[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"triple-negative-breast-cancer-tnbc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:triple-negative-breast-cancer-tnbc":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,57,0,25,[9,41,73,111,141,180,204,230,257,279,305,353,395,424,445,467,496,523,549,575,597,628,653,690,709],{"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":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":4},"100054042","phase-1-enhancing-icb-efficacy-through-il-1-inhibition-in-tnbc-100054042",false,"NCT07698106","Enhancing ICB Efficacy Through IL-1 Inhibition in TNBC","Rebooting Sensitivity to Checkpoint Blockade Therapy in Triple-Negative Breast Cancer With Isunakinra (RESETT- I)","Inclusion Criteria:\n\n1. Age \\> 18 years\n2. Newly diagnosed, locally advanced, previously untreated and centrally confirmed TNBC, as defined by the most recent American Society of Clinical Oncology (ASCO)\u002FCollege of American Pathologists (CAP) guidelines, and staging per current AJCC staging criteria for breast cancer as assessed by the investigator based on radiological and\u002For clinical assessment:\n\n   Clinical stage T1c\u002FN1-N2, T2-4\u002FN0-2\n3. Provides core needle biopsies consisting of at least 2 separate tumor cores from the primary tumor to the central laboratory\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n5. Demonstrates adequate organ function\n6. Participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study\n\nExclusion Criteria:\n\n1. Male Gender\n2. Luminal A\u002FB and HER2 positive breast cancer\n3. Multifocal early breast cancer\n4. History of invasive malignancy ≤5 years prior to signing informed consent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer\n5. Received prior chemotherapy, targeted therapy, and radiation therapy within the past 12 months\n6. Has received prior therapy with an anti-PD1, anti-PDL1\u002F-PDL2 agent or with an agent directed to another co-inhibitory T-cell receptor\n7. Participated in an interventional clinical study with an investigational compound or device within 4 weeks of randomization for this study\n8. Pre-existing inflammatory arthritis\n9. Has received a live vaccine within 30 days of the first dose of study treatment\n10. Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs)\n11. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (i.e., dosing exceeding 10 mg daily of prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment\n12. Active or uncontrolled Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C\n13. Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis\n14. Has an active infection requiring systemic therapy\n15. Has significant cardiovascular disease\n16. Is pregnant or breastfeeding, or expecting to conceive children within the duration of the study\n17. Has a known history of active tuberculosis (TB, Bacillus Tuberculosis)\n18. Platelets ≤ 100x109\u002FL. ANC ≤ 1.5 x109\u002FL. Hemoglobin ≤ 80 g\u002FL\n19. ECOG≥2\n20. History of stroke or intracranial hemorrhage within 6 months prior to enrollment\n21. Presence of moderate or severe renal function impairment (estimated creatinine clearance \\\u003C60 mL\u002Fmin\u002F1.73m2)\n22. Patients with mild, moderate, or severe hepatic impairment or inadequate liver function (total bilirubin \\> 23 umol\u002FL, serum albumin \\\u003C 35 g\u002FL, INR \\> 1.70)\n23. Known hypersensitivity to E-coli derived proteins, isunakinra or any component of the product","ALL","18 Years",{"count":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","This study is a phase I\u002FII open-label randomized clinical trial to examine whether administration of isunakinra (EBI-005), a modified recombinant IL1 receptor antagonist, can sensitize human TNBC to the PD1 inhibitor-pembrolizumab-based neoadjuvant chemotherapy (NAC\u002FP) by changing the tumor microenvironment (TME) via reducing the recruitment of immunosuppressive tumorassociated macrophages (TAMs) and increasing activated cytotoxic T-lymphocytes (CTLs).",[28],"Triple-Negative Breast Cancer (TNBC)","NOT_YET_RECRUITING","2026-07-06",{"date":32,"type":33},"2026-07-13","ACTUAL",{"date":35,"type":21},"2026-08",{"date":37,"type":21},"2034-08",{"name":39,"class":40},"University Health Network, Toronto","OTHER",{"id":42,"slug":43,"hasResults":12,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":12,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":53,"conditions":54,"keywords":58,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":68,"leadSponsor":70,"locationsCount":72},"100645329","phase-1-tislelizumab-in-combination-with-bevacizumab-and-capecitabine-in-advanced-solid-tumors-with-evaluation-in-immunotherapy-resistant-and-central-nervous-system-disease-100645329","NCT07681297","Tislelizumab in Combination With Bevacizumab and Capecitabine in Advanced Solid Tumors With Evaluation in Immunotherapy-Resistant and Central Nervous System Disease","Phase Ib\u002FII Study of Tislelizumab in Combination With Bevacizumab and Capecitabine in Advanced Solid Tumors With Evaluation in Immunotherapy-Resistant and Central Nervous System Disease (TIBEC)","TIBEC","Inclusion Criteria:\n\nPatients are eligible for enrolment if they meet all applicable general inclusion criteria and, where relevant, the cohort-specific inclusion criteria.\n\n1. General Inclusion Criteria\n\n   * Age 21 years or older at the time of informed consent.\n   * Histologically or cytologically confirmed advanced or metastatic solid tumor.\n   * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n   * Estimated life expectancy of at least 12 weeks.\n   * At least one evaluable (measurable or non-measurable) lesion as defined by RECIST version 1.1, unless otherwise specified for a disease-specific cohort.\n   * Recovery to Grade 1 or baseline from acute toxicities of prior anti-cancer therapy, except for alopecia, vitiligo, or other toxicities deemed not clinically significant by the investigator.\n   * Adequate organ and marrow function within 14 days prior to first dose of study treatment, defined as follows:\n\n     1. Absolute neutrophil count ≥1.5 × 10\\^9\u002FL\n     2. Platelet count ≥100 × 10\\^9\u002FL\n     3. Haemoglobin ≥9.0 g\u002FdL\n     4. Total bilirubin \\\u003C1.5 × upper limit of normal, except in patients with known Gilbert's syndrome, in whom total bilirubin up to 3.0 × upper limit of normal is permitted provided direct bilirubin is within normal limits\n     5. AST and ALT \\\u003C2.5 × upper limit of normal, or \\\u003C5 × upper limit of normal in the presence of liver metastases\n     6. Calculated creatinine clearance ≥50 mL\u002Fmin (calculated using the Cockcroft-Gault formula)\n     7. Urine protein dipstick \\\u003C2+, or if urine dipstick is 2+ or greater, 24-hour urine protein \\\u003C1 g per 24 hours\n   * Adequately controlled blood pressure (systolic \\\u003C150mmHg, diastolic \\\u003C100mmHg) with or without anti-hypertensive medication.\n   * Able to swallow and retain oral medication.\n   * Able to understand and willing to sign written informed consent.\n   * Willing and able to comply with study visits, treatment plan, laboratory tests, imaging, and other protocol-required procedures.\n   * Prior exposure to immune checkpoint inhibitors, anti-angiogenic therapy, or fluoropyrimidines is permitted, unless prohibited by cohort-specific criteria.\n2. TNBC Cohort Inclusion Criteria\n\n   * Histologically confirmed triple-negative breast cancer, defined as estrogen receptor \\\u003C1%, progesterone receptor \\\u003C1%, and HER2-negative according to current ASCO\u002FCAP guidelines.\n   * Metastatic or unresectable locally advanced disease not amenable to curative treatment.\n   * PD-L1-negative disease, defined as combined positive score (CPS) \\\u003C10 using an approved assay.\n   * Candidate for first-line systemic therapy for metastatic disease.\n   * Patients must have measurable or non-measurable but evaluable disease per RECIST v1.1.\n   * Patients without measurable disease may be enrolled provided they have unequivocal non-measurable disease that can be adequately assessed or disease status on serial radiologic evaluations, in the opinion of the investigator.\n   * Prior neoadjuvant or adjuvant chemotherapy is permitted.\n   * Prior immune checkpoint inhibitor therapy in the neoadjuvant or adjuvant setting is permitted, provided it was completed at least 12 months prior to start of study treatment.\n   * Prior capecitabine is permitted only in the adjuvant setting, provided it was completed at least 12 months prior to start of study treatment.\n   * Patients with prior CNS disease are eligible only if CNS disease is clinically controlled, defined as asymptomatic or minimally symptomatic, does not require corticosteroids and does not require ongoing CNS-directed therapy.\n3. CNS Cohort Inclusion Criteria\n\n   * Histologically or cytologically confirmed advanced solid tumor.\n   * Progressive brain metastases.\n   * At least one measurable CNS lesion.\n   * Leptomeningeal disease is allowed.\n   * Patients receiving corticosteroids for management of CNS disease or CNS-related symptoms are eligible provided the corticosteroid dose is stable or decreasing for at least 7 days prior to first dose of study treatment.\n   * Patients with driver mutations (e.g., EGFR-mutant or ALK-rearranged NSCLC, HER2+ metastatic breast cancer) must have received at least one prior line of matched systemic therapy, unless such therapy is contraindicated, not tolerated, unavailable, or the patient is otherwise unsuitable in the investigator's judgment.\n4. HR-Positive\u002FHER2-Negative Cohort Inclusion Criteria\n\n   * Histologically confirmed hormone receptor-positive (defined as ER\\>1% or PR\\>1%), HER2-negative metastatic or unresectable locally advanced breast cancer not amenable to curative treatment.\n   * Patients must have measurable or non-measurable but evaluable disease per RECIST v1.1.\n   * Patients without measurable disease may be enrolled provided they have unequivocal non-measurable disease that can be adequately assessed or disease status on serial radiologic evaluations, in the opinion of the investigator.\n   * Prior failure of at least one line of endocrine therapy in the advanced or metastatic setting, unless deemed endocrine-resistant in the opinion of the investigator.\n   * Up to one prior line of palliative chemotherapy is permitted.\n   * If prior capecitabine was given, it must not have been administered in the metastatic setting and must have been completed \\>12 months prior to study entry.\n   * Any CNS disease must be clinically controlled, defined as asymptomatic or minimally symptomatic, must not require corticosteroids, and must not require ongoing CNS-directed therapy.\n\nExclusion Criteria:\n\nPatients will be excluded if they meet any applicable general exclusion criterion or any relevant cohort-specific exclusion criterion.\n\n1. General Exclusion Criteria\n\n   * Treatment with an investigational agent within 14 days prior to first dose of study treatment.\n   * Known hypersensitivity or contraindication to tislelizumab, bevacizumab, capecitabine, fluoropyrimidines, or any excipients of the study drugs.\n   * Known clinically significant dihydropyrimidine dehydrogenase deficiency.\n   * Uncontrolled or clinically unstable CNS disease, including poor performance status attributable to CNS disease, ongoing requirement for escalating corticosteroids, uncontrolled seizures, or rapid neurologic deterioration.\n   * Clinically significant cardiovascular disease, including uncontrolled hypertension, unstable angina, clinically significant arrhythmia, myocardial infarction, or stroke that is of clinical concern in the opinion of the investigator.\n   * Significant bleeding risk or recent clinically significant hemorrhage.\n   * History of gastrointestinal perforation, fistula, or intra-abdominal abscess within 6 months prior to first dose, or other conditions conferring high risk in the opinion of the investigator.\n   * Non-healing wound, active ulcer, or untreated fracture.\n   * Active infection requiring systemic therapy.\n   * Active autoimmune disease requiring systemic immunosuppressive treatment within the past 2 years, with exceptions such as replacement therapy or other conditions judged unlikely to recur.\n   * Current use of systemic immunosuppressive medication, excluding physiologic corticosteroid replacement or other permitted low-dose steroids.\n   * Active pneumonitis or interstitial lung disease requiring treatment, or other clinically significant pulmonary condition that, in the opinion of the investigator, would increase the risk of study treatment.\n   * Other active malignancy requiring treatment or likely to interfere with assessment of study endpoints, in the opinion of the investigator.\n   * Pregnancy or breastfeeding.\n   * Any serious medical, psychiatric, or social condition that, in the opinion of the investigator, would compromise patient safety, interfere with study participation, or confound interpretation of study results.\n2. TNBC Cohort Exclusion Criteria\n\n   * Prior systemic therapy for metastatic TNBC.\n   * Prior capecitabine in the metastatic setting.\n   * Progressive CNS disease. Patients with progressive CNS disease should be enrolled into the CNS cohort instead.\n3. CNS Cohort Exclusion Criteria\n\n   * Severely symptomatic or clinically unstable CNS disease, including rapid neurologic deterioration, uncontrolled seizures, or requirement for rapidly escalating corticosteroids.\n   * CNS disease requiring immediate neurosurgical intervention or urgent radiation therapy, in the opinion of the investigator.\n   * Stereotactic radiosurgery (SRS) including gamma knife, within 7 days before the first dose of study treatment.\n   * Whole brain radiotherapy (WBRT) within 21 days before the first dose of study treatment.\n   * Use of checkpoint inhibitor, bevacizumab, and\u002For capecitabine within 6 months before the first dose of study treatment.\n4. HR-Positive\u002FHER2-Negative Cohort Exclusion Criteria\n\n   * More than one prior line of palliative chemotherapy.\n   * Progressive CNS disease. Patients with progressive CNS disease should be enrolled into the CNS cohort instead.","21 Years",{"count":51,"type":21},154,[24,25],"This study is designed to establish the safety of the combination of PD-1 inhibitor tislelizumab, an anti-angiogenic agent bevacizumab and a chemotherapeutic agent capecitabine, in a phase Ib setting and to evaluate preliminary efficacy in selected expansion cohorts, including PD-L1-negative metastatic triple negative breast cancer (TNBC) and patients with active CNS disease. A sequential approach to cohort expansion will allow further evaluation in hormone receptor positive (HR+), HER2 negative (HER2-) disease if a signal of activity is observed in PD-L1 negative TNBC.",[55,28,56,57],"Advanced Solid Tumor Cancer","CNS Disease","Breast Cancer",[59,60,61,57,62,63,28],"Tislelizumab","Bevacizumab","Capecitabine","Advanced Solid Tumour Cancer","CNS disease","2026-06-26",{"date":66,"type":33},"2026-07-02",{"date":35,"type":21},{"date":69,"type":21},"2028-08",{"name":71,"class":40},"National University Hospital, Singapore",1,{"id":74,"slug":75,"hasResults":12,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":22,"phases":82,"briefSummary":83,"conditions":84,"keywords":92,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":72},"100642407","phase-1-phase-i-study-of-jfi447-68gaga-dfc413-and-comparison-to-ffg233-68gaga-nns309-in-patients-with-solid-tumors-100642407","NCT07630961","Phase I Study of JFI447 [68Ga]Ga-DFC413 and Comparison to FFG233 [68Ga]Ga-NNS309 in Patients With Solid Tumors","Phase I, Open Label First in Human Study to Evaluate the Imaging Characteristics, Safety, Biodistribution and Pharmacokinetics of JFI447 [68Ga]Ga-DFC413, and Compare to FFG233 [68Ga]Ga-NNS309 in Patients With Solid Tumors","Inclusion Criteria:\n\nPatients eligible for inclusion in this study must meet all of the following criteria:\n\n1. Signed informed consent must be obtained prior to participation in the study.\n2. Age ≥ 18 years old.\n3. ECOG performance status ≤ 2.\n4. Patients with one of the following indications (regardless of lines of prior therapy):\n\n   Locally advanced unresectable or metastatic PDAC, NSCLC, HR+\u002FHER2- ductal or lobular BC, TNBC, CRC or STS.\n5. Patients must have at least one measurable lesion per RECIST v1.1 as measured by local Investigator (by conventional MRI or CT scan).\n6. Patients must have an available archival tumor sample at the screening visit. If multiple archival tumor samples are available, the most recent will be requested. Exceptions may be made after documented discussion with Novartis.\n\nExclusion Criteria:\n\nPatients meeting any of the following criteria are not eligible for inclusion in this study:\n\n1. Out-of-range laboratory values defined as:\n\n   * Estimated glomerular filtration rate \\\u003C 60 mL\u002Fmin (calculated using CKD-EPI 2021 formula, or measured based on 24-hour urine collection)\n   * Total bilirubin \\> 1.5 x ULN (except for patients with Gilbert's syndrome who are excluded if total bilirubin \\> 3.0 x ULN) or direct bilirubin \\> 1.5 x ULN\n   * Alanine aminotransferase (ALT) \\> 3.0 x ULN, except for patients with tumor involvement of the liver who are excluded if ALT \\> 5.0 x ULN\n   * Aspartate aminotransferase (AST) \\> 3.0 x ULN, except for patients with tumor involvement of the liver who are excluded if AST \\> 5.0 x ULN\n   * Absolute Neutrophil Count \\\u003C 1.0 x 109\u002FL\n   * Hemoglobin \\\u003C 9 g\u002FdL\n   * Platelet count \\\u003C 75 x 109\u002FL\n2. Unmanageable urinary tract obstruction or urinary incontinence. If ureteral obstruction can be managed with the placement of ureteral stents, this exclusion criterion does not apply.\n3. Known hypersensitivity to 68Ga-DFC413 or 68Ga-NNS309 or their excipients.\n4. Any serious uncontrolled infection (acute or chronic), such as, but not limited to, bacterial, viral or fungal infections, confirmed by clinical evidence, imaging, and\u002For relevant positive laboratory tests (e.g., blood cultures, PCR for DNA\u002FRNA). If a serious infection develops, it must resolve or be adequately controlled prior to 68Ga-DFC413 and\u002For 68Ga-NNS309 initiation.\n5. Surgery or major invasive procedure within 4 weeks prior to 68Ga-DFC413 or 68Ga-NNS309 administration or between the two imaging agents.\n6. Radiation therapy within 2 weeks prior to 68Ga-DFC413 or 68Ga-NNS309 administration or between the two imaging agents.\n7. Change in anticancer therapy within 2 weeks prior to 68Ga-DFC413 or 68Ga-NNS309 administration or between the two imaging agents.\n8. Radiological contrast administration within 48 hours prior to 68Ga-DFC413 or 68Ga-NNS309 administration.\n9. Initiation or increasing doses of corticosteroids, TGF-β signaling inhibitors or immunomodulators within 2 weeks prior to 68Ga-DFC413 or 68Ga-NNS309 administration or between the two imaging agents.\n10. Known additional malignancy that is progressing or requires active treatment.\n11. Inability to complete the required investigational and standard imaging examinations due to any reason (e.g., severe claustrophobia, inability to lie still for the entire imaging time).\n12. Presence of CTCAE version 5.0 ≥ Grade 2 toxicity due to prior cancer therapy, except for neuropathy (inclusion of patients with neuropathy of ≤ Grade 2 is permitted) and alopecia.\n13. Any medical condition that would, in the Investigator's judgment, prevent the patient's participation in the clinical study due to safety concerns, compliance with clinical study procedures (including radiation safety precautions), or interpretation of study results.\n14. Pregnant women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test.\n15. Nursing (breast-feeding) women. Women who do not breast feed for 12 hours after 68Ga-DFC413 and\u002For 68Ga-NNS309 administration, but express and discard breast milk, are eligible.\n16. Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, unless they use highly effective methods of contraception (failure rate \\\u003C1% per year) for 12 hours after the administered radioactive dose of 68Ga-DFC413 and 68Ga-NNS309.\n\n    Women are considered post-menopausal if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. hormonal profile confirming menopause and\u002For age-appropriate history of vasomotor symptoms).\n\n    Highly effective contraception methods include:\n    * Total abstinence (when this is in line with the preferred and usual lifestyle of the patient). Note that periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.\n    * Bilateral tubal ligation, female sterilization (have had bilateral oophorectomy with or without hysterectomy), total hysterectomy or bilateral salpingectomy at least six weeks before taking 68Ga-DFC413 or 68Ga-NNS309. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment are they considered to be not of childbearing potential.\n    * Male sterilization (at least 6 months prior to screening). For female patients on the study, the vasectomized male partner should be the sole partner for that patient.\n    * Use of oral (estrogen and progesterone), injected, or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS), or other forms of hormonal contraception that have comparable efficacy (failure rate \\\u003C 1%), for example, hormone vaginal ring or transdermal hormone contraception. In case of use of oral contraception, women should have been stable on the same pill for a minimum of 3 months before taking study treatment.\n\n    If local regulations deviate from the contraception methods listed above to prevent pregnancy, local regulations apply and will be described in the informed consent (IC).\n17. Sexually active males unwilling to use a condom during intercourse for 12 hours after the administered radioactive dose of 68Ga-DFC413 and 68Ga-NNS309. A condom is required for all sexually active male patients to prevent them from fathering a child and\u002For to prevent delivery of study treatment via seminal fluid to their partner. In addition, male patients must not donate sperm for the time period specified above. If local regulations deviate from the contraception methods listed above to prevent pregnancy, local regulations apply and will be described in the IC.\n\nOther protocol-defined inclusion\u002Fexclusioncriteria may apply.",{"count":81,"type":21},66,[24],"The purpose of Part 1 of this study is to evaluate the imaging characteristics, safety, biodistribution and pharmacokinetics of \\[68Ga\\]Ga-DFC413, and in Part 2 compare to \\[68Ga\\]Ga-NNS309 in patients with locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC), non-small cell lung cancer (NSCLC), HR+\u002FHER2- ductal and lobular breast cancer (BC), triple negative breast cancer (TNBC), colorectal cancer (CRC), and soft tissue sarcoma (STS). In Part 2 of this study (comparison of \\[68Ga\\]Ga-DFC413 and \\[68Ga\\]Ga-NNS309), not all indications might be explored.",[85,86,87,88,89,90,91],"Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)","Non-small Cell Lung Cancer (NSCLC)","HR+\u002FHER2- Ductal Breast Cancer (BC)","HR+\u002FHER2- Lobular Breast Cancer (BC)","Triple Negative Breast Cancer (TNBC)","Colorectal Cancer (CRC)","Soft Tissue Sarcoma (STS)",[93,94,95,96,97,98,99,100],"metastatic pancreatic ductal adenocarcinoma (PDAC)","non-small cell lung cancer (NSCLC)","HR+\u002FHER2- ductal breast cancer (BC)","HR+\u002FHER2- lobular breast cancer (BC)","triple negative breast cancer (TNBC)","colorectal cancer (CRC)","soft tissue sarcoma (STS)","radioligand imaging","RECRUITING","2026-06-25",{"date":64,"type":33},{"date":105,"type":33},"2026-06-23",{"date":107,"type":21},"2028-01-22",{"name":109,"class":110},"Novartis Pharmaceuticals","INDUSTRY",{"id":112,"slug":113,"hasResults":12,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":117,"eligibilityCriteria":118,"healthyVolunteers":12,"sex":119,"minAge":18,"maxAge":4,"enrollmentInfo":120,"targetDuration":4,"studyType":22,"phases":121,"briefSummary":122,"conditions":123,"keywords":124,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":133,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":138,"locationsCount":140},"100641604","phase-1-first-in-human-phase-1-study-of-a-self-amplifying-rna-vaccine-iti-5000-alone-or-in-combination-with-pembrolizumab-in-stage-ii---iii-triple-negative-breast-cancer-following-standard-therapy--vital-tnbc--100641604","NCT07652242","First-in-human, Phase 1 Study of a Self-amplifying RNA Vaccine (ITI-5000) Alone or in Combination With Pembrolizumab in Stage II-- III Triple Negative Breast Cancer Following Standard Therapy ( VITAL-TNBC )","A Phase 1, Multicenter, Open-label, First-in-Human Study of ITI-5000 (Self-Amplifying RNA Vaccine) Alone and in Combination With Pembrolizumab in Participants With Stage II-III Triple-Negative Breast Cancer (TNBC) Who Have Completed Standard Curative Intent Therapy (VITAL-TNBC Study)","VITAL-TNBC","Inclusion Criteria:\n\n* Age: Adults aged 18 years or over.\n* Consent: Provided a signed and dated informed consent form (ICF).\n* Diagnosis: Histologically confirmed stage 2-3 triple-negative breast cancer (TNBC), defined as HER2-negative, ER-negative, and PgR-negative by immunohistochemistry. BRCA mutations are allowed.\n* Prior Treatment: Completed all planned standard therapy (surgery, chemotherapy, radiation, and\u002For pembrolizumab as applicable) and be within 36 months of definitive surgery.\n* Performance Status: ECOG performance status of 0 or 1.\n* Organ Function: Adequate organ function at baseline (hematology, biochemistry, etc.).\n* Cardiac Function: No significant ischemic heart disease or myocardial infarction within 3 months before vaccination #1; QTc ≤470 msec for females or ≤450 msec for males.\n* Pregnancy: Women of childbearing potential must have a negative serum pregnancy test within 3 days before vaccination #1 and agree to use highly effective contraception during the study and for 123 (Part A) or 137 (Part B) days after last study drug.\n* Compliance: Able to attend required study visits and follow-up.\n* Understanding: Able to understand and provide signed informed consent per IRB\u002FIEC guidelines.\n* Vaccinations: Agrees not to receive routine vaccinations until at least 30 days after the last study vaccine.\n* Alternative Therapies: Agrees not to use alternative therapies from the time of informed consent through 30 days following vaccination #3.\n\nExclusion Criteria:\n\n* Part B only: Discontinued prior treatment with an immune checkpoint inhibitor (ICI) due to immune-related adverse events (irAEs).\n* Recent Surgery\u002FTherapy: Major surgery within 4 weeks before vaccination #1 or received cancer-directed therapy or investigational drug\u002Fdevice within 4 weeks or 5 half-lives before vaccination #1.\n* Part B only: Received other PD-1\u002FPD-L1 inhibitors (besides pembrolizumab) without proper washout.\n* Toxicities: Unresolved toxicities from prior immunotherapy or chemotherapy (must be ≤ Grade 1 or baseline, or deemed irreversible and not worsened by immunotherapy).\n* Medical Illness: Significant medical illness, underlying health condition, or abnormal laboratory finding increasing risk.\n* Autoimmune Disease: Active autoimmune disease requiring immunosuppressive treatment within the last year.\n* Pregnancy\u002FLactation: Female participants trying to conceive, pregnant, or lactating.\n* Positive Pregnancy Test: Positive serum pregnancy test at screening or positive urine test at baseline.\n* Other Trials: Concurrent participation in any other interventional clinical trial.\n* Allergies: Known allergies to any components of the study vaccine.\n* Anaphylaxis: History of anaphylaxis requiring medical intervention (including severe reactions to other mRNA vaccines).\n* Cardiac History: History of stroke, transient ischemic attack, unstable angina, or myocardial infarction within 3 months prior to first dose.\n* Myocarditis\u002FPericarditis: History of myocarditis or pericarditis.\n* Heart Failure: Symptomatic congestive heart failure (NYHA Class III or IV), significant arrhythmia, or LVEF \\\u003C45%.\n* QT Risk: History of risk factors for torsade de pointes or use of QT-prolonging medications.\n* Vaccines: Received mRNA or live virus vaccine within 28 days of planned vaccination #1 (flu and COVID boosters prohibited in that window).\n* Prior Malignancy: Prior malignancy except adequately treated basal\u002Fsquamous cell skin cancer, in situ cervical cancer, or disease-free for ≥3 years.\n* Organ Transplant: History of organ transplant requiring immunosuppression; unstable HIV\u002FAIDS.\n* Hepatitis: Known active hepatitis B or C.\n* Compliance: Unable or unwilling to comply with study schedule\u002Fprocedures.\n* Injection\u002FBlood Draw: Contraindication to IM injections or blood draws.","FEMALE",{"count":20,"type":21},[24],"This study tests an investigational cancer vaccine called ITI-5000 in people who have completed standard treatment for early-stage triple-negative breast cancer (TNBC).\n\nITI-5000 is a self-amplifying RNA (saRNA) vaccine that instructs the immune system to recognize and attack cancer cells expressing two proteins found on TNBC cells-HERV-K and CT83-fused with a molecule called LAMP-1 that helps the immune system respond more strongly. The vaccine is delivered inside lipid nanoparticles (LNPs), similar to other approved mRNA vaccines.\n\nThe study has two parts:\n\n* Part A: Participants receive ITI-5000 alone at one of two dose levels (1 µg or 10 µg), given as an injection into the upper arm muscle every 28 days for 3 doses total. The goal is to find the safest dose.\n* Part B: Participants receive ITI-5000 at the best dose identified in Part A, combined with an approved immunotherapy drug called pembrolizumab (Keytruda®), every 21 days for 3 doses total.",[89],[125,126,127,128,129,130,131,132],"TNBC","saRNA","Pembrolizumab","Phase I Clinical Trial","Immunotherapy","HERV-K","First in Human (FIH)","CT83",{"date":134,"type":33},"2026-06-29",{"date":136,"type":21},"2026-06",{"date":69,"type":21},{"name":139,"class":110},"Immunomic Therapeutics, Inc.",2,{"id":142,"slug":143,"hasResults":12,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":4,"eligibilityCriteria":147,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":148,"targetDuration":4,"studyType":22,"phases":150,"briefSummary":151,"conditions":152,"keywords":156,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":172,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":179},"100595203","phase-1-a-study-with-nkt5097-for-adults-with-advancedmetastatic-solid-tumors-100595203","NCT07029399","A Study With NKT5097 for Adults With Advanced\u002FMetastatic Solid Tumors","A Phase 1, First-in-Human, Open-Label Study to Evaluate the Safety, Tolerability, PK, and Preliminary Anti-tumor Activity of the Novel Oral Selective CDK2\u002FCDK4 Dual Degrader NKT5097 in Adults With Advanced\u002FMetastatic Solid Tumors","Inclusion Criteria:\n\n* Able to provide written informed consent\n* Advanced unresectable or metastatic solid tumor (Part 1, 2 \\& 3 only)\n* Advanced unresectable or metastatic HR+\u002FHER2- breast cancer (Part 4 \\& 5 only)\n* Refractory to or unable to tolerate existing therapies (Part 1, 2 \\& 4 only)\n* Measurable or evaluable disease (Part 1, 2, \\& 4 only).\n* Measurable disease (Part 3 \\& 5 only)\n* Eighteen years of age or older\n* ECOG status of 0 or 1\n* Adequate organ function\n* Patients with female reproductive organs must be surgically sterile, post- menopausal or willing to use effective contraception per protocol\n* Patients who are capable of insemination must be willing to use highly effective contraception and to refrain from sperm donation during treatment and for 28 days after the last dose\n* Able to swallow oral meds\n* Willing to provide tumor tissue\n\nExclusion Criteria:\n\n* Advanced solid tumor that is a candidate for curative treatment\n* History of another malignancy except for the following: adequately treated local basal cell or squamous carcinoma of the skin, in situ cervical cancer, adequately treated papillary noninvasive bladder cancer, other adequately treated Stage I or Stage II cancers currently in complete remission\n* Not recovered from the effects of prior anticancer therapy\n* Clinically significant cardiovascular event, including myocardial infarction, arterial thromboembolism, or cerebrovascular thromboembolism, within 6 months\n* Known active CNS metastases and\u002For carcinomatous meningitis\n* Active interstitial lung disease requiring treatment\n* History of uveitis, retinopathy, or other clinically significant retinal disease\n* Major surgery within 30 days of administration of first dose\n* Active uncontrolled infectious disease\n* Significant liver disease (Child Pugh class B or C)\n* Should not have received any prior selective investigational inhibitors or degraders (Part 5 only)",{"count":149,"type":21},361,[24],"The goal of this open-label dose escalation and expansion study is to evaluate the safety and tolerability of NKT5097 in adults with advanced\u002Fmetastatic tumors (emphasis on breast cancer and solid tumors with CCNE1 amplification). Main questions to answer include:\n\n* What is the recommended dose for expansion and\u002For Phase 2, for both monotherapy and in combination with ET\n* What medical issues\u002Fsymptoms do participants experience when taking NKT5097 as monotherapy as well as in combination with ET",[153,89,154,155],"HR+ Breast Cancer","CCNE1 Amplified Advanced Solid Tumors","HR+ HER2- Breast Cancer",[157,158,159,125,160,161,162,163,164,165,166,167,168,169,170,171],"CCNE1","cyclin E1","triple negative breast cancer","estrogen receptor positive","HER2-","breast cancer","post CDK4\u002F6i","HER2 expression","Fulvestrant","Letrozole","endocrine therapy","refractory","endocrine resistant","endocrine sensitivity","metastatic",{"date":64,"type":33},{"date":174,"type":33},"2025-03-25",{"date":176,"type":21},"2027-12-31",{"name":178,"class":110},"NiKang Therapeutics, Inc.",18,{"id":181,"slug":182,"hasResults":12,"nctId":183,"briefTitle":184,"officialTitle":185,"acronym":186,"eligibilityCriteria":187,"healthyVolunteers":12,"sex":119,"minAge":18,"maxAge":188,"enrollmentInfo":189,"targetDuration":4,"studyType":22,"phases":191,"briefSummary":193,"conditions":194,"keywords":195,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":196,"lastUpdatePostDateStruct":197,"startDateStruct":198,"completionDateStruct":200,"leadSponsor":202,"locationsCount":4},"100643891","phase-3-an-open-label-randomized-phase-iii-study-of-trastuzumab-rezetecan-with-or-without-bevacizumab-in-first-to-third-line-blis-subtype-tnbc-100643891","NCT07669610","An Open-Label, Randomized Phase III Study of Trastuzumab Rezetecan With or Without Bevacizumab in First to Third Line BLIS Subtype TNBC","A Randomized Phase III Study of Trastuzumab Rezetecan With or Without Bevacizumab as First- to Third-Line Treatment for Basal-like Immune-suppressed Triple-Negative Breast Cancer","TRIBE","Inclusion Criteria:\n\n1. Female patients aged ≥18 years and ≤70 years;\n2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1;\n3. Life expectancy of at least 3 months;\n4. Histologically confirmed invasive triple-negative breast cancer (defined as breast cancer with estrogen receptor \\[ER\\], progesterone receptor \\[PR\\], and human epidermal growth factor receptor 2 \\[HER-2\\] all determined to be negative by pathological testing. Specifically: ER-negative: IHC \\\u003C1%; PR-negative: IHC \\\u003C1%; HER2-negative: IHC -\u002F+ or IHC ++ with FISH\u002FCISH negative. All specimens must be verified as the BLIS subtype of the Fudan quadruple molecular classification by the Precision Medicine Center\u002FDepartment of Pathology at the study's participating center);\n5. Tumor stage: recurrent or metastatic breast cancer; for locally recurrent disease, radical surgical resection must be confirmed by the investigator to be not feasible. Number of prior lines of therapy in the advanced setting ≤2;\n6. Patients must have at least one lesion (measurable and\u002For non-measurable) that has not been previously irradiated, can be accurately assessed at baseline by CT\u002FMRI, and can be repeatedly evaluated according to RECIST 1.1;\n7. Adequate major organ function, meeting the following criteria:\n\n   Hematological parameters: hemoglobin (HB) ≥90 g\u002FL (without blood transfusion within 14 days); absolute neutrophil count (ANC) ≥1.5×10⁹\u002FL; platelet count (PLT) ≥75×10⁹\u002FL;Biochemical parameters: total bilirubin (TBIL) ≤1.5× upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3×ULN; in the presence of liver metastases, ALT and AST ≤5×ULN; serum creatinine (Cr) ≤1×ULN, and calculated creatinine clearance \\>50 mL\u002Fmin (Cockcroft-Gault formula);\n8. No prior radiotherapy, endocrine therapy, molecular targeted therapy, or surgery within 3 weeks before study initiation, and recovery from acute toxicities of prior treatment (if surgery was performed, the wound must be completely healed); no peripheral neuropathy or only grade I peripheral neurotoxicity;\n9. Female subjects of childbearing potential must agree to use a medically accepted contraceptive method during the study treatment period and for at least 3 months after the last dose of study drug;\n10. Subjects must voluntarily participate in this study, sign the informed consent form, have good compliance, and be willing to cooperate with follow-up.\n\nExclusion Criteria:\n\n* Patients with any of the following criteria will be excluded from this study:\n\n  1. Known central nervous system (CNS) metastases or a history of CNS metastases prior to screening. For patients with clinically suspected CNS metastases, contrast-enhanced CT or contrast-enhanced magnetic resonance imaging (MRI) must be performed within 28 days before the first dose to rule out CNS metastases;\n  2. History of clinically significant or uncontrolled cardiac disease, including congestive heart failure, angina pectoris, myocardial infarction within the past 6 months, or ventricular arrhythmias;\n  3. Persistent adverse events of Grade ≥1 resulting from prior treatment. Exceptions to this are alopecia or conditions that the investigator deems should not preclude enrollment. Such cases should be clearly documented in the investigator's notes;\n  4. Major surgery (excluding minor procedures such as placement of vascular access) within 3 weeks before the first cycle of study treatment;\n  5. Pregnant or lactating patients;\n  6. Other malignancies within the past 5 years, excluding cured cervical carcinoma in situ, basal cell carcinoma of the skin, or squamous cell carcinoma of the skin;\n  7. Presence of third-space fluid accumulation (e.g., massive pleural effusion or ascites) that cannot be controlled by drainage or other methods;\n  8. Participation in another anti-tumor drug clinical trial within 3 weeks before the first use of the study drug;\n  9. Long-term unhealed wounds or incompletely healed fractures;\n  10. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, or HBV DNA ≥500 IU\u002FmL, or chronic hepatitis with abnormal liver function;\n  11. History of allergic constitution, known allergy to any component of the study drug regimen, or history of allergy to other monoclonal antibodies;\n  12. History of gastrointestinal bleeding within the past 6 months, or clear evidence of a tendency for gastrointestinal bleeding, such as esophageal varices at risk of bleeding, active local ulcerative lesions, or fecal occult blood test ≥ (++). Patients with fecal occult blood test (+) should undergo gastroscopy;\n  13. Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days prior to study enrollment;\n  14. Urinalysis showing urine protein ≥ (++), or confirmed 24-hour urine protein quantification \\>1.0 g;\n  15. Hypertension that cannot be controlled to within normal range with antihypertensive medication (systolic blood pressure \\>140 mmHg, diastolic blood pressure \\>90 mmHg);\n  16. Prior use of anti-angiogenic agents or prior exposure to an antibody-drug conjugate (ADC) with a topoisomerase I inhibitor as the payload","70 Years",{"count":190,"type":21},140,[192],"PHASE3","This study is a prospective, open-label, phase III, randomized controlled clinical trial. It is planned to screen patients with inoperable locally advanced or metastatic triple-negative breast cancer of the BLIS subtype. A total of 140 patients are planned to be enrolled.",[57,89],[159],"2026-06-20",{"date":102,"type":33},{"date":199,"type":21},"2026-10-01",{"date":201,"type":21},"2029-03-30",{"name":203,"class":40},"Fudan University",{"id":205,"slug":206,"hasResults":12,"nctId":207,"briefTitle":208,"officialTitle":209,"acronym":4,"eligibilityCriteria":210,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":211,"targetDuration":4,"studyType":22,"phases":213,"briefSummary":214,"conditions":215,"keywords":218,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":224,"completionDateStruct":226,"leadSponsor":228,"locationsCount":4},"100637942","phase-1-oral-zn-telomir-monotherapy-in-patients-with-advanced-or-metastatic-triple-negative-breast-cancer-tnbc-100637942","NCT07581314","Oral Zn-Telomir Monotherapy in Patients With Advanced or Metastatic Triple-Negative Breast Cancer (TNBC)","A First-in-Human (FIH), Phase I\u002FII, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), and Preliminary Antitumor Activity of Zn-Telomir Administered Orally as Monotherapy in Patients With Advanced or Metastatic Triple-Negative Breast Cancer (TNBC)","Inclusion Criteria:\n\n1. Clinically defined histologically or cytologically confirmed triple-negative breast cancer (TNBC)\n2. Locally advanced unresectable or metastatic disease\n3. Must have completed prior anticancer therapy discontinued for a least 28 days\n4. Disease progression after prior systemic therapy for advanced\u002Fmetastatic TNBC\n5. At least one measurable lesion (tumor)\n6. Age ≥18 years\n7. Life expectancy ≥12 weeks\n8. Agreement to use highly effective contraception during study and for 3 months after treatment\n9. Ability to understand and sign informed consent\n\nExclusion Criteria:\n\n1. HER2-positive or hormone receptor-positive breast cancer\n2. Active leptomeningeal disease\n3. Uncontrolled, symptomatic CNS metastases\n4. Concurrent participation in another interventional clinical trial\n5. Clinically significant cardiovascular disease\n6. Uncontrolled infection requiring systemic therapy\n7. Known Human Immunodeficiency Virus (HIV) with detectable viral load \\>400 copies\u002FmL\n8. Active hepatitis B virus (HBV) infection or active hepatitis C virus (HCV)\n9. Significant Gastrointestinal (GI) disorders\n10. Active bleeding disorders or coagulopathy\n11. Pregnancy or breastfeeding",{"count":212,"type":21},76,[24,25],"This is a first-in-human, multicenter, open-label Phase I\u002FII study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of oral Zn-Telomir monotherapy in adults with advanced or metastatic triple-negative breast cancer. Phase I uses a modified 3+3 dose-escalation design to determine safety, tolerability, maximum tolerated dose, and recommended Phase II dose. Phase II uses a Simon two-stage expansion design at the recommended Phase II dose to evaluate preliminary antitumor activity, including objective response rate per Response Evaluation Criteria in Solid Tumors.",[28,216,217],"Advanced Triple-Negative Breast Cancer","Metastatic Triple-negative Breast Cancer",[219,220,125,221],"Triple-Negative Breast Cancer","Zn-Telomir","Metastatic Breast Cancer","2026-06-18",{"date":105,"type":33},{"date":225,"type":21},"2026-10",{"date":227,"type":21},"2027-11",{"name":229,"class":110},"Telomir Pharmaceuticals, Inc.",{"id":231,"slug":232,"hasResults":12,"nctId":233,"briefTitle":234,"officialTitle":235,"acronym":4,"eligibilityCriteria":236,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":237,"targetDuration":4,"studyType":22,"phases":239,"briefSummary":240,"conditions":241,"keywords":4,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":248,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":254,"locationsCount":256},"100557993","phase-1-study-of-xb010-in-subjects-with-solid-tumors-100557993","NCT06545331","Study of XB010 in Subjects With Solid Tumors","A Dose-Escalation and Expansion Study of XB010 as a Single Agent and Combination Therapy in Subjects With Locally Advanced or Metastatic Solid Tumors","* Age 18 years or older on the day of consent.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.\n* Adequate organ and marrow function.\n* Cytologically or histologically and radiologically confirmed solid tumor that is inoperable, locally advanced, metastatic, or recurrent.\n\n  * The Cohort Expansion stage will enroll subjects with multiple tumor types (non-small cell lung cancer, hormone-receptor-positive breast cancer, head and neck cancer, esophageal squamous cell, triple-negative breast cancer).\n* Capable of understanding and complying with the protocol requirements and must have signed the informed consent document.",{"count":238,"type":21},396,[24],"This is a FIH study is to evaluate the safety, tolerability, PK, immunogenicity, and preliminary antitumor activity of XB010 as a single agent and in combination with pembrolizumab in subjects with locally advanced or metastatic solid tumors for whom alternative therapies do not exist or available therapies are intolerable or no longer effective.",[242,243,244,245,246,89],"Locally Advanced or Metastatic Solid Tumors","Esophageal Squamous Cell Cancer","Head and Neck Squamous Cell Cancer","NSCLC (Non-small Cell Lung Cancer)","Hormone-receptor-positive Breast Cancer","2026-06-17",{"date":249,"type":33},"2026-06-22",{"date":251,"type":33},"2024-08-06",{"date":253,"type":21},"2027-10-20",{"name":255,"class":110},"Exelixis",20,{"id":258,"slug":259,"hasResults":12,"nctId":260,"briefTitle":261,"officialTitle":262,"acronym":263,"eligibilityCriteria":264,"healthyVolunteers":12,"sex":119,"minAge":18,"maxAge":4,"enrollmentInfo":265,"targetDuration":4,"studyType":267,"phases":4,"briefSummary":268,"conditions":269,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":271,"lastUpdatePostDateStruct":272,"startDateStruct":273,"completionDateStruct":275,"leadSponsor":277,"locationsCount":4},"100644318","circulating-tumor-dna-dynamics-to-optimize-neoadjuvant-therapy-in-her2-positive-and-triple-negative-breast-cancer-100644318","NCT07662252","Circulating Tumor DNA Dynamics to Optimize Neoadjuvant Therapy in HER2-Positive and Triple-Negative Breast Cancer","Evaluation of Circulating Tumor DNA Dynamics for Treatment Optimization in Stage II-III HER2-Positive and Triple-Negative Breast Cancer Candidate to NAT","NEOSHED","Inclusion Criteria:\n\n* Patients with documented stage II-III HER2+ or TNBC and fit candidates for NAT. 2. In TNBC group, confirmed negative ER, PR and HER2 disease by local testing on primary disease specimen: tumor must be negative ER, PR, and HER2 defined by immunohistochemistry (IHC) according to the American Society of Clinical Oncology (ASCO)\u002FCollege of American Pathologists (CAP) guidelines for hormone receptor testing (Allison et al., 2020; Wolff et al., 2023). 3. In HER2+ group, Confirmed HER2+ disease by local testing on primary disease specimen: tumour must be HER2+ according to ASCO\u002FCAP 2023 guidelines for HER2 testing (Wolff et al., 2023). 4. Patients with measurable disease; Patients with multifocal or multicentric breast cancer with at least one tumor lesion ≥1.0 cm in the longest diameter by ultrasound (reference lesion) are also eligible if the two largest tumor lesions have been histologically confirmed in the clinical evaluation and meet pathological criteria for TNBC and HER2+. 5. No previous treatment of the disease by chemotherapy, hormone therapy, surgery or radiotherapy. 6. Patients with breast cancer are eligible for surgery. 7. Eastern Cooperative Oncology Group (ECOG) performance status≤2.\n\nExclusion Criteria:\n\n* 1\\. Patients with bilateral invasive BC. 2. Patients with metastatic BC (local spread to axillary lymph nodes is permitted (cN1\\_cN2a).\n\n  3\\. Patients with inflammatory BC. 4. Patients with a known clinically significant history of liver disease consistent with Child-Pugh Class B or C, including hepatitis. 5. Patients with a history of invasive BC, ductal carcinoma in situ or lobular carcinoma in situ, and other malignancy within 5 years prior to screening. 6. Patients with a documented history of haemorrhagic diathesis, coagulopathy, or thromboembolism. 7. Patients with known allergy or hypersensitivity to any of the study drugs or any of their excipients. 8. Patients with history of non-compliance to medical regimens. 9. Patients refusing to perform liquid and tissue biopsy. 10. Patients unwilling to or unable to comply with the protocol. 11. Patients having had major surgery within 14 days prior to screening. 12. Pregnant or lactating females prior to treatment. 13. Patients should be excluded if they have a known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).",{"count":266,"type":21},186,"OBSERVATIONAL","The purpose of this non-interventional, observational study is to evaluate the clinical utility of circulating tumor DNA (ctDNA) utility-specifically how quickly tumor DNA disappears from the bloodstream (ctDNA clearance)-to help monitor and predict treatment responses in patients with breast cancer.\n\nThe study focuses on patients diagnosed with Stage II to III HER2-positive or Triple-Negative Breast Cancer (TNBC) who are scheduled to receive standard neoadjuvant therapy (systemic treatment administered before surgery). Because these breast cancer subtypes involve different standard treatment regimens, the study prospectively stratifies patients into three distinct treatment cohorts (Cohorts A, B, and C) to match routine clinical practice and align blood sampling with meaningful clinical milestones.",[57,89,270],"HER2 + Breast Cancer","2026-06-16",{"date":105,"type":33},{"date":274,"type":21},"2026-07",{"date":276,"type":21},"2029-06",{"name":278,"class":40},"Federico II University",{"id":280,"slug":281,"hasResults":12,"nctId":282,"briefTitle":283,"officialTitle":284,"acronym":285,"eligibilityCriteria":286,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":287,"targetDuration":4,"studyType":22,"phases":289,"briefSummary":291,"conditions":292,"keywords":293,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":297,"lastUpdatePostDateStruct":298,"startDateStruct":300,"completionDateStruct":301,"leadSponsor":303,"locationsCount":72},"100632409","a-nurse-led-coping-and-supportive-intervention-for-patients-with-triple-negative-breast-cancer-100632409","NCT07513311","A Nurse-Led, Coping and Supportive Intervention for Patients With Triple-Negative Breast Cancer","Pilot Feasibility Trial of a Nurse-Led, Coping and Supportive Intervention (RESTORE) for Patients With Triple-Negative Breast Cancer","RESTORE","Inclusion Criteria:\n\n* Diagnosis of stage 1-3 triple-negative breast cancer\n* Age ≥ to 18 years\n* Between one and 12 months post curative therapy\n* Reporting distress at least 4\u002F10 on a one-item screener\n* Ability to read and respond in English or Spanish\n\nExclusion Criteria:\n\n* Patients with stage 4 cancer\n* Patients with impaired cognition or serious mental illness that would preclude participation in study procedures",{"count":288,"type":21},75,[290],"NA","The purpose of this study is to explore the feasibility and acceptability of a nurse-led, coping, and supportive care intervention for patients with triple-negative breast cancer. The intervention aims to improve psychosocial outcomes in patients with triple-negative breast cancer (e.g., quality of life (QOL), anxiety, fear of cancer recurrence (FCR)).",[89],[159,294,295,296],"coping","supportive care","nurse-led intervention","2026-06-11",{"date":299,"type":33},"2026-06-15",{"date":136,"type":21},{"date":302,"type":21},"2028-07-31",{"name":304,"class":40},"Massachusetts General Hospital",{"id":306,"slug":307,"hasResults":12,"nctId":308,"briefTitle":309,"officialTitle":310,"acronym":4,"eligibilityCriteria":311,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":312,"targetDuration":4,"studyType":22,"phases":314,"briefSummary":315,"conditions":316,"keywords":328,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":343,"lastUpdatePostDateStruct":344,"startDateStruct":346,"completionDateStruct":348,"leadSponsor":350,"locationsCount":352},"100632708","phase-1-dose-determining-study-of-exs74539-rec-4539-in-participants-with-select-solid-tumors-100632708","NCT07517198","Dose Determining Study of EXS74539 (REC-4539) in Participants With Select Solid Tumors","A Phase 1, Multicenter, Open-Label, Dose-Escalation Study to Assess Safety, Tolerability, and Efficacy of EXS74539 as Monotherapy in Participants With Select Solid Tumors","Key Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n* Histologically confirmed diagnosis of the following solid tumors:\n\n  * SCLC\n  * High grade neuroendocrine or small cell carcinomas of non-lung origin\n  * Non-small cell lung cancer \\[NSCLC\\]\n  * Prostate cancer\n  * Ovarian cancer\n  * Renal carcinoma \\[clear and non-clear cell\\]\n  * Head and neck squamous cell carcinoma\n  * Hepatic cancer\n  * Gastric cancer\n  * Triple-negative breast cancer \\[TNBC\\]\n* Participant disease should have progressed, relapsed or the participants should have been intolerant to at least one prior standard systemic therapy for their respective underlying malignancy.\n* Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.\n\nKey Exclusion Criteria:\n\n* Any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the participant's safety or ability to participate in the study.\n* Symptomatic brain metastases, leptomeningeal metastases, or spinal cord compression due to disease. Participants with brain metastases must be clinically stable and off corticosteroids and anticonvulsants for ≥1 month prior to study treatment and not require any specific intervention for brain metastases.\n* Active and clinically significant infection requiring systemic antibacterial, antiviral, or antifungal therapy \\\u003C7 days of the first scheduled dose of the study treatment.\n* Significant cardiac abnormalities.\n* Major surgery within 28 days prior to the start of study treatment.\n\nNote: Other protocol-defined inclusion and exclusion criteria may apply.",{"count":313,"type":21},40,[24],"The primary purpose of this study is to determine the safety, tolerability, and maximum tolerated dose (MTD) of EXS74539 (REC-4539) in participants with select solid tumors.",[317,318,319,320,86,321,322,323,324,325,326,327],"Solid Tumor","Small Cell Lung Cancer (SCLC)","High Grade Neuroendocrine Cancer","Small Cell Carcinomas of Non-lung Origin","Prostate Cancer","Ovarian Cancer","Renal Carcinoma (Clear and Non-clear Cell)","Head and Neck Squamous Cell Carcinoma (HNSCC)","Hepatic Cancer","Gastric Cancer","Triple-negative Breast Cancer (TNBC)",[329,318,330,331,332,333,334,335,336,337,338,339,340,341,342],"Solid Tumors","High grade neuroendocrine cancer","Small cell carcinomas of non-lung origin","Non-small cell lung cancer (NSCLC)","Prostate cancer","Ovarian cancer","Renal carcinoma (clear and non-clear cell)","Head and neck squamous cell carcinoma (HNSCC)","Hepatic cancer","Gastric cancer","Triple-negative breast cancer (TNBC)","LSD1 inhibitor","EXS74539","REC-4539","2026-06-09",{"date":345,"type":33},"2026-06-10",{"date":347,"type":33},"2026-04-13",{"date":349,"type":21},"2029-03",{"name":351,"class":110},"Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc.",3,{"id":354,"slug":355,"hasResults":12,"nctId":356,"briefTitle":357,"officialTitle":358,"acronym":359,"eligibilityCriteria":360,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":361,"targetDuration":4,"studyType":267,"phases":4,"briefSummary":363,"conditions":364,"keywords":380,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":385,"lastUpdatePostDateStruct":386,"startDateStruct":388,"completionDateStruct":390,"leadSponsor":392,"locationsCount":394},"100437810","solid-tumor-analysis-for-hla-loss-of-heterozygosity-loh-and-apheresis-for-car-t--cell-manufacturing-100437810","NCT04981119","Solid Tumor Analysis for HLA Loss of Heterozygosity (LOH) and Apheresis for CAR T- Cell Manufacturing","An Observational Study Obtaining Solid Tumor Tissue From Participants and Apheresis for CAR T-Cell Therapy Manufacturing","BASECAMP-1","Key Eligibility Criteria (additional criteria may apply) Part 1 Key Inclusion Criteria\n\n1\\. Pathologically confirmed solid tumors, e.g., Colorectal Cancer (CRC), Non-Small Cell Lung Cancer (NSCLC), or Pancreatic Cancer (PANC), that is metastatic, unresectable locally advanced, or in the Investigator's opinion the subject is high risk for incurable relapse within two years.\n\nPart 1: Key Exclusion Criteria\n\n1. History of any of other malignancy in the past 5 years other than non-melanoma skin carcinoma, low grade localized prostate cancer, superficial bladder cancer, ductal carcinoma in situ (CIS) of the breast, CIS of the Cervix, or Stage I uterine cancer.\n2. Prior allogeneic stem cell transplant.\n3. Prior solid organ transplant.\n\nPart 2 : Key Inclusion Criteria\n\n1. Pathologically confirmed solid tumors, e.g., Colorectal Cancer (CRC), Non-Small Cell Lung Cancer (NSCLC), Pancreatic Cancer (PANC), Mesothelioma, or Ovarian Cancer (OVAC) that is metastatic, unresectable locally advanced, or in the Investigator's opinion the subject is high risk for incurable relapse within two years.\n2. Participants are germline HLA-A\\*02 heterozygous confirmed by HLA typing.\n3. Primary tumor tissue showing LOH of HLA-A\\*02 by NGS testing.\n4. Eastern Cooperative Oncology Group (ECOG) 0 or 1 performance status.\n\nPart 2: Key Exclusion Criteria\n\n1. History of any of other malignancy in the past 5 years other than non-melanoma skin carcinoma, low grade localized prostate cancer, superficial bladder cancer, ductal carcinoma in situ (CIS) of the breast, CIS of the Cervix, or Stage I uterine cancer.\n2. Prior allogeneic stem cell transplant.\n3. Prior solid organ transplant.\n4. Participants who have received any cancer therapy on any investigational therapy for any indication, including but not limited to chemotherapy, small molecules, monoclonal antibodies, or radiotherapy (with bone marrow impact) within 2 weeks of planned apheresis or 3 half-lives, whichever is shorter.\n5. Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment necessitating specific treatment, or any major episode of infection requiring treatment with Intravenous (IV) antimicrobials (e.g., IV antibiotics) or hospitalization (relating to completion of antibiotic course).\n6. Has known active central nervous system metastases. Subjects with previously treated brain metastases may participate upon medical monitor agreement.\n7. In the Investigator's judgement, any other condition or reason the subject would not complete the required study visits and procedures, and follow up visits, or comply with the study requirements for participation.",{"count":362,"type":21},200,"Objective:\n\nTo collect information on how often a solid tumor cancer might lose the Human Leukocyte Antigen (HLA) by next generation sequencing and perform apheresis to collect and store an eligible participant's own T cells for future use to make CAR T-Cell therapy for their disease treatment.\n\nDesign:\n\nThis is a non-interventional, observational study to evaluate participants with solid tumors with a high risk of relapse for incurable disease. No interventional therapy will be administered on this study. Some of the information regarding the participant's tumor analysis may be beneficial to management of their disease. Participants that meet all criteria may be enrolled and leukapheresed (blood cells collected). The participant's cells will be processed and stored for potential manufacture of CAR T-cell therapy upon relapse of their cancer.",[365,366,367,368,369,370,371,372,322,373,374,375,376,377,89,378,379],"Solid Tumor, Adult","Colorectal Cancer","Non Small Cell Lung Cancer","Pancreatic Cancer","CRC","NSCLC","Pancreas Cancer","Mesothelioma","Ovarian Neoplasms","Ovarian Carcinoma","Mesothelioma, Malignant","Mesothelioma; Lung","Cancer","Renal Cell Carcinoma (Kidney Cancer)","Head and Neck Squamous Cell Carcinoma HNSCC",[381,382,383,384,129],"CAR T Cell Therapy","Next Generation Sequencing","Leukapheresis","Apheresis","2026-05-29",{"date":387,"type":33},"2026-06-02",{"date":389,"type":33},"2021-10-29",{"date":391,"type":21},"2029-04",{"name":393,"class":110},"A2 Biotherapeutics Inc.",16,{"id":396,"slug":397,"hasResults":12,"nctId":398,"briefTitle":399,"officialTitle":400,"acronym":401,"eligibilityCriteria":402,"healthyVolunteers":12,"sex":119,"minAge":18,"maxAge":188,"enrollmentInfo":403,"targetDuration":4,"studyType":22,"phases":405,"briefSummary":406,"conditions":407,"keywords":4,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":416,"lastUpdatePostDateStruct":417,"startDateStruct":419,"completionDateStruct":421,"leadSponsor":423,"locationsCount":72},"100484012","phase-2-fudan-university-shanghai-cancer-center-breast-cancer-precision-platform-series-study--neoadjuvant-therapy-100484012","NCT05582499","Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy","Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy (FASCINATE-N)","FASCINATE-N","Inclusion Criteria:\n\n* Histologically confirmed invasive breast cancer of clinical stage T1-4N1-3M0 or cT2-4N0M0;\n* Age between18-70 years;\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1;\n* ER, PR and HER2 status were measured by immunohistochemistry (IHC);\n* LVEF≥55%；\n* Definition of SNF subtypes: SNF subtypes confirmed by digital pathology of H\\&E slices;\n* Triple negative subtyping: On the basis of triple-negative pathological diagnosis, AR, cluster of differentiation 8 (CD8) and Forkhead Box C1 (FOXC1) were combined to define the subtyping;\n* At least one measurable lesion according to RECIST version 1.1\n* Normal organ and marrow function: Hemoglobin (HB) ≥90 g\u002FL (No blood was transfused within 14 days), Absolute neutrophil count ≥ 1500\u002FμL, Platelets ≥ 75,000\u002FμL, Total bilirubin ≤ 1.5 x ULN), aspartate aminotransferase (AST) (SGOT) and alanine aminotransferase (ALT) (SGPT) ≤ 3 x ULN, creatinine \\\u003C 1 x ULN, endogenous creatinine clearance \\> 50 ml\u002Fmin (Cockcroft-Gault formula);\n* Non-pregnant and non-lactating, fertile female subjects were required to use a medically approved contraceptive method for the duration of the study treatment and at least 3 months after the last use of the study drug;\n* Ability to understand and willingness to sign a written informed consent\n\nExclusion Criteria:\n\n* Previous cytotoxic chemotherapy, endocrine therapy, biological therapy or radiotherapy for any reason;\n* Patients with New York Heart Association (NYHA) grade II or above heart disease (including grade II);\n* Patients with severe systemic infections or other serious diseases;\n* Patients with known allergy or intolerance to the study drug or its excipients;\n* Other malignant tumors in the past 5 years, except cured cervical carcinoma in situ and non-melanoma skin cancer;\n* Pregnant or lactating patients of childbearing age who refused to take appropriate contraceptive measures during the course of the study;\n* Participated in other trial studies within 30 days before the administration of the first dose of the study drug;\n* Patients who were judged by the investigator to be unsuitable for this study.",{"count":404,"type":21},716,[25],"The purpose of this study is to establish a prospective, single-center platform research based on clinical subtypes to explore precision neoadjuvant therapy in patients with operable breast cancer who met the indications for neoadjuvant chemotherapy and by the update of basic translational research in the center, especially the refinement of typing, the discovery of new targets and the development of novel targeted drugs, verified the effectiveness of new targeted drugs in neoadjuvant therapy.",[408,57,409,28,410,411,412,413,414,415],"Breast Neoplasm","Breast Tumors","HER2-positive Breast Cancer","HER2-negative Breast Cancer","Hormone Receptor Positive Tumor","Hormone Receptor Negative Tumor","Early-stage Breast Cancer","Locally Advanced Breast Cancer","2026-05-22",{"date":418,"type":33},"2026-05-28",{"date":420,"type":33},"2022-11-01",{"date":422,"type":21},"2029-09",{"name":203,"class":40},{"id":425,"slug":426,"hasResults":12,"nctId":427,"briefTitle":428,"officialTitle":429,"acronym":4,"eligibilityCriteria":430,"healthyVolunteers":12,"sex":119,"minAge":18,"maxAge":188,"enrollmentInfo":431,"targetDuration":4,"studyType":22,"phases":433,"briefSummary":434,"conditions":435,"keywords":4,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":436,"lastUpdatePostDateStruct":437,"startDateStruct":439,"completionDateStruct":441,"leadSponsor":443,"locationsCount":72},"100623265","phase-2-neoadjuvant-study-of-hifu-with-or-without-pd-1-inhibitors-followed-by-abraxane-plus-carboplatin-in-triple-negative-breast-cancer-100623265","NCT07394387","Neoadjuvant Study of HIFU With or Without PD-1 Inhibitors Followed by Abraxane Plus Carboplatin in Triple-Negative Breast Cancer.","A Single-Center, Phase II Clinical Study of HIFU With or Without PD-1 Inhibitors Followed by Abraxane Plus Carboplatin Neoadjuvant Therapy in Triple-Negative Breast Cancer.","Inclusion Criteria:\n\n1. Female patients aged ≥18 and ≤70 years.\n2. Histologically confirmed invasive breast cancer, classified as Stage II-III triple-negative breast cancer (TNBC) according to the 8th edition AJCC TNM staging.\n3. At least one measurable lesion as per RECIST v1.1 criteria.\n4. No prior chemotherapy, immunotherapy, endocrine therapy, radical surgery, or radiotherapy for breast cancer.\n5. ECOG performance status of 0 or 1.\n6. Adequate organ function, defined as:\n\n   * Hemoglobin ≥90 g\u002FL\n   * White blood cell count ≥3.5×10\\^9\u002FL\n   * Platelet count ≥100×10\\^9\u002FL\n   * Absolute neutrophil count ≥1.5×10\\^9\u002FL\n   * AST and ALT ≤3× upper limit of normal (ULN)\n   * Total bilirubin ≤1.5× ULN\n   * Serum creatinine ≤1.5× ULN\n   * No evidence of pneumonia on chest CT\n7. Adequate cardiac function, defined as:\n\n   * No myocardial ischemia on ECG\n   * NYHA class I\n   * LVEF ≥55% on echocardiogram\n   * Normal cardiac markers (cTnI and BNP)\n8. Normal thyroid function (T3, T4, FT3, FT4, TSH).\n9. Willing and able to provide written informed consent.\n\nExclusion Criteria:\n\n1. Male or inflammatory breast cancer.\n2. Metastatic (Stage IV) breast cancer.\n3. History of active autoimmune or inflammatory diseases requiring systemic treatment within the past 2 years (e.g., systemic lupus erythematosus, psoriasis, rheumatoid arthritis, inflammatory bowel disease, Hashimoto's thyroiditis). Exceptions: type I diabetes, hypothyroidism controlled with hormone replacement therapy, or skin disorders not requiring systemic treatment (e.g., vitiligo, psoriasis).\n4. Concurrent other malignancies or history of other malignancies within the past 5 years (except adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix).\n5. Any other serious non-malignant disease that may compromise compliance or place the patient at risk.\n6. Major surgery within 4 weeks prior to study initiation or anticipated need for major surgery during the study.\n7. Prior radiotherapy, chemotherapy, targeted therapy, endocrine therapy, or major surgery for breast cancer.\n8. Known hypersensitivity to any component of the study drugs.\n9. Poorly controlled cardiac disease (e.g., NYHA class II+ heart failure, unstable angina, myocardial infarction within the past year, or clinically significant arrhythmias requiring intervention).\n10. History of interstitial lung disease (ILD), current ILD, or suspected ILD on imaging during screening.\n11. Active infections, including:\n\n    * HIV positive\n    * Active tuberculosis\n    * Active hepatitis B (HBV-DNA \\> 10\\^3 IU\u002FmL)\n    * Active hepatitis C (HCV antibody positive with detectable HCV-RNA)\n12. Active autoimmune disease requiring systemic treatment.\n13. Dementia, significant intellectual impairment, or any psychiatric condition that impairs understanding of the informed consent.\n14. Unhealed wounds, ulcers, or fractures within 4 weeks prior to signing consent; or any history of clinically significant bleeding or bleeding tendency.\n15. Any other condition deemed by the investigator to be unsuitable for trial participation.",{"count":432,"type":21},58,[25],"Background:\n\nTriple-negative breast cancer (TNBC) is an aggressive type of breast cancer with limited treatment options. Research suggests that using High-Intensity Focused Ultrasound (HIFU) to destroy the tumor and\u002For PD-1 inhibitor drugs to activate the immune system before starting chemotherapy may improve treatment effectiveness. This study aims to investigate this new approach.\n\nObjective:\n\nTo evaluate the effectiveness and safety of using HIFU, with or without a PD-1 inhibitor (Sintilimab), before and during combination chemotherapy in patients with early-stage TNBC. The primary goal is to determine if this strategy can increase the rate of pathological complete response (pCR).\n\nStudy Design:\n\nThis is a single-center, Phase II clinical study. Approximately 40 participants with Stage II-III TNBC will be enrolled and assigned to one of two groups (cohorts) without randomization:\n\nCohort A: Receives HIFU treatment. Two weeks later, begins standard chemotherapy (Abraxane and carboplatin) combined with the PD-1 inhibitor Sintilimab for 6 cycles.\n\nCohort B: Receives HIFU treatment combined with a single dose of the PD-1 inhibitor Sintilimab. Two weeks later, begins the same 6 cycles of chemotherapy (Abraxane and carboplatin) combined with Sintilimab.\n\nMain Measures:\n\nThe primary measure is the rate of pathological complete response (pCR), defined as the absence of invasive cancer in the breast and lymph nodes after surgery following the completion of neoadjuvant therapy.\n\nOther important measures include:\n\nThe ability of the treatment to activate the immune system (measured by changes in CD8+ T cells or IFN-γ).\n\nThe percentage of patients whose tumors shrink significantly (Objective Response Rate).\n\nHow long patients live without their cancer getting worse (Event-Free Survival).\n\nThe rate of patients who can undergo breast-conserving surgery. The frequency and severity of side effects.",[89],"2026-05-13",{"date":438,"type":33},"2026-05-15",{"date":440,"type":33},"2025-01-01",{"date":442,"type":21},"2026-12-31",{"name":444,"class":40},"The First Affiliated Hospital with Nanjing Medical University",{"id":446,"slug":447,"hasResults":12,"nctId":448,"briefTitle":449,"officialTitle":449,"acronym":450,"eligibilityCriteria":451,"healthyVolunteers":12,"sex":119,"minAge":18,"maxAge":4,"enrollmentInfo":452,"targetDuration":4,"studyType":267,"phases":4,"briefSummary":453,"conditions":454,"keywords":455,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":458,"lastUpdatePostDateStruct":459,"startDateStruct":461,"completionDateStruct":463,"leadSponsor":465,"locationsCount":72},"100636810","predicting-response-to-immunochemotherapy-in-early-triple-negative-breast-cancer-100636810","NCT07570524","Predicting Response to Immunochemotherapy in Early Triple Negative Breast Cancer","PRIME-TNBC","Inclusion Criteria:\n\n* Female.\n* Age ≥ 18 years.\n* Histologically confirmed invasive triple-negative breast cancer (ER and PR \\\u003C 10% by IHC, HER2 0, 1+, or 2+ with negative SISH), stage II or III.\n* Eligible for neoadjuvant immunochemotherapy according to the Keynote-522 regimen.\n\nIndication for intra-tumoral clip placement.\n\n\\- Signed written informed consent\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women.\n* Hematoma requiring Grade II analgesics after diagnostic biopsy.\n* Known coagulation disorders.\n* Adults under guardianship, curatorship, or legal protection, or deprived of liberty.\n* Not affiliated with a social security system.",{"count":362,"type":21},"The goal of this clinical trial is to identify cellular and molecular determinants of response to neoadjuvant immunochemotherapy in women aged 18 or older with early-stage triple-negative breast cancer (TNBC). The main questions it aims to answer are:\n\n* Can detailed immune profiling of the tumor and its microenvironment predict pathological complete response (pCR, RCB-0) versus partial\u002Fnon-response (RCB-I, II, III) to neoadjuvant immunochemotherapy?\n* Are there specific immune or molecular biomarkers (e.g., TILs, CD3\u002F8\u002F20, FoxP3, PDL1, transcriptomic signatures) associated with progression-free survival and overall survival in this population? Researchers will compare patients achieving pCR (RCB-0) to those with residual disease (RCB-I, II, III) to determine if immune and molecular profiles can discriminate responders from non-responders and guide personalized treatment strategies.",[327],[456,457],"Biopsy","Residual Cancer Burden score","2026-04-30",{"date":460,"type":33},"2026-05-06",{"date":462,"type":21},"2026-06-01",{"date":464,"type":21},"2036-05-31",{"name":466,"class":40},"Center Eugene Marquis",{"id":468,"slug":469,"hasResults":12,"nctId":470,"briefTitle":471,"officialTitle":471,"acronym":472,"eligibilityCriteria":473,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":474,"targetDuration":4,"studyType":22,"phases":476,"briefSummary":477,"conditions":478,"keywords":481,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":487,"lastUpdatePostDateStruct":488,"startDateStruct":490,"completionDateStruct":492,"leadSponsor":494,"locationsCount":72},"100614229","phase-2-preoperative-chemotherapy-pembrolizumab-and-low-or-high-dose-radiation-in-an-expansion-cohort-of-node-triple-negative-breast-cancer-100614229","NCT07276880","Preoperative Chemotherapy, Pembrolizumab and Low or High Dose RADiation in an Expansion Cohort of Node(+), Triple Negative Breast Cancer","P-RAD(+)TN-DCT","Inclusion Criteria:\n\nIn order to participate in this study, a subject must meet all of the eligibility criteria outlined below.\n\n* Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information. Subjects are willing and able\n* to comply with study procedures based on the judgment of the investigator.\n* Age ≥ 18 years at the time of consent.\n* ECOG or Karnofsky Performance Status of 0 or 1\n\nExclusion Criteria:\n\n* Active infection requiring systemic therapy.\n* Pregnant or breastfeeding.\n* Prior ipsilateral invasive breast, chest wall or thoracic radiotherapy\n* Prior ipsilateral invasive breast cancer, contralateral breast cancer or a known\n* additional, invasive malignancy that is progressing or required active treatment in\n* the last 5 years",{"count":475,"type":21},32,[25],"This is a prospective radiation dose-finding, phase 2 expansion study of the Triple Negative (TN) cohort of the multicenter randomized study P-RAD (A Randomized Study of Preoperative Chemotherapy, Pembrolizumab and No, Low or High Dose RADiation in Node-Positive, HER2-Negative Breast Cancer; NCT04443348) that seeks to establish the optimal dose of radiation therapy (RT) to elicit an immune response when combined with immune checkpoint inhibitor (ICI) in breast cancer patients. Eligible subjects include women or men with operable, lymph node-positive, triple negative (TN) breast cancer who are candidates for standard of care neoadjuvant chemo-immunotherapy (NAC) based on the KEYNOTE-522 clinical trial. Thirty-two (n=32) patients will be randomized 1:1 to receive either low RT boost (9Gy total) or high RT boost (24Gy total). All RT will be delivered to the intact breast tumor in 3 daily fractions over 3 days.\n\nIn the Neoadjuvant Phase, the first cycle (C1) of pembrolizumab (200 mg i.v.) will be administered within 0-2 days of initiating RT. Participation in this study requires availability of residual diagnostic tissue biopsies of the primary tumor and metastatic lymph node for research use. If this tissue is not available, baseline research biopsies will be performed. Additionally, a research biopsy of the breast tumor and lymph node is required on Day 10-14 of C1 of pembrolizumab. After completion of the research biopsy in Week 2, the participants can commence standard-of-care neoadjuvant chemotherapy and pembrolizumab at the discretion of their medical oncology provider. After completing NAC, participants will undergo standard of care surgical resection of the breast and axillary lymph nodes, at the discretion of their surgical oncology provider. In the Adjuvant Phase, participants will receive standard of care adjuvant systemic therapy and standard of care adjuvant radiotherapy (if indicated), although recognizing that the breast tumor boost portion of this treatment has already been administered preoperatively. Except for late radiation adverse reactions of special interest, which will be followed yearly for up to 5 years, follow-up will occur every 6 months for 3 years.",[57,89,479,480],"HER2-Negative Breast Carcinoma","Node-positive Breast Cancer",[482,483,484,485,486],"radiation therapy","neoadjuvant treatment","pembrolizumab","immune checkpoint inhibitor","radiotherapy boost","2026-04-24",{"date":489,"type":33},"2026-04-27",{"date":491,"type":33},"2026-03-17",{"date":493,"type":21},"2032-01",{"name":495,"class":40},"UNC Lineberger Comprehensive Cancer Center",{"id":497,"slug":498,"hasResults":12,"nctId":499,"briefTitle":500,"officialTitle":501,"acronym":502,"eligibilityCriteria":503,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":504,"targetDuration":4,"studyType":22,"phases":506,"briefSummary":507,"conditions":508,"keywords":512,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":514,"lastUpdatePostDateStruct":515,"startDateStruct":517,"completionDateStruct":519,"leadSponsor":521,"locationsCount":522},"100514988","phase-1-study-to-assess-gtaexs617-in-participants-with-advanced-solid-tumors-100514988","NCT05985655","Study to Assess GTAEXS617 in Participants With Advanced Solid Tumors","A Phase 1\u002F2 Open-label Multicenter Study to Assess the Safety, Pharmacokinetics, and Anti-tumor Activity of GTAEXS617 in Patients With Advanced Solid Tumors","ELUCIDATE","Key Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1.\n* Life expectancy \\> 3 months.\n* One of the following histologically or cytologically confirmed advanced solid tumors: head and neck squamous cell carcinoma (HNSCC), pancreatic adenocarcinoma, non-small cell lung cancer (NSCLC), breast carcinoma (hormone receptor-positive \\[HR+\\] and Human Epidermal Growth Receptor 2 negative \\[HER2-\\] that has progressed to a prior treatment with Cyclin-Dependent Kinase 4 (CDK4)\u002F Cyclin-Dependent Kinase 6 \\[CDK6\\] inhibitor), or platinum-resistant high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancers (HGSOC), or triple negative breast cancer (TNBC).\n* Must have disease that is advanced (ie, surgery or radiotherapy are not considered to be potentially curative), recurrent, or metastatic following SoC treatments.\n* Adequate hematological, liver, and renal function.\n* Must have tumor lesion(s) or metastases amenable to biopsy, excluding bone metastases.\n\nKey Exclusion Criteria:\n\n* Active and clinically significant (CS) infection.\n* Refractory nausea and\u002For vomiting, chronic gastrointestinal disease, or previous significant bowel resection, with CS sequelae that would preclude adequate absorption of GTAEXS617.\n* Symptomatic central nervous system (CNS) malignancy or metastases.\n* Concurrent active or previous malignancy.\n* Prior organ or allogeneic stem-cell transplantation.\n* Moderate or severe cardiovascular disease.\n* Received anticancer therapy within 28 days or 5 half-lives (whichever is shorter) before the first dose of the study treatment.\n* Received treatment with known strong\u002Fmoderate inhibitors and\u002For strong inducers of cytochrome P450 3A isoform subfamily (CYP3A) within 14 days or 5 half-lives before the first dose of study treatment.\n* Received treatment with known inhibitors or inducers of P-glycoprotein (P-gp) or breast cancer resistance protein (BCRP) within 14 days or 5 half-lives before the first dose of study treatment.\n* Received treatment with known substrates of organic anion transporting peptide or BCRP within 14 days or 5 half-lives before the first dose of study treatment.\n* Unresolved or unstable serious toxic side-effects of prior chemotherapy or radiotherapy\n* Has had or is scheduled to have major surgery \\\u003C28 days prior to the first dose of study treatment.\n\nNote: Other protocol Inclusion\u002FExclusion criteria may apply.",{"count":505,"type":21},230,[24,25],"The primary purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and anti-tumor activity of GTAEXS617 (REC-617) in participants with advanced solid tumors.",[324,509,86,510,511,89],"Pancreatic Adenocarcinoma","Platinum-resistant High-grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers (HGSOC)","Hormone Receptor Positive [HR+] and Human Epidermal Growth Factor Receptor 2 Negative [HER2-] Breast Carcinoma",[513],"Advanced Solid Tumor","2026-04-22",{"date":516,"type":33},"2026-04-23",{"date":518,"type":33},"2023-07-06",{"date":520,"type":21},"2028-05",{"name":351,"class":110},13,{"id":524,"slug":525,"hasResults":12,"nctId":526,"briefTitle":527,"officialTitle":528,"acronym":529,"eligibilityCriteria":530,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":531,"targetDuration":4,"studyType":22,"phases":533,"briefSummary":534,"conditions":535,"keywords":538,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":542,"lastUpdatePostDateStruct":543,"startDateStruct":544,"completionDateStruct":546,"leadSponsor":548,"locationsCount":72},"100598292","phase-2-predict-rd-ctdna-surveillance-in-tnbc-with-residual-disease-100598292","NCT07069595","PREDICT-RD: ctDNA Surveillance in TNBC With Residual Disease","PREDICT-RD: Postoperative Molecular Residual Disease by ctDNA Surveillance in TNBC With Residual Disease","PREDICT-RD","Inclusion Criteria:\n\nWritten informed consent was obtained to participate in the study, and HIPAA authorization for the release of personal health information.\n\n* Participant is willing and able to comply with study procedures based on the judgment of the investigator.\n* Age ≥ 18 years at the time of consent.\n* Histological confirmation of TNBC defined by ER\u002FPR \\\u003C10%, HER2 0-1+ by IHC or 2+ by IHC and fluorescence in situ hybridization (FISH) negative.\n* Stage II\u002FIII TNBC treated with neoadjuvant systemic therapy AND have residual disease defined as RCB II\u002FIII at time of surgery.\n* Baseline staging scans at the discretion of the treating physician and demonstrate no evidence of metastatic disease.\n* The participant must have archival diagnostic tissue and\u002For surgical resection tissue Available.\n* Participants are willing and able to comply with study procedures based on the judgment of the investigator.\n\nExclusion Criteria:\n\n• Participants are pregnant or breastfeeding.",{"count":532,"type":21},78,[25],"This is a Phase II, interventional, prospective, single-arm, multi-center study that will enroll patients with stage II\u002FIII triple negative breast cancer (TNBC) who have residual cancer burden (RCB) II\u002FIII after conventional neoadjuvant chemo-immunotherapy followed by surgery. Technological advances in ctDNA assays have improved both the sensitivity and reliability of molecular residual disease (MRD) detection to enable real-time measurement with clinical-grade assays.\n\nThe primary objective of this study will be to evaluate ctDNA-based MRD status in high-risk, early-stage TNBC patients by defining the proportion of TNBC patients with MRD-only recurrence (ctDNA positive without radiographically measurable recurrence) during post-surgery surveillance. The secondary objectives will evaluate the safety, preliminary efficacy, and survival outcomes of using Dato-DXd in participants with MRD-only TNBC.\n\nDato-DXd is an investigational antibody-drug conjugate (monoclonal antibody specific for TROP2 and a topoisomerase I (Topo-1) inhibitor) that has demonstrated promising efficacy in TNBC patients with a manageable safety profile.",[57,536,89,537],"Residual Disease","Stage II\u002FIII",[539,540,541],"circulating tumor DNA (ctDNA)","surveillance","Dato-DXd","2026-04-21",{"date":514,"type":33},{"date":545,"type":33},"2026-02-26",{"date":547,"type":21},"2032-11-01",{"name":495,"class":40},{"id":550,"slug":551,"hasResults":12,"nctId":552,"briefTitle":553,"officialTitle":554,"acronym":4,"eligibilityCriteria":555,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":556,"targetDuration":4,"studyType":22,"phases":558,"briefSummary":559,"conditions":560,"keywords":4,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":566,"lastUpdatePostDateStruct":567,"startDateStruct":568,"completionDateStruct":570,"leadSponsor":572,"locationsCount":574},"100594490","phase-1-a-study-of-225acac-aky-1189-in-patients-with-solid-tumors-100594490","NCT07020117","A Study of [225Ac]Ac-AKY-1189 in Patients With Solid Tumors","NECTINIUM-2: A Phase 1b, 2 Part, Multicenter, Single Arm, Open Label Study to Evaluate the Safety and Efficacy of a Nectin-4 Radiopharmaceutical ([225Ac]Ac-AKY-1189) in Patients With Previously Treated Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n* Histologic or cytologic confirmation of locally advance or metastatic disease\n* Radiologic confirmation on CT of at least one measurable tumor lesion per RECIST v1.1\n* ECOG Performance Status of 0 or 1\n* Adequate end-organ function\n* Ability to give informed consent and comply with study requirements\n* Patients with CNS metastases are eligible if they have received therapy and are neurologically stable, asymptomatic and not receiving corticosteroids\n* Documented disease progression on prior line of therapy for metastatic disease\n\nExclusion Criteria:\n\n* Prior treatment with a therapeutic radiopharmaceutical\n* Prior treatment with a Nectin-4 targeted therapy, except enfortumab vedotin\n* Received an investigational agent within the previous 28days\n* Prior treatment with a cytotoxic chemotherapy, targeted therapy, biologic agent, immunotherapy or external-beam radiotherapy in the 3 weeks prior to study treatment\n* Concurrent serious medical condition that would impair study participation or impact the assessment of treatment related toxicity",{"count":557,"type":21},150,[24],"This is a first-in-human Phase 1b, 2-part, multicenter open-label clinical study to evaluate safety and efficacy of a Nectin-4 radiopharmaceutical (\\[225Ac\\]Ac-AKY-1189) in patients with locally advanced or metastatic solid tumors and to establish the maximum tolerated dose (MTD) or maximum administered dose (MAD) and the recommended Phase 2 dose.",[561,89,562,367,563,564,565],"Urothelial Carcinoma Bladder","Hormone Receptor Positive Breast Adenocarcinoma","Cervical Adenocarcinoma","Colorectal Adenocarcinoma","Head and Neck Cancer","2026-04-17",{"date":542,"type":33},{"date":569,"type":33},"2025-08-22",{"date":571,"type":21},"2032-06",{"name":573,"class":110},"Aktis Oncology, Inc.",9,{"id":576,"slug":577,"hasResults":12,"nctId":578,"briefTitle":579,"officialTitle":580,"acronym":581,"eligibilityCriteria":582,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":583,"targetDuration":4,"studyType":22,"phases":585,"briefSummary":586,"conditions":587,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":589,"lastUpdatePostDateStruct":590,"startDateStruct":591,"completionDateStruct":593,"leadSponsor":595,"locationsCount":4},"100634856","phase-1-a-phase-1a1b-first-time-in-human-study-of-ct-202-a-nectin-4-directed-bispecific-antibody-in-participants-with-recurring-triple-negative-breast-colorectal-urothelial-cancers-100634856","NCT07545122","A Phase 1a\u002F1b, First-Time-in-Human Study of CT-202, a Nectin-4 Directed Bispecific Antibody, in Participants With Recurring Triple Negative Breast, Colorectal, Urothelial Cancers","A Phase 1a\u002F1b, First Time in Human Study of CT-202, A Nectin-4 Directed Bispecific Antibody, in Participants With Recurring Triple Negative Breast, Colorectal, and Urothelial Cancers","CT-202","Inclusion Criteria:\n\n* Participants with nectin-4-positive triple negative breast cancer, colorectal cancer, or urothelial cancer that have received standard therapies\n* Participants with measurable disease per RECIST 1.1\n* ECOG 0, 1, or 2 and life expectancy of ≥ 12 weeks\n* Participants have adequate organ function.\n\nExclusion Criteria:\n\n* History of severe skin toxicity\n* Uncontrolled significant active infection or any medical or other condition that in the opinion of the Investigator would preclude the participant's participation in the study.\n* Concurrent participation in another investigational clinical trial.",{"count":584,"type":21},162,[24],"This is a Phase 1a\u002F1b, first time in human (FTIH), open-label, dose escalation and expansion study to evaluate the safety, tolerability, and preliminary efficacy of CT-202 (study drug), a humanized T cell engaging bispecific antibody targeting nectin-4, in participants with nectin-4 expressing recurrent, unresectable or metastatic refractory\u002Fresistant TNBC, CRC, or UC. Results of the study including PK, PD, efficacy, and safety will be used in the RP2D determination.",[89,366,588],"Urothelial Cancer","2026-04-16",{"date":514,"type":33},{"date":592,"type":21},"2026-09",{"date":594,"type":21},"2030-01",{"name":596,"class":110},"Context Therapeutics Inc.",{"id":598,"slug":599,"hasResults":12,"nctId":600,"briefTitle":601,"officialTitle":601,"acronym":602,"eligibilityCriteria":603,"healthyVolunteers":12,"sex":119,"minAge":18,"maxAge":604,"enrollmentInfo":605,"targetDuration":4,"studyType":267,"phases":4,"briefSummary":606,"conditions":607,"keywords":608,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":619,"lastUpdatePostDateStruct":620,"startDateStruct":622,"completionDateStruct":624,"leadSponsor":626,"locationsCount":574},"100633525","evaluating-ovarian-toxicity-outcomes-following-immunotherapy-in-patients-with-triple-negative-breast-cancer-tnbc-100633525","NCT07527819","Evaluating Ovarian Toxicity Outcomes Following Immunotherapy in Patients With Triple-Negative Breast Cancer (TNBC)","FERTILE","Inclusion Criteria:\n\n1. Patient has provided written informed consent using the FERTILE Patient Information and Consent form (PICF)\n2. Early-stage TNBC (definition determined as per clinicians' discretion)\n3. Female patients between 18 and 42 years of age\n4. Planned to receive at least one dose of neoadjuvant chemotherapy-ICI with a PD-(L)1 inhibitor including but not limited to pembrolizumab, atezolizumab, durvalumab or nivolumab\n5. Planned to receive gonadotrophin releasing hormone (GnRH) agonist with neoadjuvant chemotherapy\n\nExclusion Criteria:\n\n1. Previous removal of both ovaries or ovarian ablation (such as bilateral ovarian radiotherapy)\n2. Patients who have previously received immunotherapy or chemotherapy prior to registration\n3. Receiving or planned to receive adjuvant endocrine therapy Note: patients using GnRH agonist for POI prevention are not excluded\n4. Post-menopausal as defined by the investigator\n5. Presence of any psychological, social, geographical, or other condition for which, in the opinion of the site Investigator, participation would not be in the best interest of the patient (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments","42 Years",{"count":288,"type":21},"This study aims to collect information about the effects of chemotherapy combined with immunotherapy (immune checkpoint inhibitors) for early-stage triple-negative breast cancer (TNBC) on ovarian function and fertility.\n\nYou may be eligible for this study if you have been diagnosed with early-stage TNBC and are planning to receive neoadjuvant chemotherapy combined with immunotherapy before surgery. Additional eligibility criteria apply.\n\nParticipants who choose to enroll will be asked to complete questionnaires and provide blood samples before and after treatment to measure hormone levels related to ovarian function. Information about menstrual patterns, fertility preservation discussions, and reproductive health will also be collected. Some participants may undergo ultrasound assessments to evaluate ovarian reserve and endometrial thickness. Follow-up will continue for up to 24 months after treatment to assess long-term ovarian function.\n\nNo additional or experimental cancer treatments will be provided as part of this study. This is an observational study only, and participants will receive standard cancer treatment as recommended by their treating team.\n\nIt is hoped this research will provide important information about the potential effects of chemotherapy and immunotherapy on ovarian health and fertility in women receiving treatment for early-stage TNBC.",[89],[609,610,611,612,613,614,615,616,617,618],"Premature Ovarian Insufficiency","chemotherapy","immunotherapy","fertility","immune checkpoint inhibitors","ovarian function","ovarian toxicity","cytokines","inflammation","menopause","2026-04-07",{"date":621,"type":33},"2026-04-14",{"date":623,"type":21},"2026-04-08",{"date":625,"type":21},"2031-12-31",{"name":627,"class":40},"Peter MacCallum Cancer Centre, Australia",{"id":629,"slug":630,"hasResults":12,"nctId":631,"briefTitle":632,"officialTitle":633,"acronym":4,"eligibilityCriteria":634,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":635,"targetDuration":4,"studyType":22,"phases":637,"briefSummary":638,"conditions":639,"keywords":641,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":646,"lastUpdatePostDateStruct":647,"startDateStruct":648,"completionDateStruct":650,"leadSponsor":652,"locationsCount":72},"100565988","phase-2-platform-study-of-adc-rechallenge-in-adc-treated-metastatic-breast-cancer-100565988","NCT06649331","Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer","Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer：A Prospective, Open-label, Phase 2 Trial","Inclusion Criteria:\n\n1. Age ≥18 years;\n2. Locally advanced breast cancer (unable to undergo radical local treatment) or recurrent metastatic breast cancer;\n3. Previously received ADCs;\n4. The most recent pathology results will be considered for enrollment according to local testing of ER, PR and HER2. Participants with any hormone receptor (HR) status will be allowed on study.\n5. Prior endocrine therapy: Participants with HR-positive breast cancer must have received prior CDK4\u002F6 inhibitor;\n6. Participants must have measurable disease per RECIST 1.1.\n7. The functions of the main organs are basically normal and meet the following conditions:\n\n   I. Blood routine examination criteria shall meet: HB ≥90 g\u002FL (no blood transfusion within 14 days); The ANC acuity 1.5 x 10\\^9 \u002F L; PLT acuity 75 x 10\\^9 \u002F L; II. Biochemical tests should meet the following criteria: TBIL ≤1.5×ULN (upper limit of normal value); ALT and AST ≤3×ULN; If liver metastases were present, ALT and AST≤ 5×ULN; Serum Cr ≤1.5×ULN, endogenous creatinine clearance \\> 50 ml\u002Fmin (Cockcroft-Gault formula); III. LVEF≥50%\n8. They have not received radiotherapy, molecular targeted therapy, or surgery within 3 weeks before the start of the study, and have recovered from the acute toxicity of previous treatment (if surgery was performed, the wound has healed completely); No peripheral neuropathy or grade I peripheral neurotoxicity; Participants may have discontinued all CDK4\u002F6 inhibitor at least 14 days prior to study treatment initiation. Prior endocrine therapy does not require washout.\n9. ECOG score ≤2, and life expectancy ≥3 months;\n10. Fertile female subjects were required to use a medically approved contraceptive method during the study treatment period and for at least 3 months after the last use of the study drug;\n11. Subjects volunteered to join the study, signed informed consent, had good compliance, and cooperated with follow-up.\n\nExclusion Criteria:\n\n1. Radiotherapy (except for palliative causes), chemotherapy, and immunotherapy were used in the first 3 weeks of treatment, except bisphosphonate (which can be used for bone metastasis);\n2. Uncontrolled central nervous system metastases (indicating symptomatic or symptomatic treatment with glucocorticoids or mannitol);\n3. A history of clinically important or uncontrolled heart disease, including congestive heart failure, angina pectoris, myocardial infarction, or ventricular arrhythmia within the last 6 months;\n4. Presence of the third space effusion (such as massive ascites, pleural effusion, pericardial effusion) that cannot be controlled by drainage or other methods;\n5. Participants with who had used immunosuppressive agents or systemic corticosteroids within 2 weeks before the first dose (dose\\> 10mg\u002Fday prednisone or other corticosteroids at the physiological dose of the drug), excluding nasal spray or inhaled corticosteroids;\n6. Presence of any active autoimmune disease or a history of autoimmune disease with potential relapse;\n7. Known human immunodeficiency virus (HIV) infection that is not well controlled;\n8. Known active hepatitis B (HBV DNA≥2000 IU\u002FmL or 104 copies\u002FmL) and hepatitis C (positive for hepatitis C antibodies and HCV-RNA above the lower detection limit of the assay);\n9. Persistent grade 1 or higher adverse reactions caused by previous treatments. The exception to this is hair loss or something the researchers don't think should be ruled out. Such cases should be clearly documented in the investigator's notes;\n10. Underwent major surgery (except minor outpatient procedures, such as placement of vascular access) within 3 weeks of the first course of trial treatment;\n11. Pregnant or lactating patients;\n12. Malignancy (except basal cell carcinoma of the skin, which has been cured, and carcinoma in situ of the cervix) in the past 5 years;\n13. History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study agent or accompanying supportive medications;\n14. Serious physical or mental illnesses or laboratory abnormalities that may increase the risk of participating in the study or interfere with the study results\n15. Deemed by the investigator to be ineligible for participation in the study.",{"count":636,"type":21},160,[25],"This is a prospective, open-label, phase 2 platform trial. The purpose of this study is to test the safety and effectiveness of the antibody-conjugated drugs (ADCs) in patients with advanced breast cancer who had previously used antibody-conjugated drugs.",[640,221,89,411,57],"Advanced Breast Cancer",[642,643,644,645],"platform trial","adaptive design","antibody-conjugated drugs (ADCs)","Bayesian predictive probability","2026-04-02",{"date":623,"type":33},{"date":649,"type":33},"2024-10-21",{"date":651,"type":21},"2027-09",{"name":203,"class":40},{"id":654,"slug":655,"hasResults":12,"nctId":656,"briefTitle":657,"officialTitle":658,"acronym":4,"eligibilityCriteria":659,"healthyVolunteers":12,"sex":119,"minAge":18,"maxAge":4,"enrollmentInfo":660,"targetDuration":4,"studyType":22,"phases":662,"briefSummary":663,"conditions":664,"keywords":670,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":680,"lastUpdatePostDateStruct":681,"startDateStruct":683,"completionDateStruct":685,"leadSponsor":687,"locationsCount":689},"100558186","phase-1-a-study-of-mov18-ige-in-patients-with-solid-tumours-that-express-folate-receptor-alpha-100558186","NCT06547840","A Study of MOv18 IgE in Patients With Solid Tumours That Express Folate Receptor Alpha","A Phase Ib, Open-Label Trial of MOv18 IgE in Patients With Solid Tumours That Overexpress Folate Receptor Alpha","Inclusion criteria:\n\nPatients must meet all of the following criteria:\n\n1. Female ≥18 years of age.\n2. Written (signed and dated) informed consent.\n3. Histologically or cytologically confirmed advanced, recurrent or metastatic ovarian cancer, endometrial cancer, triple-negative breast cancer i. Ovarian cancer: must have epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer with high-grade serous or endometrioid features or a predominantly serous\u002Fendometrioid component ii. Endometrial cancer: must have advanced, recurrent or metastatic, endometrial cancer (any subtype excluding endometrial sarcoma) iii. Triple Negative Breast cancer: must have advanced, recurrent or metastatic triple-negative breast cancer (based on the most recently analyzed biopsy from locally recurrent or metastatic site, local laboratory) meeting the following criteria:\n\n   * HER2-negative in situ hybridization test or an immunohistochemistry (IHC) status of 0 or 1+\n   * ER and PgR expressions \\\u003C10% as determined locally by IHC assay as per most recent ASCO\u002FCAP guidelines\n4. Tumour tissue expressing FRα on at least 5% of tumour cells, as determined by immunohistochemistry using either (i) the BN3.2 antibody (Leica Biosystems) or (ii) the FOLR1 (FOLR1-2.1) antibody (Ventana) Note: All patients must be willing to provide an archival tumour tissue block, or undergo a procedure to obtain a new biopsy, using a low risk, medically routine procedure for immunohistochemistry (IHC) confirmation of FRα positivity using BN3.2 antibody (Leica Biosystems).\n\n   Note: Pre-screening for FRα positivity, using BN3.2 antibody (Leica Biosystems), may be performed at any point in advance of the first administration of MOv18 IgE i. Leica Biosystems BN3.2 antibody 1+ 2+ 3+ staining ii. Ventana FOLR1 antibody criteria 2+ 3+ membrane staining Note: Patients with a medical history confirming tumour tissue expression of FRα, as confirmed by the Ventana FOLR1 antibody, will be considered as meeting inclusion Criteria #4 and will not require a confirmation via Leica Biosystems assay prior to receiving MOv18 IgE. However, in all instances, confirmation of FRα expression using the BN3.2 antibody (Leica Biosystems), will be required to be tested during the trial. Confirmation is not required prior to C1D1.\n\n   Note: Discordant results between the two systems will not result in patient removal from the trial unless deemed appropriate by the treating Investigator.\n5. Negative basophil activation test (BAT) prior to the first administration of MOv18 IgE.\n\n   Note: this test will be performed at a reference laboratory.\n6. Ovarian cancer: platinum-free interval since last dose of platinum, of less than 6 months (182 days).\n7. Prior therapies:\n\n   Ovarian cancer: progressed following ≤2 prior regimens of anti-cancer therapy for platinum resistant ovarian cancer, and, at the time, no other authorised therapy is considered appropriate by the treating investigator.\n\n   i. Patients who received hyperthermic intraperitoneal chemotherapy (HIPEC) or other IP therapies are eligible.\n\n   Endometrial cancer: progressed after any prior line of systemic therapy, and, at the time, no other authorised therapy is considered appropriate by the treating investigator.\n\n   Breast cancer: progressed after any prior line of systemic therapy, and, at the time, no other authorised therapy is considered appropriate by the treating investigator.\n8. Has measurable disease as defined by RECIST v1.1 on CT or MRI scan i. Note: Baseline scans must be performed ≤28 days before the first administration of MOv18 IgE, after discontinuation of the prior regimen.\n\n   ii. Note: Lesions previously embolised, perfused, or irradiated without objective evidence of progression before the first administration of MOv18 IgE are not allowed to be considered for response assessment.\n9. No evidence of bowel obstruction.\n10. ECOG Performance Status Score 0-1 prior to the first administration of MOv18 IgE.\n11. Estimated life expectancy of \\>3 months, in the opinion of the Investigator.\n12. Adequate haematological function, including all of the following:\n\n    i. Absolute neutrophil count (ANC) ≥1.5 × 109\u002FL (\\>1,500\u002Fmm3). G-CSF or GM-CSF may not be used to achieve this level.\n\n    ii. Platelets ≥100 × 109\u002FL (\\>100,000 per mm3) iii. Haemoglobin level \\>9 g\u002FdL obtained within 14 days before the first administration of MOv18 IgE. Packed red blood cell transfusion is acceptable, if the patient has a stable result of ≥9 g\u002FdL for at least 1 week post-transfusion. Erythropoietin should not be used to achieve this level.\n\n    iv. Adequate coagulation function at screening as determined by prothrombin time (PT) ≤1.5 × upper limit of normal (ULN) or international normalised ratio (INR) \\\u003C1.5 and activated partial thromboplastin time (aPTT) ≤1.5 × ULN. Does not apply to patients on an anti coagulant with a stable dose within 28 days prior to first dose.\n\n    v. Lymphocyte count ≥1000 cells\u002Fmm3, (1.0x10\\*9\u002FL)\n13. Intact immune system as demonstrated by CD4 count ≥500 cells\u002Fmm3 and CD8 count ≥150 cells\u002Fmm3.\n14. Adequate renal function as demonstrated by either estimated glomerular filtration rate \\[eGFR\\] or calculated creatinine clearance \\>45 mL\u002Fmin (Cockcroft Gault equation: creatinine clearance: (140-age \\[years\\]) × weight (kg)\u002F(serum creatinine \\[mg\u002FdL\\] × 72) × 0.85 ≤1.5 × ULN, or ≥60 mL\u002Fmin for a patient with creatinine levels \\>1.5 × institutional ULN.\n15. Adequate hepatic function:\n\n    i. Serum total bilirubin ≤1.5 × ULN or direct bilirubin ≤ ULN for a patient with total bilirubin levels \\>1.5 × ULN.\n\n    ii. AST (SGOT) and ALT (SGPT) ≤2.5 × ULN or ≤5 × ULN for a patient with liver metastases.\n\n    iii. Albumin ≥3.0 g\u002FdL.\n16. Recovered from all chemotherapy-related toxicities to Grade ≤1 according to CTCAE v5.0, excluding alopecia (any grade) and peripheral neuropathy (Grade ≤2).\n17. No history of significant cardiac or pulmonary dysfunction, including but not limited to interstitial pulmonary disease and chronic obstructive pulmonary disease.\n18. No active or history of autoimmune disease, (with exception of vitiligo, type I DM, residual hypothyroidism due to autoimmune condition only requiring hormone replacement) and\u002For no history of autoimmune disease that required treatment with steroids or immunosuppressive medication within 6 months of the first administration of MOv18 IgE.\n19. Negative serum or urine pregnancy test.\n20. Women of childbearing potential must have 2 negative pregnancy tests during Screening, the second within 24 hours prior to the first administration of MOv18 IgE. This criterion does not apply to patients who have had a previous hysterectomy or bilateral oophorectomy.\n21. Female patients of child bearing potential must agree to practice true abstinence or to use two forms of contraception, one of which must be highly effective. These forms of contraception must be used from the time of signing consent, throughout the treatment period, and for 6 months, (182 days), following the last dose of any study medication. Oral or injectable contraceptive agents cannot be the sole method of contraception.\n22. Willing and able to comply with all protocol-specified assessments and the trial visit schedule.\n23. Patient has been advised to take measures to avoid or minimise exposure of the skin to UV light, including sunbathing and solarium use for the duration of the trial and for 4 weeks following last administration of MOv18 IgE.\n\nExclusion criteria:\n\nPatients must not meet any of the following criteria:\n\n1. Non-epithelial tumour of the ovary, the fallopian tube, or the peritoneum (including germ cell tumours and sarcomas).\n2. Presence of ascites\u002Fpleural effusion requiring drainage within 28 days of first dose MOv18 IgE or persistent ongoing malignant ascites or pleural effusion requiring an in-dwelling drain.\n3. Taking beta-blockers (at PI discretion) and unable to interrupt beta-blockade (which may counteract the therapeutic effects of adrenaline), or full dose tricyclic anti-depressants\u002FMAOIs (which can dangerously augment the effects of adrenaline). These agents should be discontinued at least 4 half-lives before administration of the first dose of MOv18 IgE. Treatment may be reintroduced 48 hours post dose administration.\n\n   i. Note: Beta blockers may continue if, in the opinion of the Investigator, it would not pose additional risk to the patient ii. Note: Only applies to full dose tricyclic anti-depressants. Low dose tricyclic anti-depressants to support conditions such as peripheral neuropathy, chronic pain, or insomnia, may be permitted at PI discretion\n4. History of laryngeal oedema, uncontrolled or high-risk asthma, or anaphylaxis. Patients with a history of hypersensitivity to carboplatin, taxanes, or contrast media may enter the trial at the Investigator's discretion.\n5. History of parasitic infections, such as helminthiasis within 5 years of the first administration of MOv18 IgE.\n6. Baseline elevation in serum tryptase (indicating possible mastocytosis) or a positive BAT. Tryptase normal range is 2-15 ng\u002FmL.\n7. Receiving systemic anti-cancer therapy, including immunostimulatory agents (e.g., cytokine-based modality, antigen-specific peptide immunotherapy, immune checkpoint blockade, co-stimulatory agonists) within 28 days of the first administration of MOv18 IgE.\n8. Administration of other simultaneous chemotherapy drugs, anti-cancer therapy or anti-neoplastic hormonal therapy, or simultaneous radiotherapy during the trial treatment period (hormonal replacement therapy and denosumab is permitted).\n9. Receiving radiation therapy within 14 days prior to the first administration of MOv18 IgE. Local palliative radiotherapy is permitted; however, if the radiotherapy is to a target lesion, that lesion must be excluded from tumour response assessments.\n10. Chronic treatment with systemic corticosteroids or other systemic immunosuppressive medications (including but not limited to prednisone (\\>10 mg), cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF agents) within 14 days prior to the first administration of MOv18 IgE, or anticipated requirement for systemic immunosuppressive medications during the trial.\n11. Administration of a live, attenuated vaccine within 28 days prior to Day 1 or anticipation that such a live attenuated vaccine will be required during the trial or within 5 months, (152 days), after the last dose of MOv18 IgE. Influenza vaccination should be given during influenza season only. Patients must not receive live, attenuated influenza vaccination. COVID vaccination is permitted as necessitated.\n12. Previous allogeneic bone marrow transplant or previous solid organ transplantation.\n13. Historical positive serology test for human immunodeficiency virus (HIV).\n14. History of interstitial lung disease or active pneumonitis.\n15. Has a known hypersensitivity to a component of protocol therapy, MOv18 IgE or its vehicle (sodium citrate, L-arginine, sucrose and polysorbate 20).\n16. Positive serology for hepatitis B or C.\n17. Uncontrolled concurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness.\n18. Has a history within last 12 months or ongoing clinically significant cardiovascular disease such as unstable angina, myocardial infarction, or acute coronary syndrome, symptomatic or uncontrolled arrhythmia, left ventricular failure, congestive heart failure, baseline ECG abnormalities that, in the Investigator's opinion, would be likely to interfere with their participation in the study, or with the interpretation of the results, including, but not limited to, QTc prolongation to greater than 470 ms (as determined by the Fridericia formula), or any Class III or IV cardiac disease as defined by the New York Heart Association Functional Classification.\n19. Concomitant use of drugs known to prolong QT\u002FQTc interval (Appendix 1).\n20. Has a fever ≥38oC within 3 days before the first dose of MOv18 IgE.\n21. No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in-situ cervical cancer, surgically treated Stage I or II cancer from which the patient is currently in complete remission (at least to 5 years), or any other non-metastatic cancer controlled by surgery alone or surgery plus radiotherapy from which the patient has been disease-free for 5 years.\n22. Presence of CNS metastases (including spinal metastases) or CNS primary tumour, e.g., glioblastoma.\n23. Clinically significant illness or major surgery within 4 weeks before the administration of MOv18 IgE.\n24. Currently breastfeeding.\n25. Any condition which could interfere with, or the treatment for which might interfere with, the conduct of the trial, or which would, in the opinion of the Investigator, unacceptably increase the patient's risk by participating in the trial\n26. Patient is under legal custodianship.\n27. First-degree relatives of the Investigator, trial staff or Sponsor employees.",{"count":661,"type":21},45,[24],"EPS101-10-02 is a Phase Ib open label, multicentre clinical trial comprising of a Dose Escalation phase (Part 1) followed by a Dose Expansion phase (Part 2) of MOv18 IgE in patients with folate receptor alpha-expressing (5% or higher) platinum resistant ovarian cancer\n\nThe dose escalation part of the study will primarily assess the safety and tolerability of MOv18 IgE in ascending dose cohorts, until the determination of the maximum tolerated dose (MTD) or maximum administered dose (MAD).\n\nPart 2 (dose expansion) will further assess the safety, tolerability and anti-tumour activity of MOv18 IgE.",[665,666,89,667,668,669],"Advanced Ovarian Cancer","Platinum-resistant Ovarian Cancer","Triple -Negative Breast Cancer","Endometrial Cancer","Advanced Endometrial Cancer",[671,377,672,673,674,675,676,677,678,679],"Ovarian","Resistant","IgE","Advanced","Platinum","Folate Receptor alpha","Antibody","Endometrial","Triple Negative Breast","2026-03-31",{"date":682,"type":33},"2026-04-06",{"date":684,"type":33},"2024-09-03",{"date":686,"type":21},"2027-03",{"name":688,"class":110},"Epsilogen Ltd",7,{"id":691,"slug":692,"hasResults":12,"nctId":693,"briefTitle":694,"officialTitle":695,"acronym":4,"eligibilityCriteria":696,"healthyVolunteers":12,"sex":119,"minAge":18,"maxAge":4,"enrollmentInfo":697,"targetDuration":4,"studyType":22,"phases":698,"briefSummary":699,"conditions":700,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":701,"lastUpdatePostDateStruct":702,"startDateStruct":704,"completionDateStruct":706,"leadSponsor":708,"locationsCount":4},"100632117","phase-2-qlc5513-alone-or-in-combination-with-ql1706-in-previously-treated-advanced-or-metastatic-tnbc-100632117","NCT07509515","QLC5513 Alone or in Combination With QL1706 in Previously Treated Advanced or Metastatic TNBC.","An Open-label, Phase 2 Study of QLC5513 Alone or in Combination With Epalolimab Tovolimab (QL1706) in Previously Treated Advanced or Metastatic TNBC.","Inclusion Criteria:\n\n1. Female aged ≥18 years;\n2. TNBC invasive breast cancer confirmed by histology (specific definition: ER \\\u003C1% positive tumor cells by immunohistochemistry are defined as ER negative, PR \\\u003C1% positive tumor cells are defined as PR negative, HER2 0-1+ or HER2 ++ but negative by FISH without amplification was defined as HER2 negative);\n3. Locally advanced breast cancer (unable to undergo radical local treatment) or recurrent metastatic breast cancer;\n4. Progression after at least one prior therapeutic regimens for advanced\u002Fmetastatic TNBC.\n5. At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors version 1.1.\n6. Has protocol-defined adequate bone marrow, renal, hepatic and blood clotting functions.\n7. They have not received radiotherapy, molecular targeted therapy, or surgery within 3 weeks before the start of the study, and have recovered from the acute toxicity of previous treatment (if surgery was performed, the wound has healed completely); No peripheral neuropathy or grade I peripheral neurotoxicity;\n8. Eastern Cooperative Oncology Group (ECOG) score status 0-1 and life expectancy ≥3 months;\n9. Fertile female subjects were required to use a medically approved contraceptive method during the study treatment period and for at least 3 months after the last use of the study drug;\n10. Subjects volunteered to join the study, signed informed consent, had good compliance, and cooperated with follow-up.\n\nExclusion Criteria:\n\n1. Radiotherapy (except for palliative causes), chemotherapy, and immunotherapy were used in the first 3 weeks of treatment, except bisphosphonate (which can be used for bone metastasis);\n2. Uncontrolled central nervous system metastases (indicating symptomatic or symptomatic treatment with glucocorticoids or mannitol);\n3. A history of clinically important or uncontrolled heart disease, including congestive heart failure, angina pectoris, myocardial infarction, or ventricular arrhythmia within the last 6 months;\n4. Persistent grade 1 or higher adverse reactions caused by previous treatments. The exception to this is hair loss or something the researchers don't think should be ruled out. Such cases should be clearly documented in the investigator's notes;\n5. Underwent major surgery (except minor outpatient procedures, such as placement of vascular access) within 3 weeks of the first course of trial treatment;\n6. Pregnant or lactating patients;\n7. Malignancy (except basal cell carcinoma of the skin, which has been cured, and carcinoma in situ of the cervix) in the past 5 years.\n8. A prior history of treatment with antibody-drug conjugates (ADCs).",{"count":20,"type":21},[25],"The study will evaluate the safety and efficacy of QLC5513 alone or in combination with QL1706 in patients with advanced or metastatic triple-negative breast cancer (TNBC) who had received ≥1 line of prior systematic therapy.",[327],"2026-03-29",{"date":703,"type":33},"2026-04-03",{"date":705,"type":21},"2026-04-15",{"date":707,"type":21},"2028-03-30",{"name":203,"class":40},{"id":710,"slug":711,"hasResults":12,"nctId":712,"briefTitle":713,"officialTitle":714,"acronym":4,"eligibilityCriteria":715,"healthyVolunteers":12,"sex":119,"minAge":18,"maxAge":4,"enrollmentInfo":716,"targetDuration":4,"studyType":22,"phases":718,"briefSummary":719,"conditions":720,"keywords":723,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":726,"lastUpdatePostDateStruct":727,"startDateStruct":729,"completionDateStruct":730,"leadSponsor":732,"locationsCount":734},"100575180","phase-2-biolosion-combined-standard-neoadjuvant-therapy-to-treat-triple-negative-breast-cancer-100575180","NCT06768931","Biolosion Combined Standard Neoadjuvant Therapy to Treat Triple-negative Breast Cancer","A Multicenter, Randomized Controlled Phase II Clinical Study of Standard Neoadjuvant Therapy Combined With Biolosion (Oral Probiotic Compound Preparation) in Triple-negative Breast Cancer","Inclusion Criteria:\n\n1. Women aged 1.18 years and above, diagnosed with triple-negative breast cancer (ER≤10%, PR≤10%, HER-2 negative) by pathology;\n2. Patients must have tumor specimens (formalin-fixed, paraffin-embedded, or fresh pre-treated tumor tissue) available for PD-L1 expression testing;\n3. Researchers assess indications for neoadjuvant chemotherapy, with staging from IIA to IIIC, based on imaging or pathological evaluation of cT1c, N1-3, or cT2\\~cT4, cN0\\~N3, and patients with no distant metastasis as evaluated by imaging;\n4. Patients must not have received chemotherapy or targeted therapy for advanced breast cancer;\n5. ECOG PS: 0-2;\n6. Expected survival of ≥12 weeks;\n7. Major organ function levels must meet the following criteria:\n\n1\\) Hematological examination standards must meet: ANC≥1.5×10\\^9\u002FL, PLT≥75×10\\^9\u002FL, Hb≥90g\u002FL (no blood transfusions or blood products within 14 days, and no use of G-CSF or other hematopoietic growth factors for correction) 2) Biochemical examination must meet the following standards: TBIL\\\u003C1.5×ULN, ALT, AST\\\u003C2.5×ULN, for patients with liver metastasis, ALT, AST may be \\\u003C5×ULN, BUN and Cr≤1×ULN or endogenous creatinine clearance ≥50ml\u002Fmin (Cockcroft-Gault formula); 8. Women of childbearing age must have taken reliable contraceptive measures or undergone a pregnancy test (serum or urine) within 7 days prior to enrollment, with a negative result, and must be willing to use appropriate contraceptive methods during the trial and for 8 weeks after the last administration of the investigational drug.\n\n9\\. Participants voluntarily join this study, demonstrate good compliance, and cooperate with follow-up.\n\nExclusion Criteria:\n\n1. There is a clear distant transfer;\n2. A history of autoimmune diseases;\n3. Acute or chronic active hepatitis B (defined as positive hepatitis B surface antigen and\u002For hepatitis B core antibody, with hepatitis B virus DNA copy number ≥1×10³ copies\u002Fml or ≥200 IU\u002Fml) or positive antibodies for acute or chronic active hepatitis C, with positive hepatitis C antibodies but negative RNA testing allowed for enrollment.\n4. Previous treatment with immune checkpoint inhibitors;\n5. Received systemic immunostimulants, systemic corticosteroids, or immunosuppressants within the last 4 weeks;\n6. Any severe underlying disease, comorbidities, and active infections, or patients with severe metabolic disorders;\n7. Currently receiving other antitumor treatments;\n8. Known comorbidities (e.g., chronic diarrhea, inflammatory bowel disease, etc.) that, in the investigator's assessment, would increase the risk associated with the administration of the study drug or interfere with the interpretation of study results.\n9. Currently using or planning to use probiotics, yogurt, or bacterial-enhanced foods during the treatment period.\n10. A history of epilepsy or seizure-inducing states;\n11. Pregnant or breastfeeding patients;\n12. Poor compliance or inability to undergo normal follow-up;\n13. Individuals allergic to the study drug;\n14. Diagnosis of other malignancies within the past 5 years, with the exception of: surgically removed non-melanoma skin cancer, adequately treated cervical carcinoma in situ, locally curative prostate cancer, surgically treated ductal carcinoma in situ, or malignancies diagnosed 2 years prior to randomization without evidence of disease and untreated for ≤2 years;\n15. The investigator's judgment on other conditions that may affect the conduct of the clinical study and the determination of study results.",{"count":717,"type":21},192,[25],"To evaluate the efficacy and safety of compound preparation Biolosion in combination with standard neoadjuvant therapy for locally advanced triple-negative breast cancer",[57,89,721,129,722],"Early Stage Breast Cancer","Probiotic",[724,725,129],"Triple negative breast cancer","Probiotics","2026-03-26",{"date":728,"type":33},"2026-04-01",{"date":728,"type":21},{"date":731,"type":21},"2035-02-08",{"name":733,"class":40},"Sun Yat-sen University",5]