":223,"lastUpdatePostDateStruct":224,"startDateStruct":226,"completionDateStruct":228,"leadSponsor":230,"locationsCount":57},"100565063","early-phase-1-neoadjuvant-dupilumab-pembrolizumab-paclitaxel-and-carboplatin-in-locally-advanced-triple-negative-breast-cancer-100565063","NCT06637306","Neoadjuvant Dupilumab, Pembrolizumab, Paclitaxel, and Carboplatin in Locally Advanced Triple Negative Breast Cancer","Pilot Trial of the IL-4 Receptor Antagonist Dupilumab Plus Pembrolizumab, Paclitaxel, and Carboplatin in Locally Advanced Triple Negative Breast Cancer","Inclusion Criteria:\n\n* Patients with pathologically confirmed diagnosis of triple negative breast cancer, as defined by the most recent ASCO\u002FCAP guidelines.\n* Patients must have previously untreated, localized TNBC with either tumor size ≥ 2 centimeters (T2-4N0) or lymph node involvement with at least a 1cm tumor (T1c-T4N1-3).\n* Patients must have previously untreated disease with no prior definitive breast surgery, radiation therapy, or systemic chemotherapy with therapeutic intent for this breast cancer.\n* Patients must be eligible to receive chemotherapy agents in the study including paclitaxel and carboplatin.\n* Patients must be willing and able to provide blood samples at the time points indicated in the study calendar.\n* Patients must be willing and able to have core needle biopsies of tumor prior to initiation of treatment. Should patients undergo pre-treatment or on-treatment biopsy procedure and inadequate number of biopsies are obtained, they may proceed with initiation\u002Fcontinuation of treatment at the discretion of the investigator and treating physician.\n* Age ≥ 18 years.\n* ECOG performance status 0-1.\n* Adequate organ and marrow function as defined below:\n\n  * absolute neutrophil count ≥ 1,500\u002FmcL\n  * platelets ≥ 100,000\u002Fmcl\n  * total bilirubin within normal institutional limits\n  * AST(SGOT)\u002FALT(SPGT) ≤ 2.5 X institutional upper limit of normal\n  * creatinine within normal institutional limits\n* Women of child-bearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 6 months following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.\n\nA female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:\n\n* Has not undergone a hysterectomy or bilateral oophorectomy; or\n* Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).\n* Ability to understand and the willingness to sign a written informed consent.\n\nExclusion Criteria:\n\n* Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or any treatment with therapeutic intent for the breast cancer.\n* Patients may not be receiving any other investigational agents.\n* Patients who have any distant metastases and considered to have Stage IV disease.\n* Patients who have a diagnosis of immunodeficiency or are receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. Patients on chronic steroids (more than 4 weeks at stable dose) equivalent to ≤ 10mg prednisone will not be excluded.\n* Patients with active autoimmune disease that has required systemic treatment in the past 1 year (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is acceptable.\n* History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating Investigator.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to carboplatin, paclitaxel, dupilumab or pembrolizumab used in study. Documented allergic or hypersensitivity response to any protein therapeutics (e.g., recombinant proteins, vaccines, intravenous immune globulins, monoclonal antibodies, receptor traps).\n* HIV positive with detectable viral load, or anyone not on stable anti-viral (HAART) regimen, or with \\\u003C350 CD4+ T cells\u002Fmicroliter in the peripheral blood.\n* Known active Hepatitis B (e.g., HBV detected by PCR or active Hepatitis C (e.g., HCV RNA \\[qualitative\\] is detected). Patients with hepatitis B (HepBsAg+) who have controlled infection (serum hepatitis B virus DNA PCR that is below the limit of detection AND receiving anti-viral therapy for hepatitis B) are permitted. Patients with controlled infections must undergo periodic monitoring of HBV DNA. Patients must remain on anti-viral therapy for at least 6 months beyond the last dose of investigational study drug.\n* Known, untreated helminth infections. Patients with prior history of a helminth infection who were fully treated are permitted.\n* History of allogeneic hematopoietic cell transplantation or solid organ transplantation.\n* Receipt of a live vaccine within 30 days of planned start of study medication.\n* History of irAE in response to prior immunotherapy that has not improved to a Grade 0 or 1; this does not include chronic conditions such as endocrinopathies which can be treated with hormone replacement therapy.\n* History of interstitial lung disease (e.g., idiopathic pulmonary fibrosis, organizing pneumonia) or active, noninfectious pneumonitis attributed to prior use of cancer immunotherapy that required immune-suppressive doses of glucocorticoids to assist with management. History of radiation pneumonitis treated with glucocorticoids.\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Patients must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.",{"count":213,"type":21},15,[24],"Pilot trial of the IL-4 receptor antagonist dupilumab plus pembrolizumab, paclitaxel, and carboplatin in locally advanced triple negative breast cancer (TNBC).\n\nPrimary Objective: To assess the safety of neoadjuvant dupilumab and pembrolizumab plus weekly paclitaxel and carboplatin as measured by the proportion of severe immune-related adverse events (irAEs) in patients with locally advanced TNBC.\n\nSecondary Objectives: To determine the rates of pathologic complete response with the addition of dupilumab to NAC and pembrolizumab; to determine the rate of residual cancer burden 0-1; to estimate the recurrence-free survival and overall survival; to assess the toxicity of the combination of dupilumab, pembrolizumab, and paclitaxel-carboplatin.",[217,29],"Locally Advanced Triple Negative Breast Cancer",[219,72,220,28,221,222],"Dupilumab","IL-4 Receptor Antagonist","Triple Negative","Locally Advanced","2026-05-11",{"date":225,"type":49},"2026-05-14",{"date":227,"type":49},"2025-03-05",{"date":229,"type":21},"2027-03-10",{"name":231,"class":84},"Rima Patel",{"id":233,"slug":234,"hasResults":12,"nctId":235,"briefTitle":236,"officialTitle":237,"acronym":238,"eligibilityCriteria":239,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":240,"targetDuration":4,"studyType":22,"phases":242,"briefSummary":243,"conditions":244,"keywords":253,"overallStatus":107,"whyStopped":4,"lastUpdateSubmitDate":266,"lastUpdatePostDateStruct":267,"startDateStruct":269,"completionDateStruct":271,"leadSponsor":273,"locationsCount":275},"100136130","phase-2-i-spy-trial-neoadjuvant-and-personalized-adaptive-novel-agents-to-treat-breast-cancer-100136130","NCT01042379","I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer","I-SPY Trial (Investigation of Serial Studies to Predict Your Therapeutic Response With Imaging And moLecular Analysis 2)","I-SPY","Inclusion Criteria:\n\n* Histologically confirmed invasive cancer of the breast\n* Clinically or radiologically measureable disease in the breast after diagnostic biopsy, defined as longest diameter greater than or equal to 25 mm (2.5cm)\n* No prior cytotoxic regimens are allowed for this malignancy. Patients may not have had prior chemotherapy or prior radiation therapy to the ipsilateral breast for this malignancy. Prior bis-phosphonate therapy is allowed\n* Age ≥18 years\n* ECOG performance status 0-1\n* Willing to undergo core biopsy of the primary breast lesion to assess baseline biomarkers\n* Non-pregnant and non-lactating\n* No ferromagnetic prostheses. Patients who have metallic surgical implants that are not compatible with an MRI machine are not eligible.\n* Ability to understand and willingness to sign a written informed consent (I-SPY TRIAL Screening Consent)\n* Eligible tumors must meet one of the following criteria: Stage II or III, or T4, any N, M0, including clinical or pathologic inflammatory cancer or Regional Stage IV, where supraclavicular lymph nodes are the only sites metastasis\n* Any tumor ER\u002FPgR status, any HER-2\u002Fneu status as measured by local hospital pathology laboratory and meets any tumor assay profile described in protocol section 4.1.2F\n* Normal organ and marrow function: Leukocytes ≥ 3000\u002FμL, Absolute neutrophil count ≥ 1500\u002FμL, Platelets ≥ 100,000\u002FμL, Total bilirubin within normal institutional limits, unless patient has Gilbert's disease, for which bilirubin must be ≤ 2.0 x ULN, AST(SGOT)\u002FALT (SGPT) ≤ 1.5 x institutional ULN, creatinine \\\u003C 1.5 x institutional ULN\n* No uncontrolled or severe cardiac disease. Baseline ejection fraction (by nuclear imaging or echocardiography) must by ≥ 50%\n* No clinical or imaging evidence of distant metastases by PA and Lateral CXR, Radionuclide Bone scan, and LFTs including total bilirubin, ALT, AST, and alkaline phosphatase\n* Tumor assay profile must include on of the following: MammaPrint High, any ER status, any HER2 status, or MammaPrint Low, ER negative (\\\u003C5%), any HER2 status, or MammaPrint Low, ER positive, HER2\u002Fneu positive by any one of the three methods used (IHC, FISH, TargetPrint™)\n* Ability to understand and willingness to sign a written informed consent document (I-SPY 2 TRIAL Consent #2)\n\nExclusion Criteria:\n\n* Use of any other investigational agents within 30 days of starting study treatment\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study agent or accompanying supportive medications.\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements",{"count":241,"type":21},5000,[67],"The purpose of this study is to further advance the ability to practice personalized medicine by learning which new drug agents are most effective with which types of breast cancer tumors and by learning more about which early indicators of response (tumor analysis prior to surgery via magnetic resonance imaging (MRI) images along with tissue and blood samples) are predictors of treatment success.",[245,28,246,247,29,248,165,249,250,251,252],"Breast Neoplasms","Breast Tumors","Angiosarcoma","HER2-positive Breast Cancer","Hormone Receptor Positive Tumor","Hormone Receptor Negative Tumor","Early-stage Breast Cancer","Locally Advanced Breast Cancer",[254,255,256,257,258,259,260,261,262,263,264,265],"Neoadjuvant","Breast","Cancer","Neoplasm","Adaptive","pCR","Pathologic Complete Response","Biomarkers signature","MRI Volume","Endocrine Therapy","Chemotherapy","Immunotherapy","2026-05-04",{"date":268,"type":49},"2026-05-06",{"date":270,"type":49},"2010-03-01",{"date":272,"type":21},"2031-12",{"name":274,"class":84},"QuantumLeap Healthcare Collaborative",42,{"id":277,"slug":278,"hasResults":12,"nctId":279,"briefTitle":280,"officialTitle":280,"acronym":4,"eligibilityCriteria":281,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":282,"phases":4,"briefSummary":283,"conditions":284,"keywords":286,"overallStatus":289,"whyStopped":4,"lastUpdateSubmitDate":290,"lastUpdatePostDateStruct":291,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":293,"locationsCount":57},"100634217","an-open-label-multicenter-non-randomized-expanded-access-protocol-eap-designed-to-provide-leronlimab-to-patients-with-locally-advanced-or-metastatic-triple-negative-breast-cancer-mtnbc-100634217","NCT07536815","An Open-Label, Multicenter, Non-Randomized Expanded Access Protocol (EAP) Designed to Provide Leronlimab to Patients With Locally Advanced or Metastatic Triple-Negative Breast Cancer (mTNBC)","Inclusion Criteria:\n\n* Adult participants \\> 18 years of age.\n* Histologically confirmed HR-\u002FHER2- metastatic TNBC using ASCO\u002FCAP criteria, Stage IIIB-IV.\n* Must have experienced disease progression on prior standard of care (SoC) therapy, be ineligible for SoC due to intolerance or contraindications, or have no remaining SoC treatment options available.\n* Be willing to provide tissue from a newly obtained core or excisional biopsy of an accessible tumor lesion if archival tissue is not available.\n* Must not be eligible for or able to enroll in any trials investigating leronlimab that are currently recruiting.\n* Participant must have adequate organ and bone marrow function within 14 days prior to enrollment as determined by the investigator.\n* ECOG performance status 0-2.\n* Participants of childbearing potential (POCBP) and males must agree to use two medically accepted methods of contraception with hormonal or barrier method of birth control, or abstinence, prior to study entry, for the duration of study participation and 4 months after the last dose of study drug.\n* Willingness and ability to comply with protocol requirements and attend follow-up visits.\n* Participants must have the ability to understand and the willingness to sign a written informed consent prior to registration on study.\n\nExclusion Criteria:\n\n* Participants who have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to leronlimab (PRO 140) are not eligible.\n* Have known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis. Note: Subjects with previously treated\u002Fstable brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline) and have no evidence of new or enlarging brain metastases. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.\n* Any uncontrolled concurrent illness (e.g., infection, heart failure) that, in the investigator's judgment, would interfere with the patient's ability to safely receive treatment. Note: Patients must complete any treatment with antibiotics prior to registration.\n* Concurrent participation in another interventional clinical trial.\n* Pregnant or breastfeeding women.\n* Any condition that, in the investigator's judgment, would interfere with the patient's ability to safely receive treatment.\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.","EXPANDED_ACCESS","This Expanded Access Program provides investigational access to leronlimab (PRO 140) for patients with advanced or metastatic triple-negative breast cancer (TNBC) who lack satisfactory treatment options and are unable to participate in a clinical trial.",[38,29,285],"TNBC, Triple Negative Breast Cancer",[287,288],"leronlimab","PRO 140","AVAILABLE","2026-04-23",{"date":292,"type":49},"2026-04-27",{"name":294,"class":56},"CytoDyn, Inc.",{"id":296,"slug":297,"hasResults":12,"nctId":298,"briefTitle":299,"officialTitle":300,"acronym":4,"eligibilityCriteria":301,"healthyVolunteers":12,"sex":302,"minAge":18,"maxAge":303,"enrollmentInfo":304,"targetDuration":4,"studyType":128,"phases":4,"briefSummary":306,"conditions":307,"keywords":308,"overallStatus":107,"whyStopped":4,"lastUpdateSubmitDate":312,"lastUpdatePostDateStruct":313,"startDateStruct":315,"completionDateStruct":317,"leadSponsor":319,"locationsCount":57},"100635312","real-world-patient-reported-outcome-of-sacituzumab-govitecan-in-chinese-metastatic-breast-cancer-100635312","NCT07551050","Real-world Patient-reported Outcome of Sacituzumab Govitecan in Chinese Metastatic Breast Cancer","A Real-world, Multicenter, Prospective Study to Evaluate the Patient-reported Outcome in Chinese Patients Who Received Sacituzumab Govitecan or Chemotherapy of the Physician's Choice for Metastatic Breast Cancer Progressing on First-line Treatment","Inclusion Criteria:\n\n1. Patients aged 18 to 75 years.\n2. Patients have been diagnosed with metastatic HER2 negative breast cancer. HER2 status were determined locally by immunohistochemistry (IHC) of patients' primary or metastatic tumor sections. HER2-negative status was defined by IHC staining 0 to 1+ or fluorescence in situ hybridization ratio \\\u003C2.0 if IHC 2+ or IHC not performed.\n3. The metastatic disease was confirmed by clinical, imaging, histological, or cytological measures, including unresectable locally advanced breast cancer, de novo stage IV breast cancer, and recurrent metastatic breast cancer.\n4. ECOG-PS ≤2\n5. For patients with triple-negative breast cancer (TNBC): at least 1 line of systemic therapy in the metastatic setting; for patients with HR+\u002FHER2- breast cancer: prior treatment with endocrine therapy and CDK4\u002F6 inhibitors, and at least 1 line of systemic therapy in the metastatic setting.\n6. At least one evaluable lesion by CT or MRI according to RECIST 1.1.\n7. Willing to accept the treatment by the investigator based on the patient's preference, physical condition, prior treatment history, and financial circumstances.\n8. Willing to use contraceptive measures during the study period.\n9. Willing and able to complete electronic questionnaires\u002Fscales on a smartphone, tablet, or other electronic device.\n10. All patients can provide an informed consent before enrolment and data collection.\n\nExclusion Criteria:\n\n1. Insufficient bone marrow, hepatic, or renal function, defined as:\n\n   * Bone marrow: White blood cell count \\\u003C 3.0 × 10⁹\u002FL, or absolute neutrophil count \\\u003C 1.5 × 10⁹\u002FL, or platelet count \\\u003C 75 × 10⁹\u002FL, or hemoglobin \\\u003C 8.0 g\u002FdL.\n   * Hepatic function: Total bilirubin \\> 1.5 × upper limit of normal (ULN), or ALT\u002FAST \\> 3.0 × ULN (or \\> 5.0 × ULN in the presence of liver metastases).\n   * Renal function: Serum creatinine \\> 1.5 × ULN, or creatinine clearance \\\u003C 50 mL\u002Fmin.\n2. History of other malignancies or hematologic malignancies.\n3. Hypersensitivity to the study treatment drugs.\n4. Systemic anti-tumor therapy (including chemotherapy, radiotherapy, immunotherapy, etc.) within 2 weeks prior to study drug administration.\n5. Treatment with an investigational product within 4 weeks before the first treatment.\n6. Presence of any toxicity from prior therapy (excluding alopecia) ≥ Grade 2 according to CTCAE version 5.0, prior to study drug administration.\n7. Systemic inflammatory diseases, including but not limited to systemic lupus erythematosus, juvenile chronic arthritis, spondyloarthropathy, Crohn's disease, ulcerative colitis, psoriatic arthritis, or active vasculitis.\n8. Severe psychiatric or neurological disorders, including but not limited to schizophrenia, depression, mania, Alzheimer's disease, myasthenia gravis, seizure disorders, or known conditions that may provoke seizures.\n9. Pregnant or breastfeeding women.","FEMALE","75 Years",{"count":305,"type":21},300,"A real-world, multicenter, prospective study to evaluate the patient-reported outcome in Chinese patients who received sacituzumab govitecan or chemotherapy of the physician's choice for metastatic breast cancer progressing on first-line treatment",[29],[309,310,311,38],"Sacituzumab Govitecan","chemotherapy","metastatic breast cancer","2026-04-20",{"date":314,"type":49},"2026-04-24",{"date":316,"type":21},"2026-05-15",{"date":318,"type":21},"2029-06-15",{"name":320,"class":84},"Fudan University",{"id":322,"slug":323,"hasResults":12,"nctId":324,"briefTitle":325,"officialTitle":326,"acronym":4,"eligibilityCriteria":327,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":328,"targetDuration":4,"studyType":22,"phases":330,"briefSummary":331,"conditions":332,"keywords":333,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":338,"lastUpdatePostDateStruct":339,"startDateStruct":340,"completionDateStruct":341,"leadSponsor":343,"locationsCount":57},"100594162","phase-2-astraea-reinvigorating-response-to-immunotherapy-in-metastatic-tnbc-with-combination-myeloid-inhibition-and-radiation-100594162","NCT07015853","ASTRAEA: ReinvigorAting ReSponse To ImmunotheRApy in MEtAstatic TNBC With Combination Myeloid Inhibition and Radiation","IIT2024-02-SHIAO-ASTRAEA: ReinvigorAting ReSponse To ImmunotheRApy in MEtAstatic TNBC With Combination Myeloid Inhibition and Radiation","Inclusion Criteria\n\n* Age ≥ 18 years at the time of consent.\n* Patients with metastatic or locally recurrent TNBC who received prior immunotherapy in any setting (curative or advanced\u002Fmetastatic).\n* Have ≥2 measurable, non-osseous, non-hepatic recurrent or metastatic lesions. Of these lesions, at least one is indicated for radiation therapy and at least one will not be irradiated to be used to determine response. Notes on lesions: patients are still eligible if they have liver or bone lesions, so long as at least 2 measurable lesions are non-osseous, non-hepatic recurrent or metastatic per above criterion.\n* Histologically or cytologically-confirmed TNBC, defined as ER \\\u003C10%, PR \\\u003C10%, HER2-negative by ASCO CAP guidelines. Note: HER2 0-2+ IHC is allowed (i.e., if FISH-negative, this is still considered HER2-negative).\n* ECOG Performance Status ≤ 1.\n* Demonstrate adequate organ function\n* Female subject of childbearing potential should have a negative serum or urine pregnancy test or documentation of absence of pregnancy by a gynecologist within 14 days of initiating first dose of pembrolizumab for eligibility verification.\n* Female subjects of childbearing potential should be willing to use highly effective contraceptive methods (Appendix 12.6) during the treatment period through 120 days after the last dose of study medication. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \\> 1 year.\n* Male participants should be willing to use highly effective contraceptive methods (Appendix 12.6) during the treatment period through 120 days after the last dose of study treatment and refrain from donating sperm during this period.\n* Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.\n\nExclusion Criteria\n\n* Has received prior radiotherapy within 2 weeks of start of study intervention or radiation-related toxicities requiring corticosteroids. Note: Two weeks or fewer of palliative radiotherapy for non-CNS disease is permitted. The last radiotherapy treatment must have been performed at least 7 days before the first dose of study intervention.\n* Is currently participating and receiving study therapy, or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.\n* Has a known history of active TB (Bacillus Tuberculosis).\n* Has severe hypersensitivity (≥Grade 3) to pembrolizumab and\u002For any of its excipients.\n* Has had prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study treatment Day 1 or who has not recovered (i.e., \\> Grade 1 or baseline) from adverse events due to agents administered more than 4 weeks earlier.\n* Has had prior chemotherapy or targeted small molecule therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., \\> Grade 1 or baseline) from adverse events due to a previously administered agent. Note: Subjects with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study.\n* Has a known additional malignancy that is progressing or has required treatment within the last 5 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ, excluding carcinoma in situ of the bladder, that have undergone potentially curative therapy are not excluded. Participants with low-risk early-stage prostate cancer (T1-T2a, Gleason score ≤6, and PSA \\\u003C10 ng\u002FmL) either treated with definitive intent or untreated in active surveillance with stable disease are not excluded.\n* Has known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least four weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention.\n* Has active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.).\n* Has known history of\u002Factive, non-infectious pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Factive interstitial lung disease.\n* Has an active infection requiring systemic therapy.\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n* Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment. Note: Negative urine or serum pregnancy test is also conducted within 72 hours prior to C1D1 for study procedures but if screening pregnancy test is done within 72 hours of C1D1, it is not required to be repeated.\n* Has a known history of Human Immunodeficiency Virus (HIV). HIV testing is not required unless mandated by local health authority.\n* History of Hepatitis B (defined as HBsAg reactive) or known active Hepatitis C virus (defined as detectable HCV RNA \\[qualitative\\]) infection. Note: Testing for Hepatitis B or C is not required unless mandated by local health authority.\n* Has received a live vaccine or live-attenuated vaccine within 30 days of planned start of pembrolizumab. Administration of killed vaccines is allowed.\n* Has had an allogeneic tissue\u002Fsolid organ transplant, including patients with prior allogeneic hematopoietic stem-cell transplant.\n* Patients eligible for PARP inhibitor therapy.\n* Any patient with prior immune-related treatment toxicity for which permanent discontinuation is indicated.\n* History of acute or chronic pancreatitis. Note: Participants who had a defined pancreatitis etiology (e.g., pancreatitis due to gallstones, trauma\u002Finjury, or medications such as asparaginase) may be enrolled if pancreatitis resolved prior to study enrollment.\n* History of thromboembolic events (such as deep vein thrombosis, pulmonary embolism, stroke, myocardial infarction) in the 6 months prior to study enrollment.\n* Currently active significant cardiac disease, such as uncontrolled arrhythmias, uncontrolled hypertension, or Class 3 or 4 congestive heart failure as defined by New York Heart Association, or a history of myocardial infarction or unstable angina within 6 months prior to study enrollment.",{"count":329,"type":21},34,[67],"Open label, single-arm, prospective therapeutic trial. Pembrolizumab (MK-3475), 200 mg IV Q3W starting at C1D1\u002FWeek 1 for up to 2 years, until disease progression, or treatment intolerance. RT, 8 Gy x 3 fractions over 3 consecutive days at C1D8\u002FWeek 2; Axatilimab (SNDX-6352; INCA034176), 1 mg\u002Fkg, IV, Q2W starting 1 week post- RT C1D15\u002FWeek 3 until disease progression or treatment intolerance.",[29,28],[72,334,335,336,337],"Axatilimab","CSF-1R inhibitor","potent humanized immunoglobulin G4 (IgG4)","Radiation Therapy","2026-04-16",{"date":312,"type":49},{"date":51,"type":21},{"date":342,"type":21},"2033-07",{"name":344,"class":84},"Stephen Shiao",{"id":346,"slug":347,"hasResults":12,"nctId":348,"briefTitle":349,"officialTitle":350,"acronym":4,"eligibilityCriteria":351,"healthyVolunteers":12,"sex":302,"minAge":18,"maxAge":4,"enrollmentInfo":352,"targetDuration":4,"studyType":22,"phases":354,"briefSummary":355,"conditions":356,"keywords":357,"overallStatus":107,"whyStopped":4,"lastUpdateSubmitDate":338,"lastUpdatePostDateStruct":361,"startDateStruct":362,"completionDateStruct":364,"leadSponsor":366,"locationsCount":57},"100476997","phase-2-reinvigorating-tnbc-response-to-immunotherapy-with-combination-myeloid-inhibition-and-radiation-100476997","NCT05491226","Reinvigorating TNBC Response to Immunotherapy With Combination Myeloid Inhibition and Radiation","IIT2021-01-Shiao-CSF1Ri: Reinvigorating TNBC Response to Immunotherapy With Combination Myeloid Inhibition and Radiation","Inclusion Criteria:\n\n* Female patients diagnosed with high-risk triple negative breast cancer (TNBC) with intent for neoadjuvant therapy.\n* Low tumor-infiltrating lymphocyte (TIL) score, defined as stromal TIL (sTIL) ≤40%; or node-positive; or combined positive score (CPS) \\\u003C 10 or PD-L1 tumor positivity \\\u003C1%.\n* Written informed consent obtained from subject and ability for subject to comply with the requirements of the study, including consent for research blood draws and use of available archived tissue.\n* Age ≥ 18 years of age on day of signing informed consent.\n* Histologically or cytologically-confirmed TNBC (defined as ER \\\u003C1%, PR\\\u003C1%, her-2-neu 0-1+ by IHC or FISH-negative).\n* If an archived tumor tissue is unavailable, be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion. Newly-obtained is defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment on Day 1 of RT.\n* Have a performance status of 0 or 1 on the ECOG Performance Scale.\n* Demonstrate adequate organ function.\n* Female subject of childbearing potential should have a negative serum or urine pregnancy test or documentation of absence of pregnancy by a gynecologist within 14 days of initiating first dose of pembrolizumab (1 week lead-in) for eligibility verification.\n* Female subjects of childbearing potential should be willing to comply to the contraceptive guidance in Appendix 12.2 during the treatment period through 120 days after the last dose of study medication. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \\> 1 year.\n\nExclusion Criteria:\n\n* Evidence of metastatic disease.\n* Has received prior radiotherapy within 2 weeks of start of study intervention.\n* Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.\n* Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.\n* Has a known history of active TB (Bacillus Tuberculosis).\n* Hypersensitivity to pembrolizumab or any of its excipients.\n* Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., \\> Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.\n* Has had prior chemotherapy or targeted small molecule therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., \\> Grade 1 or at baseline) from adverse events due to a previously administered agent. Note: Subjects with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study.\n* Has a known additional malignancy that progressed or required treatment in the last 5 years. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.\n* Has known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis. Subjects with previously treated brain parenchymal metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis, which is excluded regardless of clinical stability.\n* Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.\n* Has known history of\u002Factive, non-infectious pneumonitis requiring treatment with steroids or has history of\u002Factive interstitial lung disease.\n* Has an active infection requiring systemic therapy.\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n* Is pregnant or breastfeeding, or expecting to conceive within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment. A WOCBP who has a positive urine pregnancy test within 2 weeks prior to start of study treatment (first dose of pembrolizumab). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. Note: Negative urine or serum pregnancy test is also conducted within 72 hours prior to C1D1 for study procedures but if screening pregnancy test is done within 72 hours of C1D1, it is not required to be repeated..\n* Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1\u002F2 antibodies).\n* Has a known history of active Hepatitis B (e.g., HBsAg reactive) or known active Hepatitis C (e.g., HCV RNA \\[qualitative\\] is detected).\n* Has received a live vaccine or live-attenuated vaccine within 30 days of planned start of pembrolizumab. Administration of killed vaccines is allowed.\n* Has had an allogenic tissue\u002Fsolid organ transplant.",{"count":353,"type":21},35,[67],"This is an open-label prospective, single institution, Phase II study of pembrolizumab in combination with radiation therapy and CSF-1R inhibition in patients with high-risk TNBC. The primary objective is to assess the pathologic complete response (pCR) rate where pCR is defined as the absence of invasive disease in the breast and lymph nodes at the time of standard of care (SOC) treatment. Secondary objectives include evaluating the change in tumor infiltrating lymphocytes (TILs), safety and tolerability of the combination, progression-free survival, event-free survival, overall survival, and node clearance.",[29,28],[358,359,360],"pembrolizumab","axatilimab","radiation therapy",{"date":312,"type":49},{"date":363,"type":49},"2023-11-17",{"date":365,"type":21},"2026-12-01",{"name":344,"class":84},{"id":368,"slug":369,"hasResults":12,"nctId":370,"briefTitle":371,"officialTitle":372,"acronym":4,"eligibilityCriteria":373,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":374,"targetDuration":4,"studyType":22,"phases":375,"briefSummary":376,"conditions":377,"keywords":378,"overallStatus":107,"whyStopped":4,"lastUpdateSubmitDate":383,"lastUpdatePostDateStruct":384,"startDateStruct":386,"completionDateStruct":388,"leadSponsor":390,"locationsCount":392},"100594302","phase-2-phase-ii-trial-of-ivonescimab-in-combination-with-carboplatin--docetaxel-in-patients-with-early-stage-triple-negative-breast-cancer-100594302","NCT07017673","Phase II Trial of Ivonescimab in Combination With Carboplatin + Docetaxel in Patients With Early-Stage Triple Negative Breast Cancer","Phase II Trial of Ivonescimab in Combination With Carboplatin + Docetaxel in Patients With Early Stage Triple Negative Breast Cancer","Inclusion Criteria\n\n* Age ≥ 18 years of age\n* ECOG ≤ 1\n* High-risk early stage triple negative breast cancer (TNBC), defined by ER≤10%, PR≤10% and HER2 negative (by IHC or FISH), per ASCO\u002FCAP guidelines\n* Clinically ≥T1cN0, or any T, N1-2\n* Plan to receive neoadjuvant chemotherapy and immune checkpoint inhibitor before surgery as standard-of-care treatment\n* Adequate organ function as defined in the following. Specimens must be collected within 14 days prior to the start of study treatment.\n\n  * ANC ≥ 1,500\u002Fmm3\n  * Platelets ≥ 100,000\u002Fmm3\n  * Hemoglobin ≥ 9.0 g\u002FdL.\n  * Total serum bilirubin ≤ 1.5 x ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels \\>1.5 x ULN\n  * AST \\\u003C 3 x ULN\n  * ALT \\\u003C 3 x ULN\n  * Creatinine clearance ≥ 30 mL\u002Fmin\n  * INR or PT, aPTT \\\u003C 1.5 x ULN\n* Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test within 14 days of start of study treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. Note: If egg harvesting was completed prior to enrollment, the pregnancy test may be falsely positive and the PI will assess and determine eligibility for these cases.\n* Female participants: A female participant is eligible to participate if she is not pregnant (see Appendix B), not breastfeeding, and at least one of the following conditions applies:\n\n  \\-- Not a woman of childbearing potential (WOCBP) as defined in Appendix B OR Females of child-bearing potential must be willing to use effective contraception during study and for 120 days after the last dose.\n* Male participants: A male participant must agree to use a contraception as detailed in Appendix B of this protocol during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period.\n* Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.\n\nExclusion Criteria\n\n* Evidence of metastatic disease.\n* Is currently participating in or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.\n* History of bleeding tendencies or coagulopathy and\u002For clinically significant bleeding symptoms or risk within 4 weeks prior to start of study treatment, including but not limited to:\n\n  * Hemoptysis (defined as coughing up ≥ 0.5 teaspoon of fresh blood or small blood clots) Note: transient hemoptysis associated with diagnostic bronchoscopy is allowed.\n  * Nasal bleeding\u002Fepistaxis (bloody nasal discharge is allowed)\n  * Current use of prophylactic or full-dose anticoagulants or anti-platelet agents for therapeutic purposes that is not stable, in the opinion of the treating investigator, prior to start of study treatment is not allowed. The use of full-dose anticoagulants is permitted as long as the INR or activated partial thromboplastin time (aPTT) is within therapeutic limits according to the medical standard of the enrolling institution.\n* Poorly controlled hypertension with repeated systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg after oral antihypertensive therapy\n* Women who are or are planning to become pregnant or breastfeed\n* Known allergy to any of the components within the study agents and\u002For their excipients\n* Medical history and concurrent diseases\n\n  * Autoimmune diseases\n  * Any prior malignancy except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for at least three years\n  * History of (non-infectious) pneumonitis that required steroids or has current pneumonitis\n  * Active infection requiring systemic therapy\n  * Known history of Human Immunodeficiency Virus (HIV) infection\n  * Known history of active Hepatitis B (defined as Hepatitis B surface antigen \\[HBsAg\\] reactive) or known active Hepatitis C virus (defined as HCV RNA \\[qualitative\\] is detected) infection. Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority\n  * Known history of active TB (Mycobacterium tuberculosis)\n  * History of unstable angina, myocardial infarction, congestive heart failure (New York Heart Association \\[NYHA\\] classification ≥ grade 2) or unstable vascular disease (eg, aortic aneurysm at risk of rupture, Moyamoya disease) that required hospitalization within 12 months prior to randomization, or other cardiac impairment that may affect the safety evaluation of the study drug (eg, poorly controlled arrhythmias, myocardial ischemia)\n  * Prolongation of QTc interval \\>480 msec\n  * Prior allogeneic bone marrow transplantation or prior solid organ transplantation\n  * History of esophageal gastric varices, severe ulcers, wounds that do not heal, abdominal fistula, intra-abdominal abscesses, or acute gastrointestinal bleeding within 6 months prior to start of study treatment\n  * History of any grade arterial thromboembolic event, Grade 3 and above venous thromboembolic event, as specified in National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 5.0, transient ischemic attack, cerebrovascular accident, hypertensive crisis, or hypertensive encephalopathy within 12 months prior to start of study treatment\n  * Acute exacerbation of chronic obstructive pulmonary disease within 4 weeks before start of study treatment\n  * History of perforation of the gastrointestinal tract and\u002For fistula, history of gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive bowel resection (partial colectomy or extensive small bowel resection) within 6 months prior to start of study treatment\n* Prohibited Treatments and\u002For Therapies\n\n  * Other non-protocol specified anti-cancer therapy: systemic radiotherapy, immunotherapy, biologic, or hormonal therapy. tretinoin therapy, nitrosourea, mitomycin C, small molecule tyrosine kinase inhibitor therapy\n\n    \\--- Concomitant use of hormones for non-tumor-related conditions (e.g., insulin and hormone replacement therapy for diabetes mellitus) is acceptable\n  * Any live vaccine within 30 days prior to the first dose of study drug and up to 120 days after the last dose. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed\n  * Prior systemic therapy or radiation therapy with curative intent for the current breast cancer\n  * A previous definitive ipsilateral breast surgery for the current breast cancer\n  * Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. CTLA-4, OX-40, CD137).\n  * Immunosuppressive drugs, including, but not limited to, prednisone or equivalent, methotrexate, azathioprine, and TNF-α antagonists at doses exceeding 10 mg per day. The following exceptions are allowed:\n\n    * The use of immunosuppressive drugs for the treatment of study drug-associated AEs or the use of immunosuppressive drugs in subjects with contrast allergy is acceptable.\n    * The use of inhaled, topical, and intranasal glucocorticoids is permitted.\n    * Corticosteroids are allowed as a prophylactic drug for hypersensitivity reactions (eg, before CT or MRI).\n    * Corticosteroids are allowed as antiphylactic and therapeutic agents for chemotherapy-induced vomiting.\n    * Short-term use of glucocorticoids for underlying or intercurrent conditions may be permitted after discussion with the PI.\n* Major surgery within 28 days prior to start of study treatment and within 4 weeks after first dose. Participants must have fully recovered from the effects of prior major surgery in the opinion of the treating investigator.\n* Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures.",{"count":329,"type":21},[67],"This is a single arm phase II trial combination of ivonescimab and carbo-docetaxel every 3 weeks for 6 cycles in patients with early-stage triple negative breast cancer. The trial is designed to test the safety and efficacy of adding ivonescimab in patients with early TNBC undergoing neoadjuvant chemotherapy with carboplatin and docetaxel. Patients will receive ivonescimab 20 mg\u002Fkg IV on Day 1 of each cycle, and carboplatin AUC6 and docetaxel 75 mg\u002Fm2 on Day 1 of each cycle for 6 cycles. Cycles will be 21 days for a total of 6 cycles. Curative intent surgery will be performed within 6 weeks (maximum 12 weeks) time frame upon completion of last dose of chemoimmunotherapy. The surgical pathology information will be used for assessment of pathological response, which serve as the primary endpoint of this study. Patients will undergo assessment at baseline, C1D1 of each cycle and end of treatment visit for collection of treatment-emergent adverse events, evaluated by CTCAE v5.0. Patient reported outcomes will be collected at cycles 1, 4, and 6, and at EOT. All study patients will be followed for at least 5 years for EFS and OS follow up. Research biopsies, peripheral blood and stool samples will be collected at the following time points: baseline, C4D1 (+\u002F-14 days), and surgery (+\u002F-14 days). Baseline and EOT breast MRI will be performed as standard of care for assessment of clinical response. Mid treatment breast ultrasound (C4D1 +\u002F-14 days) will be repeated as standard of care to assess clinical response to treatment. Mid-treatment C4D1 tumor biopsy may be omitted if the primary tumor is no longer visible or the tumor deemed too small for biopsy by radiologist.",[38,29,70],[379,380,381,382,38,74],"Ivonescimab","Carboplatin","Docetaxel","Neoadjuvant chemotherapy","2026-04-01",{"date":385,"type":49},"2026-04-02",{"date":387,"type":49},"2025-07-25",{"date":389,"type":21},"2032-11",{"name":391,"class":84},"Cedars-Sinai Medical Center",4,{"id":394,"slug":395,"hasResults":12,"nctId":396,"briefTitle":397,"officialTitle":398,"acronym":4,"eligibilityCriteria":399,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":400,"targetDuration":4,"studyType":22,"phases":402,"briefSummary":403,"conditions":404,"keywords":406,"overallStatus":107,"whyStopped":4,"lastUpdateSubmitDate":412,"lastUpdatePostDateStruct":413,"startDateStruct":414,"completionDateStruct":416,"leadSponsor":417,"locationsCount":419},"100543646","phase-2-intratumoral-int230-6-followed-by-neoadjuvant-immuno-chemotherapy-in-patients-with-early-tnbc-invincible-4-sakk-100543646","NCT06358573","Intratumoral INT230-6 Followed by Neoadjuvant Immuno-chemotherapy in Patients With Early TNBC. INVINCIBLE-4-SAKK","Intratumoral INT230-6 Followed by Neoadjuvant Immuno-chemotherapy in Patients With Early Triple-negative Breast Cancer (TNBC). An Open-label Randomized Two-cohort Phase 2 Clinical Trial. INVINCIBLE-4-SAKK","Inclusion Criteria:\n\n* Written informed consent according to country specific law and ICH GCP E6(R2) regulations before registration and prior to any trial specific procedures.\n* Newly histologically diagnosed, previously untreated locally advanced non-metastatic TNBC as defined by the most recent American Society of Clinical Oncology (ASCO) \u002F College of American Pathologist (CAP) guidelines .\n* The following stages according to staging per American Joint Committee on Cancer (AJCC) for breast cancer staging criteria version 8 are included: cT1c (1.5-2cm) N1-3 M0 or cT2-4c N0-3 M0.\n* Multifocal and multicentric primary tumors are allowed and the tumor with the most advanced T stage should be used to assess eligibility. If multifocal or multicentric disease TNBC needs to be confirmed for each focus.\n* Measurable disease in the breast with at least one lesion with a diameter ≥ 1.5cm that is evaluable per RECIST v1.1, visible in ultrasound and injectable.\n* Male or female subject Age ≥ 18 years.\n* ECOG performance status 0-1\n* Adequate bone marrow function (administration of G-CSF, EPO and\u002For blood transfusion within 14 days before registration is not allowed):\n\n  * neutrophil count ≥ 1.5 x 109\u002FL\n  * platelet count ≥ 100 x 109\u002FL\n  * hemoglobin ≥ 90 g\u002FL\n* Adequate hepatic function:\n\n  * total bilirubin ≤ 1.5 x ULN, or direct bilirubin ≤ ULN for subjects with total bilirubin levels \\> 1.5 x ULN\n  * AST and ALT ≤ 2.5 x ULN,\n  * Albumin 30 ≥ g\u002FL\n  * Lactate Dehydrogenase (LDH) \\\u003C2.5 ULN\n* Adequate renal function: estimated glomerular filtration rate (eGFR) ≥ 50 ml\u002Fmin\u002F1.73 m2 (according to CKD-EPI formula)\n* Adequate cardiac function: Left ventricular Ejection Fraction (LVEF) ≥ 50% as determined by echocardiography (ECHO)\n* Adequate coagulation function:\n\n  * INR ≤ 1.5 x ULN unless the patient is receiving anticoagulant therapy\n  * aPTT ≤ 1.5 x ULN unless the patient is receiving anticoagulant therapy\n  * If the patient is receiving anticoagulant therapy, the treating physician must determine that the anticoagulation can be stopped at least 24 hours prior to injection.\n* Women of childbearing potential must use highly effective contraception, are not pregnant or lactating and agree not to become pregnant during trial treatment and until 7 months after the last dose of INT230-6 or 6 months after standard of care treatment. A negative pregnancy test before inclusion into the trial is required for all women of childbearing potential. (www.swissmedicinfo.ch).\n* Men agree not to donate sperm or to father a child by using effective contraception during trial treatment and until 6 months after the last dose of INT230-6 or standard of care treatment (www.swissmedicinfo.ch).\n\nExclusion Criteria:\n\n* Inflammatory Breast Cancer cT4d\n* Unfavorable relation between tumor size and breast size as determined by judgement of the treating physician, surgeon and\u002For investigator, where tumor shrinkage during neoadjuvant immunochemotherapy is required for breast conserving surgery to be considered.\n* Unfavorable tumor location that can potentially result in an unfavorable cosmetic outcome (e.g. high upper inner quadrant) and\u002For close skin contact by judgment of the treating physician, surgeon and\u002For investigator.\n* The following histological subtypes of TNBC are excluded: Classic adenoid cystic carcinoma, secretory carcinoma, low-grade adenosquamous carcinoma, tall cell carcinoma with reversed polarity, high-grade metaplastic\n* History of invasive malignancy ≤3 years prior to signing informed consent (except treated basal cell or squamous cell skin cancer or in situ cervical cancer)\n* Prior chemotherapy, targeted therapy, radiation therapy or anti-PD-L1 agent for previous breast cancer or Ductal Carcinoma in Situ (DCIS) on the same side.\n* Concurrent bilateral breast cancer\n* Concomitant treatment with any other experimental drug for recent breast cancer diagnosis in another clinical trial.\n* Severe or uncontrolled cardiovascular disease (congestive heart failure NYHA II or IV; unstable angina pectoris, history of myocardial infarction and acute coronary syndrome requiring stenting\u002Fbypass surgery within the last six months, serious arrhythmias requiring medication (with exception of atrial fibrillation or paroxysmal supraventricular tachycardia), significant QT-prolongation, uncontrolled hypertension.\n* Known history of human immunodeficiency virus (HIV) or active chronic hepatitis C or hepatitis B virus infection or any uncontrolled active systemic infection requiring intravenous (iv) antimicrobial treatment.\n* Active autoimmune disease that required systemic treatment in past 2 years (e.g., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroid hormone replacement, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment.\n* History of (non-infectious) pneumonitis that required steroids or current pneumonitis.\n* Known history of tuberculosis.\n* Known history of allogeneic organ or stem cell transplant.\n* Receipt of live attenuated vaccine (including yellow fever vaccine) within 30 days prior to registration.\n* Diagnosis of immunodeficiency, concomitant or prior use of immunosuppressive medication within 7 days before registration, with the exceptions of local (intranasal, topical and inhaled) corticosteroids, or systemic corticosteroids which must not exceed 10 mg\u002Fday of prednisone or a dose equivalent corticosteroid, and the premedication for chemotherapy.\n* Concomitant anticoagulation with warfarin or equivalent vitamin K antagonists (e.g. phenprocoumon), factor Xa inhibitors (e.g. rivaroxaban, apixaban), direct thrombin inhibitors (e.g. dabigatran) or platelet inhibitors\u002Fantiplatelet agents that cannot be stopped 24 hours before the administration of INT230-6. Aspirin (up to 300 mg\u002Fday) is allowed.\n* Any concomitant drugs contraindicated for use with the trial drug according to the Investigator Brochure (IB) and the immuno-chemotherapy treatment according to the approved product information.\n* Known hypersensitivity to trial drug or to any component of the trial drug or immuno-chemotherapy treatment.\n* Incapacitated adults and any other serious underlying medical, psychiatric, psychological, familial or geographical condition, which in the judgment of the investigator may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications.",{"count":401,"type":21},61,[67],"About 10-20% of all individuals with breast cancer have a so-called triple-negative tumor (TNBC). This type of breast cancer has a particularly unfavorable course and a higher mortality rate compared to other forms of breast cancer. Research studies show that it is important for individuals with TNBC to achieve a so-called pathologic complete response (pCR) to treatment. In the phase II study SAKK 66\u002F22, it is being investigated whether the administration of the drug INT230-6 before surgery for breast cancer can increase the rate of pCR in the tumor and affected lymph nodes. The tolerability of INT230-6 as well as other factors such as response to treatment and the possibility of breast-conserving surgery are also being examined.",[405,29],"Triple-negative Breast Cancer",[407,38,408,409,410,411],"triple-negative breast cancer","Intratumoral INT230-6","neoadjuvant immuno-chemotherapy","INT230-6","early stage","2026-03-27",{"date":385,"type":49},{"date":415,"type":49},"2024-10-24",{"date":272,"type":21},{"name":418,"class":84},"Swiss Cancer Institute",9,{"id":421,"slug":422,"hasResults":12,"nctId":423,"briefTitle":424,"officialTitle":424,"acronym":4,"eligibilityCriteria":425,"healthyVolunteers":12,"sex":302,"minAge":18,"maxAge":4,"enrollmentInfo":426,"targetDuration":4,"studyType":22,"phases":428,"briefSummary":429,"conditions":430,"keywords":431,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":433,"lastUpdatePostDateStruct":434,"startDateStruct":436,"completionDateStruct":438,"leadSponsor":440,"locationsCount":4},"100626890","phase-2-a-phase-ii-single-arm-study-to-evaluate-the-efficacy-and-safety-of-inavolisib-in-combination-with-eribulin-in-pretreated-advanced-triple-negative-breast-cancer-harboring-a-pik3ca-mutation-100626890","NCT07441512","A Phase II, Single-arm Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Eribulin in Pretreated Advanced Triple-negative Breast Cancer Harboring a PIK3CA Mutation","Inclusion Criteria:\n\n* Patients must meet the following criteria for study entry:\n\n  * Signed Informed Consent Form\n  * Female participants who are at least 18 years of age on the day of signing informed consent\n  * Evaluable or measurable disease per RECIST v1.1\n  * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n  * Life expectancy of \\> 12 weeks\n  * Adequate hematologic and organ function within 14 days prior to initiation of study treatment, defined by the following:\n\n    * Absolute neutrophil count ≥ 1500\u002FμL\n    * Hemoglobin ≥ 9 g\u002FdL\n    * Platelet count ≥ 100,000\u002FμL\n    * Fasting glucose \\\u003C 126 mg\u002FdL or \\\u003C 7 mmol\u002FL and glycosylated hemoglobin (HbA1C) \\\u003C 6.5% or \\\u003C 48 mmol\u002Fmol\n    * Total bilirubin ≤ 1.5 × upper limit of normal (ULN) (\\\u003C 3 × ULN if Gilbert's disease)\n    * Serum albumin ≥ 2.5 g\u002FdL or 25 g\u002FL\n    * AST and ALT ≤ 2.5 × ULN with the following exception:\n* Patients with documented liver metastases: AST and ALT ≤ 5.0 × ULN\n\n  o ALP ≤ 2.5 × ULN with the following exception:\n* Participants with documented liver or bone metastases: ALP ≤ 5.0 × ULN\n\n  o INR \\\u003C 1.5 × ULN and aPTT \\\u003C 1.5 × ULN\n* For participants requiring anticoagulation therapy with warfarin or similar agents (such as Vitamin K antagonists), a stable INR between 2 and 3 is required. If anticoagulation is required for a prosthetic heart valve, then stable INR between 2.5 and 3.5 is permitted.\n\n  * Creatinine clearance ≥ 60 mL\u002Fmin on the basis of the Cockcroft-Gault glomerular filtration rate estimation.\n\n    • Participants with controlled HBV infection are allowed if they have:\n  * Normal ALT levels\n  * Positive hepatitis B surface antigen (HbsAg) and negative total hepatitis B core antibody (HbcAb) or positive HbcAb and\n  * HBV DNA ≤ 2000 UI\u002FmL\n* They are under antiviral treatment following local guidelines. Prophylactic treatment and follow-up must be done by a specialized physician per local SoC. The overall potential benefits associated with study treatment should be deemed to exceed the overall risks by the investigator\n\n  * Negative hepatitis C virus (HCV) antibody test at screening, or a positive HCV antibody test followed by a negative HCV RNA test at screening\n  * Histologically or cytologically documented adenocarcinoma of the breast that is locally advanced or metastatic, not amenable to surgical or radiation therapy with curative intent\n\n    * Documented HR-negative tumor in accordance with American Society of Clinical Oncology (ASCO)\u002FCollege of American Pathologists (CAP) guidelines31, defined as \\\u003C 1% of tumor cells staining positive for estrogen receptor (ER) and progesterone receptor (PgR), as per the most recently available local assessment.\n    * Documented HER2-negative tumor in accordance with ASCO\u002FCAP guidelines, defined as a HER2 immunohistochemistry (IHC) score of 0 or 1+ , or an IHC score of 2+ accompanied by a negative fluorescence, chromogenic, or silver in situ hybridization test indicating absence of HER2 gene amplification, or a HER2\u002FCEP17 ratio of \\\u003C 2.0, based on the most recently available local assessment.\n  * Have progressed after at least one line of systemic therapy in advanced setting.\n\n    o Patients who received chemotherapy or antibody-drug conjugate (ADC), either with or without a checkpoint inhibitor treatment, in advanced setting are eligible for enrollment\n  * Consent to provide fresh (preferred) or archival tumor tissue specimen, and freshly collected pretreatment blood sample. It is preferred that the specimen be from the most recently collected and available tumor tissue, and whenever possible, from a metastatic site of disease. Archival tumor tissue is defined as tumor tissue that was collected prior to the participant being (pre)screened for the study, and it can be from either the metastatic disease (preferred) or the primary tumor. See Section 8.2.8 for specimen requirements.\n  * Confirmation of biomarker eligibility: valid results from central testing of tumor tissue documenting the presence of a study-eligible PIK3CA mutation. Eligible PIK3CA mutations are defined as follows (71 PIK3CA mutations): H1047D\u002FI\u002FL\u002FN\u002FP\u002FQ\u002FR\u002FT\u002FY G1049A\u002FC\u002FD\u002FR\u002FS E545A\u002FD\u002FG\u002FK\u002FL\u002FQ\u002FR\u002FV E453A\u002FD\u002FG\u002FK\u002FQ\u002FV E542A\u002FD\u002FG\u002FK\u002FQ\u002FR\u002FV K111E\u002FN\u002FR Q546E\u002FH\u002FK\u002FL\u002FP\u002FR G106A\u002FD\u002FR\u002FS\u002FV N345D\u002FH\u002FI\u002FK\u002FS\u002FT\u002FY G118D C420R R88Q M1043I\u002FT\u002FV N1044H\u002FI\u002FK\u002FS\u002FT\u002FY T1025A\u002FI\u002FS The central test for identification of eligible PIK3CA mutations is the whole exome sequencing performed at Sponsor-designated central testing laboratory.\n  * For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use a highly effective form of contraceptive method (non-hormonal) with a failure rate of \\\u003C 1% per year in combination with use of male condom with spermicide (for male partners), unless male sterilization has been confirmed. Agreement to refrain from donating eggs during the treatment period and for at least 60 days after the last dose of inavolisib and at least 3 months after the last dose of eribulin.\n\nA woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state ( ≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and\u002For uterus).\n\nThe reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or post-ovulation methods) and withdrawal are not acceptable methods of contraception.\n\nExclusion Criteria:\n\n* Patients who meet any of the following criteria will be excluded from study entry:\n\n  * Pregnancy, lactation, or intention to become pregnant during the study\n\n    o Women of childbearing potential (including those who have had a tubal ligation) must have a negative pregnancy test result within 14 days prior to initiation of study treatment.\n  * Metaplastic breast cancer\n  * Radiotherapy within 4 weeks before Cycle 1 Day 1\n  * Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes\n  * Malabsorption syndrome or other condition that would interfere with enteral absorption\n  * Inability or unwillingness to swallow pills\n  * Any history of leptomeningeal disease or carcinomatous meningitis\n  * Known and untreated, or active CNS metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control). Patients with a history of treated CNS metastases are eligible, provided they meet all of the following criteria:\n\n    * Measurable or evaluable disease (per RECIST v1.1) outside the CNS\n    * No ongoing requirement for corticosteroids as therapy for CNS metastases, with corticosteroids discontinued for ≥ 2 weeks prior to enrollment and no ongoing symptoms attributed to CNS metastases\n    * Radiographic demonstration of improvement upon the completion of CNS-directed therapy and no evidence of interim progression between the completion of CNS-directed therapy and the screening radiographic study\n    * The screening CNS radiographic study is ≥ 4 weeks since completion of radiotherapy\n    * No history of intracranial hemorrhage or spinal cord hemorrhage\n  * Pleural effusion, pericardial effusion, or ascites requiring drainage procedures every 14 days or more frequently\n\n    o Indwelling pleural or abdominal catheters may be allowed, provided the patient has adequately recovered from the procedure, is hemodynamically stable and symptomatically improved.\n  * Symptomatic hypercalcemia requiring continued use of bisphosphonate or denosumab therapy\n\n    o Bisphosphonate and denosumab therapy for bone metastases or osteopenia\u002Fosteoporosis is allowed.\n  * Any active infection that, in the opinion of the investigator, could impact patient safety; or serious infection requiring intravenous (IV) antibiotics within 7 days prior to Day 1 of Cycle 1\n  * Active inflammatory (e.g., uveitis or vitritis) or infectious (e.g., conjunctivitis, keratitis, scleritis, or endophthalmitis) conditions in either eye or history of idiopathic or autoimmune-associated uveitis in either eye\n  * Requirement for daily supplemental oxygen\n  * Symptomatic active lung disease that is not specifically due to underlying breast cancer, including pneumonitis\n  * Active tuberculosis\n  * History of or active inflammatory disease (e.g., Crohn's disease or ulcerative colitis), or any active bowel inflammation (including diverticulitis)\n\n    o Patients currently receiving immunosuppressants (e.g., sulfasalazines) are considered to have active disease and are thus ineligible.\n  * Any serious medical condition or abnormality in clinical laboratory tests that precludes an individual's safe participation in and completion of the study\n  * Prior hematopoietic stem cell or bone marrow transplantation, or radiation therapy encompassing \\> 30% of marrow\n  * Unresolved toxicity \\> Grade 1 from prior cancer therapy, except for:\n\n    * Hot flashes and alopecia (may be any grade)\n    * Peripheral neuropathy (may be up to Grade 1)\n  * Significant traumatic injury or major surgical procedure within 4 weeks prior to initiation of study treatment, or planned surgery during the study\n  * Positive HIV test at screening\n  * Clinically significant history of liver disease, including severe liver impairment (ChildPugh Class B\u002FC), active viral or other hepatitis, current alcohol abuse, or cirrhosis\n\n    o Patients with active HBV infection defined as: positive HbsAg, positive HbcAb, HBV DNA \\> 2000 UI\u002FmL, and\u002For elevated ALT levels\n  * History of malignancy within 5 years prior to consent, with the exception of the cancer under investigation in this study and malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate \\> 90%), such as adequately treated carcinoma in situ of the cervix, nonmelanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer\n  * History or presence of an abnormal ECG that is deemed clinically significant, (e.g., complete left bundle branch block, second- or third-degree atrioventricular heart block) or evidence of prior myocardial infarction\n  * History of or active clinically significant cardiovascular dysfunction, including the following:\n\n    * History of stroke or transient ischemic attack within 6 months prior to first dose of study treatment\n    * History of myocardial infarction within 6 months prior to first dose of study treatment\n    * New York Heart Association Class III or IV cardiac disease or congestive heart failure requiring medication\n    * Uncontrolled arrhythmias, history of or active ventricular arrhythmia requiring medication\n    * Coronary heart disease that is symptomatic or unstable angina\n    * Congenital long QT syndrome or QT interval corrected with Fridericia's formula (QTcF) \\> 470 ms demonstrated by at least two ECGs \\> 30 minutes apart, history of long or short QT syndrome, Brugada syndrome or known history of corrected QT interval prolongation, or torsades de pointes.\n  * Known allergy or hypersensitivity to any of the study drugs or any of their excipients\n  * Patients with any of the following prior treatment histories are excluded:\n\n    * Prior treatment with PARP inhibitors for advanced TNBC\n    * Progressed solely on endocrine therapy or HER2-targeted therapy without prior chemotherapy for advanced TNBC\n    * Treatment with investigational therapy within 28 days prior to initiation of study treatment\n    * Prior treatment with any of the PI3K, AKT, or mTOR inhibitor or with eribulin",{"count":427,"type":21},26,[67],"This is an open-label, Simon's optimal two-stage design, single-arm, Phase II study with first 6 patients in the safety run-in portion. PIK3CAmut advanced triple-negative breast cancer(TNBC) patients who have progressed on at least one prior line of systemic therapy in advanced setting will be enrolled to receive inavolisib plus eribulin treatment. The study is carried out in two stages. In Stage One, 10 patients are accrued. If there are 4 or more responses among these 10 patients and positive recommendation by the safety review meeting based on the evaluation of first 6 safety run-in patients' data, additional 16 patients will be accrued in Stage Two, resulting in a total patient number of 26. Otherwise, the study will be terminated and a report will be prepared outlining the observed data and the rationale for termination.",[29,38],[432,38],"ML46206","2026-02-27",{"date":435,"type":49},"2026-03-02",{"date":437,"type":21},"2026-03-15",{"date":439,"type":21},"2028-03-15",{"name":441,"class":84},"Hu Hai",{"id":443,"slug":444,"hasResults":12,"nctId":445,"briefTitle":446,"officialTitle":447,"acronym":4,"eligibilityCriteria":448,"healthyVolunteers":12,"sex":302,"minAge":18,"maxAge":4,"enrollmentInfo":449,"targetDuration":4,"studyType":22,"phases":450,"briefSummary":452,"conditions":453,"keywords":455,"overallStatus":107,"whyStopped":4,"lastUpdateSubmitDate":461,"lastUpdatePostDateStruct":462,"startDateStruct":464,"completionDateStruct":466,"leadSponsor":468,"locationsCount":57},"100573298","nearwave-optical-molecular-monitoring-100573298","NCT06744465","NearWave Optical Molecular Monitoring","NearWave Optical Molecular Monitoring for Predicting Complete Pathological Response (pCR) to Neoadjuvant Chemotherapy (NAC) in Breast Cancer Patients","Inclusion Criteria:\n\n1. Women ≥ 18 years old at the time of informed consent\n2. Ability to provide written informed consent and HIPAA authorization\n3. Patients who:\n\n   1. have been diagnosed with invasive breast cancer by tissue biopsy and have not yet started any therapy for the disease; a) Subtype HER2 positive (IHC 3+ or if IHC 2+, then positive by FISH), with any ER status, OR b) Subtype TNBC, defined by: HER2 negative and ER\u002FPR negative or low (ER and PR ≤ 9%, weak staining)\n   2. with ≥2 cm tumor size in the largest dimension as measured by ultrasound, MRI, or mammography. If multifocal disease, at least one tumor must measure ≥2 cm\n   3. are planned to receive neoadjuvant chemotherapy followed by surgery\n   4. Will be at least two weeks out from biopsy of the primary lesion at the time of baseline visit\n   5. Have a palpable breast mass as determined by a treating physician\n\nExclusion Criteria:\n\n1. Patients with significant bruising or hematoma from diagnostic breast biopsy, as determined by clinical judgement (mild ecchymosis okay)\n2. Inflammatory breast cancer\n3. Prior breast cancer requiring surgery or radiation in either breast\n4. Pregnant or nursing due to changes in breast architecture\n5. Patients with a BMI of ≥ 40, unless the lesion is near the surface (\\\u003C3 cm from the skin surface), based on diagnostic scan measurements\n6. Patients with any tattoos on their breasts",{"count":213,"type":21},[451],"NA","The purpose of this study is to assess the feasibility of the NearWave optical molecular monitoring system for monitoring therapy progression and predicting pathologic complete response (pCR) of breast cancer patients undergoing neoadjuvant chemotherapy (NAC).",[28,248,29,165,454],"Invasive Breast Carcinoma",[456,457,458,459,460],"neoadjuvant chemotherapy","breast cancer","imaging","NearWave","invasive breast cancer","2026-02-12",{"date":463,"type":49},"2026-02-17",{"date":465,"type":49},"2025-03-07",{"date":467,"type":21},"2027-01",{"name":469,"class":84},"Indiana University",{"id":471,"slug":472,"hasResults":12,"nctId":473,"briefTitle":474,"officialTitle":475,"acronym":4,"eligibilityCriteria":476,"healthyVolunteers":12,"sex":302,"minAge":18,"maxAge":4,"enrollmentInfo":477,"targetDuration":4,"studyType":22,"phases":478,"briefSummary":479,"conditions":480,"keywords":481,"overallStatus":107,"whyStopped":4,"lastUpdateSubmitDate":461,"lastUpdatePostDateStruct":487,"startDateStruct":488,"completionDateStruct":490,"leadSponsor":491,"locationsCount":492},"100414981","phase-2-a-study-of-radiation-therapy-with-pembrolizumab-and-olaparib-or-other-radiosensitizers-in-women-who-have-triple-negative-or-hormone-receptor-positiveher2-negative-breast-cancer-100414981","NCT04683679","A Study of Radiation Therapy With Pembrolizumab and Olaparib or Other Radiosensitizers in Women Who Have Triple-Negative or Hormone-Receptor Positive\u002FHer2 Negative Breast Cancer","Phase II Study of Pembrolizumab and Ablative Radiotherapy With or Without Olaparib in Metastatic Triple-Negative or Hormone-Receptor Positive\u002FHer2 Negative Breast Cancers : Initial Test Cohorts of a Platform Trial to Sequentially Investigate Immunotherapy Combinations for the Augmentation of Immune Responses","Inclusion Criteria:\n\n* Female participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of triple negative breast cancer or ER+\u002FHer2 will be enrolled in this study.\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 30 days prior to the date of allocation\u002Frandomization\n* Histologically or cytologically-confirmed TNBC (defined as ER \\\u003C5%, PR \\\u003C5%, HER- 2-neu 0-1+ by IHC or FISH-negative or per MD discretion).\n* Histologically of cytologically-confirmed ER+ breast cancer, defined as ER 1-100% and HER-2\u002Fneu 0-1+ by IHC or FISH-negative\n* Metastatic or recurrent TNBC.\n* Metastatic or recurrent ER+ breast cancer\n* For mTNBC patients, prior receipt of ICI with progression and\u002For PDL1-negative. PDL-1 status is not used to determine eligibility among mER+BC patients\n* Note: PDL1-status may be determined on tissues from either primary or mTNBC. Determination of PD-L1 status by any prototype assays is acceptable. PD-L1 status is required or archival tissue must be readily available for testing during screening if status was not previously determined.\n* The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.\n* Have measurable disease based on RECIST 1.1. There should be at least one radiographically-confirmed non-bone metastatic lesion that will not undergo RT and is measurable based on RECIST and suitable for repeated measurements.\n* Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.\n* No more than 3 prior lines of systemic therapy (including conventional cytotoxics, targeted therapies, biologics, or other invesigational systemic treatments) for inoperable\u002Frecurrent or metastatic disease in the TNBC cohort. A line of treatment in this instance refers to any systemic therapy directed at metastatic TNBC and which was discontinued due to disease progression. Treatment discontinued due to toxicity will not be counted. Systemic therapy previously delivered for hormone-receptor positive or Her2+ breast cancer (that has now switched to TNBC subtype) will not count as a prior line of treatment. Any number of prior lines of treatment for mER+BC are allowed.\n* At least one tumor site for which palliative RT is considered clinically appropriate. The site under consideration can be a metastatic site, or uncontrolled primary\u002Flocally recurrent disease in the breast\u002Fchest wall or in the nodes. Prior radiotherapy to the target site is allowed. Investigators should remain within departmental radiotherapy for normal tissue; exceptions should be discussed with the PI.\n* Have provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion. Formalin- fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue. Newly-obtained is defined as a specimen obtained up to 30 days prior to initiation of treatment on Day 1 of pembro. (Note: PI can waive this requirement at his discretion if specimen collection is deemed unfeasible).\n* A female participant is eligible to participate if she is not pregnant (see Appendix C), not breastfeeding, and at least one of the following conditions applies:\n\n  1. Not a woman of childbearing potential (WOCBP) as defined in Appendix C\n\n     OR\n  2. A WOCBP who agrees to follow the contraceptive guidance in Appendix C during the treatment period and for at least one month after the last dose of study treatment.\n* Have adequate organ function as defined in the following table (Table 2). Specimens must be collected within 30 days prior to the start of study treatment.\n\nTable 2 Adequate Organ Function Laboratory Values\n\nSystem: Laboratory Value\n\nHematological Absolute neutrophil count (ANC): ≥ 1500\u002FµL Platelets: ≥ 100 000\u002FµL Hemoglobin: ≥ 9.0 g\u002FdL with no blood transfusion in the past 28 days\n\nRenal Creatinine: 1.5 x ULN OR Measured or calculatedb creatinine clearance (GFR can also be used in place of creatinine or CrCl): ≥ 51 mL\u002Fmin\n\nHepatic Total bilirubin: ≤ 1.5 x ULN OR direct bilirubin ≤ ULN for participants with total bilirubin levels \\>1.5 x ULN AST (SGOT) and ALT (SGPT): ≤ 2.5 x ULN (≤ 5 x ULN for participants with liver metastases)\n\nCoagulation International normalized ratio (INR) OR prothrombin time (PT); Activated partial thromboplastin time (aPTT): ≤ 1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants\n\nALT (SGPT)=alanine aminotransferase (serum glutamic pyruvic transaminase); AST (SGOT)=aspartate aminotransferase (serum glutamic oxaloacetic transaminase); GFR=glomerular filtration rate; ULN=upper limit of normal.\n\na - Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks.\n\nb - Creatinine clearance (CrCl) should be calculated per institutional standard.\n\nNote: This table includes eligibility-defining laboratory value requirements for treatment; laboratory value requirements should be adapted according to local regulations and guidelines for the administration of specific chemotherapies.\n\n* Participant must agree not to breastfeed during the study or for 180 days after the last dose of study treatment.\n* Participant receiving corticosteroids may continue as long as their dose is stable for at least 4 weeks prior to initiating protocol therapy.\n* Ability to swallow (whole) and retain oral medications.\n\nExclusion Criteria:\n\n* Receipt of \\> 3 lines of systemic therapy in mTNBC patients\n* A WOCBP who has a positive urine pregnancy test within 72 hours or a serum pregnancy test within 14 days prior to treatment (see Appendix C). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n\n  * A minimum 2-week washout required for all anti-cancer agents, including cytotoxic chemotherapeutic agents, immunotherapy, biologic therapy, and targeted therapies. A 3-4 week washout is preferred when reasonable.\n  * Note: in the event that 72 hours have elapsed between the screening pregnancy test and the first dose of study treatment, another pregnancy test (urine or serum) must be performed and must be negative in order for subject to start receiving study medication.\n* Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks (preferred) or a minimum of 2 weeks prior to the start of study treatment.\n\n  * Note: Participants must have recovered from all AEs due to previous therapies to ≤ Grade 1 or baseline. Participants with ≤ Grade 2 neuropathy may be eligible.\n  * Note: If participant received major surgery, they must have recovered adequately from the toxicity and\u002For complications from the intervention prior to starting study treatment.\n* Has received prior radiotherapy within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤ 2 weeks of radiotherapy) to non-CNS disease.\n* Has previously experienced grade 3 or higher immune-mediated adverse events from prior courses of immunotherapy.\n* Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.\n\n  ° Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.\n* Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 (preferred, or 2 weeks minimum) weeks prior to the first dose of study treatment.\n\n  * Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been at least 2 weeks (prefer 4 weeks) after the last dose of the previous investigational agent.\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.\n* Has a known additional malignancy that is progressing or has required active treatment within the past 2 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.\n* Has severe hypersensitivity (≥ Grade 3) to pembrolizumab and\u002For olaparib and\u002For any of their excipients.\n* Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.\n* Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.\n* Has an active infection requiring systemic therapy.\n* Has a known history of Human Immunodeficiency Virus (HIV).\n\n  * Note: No HIV testing is required.\n* Has a known history of Hepatitis B (defined as Hepatitis B surface antigen \\[HBsAg\\] reactive) or known active Hepatitis C virus (defined as HCV RNA is detected) infection. Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority.\n* Has a known history of active TB (Bacillus Tuberculosis).\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n* Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment\n* Has had an allogenic tissue\u002Fsolid organ transplant\n* Resting ECG indicating uncontrolled, potentially reversible cardiac conditions, as judged by the investigator (eg., unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, QTcF prolongation \\> 500 ms, electrolyte disturbances, etc.), or patients with congenital long QT syndrome.\n* Persistent toxicities (\\>Common Terminology Criteria for Adverse Event (CTCAE 5.0) grade 2) caused by previous cancer therapy, excluding alopecia.\n* Patients with myelodysplastic syndrome\u002Facute myeloid leukemia or with features suggestive of MDS\u002FAML.\n* Patients with symptomatic uncontrolled brain metastases. A scan to confirm the absence of brain metastases is not required. The patient can receive a stable dose of corticosteroids before and during the study as long as these were started at least 4 weeks prior to treatment. Patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days.\n* Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, nonmalignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, extensive interstitial bilateral lung disease on High Resolution Computed Tomography (HRCT) scan or any psychiatric disorder that prohibits obtaining informed consent.\n* Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication.\n* Concomitant use of known strong CYP3A inhibitors (eg. itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (eg. ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The required washout period prior to starting olaparib is 2 weeks.\n* Concomitant use of known strong (eg. phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort ) or moderate CYP3A inducers (eg. bosentan, efavirenz, modafinil). The required washout period prior to starting olaparib is 5 weeks for enzalutamide or phenobarbital and 3 weeks for other agents.\n* Major surgery within 2 weeks of starting study treatment and patients must have recovered from any effects of any major surgery.\n* Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT).\n* Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements.\n* Previous enrollment in the present study.",{"count":329,"type":21},[67],"The purpose of this study is to find out whether adding pembrolizumab, with or without olaparib, to standard radiation therapy is a safe and effective treatment for metastatic breast cancer, , and to see whether the study treatment is better than, the same as, or worse than the usual approach (radiation therapy alone).",[36,29,28,166],[407,38,28,482,358,483,484,485,166,486],"PDL-1 negative","olaparib","20-505","Memorial Sloan Kettering Cancer Center","Her2",{"date":463,"type":49},{"date":489,"type":49},"2021-04-21",{"date":467,"type":21},{"name":485,"class":84},7,{"id":494,"slug":495,"hasResults":12,"nctId":496,"briefTitle":497,"officialTitle":498,"acronym":4,"eligibilityCriteria":499,"healthyVolunteers":12,"sex":302,"minAge":18,"maxAge":4,"enrollmentInfo":500,"targetDuration":4,"studyType":128,"phases":4,"briefSummary":502,"conditions":503,"keywords":4,"overallStatus":107,"whyStopped":4,"lastUpdateSubmitDate":504,"lastUpdatePostDateStruct":505,"startDateStruct":506,"completionDateStruct":508,"leadSponsor":510,"locationsCount":57},"100509556","immunotherapy-related-crp-kinetics-in-early-and-metastatic-triple-negative-breast-cancer-100509556","NCT05914961","Immunotherapy-related CRP Kinetics in Early and Metastatic Triple-negative Breast Cancer","ICK-Breast: Immunotherapy-related CRP Kinetics in Early and Metastatic Triple-negative Breast Cancer","Inclusion Criteria:\n\n* women ≥ 18 years of age\n* histologically proven early or advanced or metastatic invasive breast cancer irrespective of therapy line\n* ER-negative and progesterone receptor (PR)-negative and human epidermal growth factor receptor 2 (HER2)-negative (IHC 0-2+, Fluorescence In Situ Hybridization (FISH) neg.)\n* patients with advanced or metastatic disease must be programmed cell death ligand 1 (PD-L1)-positive (IC ≥ 1 or combined positive score (CPS) ≥ 10) in the experimental group\n* planned ICI therapy in combination with chemotherapy in the experimental group\n* written informed consent into ICK-breast\n\nExclusion Criteria:\n\n* ER-positive or PR-positive\n* HER2-positive (IHC 2+, FISH pos or IHC 3+)\n* any systemic breast cancer therapy before inclusion into the trial for early breast cancer patients\n* any ICI therapy before inclusion into the trial\n* pregnant or lactating patients\n* inadequate general condition (not fit for chemotherapy)",{"count":501,"type":21},225,"ICK-breast is a prospective, multicentric, non-interventional investigator-initiated trial (IIT) that aims to investigate the prognostic value of CRP kinetics in early and advanced or metastatic triple negative breast cancer (TNBC) under immune checkpoint inhibitor (ICI) therapy on pathological complete response (pCR) and event-free survival in early TNBC patients, and objective response rate (ORR), progression-free survival (PFS) and overall survival (OS) in advanced or metastatic TNBC.",[29],"2026-02-09",{"date":461,"type":49},{"date":507,"type":49},"2024-06-01",{"date":509,"type":21},"2035-04",{"name":511,"class":84},"University Hospital Tuebingen",{"id":513,"slug":514,"hasResults":12,"nctId":515,"briefTitle":516,"officialTitle":517,"acronym":4,"eligibilityCriteria":518,"healthyVolunteers":12,"sex":302,"minAge":18,"maxAge":519,"enrollmentInfo":520,"targetDuration":4,"studyType":22,"phases":522,"briefSummary":524,"conditions":525,"keywords":526,"overallStatus":107,"whyStopped":4,"lastUpdateSubmitDate":530,"lastUpdatePostDateStruct":531,"startDateStruct":533,"completionDateStruct":535,"leadSponsor":537,"locationsCount":57},"100564325","phase-3-sbrt-combined-with-pd-1-inhibitor-and-chemotherapy-in-early-stage-tnbc-100564325","NCT06627712","SBRT Combined With PD-1 Inhibitor and Chemotherapy in Early-stage TNBC","Stereotactic Body Radiotherapy (SBRT) Combined With PD-1 Inhibitor and Chemotherapy in Early-stage Treatment-naive Triple-negative Breast Cancer Patients: A Multicenter Phase III Clinical Study","Inclusion Criteria:\n\n* 1\\. Histologically or cytologically confirmed TNBC (ER-, PR-, HER2-)\n* 2\\. cT1cN1-2M0 or cT2N0-2M0；（AJCC 7th）\n* 3\\. ECOG performance status of 0-1;\n* 4\\. Adequate bone marrow function, defined as: Hb ≥ 9.0 g\u002FdL (90 g\u002FL); ANC ≥ 1,500\u002FmcL (1.5 × 10\\^9\u002FL); PLT ≥ 100,000\u002FmcL (100 × 10\\^9\u002FL) and no blood transfusion within 3 weeks or growth factor (G-CSF, EPO) therapy within 2 weeks prior to dosing;\n* 5\\. Adequate liver function, defined as: TBIL ≤ 1.5× upper limit of normal (ULN); If no liver metastases, AST and ALT ≤ 2.5× ULN; if liver metastases are present, AST or ALT ≤ 3.0× ULN; ALP ≤ 1.5× ULN; if liver metastases ≤ 2× ULN; Serum albumin ≥ 30g\u002FL;\n* 6\\. Adequate coagulation function: INR or PT, APTT ≤ 1.5× ULN. Participants on anticoagulant therapy should have these laboratory indices closely monitored;\n* 7\\. Adequate renal function, defined as creatinine ≤ 1.5× ULN or Ccr ≥ 50 mL\u002Fmin calculated using the Cockcroft-Gault formula corrected for body surface area;\n* 8\\. Baseline left ventricular ejection fraction (LVEF) ≥ 50% measured by multiple-gated acquisition (MUGA) or echocardiogram (ECHO);\n* 9\\. No severe organic heart disease or arrhythmias;\n* 10\\. Women of childbearing potential (aged 15-49 years) must have a negative pregnancy test within 7 days before starting treatment. Both male and female participants of reproductive potential must agree to use effective contraceptive measures during the study period and for 3 months after discontinuation of treatment;\n* 11\\. Voluntary signed informed consent by the study participant.\n\nExclusion Criteria:\n\n* 1\\. Patients with a history of mental illness or those diagnosed with mental disorders at the time of enrollment in the clinical trial.\n* 2\\. Patients with communication barriers due to confusion, aphasia, intellectual disability, or other reasons that prevent them from responding normally.\n* 3\\. Poorly controlled tumor-related pain.\n* 4\\. Patients participating in other clinical studies simultaneously.\n* 5\\. Patients with active or past autoimmune diseases or immunodeficiencies, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, or multiple sclerosis.\n* 6\\. A history of idiopathic pulmonary fibrosis, organizing pneumonia (such as obliterative bronchiolitis), drug-induced pneumonia, or idiopathic pneumonia, or evidence of active pneumonia on chest CT scans at screening.\n* 7\\. Active pulmonary tuberculosis.\n* 8\\. Severe cardiovascular diseases occurring within 3 months prior to the start of study treatment (e.g., NYHA class II or higher heart disease, myocardial infarction, or cerebrovascular accident), unstable arrhythmias, or unstable angina.\n* 9\\. Patients who underwent significant surgical procedures, other than diagnostic surgeries, within 4 weeks prior to the start of the study treatment, or are expected to require significant surgical procedures during the study period.\n* 10\\. Patients who had malignant tumors other than breast cancer within the last 5 years, except for malignancies in the study that have negligible risks of metastasis or death (e.g., a 5-year overall survival rate \\> 90%), such as adequately treated cervical carcinoma in situ, non-melanoma skin cancer, ductal carcinoma in situ, or stage I uterine cancer.\n* 11\\. Patients who experienced severe infections within 4 weeks prior to the start of the study treatment, including but not limited to those requiring hospitalization due to infections, bacteremia, severe pneumonia, or any active infection that may impact patient safety.\n* 12\\. Patients who have previously received allogeneic stem cell or solid organ transplants.\n* 13\\. Any other diseases, metabolic dysfunctions, physical examination abnormalities, or clinical laboratory abnormalities that contraindicate the use of the study drug, may affect the interpretation of results, or pose a high risk of treatment complications for the patient.","65 Years",{"count":521,"type":21},318,[523],"PHASE3","Triple-negative breast cancer (TNBC) presents significant challenges due to its limited treatment options and poor efficacy. While neoadjuvant chemotherapy has improved breast-conserving rates and extended survival for TNBC patients, this subtype still faces issues such as restricted treatment modalities, low pathological response rates, and unfavorable prognosis compared to other subtypes. Studies like Keynote522 and IMpassion031 have shown that combining chemotherapy with immunotherapy yields a pCR rate of 64.8% in early-stage high-risk TNBC patients, suggesting that such combinations can offer substantial benefits. However, the low immunogenicity of breast cancer and the lack of clear predictive molecular markers for effective immunotherapy result in suboptimal pCR and objective response rates for this group. Radiotherapy has systemic immune regulatory effects by promoting the release of antigens from tumor cells, enhancing T-cell infiltration, and directly killing tumor cells. Therefore, this study aims to investigate the efficacy and safety of stereotactic radiotherapy combined with PD-1 inhibitors and chemotherapy in the neoadjuvant treatment of TNBC.",[29],[527,528,264,529],"Triple negative breast cancer","SBRT","PD-1 Inhibitor","2026-01-28",{"date":532,"type":49},"2026-01-30",{"date":534,"type":49},"2024-11-01",{"date":536,"type":21},"2031-11-01",{"name":538,"class":84},"West China Hospital",{"id":540,"slug":541,"hasResults":12,"nctId":542,"briefTitle":543,"officialTitle":544,"acronym":4,"eligibilityCriteria":545,"healthyVolunteers":12,"sex":302,"minAge":18,"maxAge":303,"enrollmentInfo":546,"targetDuration":4,"studyType":22,"phases":548,"briefSummary":549,"conditions":550,"keywords":551,"overallStatus":107,"whyStopped":4,"lastUpdateSubmitDate":554,"lastUpdatePostDateStruct":555,"startDateStruct":557,"completionDateStruct":559,"leadSponsor":561,"locationsCount":563},"100619966","phase-2-neoadjuvant-chemotherapy-combined-with-sintilimab-and-bevacizumab-for-tnbc-neotorch-breast07-100619966","NCT07351487","Neoadjuvant Chemotherapy Combined With Sintilimab and Bevacizumab for TNBC (NEOTORCH-BREAST07)","Neoadjuvant Chemotherapy Combined With Sintilimab and Bevacizumab for Triple Negative Breast Cancer:A Prospective, Single-Arm, Multicenter Clinical Study (NEOTORCII-BREASTO7)","Inclusion Criteria:\n\n1. Female patients aged 18-70 years old;\n2. ECOG score is 0-1 points;\n3. Histologically confirmed stage II-III (T1N1-3; T2-4N0-2) invasive breast cancer;\n4. ER-negative, PR-negative, and HER2 receptor-negative. Alternatively, if ER and PR expression is less than 10% and HER2 receptor is negative, it is also classified as TNBC;\n5. Pathological examination of PD-L1 expression: The Combined Positive Score (CPS) refers to the percentage of PD-L1 positive cells (including tumor cells, lymphocytes, macrophages) in all tumor cells. Our center detected the PD-L1 antibody site as 22C3.\n6. The functional level of major organs must meet requirements\n7. For female patients who have not yet reached menopause or undergone surgical sterilization: during the treatment period and in the study treatment, the final use effective contraceptive methods for at least 6 months after a single administration.\n8. Voluntarily join this study, sign an informed consent form, have good compliance, and are willing to cooperate with follow-up.\n\nExclusion Criteria:\n\n1. Stage IV breast cancer.\n2. Inflammatory breast cancer.\n3. Previously received anti-tumor treatment or radiation therapy for any malignant tumor, excluding those that have been cured Malignant tumors such as cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma.\n4. Simultaneously undergoing anti-tumor treatment in other clinical trials, including but not limited to chemotherapy and endocrine therapy. Treatment, biological therapy, bone improvement drug therapy, or immune checkpoint inhibitor therapy, etc.\n5. The patient had undergone major surgical procedures unrelated to breast cancer within 4 weeks before the first administration of the study drug, or the patient has not fully recovered from such surgical procedures.\n6. Serious heart disease or discomfort, including but not limited to the following diseases:\n\n1\\) Diagnosed history of heart failure or systolic dysfunction (LVEF less than 50%).2) High risk uncontrolled arrhythmias, such as atrial tachycardia, resting heart rate greater than 100bpm, significant ventricular arrhythmias (such as ventricular tachycardia), or higher-level atrioventricular block (i.e. Mobitz II second or third degree atrioventricular block).3) Angina requiring medication for treatment. 4) Heart valve disease with clinical significance. 5) ECG shows transmural myocardial infarction. 6) Poor control of hypertension (systolic blood pressure greater than 180mmHg and\u002For diastolic blood pressure greater than 180mmHg after drug treatment) 100mmHg).\n\n7\\. Uncontrolled active infections that require treatment; History of immunodeficiency, including HIV testing positive Sexual, or suffering from other acquired or congenital immunodeficiency diseases, or having a history of organ transplantation.\n\n8\\. Patients with chronic active hepatitis B or active hepatitis C (excluding hepatitis B virus carriers, stable hepatitis B after drug treatment \\[HBV-DNA test negative or\\<50IU\u002Fml\\] and cured hepatitis C patients \\[HCV RNA test negative\\]).\n\n9\\. Have received immunotherapy and experienced adverse immune events such as immune related pneumonia and myocarditis, which have been determined by researchers to potentially affect the safety of the experimental medication.\n\n10\\. Individuals with a known history of allergies to the components of this medication regimen.\n\n11\\. Pregnant and lactating female patients, female patients with fertility and positive baseline pregnancy test results, or reproductive age patients who are unwilling to take effective contraceptive measures during the entire trial period and within 6 months after the last study medication.\n\n12\\. Suffering from serious accompanying diseases or other comorbidities that may interfere with the planned treatment, or any other circumstances that the researcher deems unsuitable for the patient to participate in this study.",{"count":547,"type":21},37,[67],"This study is a prospective, single arm, multi-center phase II clinical trial. The primary study objective is to evaluate the pathologic complete response（PCR） of treatment of TNBC breast cancer with neoadjuvant chemotherapy combined with Sintilimab and Bevacizumab , including the incidences and types of adverse events. The secondary study objective is to observe and evaluate the event-free survival (EFS), Objective Response Rate(ORR), and radiologic complete response (rCR).",[29],[38,552,553],"Sintilimab","Bevacizumab","2026-01-12",{"date":556,"type":49},"2026-01-20",{"date":558,"type":49},"2025-09-25",{"date":560,"type":21},"2030-09-25",{"name":562,"class":84},"First Affiliated Hospital of Zhejiang University",2,{"id":565,"slug":566,"hasResults":12,"nctId":567,"briefTitle":568,"officialTitle":569,"acronym":4,"eligibilityCriteria":570,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":571,"enrollmentInfo":572,"targetDuration":4,"studyType":22,"phases":574,"briefSummary":575,"conditions":576,"keywords":577,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":579,"lastUpdatePostDateStruct":580,"startDateStruct":582,"completionDateStruct":584,"leadSponsor":586,"locationsCount":4},"100612698","phase-2-toripalimab-combined-with-anthracycline-free-or-anthracycline-containing-chemotherapy-as-neoadjuvant-chemotherapy-for-early-triple-negative-breast-cancer-100612698","NCT07256964","Toripalimab Combined With Anthracycline-free or Anthracycline-containing Chemotherapy as Neoadjuvant Chemotherapy for Early Triple Negative Breast Cancer","A Prospective, Randomized Controlled, Multicenter Phase II Clinical Study of Toripalimab Combined With PCb-EC Regimen (Albumin Paclitaxel + Carboplatin Followed by Epirubicin + Cyclophosphamide) or PCb Regimen (Albumin Paclitaxel + Carboplatin) as Neoadjuvant Therapy for Triple-Negative Breast Cancer","Inclusion Criteria:\n\n1. Age: 18-70 years.\n2. Disease Status: Clinical pathological confirmation of cT2-cT4d, or cT1c with axillary lymph node metastasis.\n3. Pathology: Histopathologically confirmed triple-negative, invasive breast carcinoma.\n4. Definition of Triple-Negative Breast Cancer:\n5. ER and PR negative (IHC nuclear staining \\\u003C10%).\n6. Her-2 negative (IHC 0 or 1+ without FISH, or IHC 2+ with FISH demonstrating no amplification).\n7. Measurable Disease: Presence of clinically measurable lesion(s) confirmed by ultrasound, mammography, or optional MRI within 1 month prior to randomization.\n8. Adequate Organ and Bone Marrow Function (within 1 month prior to chemotherapy), indicating no contraindications for chemotherapy:\n9. Absolute Neutrophil Count (ANC) ≥ 1.5 × 10⁹\u002FL\n10. Hemoglobin (Hb) ≥ 90 g\u002FL\n11. Platelet count (PLT) ≥ 100 × 10⁹\u002FL\n12. Total Bilirubin (TBIL) \\\u003C 1.5 × ULN (Upper Limit of Normal)\n13. Serum Creatinine (Cr) \\\u003C 1.5 × ULN\n14. Aspartate Aminotransferase (AST) \u002F Alanine Aminotransferase (ALT) \\\u003C 1.5 × ULN\n15. Cardiac Function: Left ventricular ejection fraction (LVEF) ≥ 50% as measured by echocardiogram.\n16. Pregnancy Status: For women of childbearing potential, a negative serum pregnancy test within 14 days prior to randomization.\n17. Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 1.\n18. Informed Consent: Signed informed consent obtained.\n\nExclusion Criteria:\n\n1. Metastatic Disease: Evidence of metastatic breast cancer. (To exclude metastasis, CT scans of the chest and abdomen, and a bone scan must be performed at any time point from diagnosis to randomization; PET\u002FCT may serve as an alternative imaging modality).\n2. Prior Anti-Cancer Therapy: Any prior chemotherapy, endocrine therapy, targeted therapy, or radiotherapy for the current breast cancer.\n3. Second Primary Malignancy: Presence of a second primary malignancy, except for:\n4. Adequately treated non-melanoma skin carcinoma.\n5. Prior Immunotherapy: Previous treatment with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or any other immunomodulatory therapy.\n6. Immunodeficiency or Autoimmune Disease: Diagnosed immunodeficiency or active autoimmune disease requiring systemic treatment.\n7. Severe Comorbidities: Severe or uncontrolled pulmonary or cardiac disease.\n8. Active Hepatitis: Active Hepatitis B or Hepatitis C infection.\n9. Transplantation History: History of solid organ or bone marrow transplantation.\n10. Pregnancy\u002FLactation: Pregnant or lactating women.\n11. Other Medical Conditions: Any other severe, uncontrolled medical condition that, in the investigator's judgment, constitutes a contraindication to chemotherapy.","70 Years",{"count":573,"type":21},216,[67],"This study aims to evaluate the efficacy and safety of a PD-1 inhibitor combined with different chemotherapy regimens (PCb-EC and PCb), in order to develop a superior and well-tolerated neoadjuvant therapeutic strategy for patients with triple-negative breast cancer.",[29],[578,38,382],"PD1","2025-11-27",{"date":581,"type":49},"2025-12-02",{"date":583,"type":21},"2025-11-26",{"date":585,"type":21},"2033-12-31",{"name":587,"class":588},"Henan Cancer Hospital","OTHER_GOV",{"id":590,"slug":591,"hasResults":12,"nctId":592,"briefTitle":593,"officialTitle":594,"acronym":4,"eligibilityCriteria":595,"healthyVolunteers":12,"sex":302,"minAge":18,"maxAge":4,"enrollmentInfo":596,"targetDuration":4,"studyType":22,"phases":598,"briefSummary":599,"conditions":600,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":602,"lastUpdatePostDateStruct":603,"startDateStruct":605,"completionDateStruct":607,"leadSponsor":609,"locationsCount":4},"100611768","phase-2-sac-tmt-combined-with-toripalimab-for-first-line-treatment-of-pd-l1-positive-amtnbc-100611768","NCT07244874","Sac-TMT Combined With Toripalimab for First-line Treatment of PD-L1 Positive a\u002FmTNBC","A Single Arm, Phase II Study of Sacituzumab Tirumotecan（Sac-TMT） Combined With Toripalimab for First-line Treatment of PD-L1 Positive Unresectable Locally Advanced\u002FMetastatic Triple Negative Breast Cancer (a\u002FmTNBC)","Inclusion Criteria:\n\n1. Female patients with breast cancer aged \\>= 18 years.\n2. Based on the pathological report of the latest biopsy or other pathological specimens, the histology and\u002For cytology are confirmed as invasive breast cancer, and the following conditions are met: a) Pathological classification: ER \\\u003C= 10%, PR \\\u003C= 10%; HER2 negative (IHC 0, 1+, 2+and FISH negative); Note: Subjects with initial histopathological diagnosis of HR\\>10% or HER2+breast cancer and recent pathological findings of metastatic lesions meeting the above conditions are allowed to be included in the study. b) Tumor staging: locally advanced, recurrent, or metastatic tumors that cannot be surgically removed; Note: Patients who have received perioperative treatment in the past are required to have a disease-free survival period of \\>= 6 months;\n3. ECOG overall state is 0-1.\n4. Have not received systematic treatment for advanced diseases.\n5. There are tissue samples available for PD-L1 testing, and the test results show PD-L1 positive: CPS \\>= 1.\n6. The expected survival period is not less than 3 months.\n7. According to the RECIST v1.1 standard, there must be at least one measurable lesion present.\n8. Having sufficient organ and bone marrow function (without receiving blood transfusion, recombinant human thrombopoietin or colony-stimulating factor therapy within 2 weeks prior to the first administration), defined as follows: a) Blood routine: neutrophil count (NEUT #) \\>= 1.5 × 10\\^9\u002FL; platelet count (PLT) \\>= 100 × 10\\^9\u002FL; hemoglobin \\>= 90g\u002FdL; b) Liver function: Aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP) \\\u003C= 2.5 x upper limit of normal (ULN); Total bilirubin (TBIL) \\\u003C= 1.5 × ULN; For patients with liver metastases, ALT and AST should be \\\u003C= 5 × ULN, and TBIL should be \\\u003C= 2 × ULN; For patients with liver or bone metastases, ALP \\\u003C= 5 × ULN; c) Renal function: creatinine clearance rate (Ccr) \\>= 60ml\u002Fmin; d) Coagulation function: International normalized ratio (INR), activated partial thromboplastin time (APTT), and prothrombin time (PT) \\\u003C= 1.5 × ULN; e) Cardiac function: Echocardiography (ECHO) or multi circuit controlled acquisition (MUGA) scan shows left ventricular ejection fraction (LVEF) \\>= 50%;\n9. Patients must recover from all toxicity caused by previous treatment (to \\\u003C= grade 1, evaluated based on CTCAE 5.0, or meet the inclusion criteria of the protocol), except for hair loss and vitiligo.\n10. Patients with negative serum pregnancy test results and those with fertility potential must agree to use effective non hormonal contraceptive methods during treatment and for at least 6 months after the last use of the test drug.\n11. Voluntarily joining this study, signing informed consent, having good compliance, and willing to cooperate with follow-up.\n\nExclusion Criteria:\n\n1. Patients with central nervous system metastases.\n2. Received radiotherapy, endocrine therapy, chemotherapy, surgical treatment (excluding local puncture or biopsy) or molecular targeted therapy during the recurrence\u002Fmetastasis stage.\n3. Participated in clinical trials of other drugs within 4 weeks prior to enrollment.\n4. Previously treated with anti-PD-1, anti-PD-L1, anti-PD-L-2, or anti-CTLA-4 antibodies, or any other antibodies or drugs that specifically target T cell co stimulatory or checkpoint pathways.\n5. Previously used treatment targeting TROP2 and\u002For topoisomerase I inhibitors.\n6. Other malignant tumors within the past 5 years, excluding cured cervical carcinoma in situ, basal cutaneous carcinoma, or squamous cell carcinoma of the skin.\n7. Known history of allergies to the drugs and their components in this protocol.\n8. Human immunodeficiency virus (HIV) test is positive or there is a history of acquired immunodeficiency syndrome (AIDS); Known active syphilis infection.\n9. History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.\n10. Vaccination with live vaccine within 30 days prior to the first study administration.\n11. History of (non infectious) interstitial lung disease (ILD) or non infectious pneumonia requiring steroid treatment, current ILD or non infectious pneumonia, or suspected ILD or non infectious pneumonia that cannot be excluded by imaging examination during screening; Clinical severe lung damage caused by concurrent lung diseases, including but not limited to any underlying lung disease (such as pulmonary embolism, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc. within 3 months prior to administration) or any autoimmune, connective tissue, or inflammatory disease that may affect the lungs (i.e. rheumatoid arthritis, Sjogren's syndrome, sarcoidosis, etc.), or previous total pneumonectomy.\n12. Patients with active autoimmune diseases that need systematic treatment in the past two years (hormone replacement therapy is not considered as systematic treatment, such as type I diabetes, hypothyroidism requiring only thyroid hormone replacement therapy, adrenal or pituitary insufficiency requiring only physiological dose of glucocorticoid hormone replacement therapy).\n13. Active infections requiring systemic treatment within 2 weeks prior to the first administration.\n14. ccording to the investigator's judgment, there are concomitant diseases that seriously endanger the patient's safety or affect the patient's completion of the study, including but not limited to high blood pressure beyond the control of drugs, serious diabetes, active infection, etc.\n15. There is a recorded history of severe dry eye syndrome, severe meibomian gland disease and\u002For blepharitis, or corneal diseases that hinder delayed corneal healing.\n16. Pregnant and lactating female patients, female patients with fertility and positive baseline pregnancy test results, and female patients of childbearing age who are unwilling to take effective contraceptive measures during the trial drug treatment period and the last 6 months of medication..\n17. The researchers believe that the patient is not suitable to participate in any other circumstances of this study.",{"count":597,"type":21},41,[67],"This study is aimed to evaluate the efficacy and safety of Sacituzumab Tirumotecan combined with Toripalimab for first-line treatment of PD-L1 positive unresectable Locally Advanced\u002Fmetastatic triple negative breast cancer (a\u002FmTNBC).",[29,601],"PD-L1 Positive","2025-11-17",{"date":604,"type":49},"2025-11-24",{"date":606,"type":21},"2025-12-01",{"date":608,"type":21},"2029-07-30",{"name":610,"class":84},"Tianjin Medical University Cancer Institute and Hospital",{"id":612,"slug":613,"hasResults":12,"nctId":614,"briefTitle":615,"officialTitle":616,"acronym":4,"eligibilityCriteria":617,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":618,"targetDuration":4,"studyType":22,"phases":620,"briefSummary":621,"conditions":622,"keywords":630,"overallStatus":107,"whyStopped":4,"lastUpdateSubmitDate":602,"lastUpdatePostDateStruct":633,"startDateStruct":635,"completionDateStruct":637,"leadSponsor":639,"locationsCount":641},"100505889","phase-1-study-of-avzo-021-in-patients-with-advanced-solid-tumors-100505889","NCT05867251","Study of AVZO-021 in Patients With Advanced Solid Tumors","A Phase 1\u002F2, First-in-Human Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of AVZO-021 as a Single Agent and in Combination Therapy in Patients With Advanced Solid Tumors","Key Inclusion Criteria:\n\n1. Male or female aged ≥18 years old at screening with Eastern Cooperative Oncology Group (ECOG) 0-1.\n2. Disease-related inclusion criteria by study phase and part:\n\n   i) Phase 1a Monotherapy Dose Escalation: Patients with locally advanced or metastatic HR+\u002FHER2- breast cancer, CCNE1-amplified tumors that are either epithelial ovarian cancer, primary peritoneal cancer, fallopian tube cancer, endometrial cancer or TNBC, with no other oncogenic driver mutations that are treatable and standard therapies are no longer effective, appropriate, or safe in the opinion of the investigator and medical monitor. Patients with any additional tumor type with CCNE1 amplification can be enrolled only if clinical data is supportive and approved by medical monitor (Cohort 1A).\n\n   ii) Phase 1b Combination Dose Escalation: histologically or cytologically confirmed diagnosis of locally advanced or metastatic HR+ HER2- (HER2-low may be allowed if failed standard of care therapy) breast cancer, who have been previously treated with inhibitor of CDK4\u002F6 and endocrine therapy(Cohorts 1B1, 1B2, 1B3, 1B4, and 1B5); or histologically or cytologically confirmed diagnosis of CCNE1- amplified, locally advanced or metastatic, platinum-refractory or platinum-resistant EOC, primary peritoneal, or fallopian tube cancer (Cohort 1C).\n\n   iii) Phase 2a Monotherapy dose expansion: Histologically or cytologically confirmed diagnosis of locally advanced or metastatic CCNE1 amplified epithelial ovarian cancer, primary peritoneal cancer, fallopian tube cancer, endometrial cancer or TNBC, with no other oncogenic driver mutations that are treatable and standard therapies are no longer effective, appropriate, or safe in the opinion of the investigator and medical monitor (Cohort 2A).\n\n   iv) Phase 2b Combination dose expansion: Histologically or cytologically confirmed diagnosis of locally advanced or metastatic HR+\u002FHER2- (HER2-low may be allowed if failed standard of care therapy) breast cancer who have been previously treated with no more than 1 prior CDK4\u002F6 inhibitor and endocrine therapy (Cohorts 2B1, 2B2, 2B3, 2B4, and 2B5); or Histologically or cytologically confirmed diagnosis of locally advanced or metastatic, CCNE1-amplified, platinum-refractory or platinum-resistant EOC, primary peritoneal cancer, or fallopian tube cancer (Cohort 2C).\n3. No more than 2 prior cytotoxic chemotherapy regimens for locally advanced\u002Fmetastatic disease (excepting patients treated with an antibody-drug conjugate, with ovarian cancer if there disease is platinum resistant or refractory, having progressed beyond all SOC care; and patients who have received prior chemotherapy in the adjuvant or neoadjuvant setting \\>12 months prior to starting AVZO-021 treatment).\n4. Measurable disease as determined by RECIST version 1.1.\n5. Adequate bone marrow and organ function.\n6. Ability to swallow capsules or tablets.\n\nKey Exclusion Criteria:\n\n1. Received an investigational agent or anticancer therapy within 2 weeks, or 5 half-lives of the drug, whichever is shorter, prior to planned start of AVZO-021.\n2. Received any CDK2 inhibitor, protein kinase membrane associated tyrosine\u002Fthreonine 1 (PKMYT1) inhibitor, or WEE1 inhibitor anticancer therapy. For cohort B5, prior therapy with topoisomerase inhibitors is not permitted.\n3. Undergone major surgery within 4 weeks prior to planned start of AVZO-021.\n4. Received radiotherapy for palliation within 7 days of the first dose of study treatment, unless specified otherwise in the protocol.\n5. Active CNS metastases or confirmed leptomeningeal disease are not eligible.\n6. Unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 Grade \\>1 at the time of starting study treatment.\n7. Clinically unstable cardiac function as described in the protocol.\n8. Any active or chronic infection\u002Fdisease that compromises the immune system.\n9. Current treatment with strong or moderate cytochrome P450 (CYP)3A4 inhibitors or inducers.\n10. Active second malignancy unless in remission with life expectancy \\> 2 years and with documented sponsor approval.\n11. Pregnancy, lactation, or plans to breastfeed during the study or within 6 months of the last dose of study intervention.",{"count":619,"type":21},430,[96,67],"This study, the first clinical trial of AVZO-021, aims to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, maximum tolerated dose, and anti-tumor effects of AVZO-021 in patients with advanced solid tumors. AVZO-021 is an oral medication that inhibits cyclin-dependent kinase 2 (CDK 2).",[99,623,624,625,626,627,628,629,29],"HR+\u002FHER2- Breast Cancer","HR+, HER2-, Advanced Breast Cancer","CCNE1 Amplification","Epithelial Ovarian Cancer","Primary Peritoneal Cancer","Fallopian Tube Cancer","Endometrial Cancer",[631,623,28,632,625,626,627,628,629,36],"Advanced solid tumor","Advanced Breast Cancer",{"date":634,"type":49},"2025-11-19",{"date":636,"type":49},"2023-08-30",{"date":638,"type":21},"2030-01-31",{"name":640,"class":56},"Avenzo Therapeutics, Inc.",13,{"id":643,"slug":644,"hasResults":12,"nctId":645,"briefTitle":646,"officialTitle":647,"acronym":4,"eligibilityCriteria":648,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":303,"enrollmentInfo":649,"targetDuration":4,"studyType":22,"phases":651,"briefSummary":652,"conditions":653,"keywords":655,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":657,"lastUpdatePostDateStruct":658,"startDateStruct":660,"completionDateStruct":662,"leadSponsor":664,"locationsCount":4},"100599140","phase-2-sc-101-in-subjects-with-advanced-nectin4-amplified-cancers-100599140","NCT07080619","SC-101 in Subjects With Advanced NECTIN4-Amplified Cancers","A Phase IIa Clinical Study to Assess the Efficacy and Safety of SC-101 in Patients With Advanced Malignant Tumors Positive for NECTIN4 Gene Amplification","Inclusion Criteria:\n\nAge between 18 and 75 years (inclusive), regardless of gender.\n\nECOG performance status of 0-1.\n\nExpected survival of more than 3 months, as assessed by the investigator.\n\nFertile participants must agree to use contraception.\n\nAble to understand the trial requirements and willing and able to comply with the trial and follow-up procedures.\n\nAdequate bone marrow and organ function.\n\nNECTIN-4 gene amplification positive.\n\nExclusion Criteria:\n\nUnstable central nervous system tumors.\n\nAdverse reactions from previous anticancer treatments have not recovered to a CTCAE 5.0 grade ≤1.\n\nA history of severe cardiovascular or cerebrovascular disease.",{"count":650,"type":21},120,[67],"This study is an open-label, multicenter Phase IIa trial to evaluate the efficacy and safety of SC-101 monotherapy in patients with locally advanced or metastatic malignant tumors who are positive for NECTIN4 gene amplification.",[29,654],"HR+ Breast Cancer",[656],"SC-101","2025-09-04",{"date":659,"type":49},"2025-09-11",{"date":661,"type":21},"2025-09-20",{"date":663,"type":21},"2027-12-30",{"name":665,"class":56},"Tianjin ConjuStar Biologics Co., Ltd.",{"id":667,"slug":668,"hasResults":12,"nctId":669,"briefTitle":670,"officialTitle":671,"acronym":4,"eligibilityCriteria":672,"healthyVolunteers":12,"sex":302,"minAge":18,"maxAge":4,"enrollmentInfo":673,"targetDuration":4,"studyType":22,"phases":675,"briefSummary":676,"conditions":677,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":678,"lastUpdatePostDateStruct":679,"startDateStruct":681,"completionDateStruct":683,"leadSponsor":685,"locationsCount":4},"100600755","phase-2-a-randomized-study-of-js004-and-toripalimab-combined-with-chemotherapy-vs-toripalimab-combined-with-chemotherapy-vs-chemotherapy-alone-as-neoadjuvant-therapy-for-stage-ii-iii-triple-negative-breast-cancer-tnbc-100600755","NCT07101614","A Randomized Study of JS004 and Toripalimab Combined With Chemotherapy vs Toripalimab Combined With Chemotherapy vs Chemotherapy Alone as Neoadjuvant Therapy for Stage II-III Triple-negative Breast Cancer (TNBC).","An Open-label, Randomized, Multi-center, Multi-cohort Clinical Study of JS004 and Toripalimab Combined With Chemotherapy vs Toripalimab Combined With Chemotherapy vs Chemotherapy Alone as Neoadjuvant Therapy for Stage II-III Triple-negative Breast Cancer (TNBC).","Inclusion Criteria:\n\n1. Subjects must voluntarily participate in this study, sign the informed consent form, demonstrate good compliance, and cooperate with follow-up visits.\n2. Age ≥ 18 years.\n3. ECOG score ≤ 1.\n4. Newly diagnosed, non-metastatic breast cancer of stage II-III, confirmed by histopathology or cytopathology (T1c-2 cN1-2 (≥2cm) or T3-4 cN0-2).\n5. Pathologically confirmed hormone receptor-negative (ER and PR negative) and HER2-negative advanced breast cancer. In cases of multiple pathological results, the definition of triple-negative breast cancer is based on the final molecular subtype result from the last biopsy pathology. (ER negativity: immunohistochemical staining in \\\u003C1% of tumor cells; PR negativity: immunohistochemical staining in \\\u003C1% of tumor cells; HER2 negativity: immunohistochemical score of 0, 1+, or FISH\u002FCISH negative).\n6. Have at least one measurable lesion according to the RECIST v1.1 criteria.\n7. Functional levels of vital organs must meet the following requirements (without any corrective treatment with blood components or cytokine growth factors within 14 days before the first dose):\n\n   1. Bone marrow function: Absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL, hemoglobin ≥ 90 g\u002FL.\n   2. Liver and kidney function: Albumin level ≥ 3.0 g\u002FdL, total bilirubin ≤ 1.5 × upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN, alkaline phosphatase ≤ 2.5 × ULN, urea nitrogen and serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 60 mL\u002Fmin (calculated according to the Cockcroft-Gault formula).\n   3. Prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.\n   4. Echocardiography (ECHO) showing left ventricular ejection fraction (LVEF) ≥ 50%.\n   5. QTcF ≤ 470 msec.\n8. Within 7 days before the first dose, women of reproductive potential must have a negative serum pregnancy test and agree to use effective contraceptive measures during the study drug administration and for 6 months after the last dose. For this protocol, women of reproductive potential are defined as sexually mature women who: 1) have not undergone hysterectomy or bilateral oophorectomy, and 2) have not experienced spontaneous menstruation cessation for a continuous period of 24 months (amenorrhea following cancer treatment does not exclude fertility) (i.e., menstruation has occurred at any time within the previous 24 consecutive months). For male patients with female partners of reproductive potential, they must agree to use effective contraceptive measures during the study drug administration and for 6 months after the last dose.\n9. Voluntarily participate in this study, sign the informed consent form, demonstrate good compliance, and be willing to cooperate with visits and study-related procedures.\n\nExclusion Criteria:\n\n1. Prior exposure to drugs targeting the same therapeutic target as the study treatment drug planned for administration.\n2. Radiotherapy, chemotherapy, surgery, or other targeted immunotherapy for triple-negative breast cancer before enrollment.\n3. Uncontrolled central nervous system metastases (symptomatic or requiring glucocorticoids or mannitol for symptom control).\n4. Inflammatory breast cancer, bilateral breast cancer, or occult breast cancer.\n5. History of clinically significant or uncontrolled cardiac disease within 6 months before the first dose, including congestive heart failure, angina pectoris, myocardial infarction, or ventricular arrhythmias.\n6. Presence of severe concomitant diseases that, in the investigator's judgment, pose a significant risk to the patient's safety or ability to complete the study (including but not limited to severe hypertension not controlled by medication, severe diabetes, active infections, etc.).\n7. Malignancy within 5 years before the first dose (except for cured basal cell carcinoma of the skin and cervical carcinoma in situ).\n8. Active autoimmune diseases requiring systemic treatment within 2 years before the first dose, except for vitiligo, type 1 diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis requiring only hormone replacement therapy.\n9. Receipt of live or attenuated vaccines within 4 weeks before the first dose of the study drug.\n10. Known or suspected interstitial pneumonia. Presence of other moderate to severe respiratory diseases within 3 months before the first dose that may interfere with the detection or management of drug-related lung toxicity, including but not limited to idiopathic pulmonary fibrosis, organizing pneumonia\u002Fbronchiolitis obliterans, pulmonary embolism, severe asthma, severe chronic obstructive pulmonary disease (COPD), obstructive\u002Frestrictive lung diseases, etc.; as well as any autoimmune, connective tissue, or inflammatory diseases affecting the lungs, such as rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc., or prior total lung resection surgery.\n11. Known history of human immunodeficiency virus (HIV) infection.\n12. Known history of hepatitis B or active hepatitis C virus infection.\n13. Prior allergy to any component or excipient of the study drug planned for administration.\n14. Other conditions deemed unsuitable for participation in the study by the investigator.",{"count":674,"type":21},125,[67],"The objective of this study is to evaluate the efficacy and safety of chemotherapy plus toripalimab, with or without JS004,as neoadjuvant therapy for patients with triple-negative breast cancer (TNBC). TNBC patients were randomly assigned in a 2:2:1 ratio to receive either JS004 plus toripalimab plus chemotherapy, toripalimab plus chemotherapy, or chemotherapy alone.Surgery will be performed within 5 weeks after the last dose of neoadjuvant treatment.",[29],"2025-07-28",{"date":680,"type":49},"2025-08-03",{"date":682,"type":21},"2025-09-01",{"date":684,"type":21},"2028-11-30",{"name":686,"class":84},"Shengjing Hospital"]