[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"triple-negative-breast-neoplasms\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:triple-negative-breast-neoplasms":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,17,0,[8,46,91,114,155,185,228,259,296,347,373,396,426,453,481,510,534],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100590383","phase-3-a-clinical-study-of-sacituzumab-tirumotecan-sac-tmt-mk-2870-in-people-with-breast-cancer-mk-2870-032-100590383",false,"NCT06966700","A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in People With Breast Cancer (MK-2870-032)","A Phase 3, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Sac-TMT (Sacituzumab Tirumotecan, MK-2870) Followed by Carboplatin\u002FPaclitaxel vs Chemotherapy, Both in Combination With Pembrolizumab as Neoadjuvant Therapy for High-Risk, Early-Stage, Triple-Negative Breast Cancer or Hormone Receptor-low Positive\u002FHuman Epidermal Growth Factor Receptor-2 Negative Breast Cancer","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has previously untreated high-risk, early-stage, non-metastatic (M0) breast cancer (BC), defined as any of the following combined primary tumor (T) and regional lymph node (N) staging per AJCC 8th edition criteria as assessed by the physician investigator based on radiological and\u002For clinical assessment:\n\n  * cT1c, N1-N2\n  * cT2, N0-N2\n  * cT3, N0-N2\n  * cT4a-d, N0-N2\n* The participant must have a centrally confirmed diagnosis of BC that is triple-negative or HR-low+\u002FHER2- (defined as estrogen receptor (ER)-low+ expression in 1% to 10% cells and HER2- as by the most recent American Society of Clinical Oncology (ASCO)\u002FCollege of American Pathologists (CAP) guidelines.\n* Provides a core needle biopsy from the primary breast tumor at screening to the central laboratory.\n* Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 performed within 28 days before Cycle1 Day 1 (C1D1).\n* Demonstrates adequate organ function.\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Metastatic (Stage IV) breast cancer or clinical node stage 3 (cN3) nodal involvement\n* Has received any prior treatment, including radiation, systemic therapy,and\u002For definitive surgery for currently diagnosed breast cancer\n* Has undergone excisional biopsy of the primary tumor, axillary lymph node dissection, and\u002For axillary sentinel lymph node biopsy prior to study treatment.\n* Received prior systemic anticancer therapy including investigational agents within 4 weeks before C1D1.\n* Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, CTLA-4, OX- 40, CD137).\n* Received prior treatment with a TROP2-targeted antibody-drug conjugate (ADC).\n* Received prior treatment with a topoisomerase I inhibitor-containing ADC.\n* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.\n* Known additional malignancy that is progressing or has required active treatment within the past 5 years.\n* Uncontrolled systemic disease.\n* History of (noninfectious) pneumonitis\u002Finterstitial lung disease that required steroids, has current pneumonitis\u002Finterstitial lung disease or has suspected interstitial lung disease (ILD) or pneumonitis that cannot be ruled out by standard diagnostic assessments at Screening..","ALL","18 Years",{"count":19,"type":20},2400,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","Researchers are looking for new ways to treat types of breast cancer that are both:\n\n* High-risk, which means the cancer may have a higher chance of getting worse or coming back after treatment\n* Early-stage, which means the cancer is in the breast or the lymph nodes around the breast The 2 types of breast cancer in this study are triple-negative breast cancer (TNBC) and hormone receptor (HR)-low positive\u002Fhuman epidermal growth factor receptor-2 (HER2) negative breast cancer. These cancers have zero or a low amount of a protein called HER2 and other proteins that attach to the hormones estrogen or progesterone.\n\nSacituzumab tirumotecan (also known as sac-TMT or MK-2870), the study medicine, is a type of targeted therapy. A targeted therapy is a treatment that works to control how specific types of cancer cells grow and spread.\n\nThe main goals of this study are to learn if people who receive sac-TMT, pembrolizumab, and chemotherapy:\n\n* Have fewer cancer cells found in the tumors and lymph nodes removed during surgery compared to those who receive only pembrolizumab and chemotherapy\n* Live longer without the cancer growing, spreading, or coming back compared to people who receive only pembrolizumab with chemotherapy",[26,27,28],"Breast Neoplasms","Triple Negative Breast Neoplasms","HR Low-Positive\u002FHER2-Negative Breast Neoplasms",[30,31,32],"Programmed Cell Death-1 (PD1, PD-1)","Programmed Cell Death 1 Ligand 1 (PDL1, PD-L1)","Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)","RECRUITING","2026-06-30",{"date":36,"type":37},"2026-07-02","ACTUAL",{"date":39,"type":37},"2025-06-30",{"date":41,"type":20},"2034-12-29",{"name":43,"class":44},"Merck Sharp & Dohme LLC","INDUSTRY",310,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":58,"conditions":59,"keywords":70,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":90},"100431255","phase-1-a-study-of-bms-986340-as-monotherapy-and-as-combination-therapy-in-participants-with-advanced-solid-tumors-100431255","NCT04895709","A Study of BMS-986340 as Monotherapy and as Combination Therapy in Participants With Advanced Solid Tumors","A Phase 1\u002F2 Study of BMS-986340 as Monotherapy and as Combination Therapy in Participants With Advanced Solid Tumors","Inclusion Criteria\n\n* Fresh pre-treatment and on-treatment tumor biopsy must be provided for biomarker analysis.\n* Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and at least 1 lesion accessible for biopsy. Fine needle biopsy, cytology, and bone lesion biopsies are not acceptable.\n* Eastern Cooperative Oncology Group Performance Status of 0 or 1.\n* Radiographically documented progressive disease on or after the most recent therapy.\n* Received standard-of-care therapies, (except for Part 1C, 2C and 2D, where participants with prior docetaxel use for the advanced\u002Fmetastatic setting will be excluded), including an available programmed death (ligand)-1 inhibitor known to be effective in the tumor type for which they are being evaluated.\n* Advanced or metastatic disease and have received, be refractory to, not be a candidate for, or be intolerant of existing therapies known to provide clinical benefit for the condition of the participant.\n\nExclusion Criteria\n\n* Women who are pregnant or breastfeeding.\n* Primary central nervous system (CNS) malignancy.\n* Untreated CNS metastases.\n* Leptomeningeal metastases.\n* Concurrent malignancy requiring treatment or history of prior malignancy active within 2 years prior to the first dose of study treatment.\n* Active, known, or suspected autoimmune disease.\n* Condition requiring systemic treatment with either corticosteroids within 14 days or other immunosuppressive medications within 30 days of the first dose of study treatment.\n* Prior organ or tissue allograft.\n* Uncontrolled or significant cardiovascular disease.\n* Major surgery within 4 weeks of study drug administration.\n* History of or with active interstitial lung disease or pulmonary fibrosis.\n* Other protocol-defined inclusion\u002Fexclusion criteria apply.",{"count":54,"type":20},1109,[56,57],"PHASE1","PHASE2","The purpose of this study is to assess the safety, tolerability, and recommended dose(s) of BMS-986340 as monotherapy and in combination with nivolumab, docetaxel, or Pumitamig in participants with advanced solid tumors. This study is a first-in-human (FIH) study of BMS-986340 in participants with advanced solid tumors.",[60,61,62,63,64,65,66,67,68,69,27],"Cervical Cancer","Gastric\u002FGastroesophageal Junction Adenocarcinoma","Microsatellite Stable Colorectal Cancer","Non-Small-Cell Lung Cancer","Squamous Cell Carcinoma of Head and Neck","Carcinoma, Renal Cell","Urothelial Carcinoma","Pancreatic Adenocarcinoma","Melanoma","Ovarian Neoplasms",[71,60,72,73,74,61,75,62,76,77,63,78,79,64,65,66,67,68,69,27,80,81],"BMS-986340","CRC","First-in-human","GEJ","HNSCC","MSS CRC","Nivolumab","NSCLC","SCCHN","Docetaxel","Pumitamig","2026-06-29",{"date":34,"type":37},{"date":85,"type":37},"2021-05-27",{"date":87,"type":20},"2031-08-31",{"name":89,"class":44},"Bristol-Myers Squibb",47,{"id":92,"slug":93,"hasResults":11,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":4,"eligibilityCriteria":97,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":98,"targetDuration":4,"studyType":21,"phases":100,"briefSummary":101,"conditions":102,"keywords":103,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},"100580749","phase-3-a-study-of-sacituzumab-tirumotecan-sac-tmt-mk-2870-as-monotherapy-and-in-combination-with-pembrolizumab-mk-3475-in-participants-with-triple-negative-breast-cancer-mk-2870-011trofuse-011-100580749","NCT06841354","A Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Participants With Triple-Negative Breast Cancer (MK-2870-011\u002FTroFuse-011)","A Phase 3, Randomized, Open-label Study Comparing Efficacy and Safety of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) as a Monotherapy and in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice in Participants With Previously Untreated Locally Recurrent Unresectable or Metastatic Triple-Negative Breast Cancer Expressing PD-L1 at CPS Less Than 10 (TroFuse-011)","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has locally recurrent unresectable or metastatic TNBC that cannot be treated with curative intent\n* Has not received systemic treatment for locally recurrent unresectable or metastatic breast cancer\n* Participants previously treated for early-stage breast cancer must have completed all prior therapy for early-stage breast cancer with curative intent at least 6 months before the first disease recurrence\n* Is a candidate for treatment with pembrolizumab and one of the TPC options: paclitaxel or nab-paclitaxel or gemcitabine + carboplatin\n* Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline with the exception of alopecia or vitiligo. Participants with endocrine-related AEs who are adequately treated with hormone replacement are eligible\n* Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load\n* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has breast cancer amenable to treatment with curative intent\n* Has TNBC with evaluable tumor programmed death ligand 1 (PD-L1) expression at combined positive score (CPS) ≥10\n* Has received prior systemic therapy for treatment of locally recurrent unresectable or metastatic breast cancer\n* Has Grade ≥2 peripheral neuropathy\n* Has history of documented severe dry eye syndrome, severe Meibomian gland disease and\u002For blepharitis, or severe corneal disease that prevents\u002Fdelays corneal healing\n* Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease\n* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease\n* Has skin only metastatic disease\n* Has advanced\u002Fmetastatic, symptomatic visceral spread at risk of rapidly evolving into life-threatening complications\n* Human immunodeficiency virus (HIV)-infected participants with a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease\n* Has known additional malignancy that is progressing or has required active treatment within the past 5 years\n* Has known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable\n* Active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed\n* Has a history of (noninfectious) pneumonitis\u002Finterstitial lung disease (ILD) that required steroids, has current pneumonitis\u002FILD, or has suspected ILD or pneumonitis that cannot be ruled out by standard diagnostic assessments\n* Concurrent active Hepatitis B (defined as HBsAg positive and\u002For detectable HBV deoxyribonucleic acid (DNA)) and Hepatitis C virus (HCV) (defined as anti-HCV antibody (Ab) positive and detectable HCV ribonucleic acid (RNA)) infection\n* History of stem cell\u002Fsolid organ transplant\n* Has not adequately recovered from major surgery or has ongoing surgical complications",{"count":99,"type":20},1000,[23],"Researchers want to know if sacituzumab tirumotecan given alone or with pembrolizumab can treat triple negative breast cancer (TNBC). The main goal of this study is to learn if people treated with sacituzumab tirumotecan alone or with pembrolizumab live longer overall or without the cancer growing or spreading compared to people treated with chemotherapy.",[27],[30,31,32,104,105],"Antibody-drug conjugate (ADC)","Trophoblast cell-surface antigen 2 (TROP2)","2026-06-26",{"date":82,"type":37},{"date":109,"type":37},"2025-03-16",{"date":111,"type":20},"2030-05-18",{"name":43,"class":44},263,{"id":115,"slug":116,"hasResults":11,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":4,"eligibilityCriteria":120,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":121,"targetDuration":4,"studyType":21,"phases":123,"briefSummary":124,"conditions":125,"keywords":131,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":154},"100546861","phase-1-a-study-of-ly4170156-in-participants-with-selected-advanced-solid-tumors-100546861","NCT06400472","A Study of LY4170156 in Participants With Selected Advanced Solid Tumors","A First-in-Human, Phase 1a\u002F1b Trial to Assess the Safety, Tolerability and Preliminary Efficacy of LY4170156, an Antibody-Drug Conjugate Targeting Folate Receptor α-Expressing Tumor Cells, in Participants With Selected Advanced Solid Tumors","Inclusion Criteria:\n\n* Have one of the following solid tumor cancers:\n\n  * Dose Escalation: Ovarian (epithelial ovarian, primary peritoneal, and fallopian tube) cancer, endometrial cancer, cervical cancer, non-small cell lung cancer (NSCLC), triple negative breast cancer (TNBC), pancreatic cancer, or colorectal cancer (CRC)\n  * Dose Optimization: Ovarian (epithelial ovarian, primary peritoneal, and fallopian tube) and endometrial cancer\n  * Dose Expansion: Low grade serous ovarian cancer, cervical cancer, NSCLC, and TNBC\n\nExclusion Criteria:\n\n* Individual with known or suspected uncontrolled central nervous system (CNS) metastases\n* Individual with history of carcinomatous meningitis\n* Individual with active uncontrolled systemic bacterial, viral, fungal, or parasitic infection\n* Individual with evidence of corneal keratopathy or history of corneal transplant\n* Any serious unresolved toxicities from prior therapy\n* Significant cardiovascular disease\n* Prolongation of QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥ 470 milliseconds (ms)\n* History of pneumonitis\u002Finterstitial lung disease\n* Individuals who are pregnant, breastfeeding or plan to breastfeed during study or within 30 days of last dose of study intervention",{"count":122,"type":20},495,[56],"The purpose of this study is to find out whether the study drug, LY4170156, is safe, tolerable and effective in participants with advanced solid tumors. The study is conducted in two parts - phase Ia (dose-escalation, dose-optimization) and phase Ib (dose-expansion). The study will last up to approximately 4 years.",[69,126,127,128,27,129,130],"Endometrial Neoplasms","Uterine Cervical Neoplasms","Carcinoma, Non-Small-Cell Lung","Pancreatic Neoplasm","Colorectal Neoplasms",[132,78,133,134,135,136,137,138,139,140,141,142,143,144],"Folate receptor alpha","Ovarian cancer","Cervical cancer","Endometrial cancer","Solid tumor","Lung cancer","Breast cancer","Pancreatic cancer","Colorectal cancer","Anti-drug conjugate","Phase I","Chemotherapy","sofe-m","2026-06-17",{"date":147,"type":37},"2026-06-18",{"date":149,"type":37},"2024-05-20",{"date":151,"type":20},"2027-04",{"name":153,"class":44},"Eli Lilly and Company",23,{"id":156,"slug":157,"hasResults":11,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":4,"eligibilityCriteria":161,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":162,"enrollmentInfo":163,"targetDuration":4,"studyType":21,"phases":165,"briefSummary":166,"conditions":167,"keywords":4,"overallStatus":174,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":184},"100643672","phase-2-a-phase-ii-study-of-gv20-0251-in-combination-with-anti-pd-1-monoclonal-antibodies-in-patients-with-unresectable-locally-advanced-or-metastatic-solid-tumors-100643672","NCT07623642","A Phase II Study of GV20-0251 in Combination With Anti-PD-1 Monoclonal Antibodies in Patients With Unresectable, Locally Advanced, or Metastatic Solid Tumors.","An Open-Label, Multicenter, Non-Randomized, Phase II Study of GV20-0251 in Combination With Anti-PD-1 Monoclonal Antibodies in Patients With Unresectable, Locally Advanced, or Metastatic Solid Tumors","Inclusion Criteria\n\n1. Voluntarily signed written informed consent (ICF) prior to any study-specific procedures.\n2. Able and willing to participate in and comply with study procedures throughout the study.\n3. Age ≥ 18 and ≤ 80 years, any gender.\n4. Histologically confirmed unresectable, locally advanced, or metastatic solid tumor.\n5. Must have failed standard of care (SOC), be intolerant to SOC, or be deemed by the investigator to be unsuitable for a specific form of SOC. If SOC failure, documented progression from SOC is required.\n6. No more than 2 prior lines of systemic therapy. Subjects with more lines may be enrolled after sponsor approval. Treatment-naive subjects with locally advanced or metastatic melanoma who have not received systemic therapy may enroll.\n7. Tumor types include: endometrial cancer, cervical cancer, ovarian cancer, triple-negative breast cancer, prostate cancer, head and neck squamous cell carcinoma, esophageal squamous cell carcinoma, hepatocellular carcinoma (HCC), biliary tract malignancies (including only intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer; excluding ampullary carcinoma), pMMR\u002FMSS colorectal adenocarcinoma, pancreatic ductal adenocarcinoma, non-small cell lung cancer (NSCLC), small cell lung cancer, and melanoma (assessed per local institutional standard practice).\n8. For certain tumor types, IGSF8 protein expression on the tumor cell membrane must be positive at pre-screening or screening.\n9. If the subject has received prior anti-PD-1\u002FPD-L1 therapy, documented disease progression during treatment with anti-PD-1\u002FPD-L1 monoclonal antibody (as monotherapy or combined with other checkpoint inhibitors\u002Ftherapies) is required.\n10. Eligible subjects of childbearing potential (female and male) must agree to use effective contraception (hormonal or barrier method) starting 28 days prior to the first dose of GV20-0251, throughout the treatment period, and for at least 4 months after the last dose.\n11. Must have at least one measurable lesion per RECIST v1.1. Previously irradiated lesions with documented progression may be considered measurable.\n12. Must provide archival tumor tissue collected within 3 years prior to signing the ICF. If archival tissue is \\>3 years old, enrollment requires medical confirmation with the sponsor.\n13. ECOG performance status of 0-1 prior to the first dose on C1D1.\n14. Expected survival ≥ 24 weeks.\n15. No history of other primary malignancies, except: (a) a curatively treated malignancy with no active disease for at least 2 years prior to consent and low risk of subsequent relapse; or (b) curatively treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or carcinoma in situ of the breast.\n16. Adequate organ, Hepatic, and Coagulation function at screening.\n17. All adverse events related to prior anticancer therapy have resolved to ≤ Grade 1 (per NCI CTCAE v5.0). For persistent Grade 2 toxicities deemed by the investigator unlikely to resolve, eligibility may be discussed with the sponsor.\n18. For HCC or biliary tract malignancy subjects only, as Child-Pugh Class A.\n\nExclusion Criteria\n\n1. Prior immunotherapy discontinued due to ≥ Grade 3 immune-related adverse events (irAEs) - except endocrine disorders manageable with replacement therapy or asymptomatic elevated serum amylase\u002Flipase - Grade 2 myocarditis, or recurrent Grade 2 pneumonitis.\n2. Insufficient washout period from prior systemic anticancer therapy before initiating GV20-0251 and anti-PD-1 therapy (C1D1)\n3. Received radiotherapy within 2 weeks prior to initiating GV20-0251 and anti-PD-1 therapy, or has radiation-related toxicity requiring corticosteroids. For NSCLC subjects: pulmonary radiotherapy \\> 30 Gy within 6 months prior to C1D1.\n4. Currently enrolled in a drug or device clinical trial; or received an investigational device or investigational drug within 4 weeks prior to C1D1.\n5. Diagnosed with immunodeficiency; or currently receiving chronic systemic corticosteroids (\\> 10 mg\u002Fday prednisone equivalent) or any other form of immunosuppressive therapy.\n6. History of gastrointestinal perforation and\u002For fistula within 6 months prior to consent; or active gastric\u002Fduodenal ulcer, ulcerative colitis, or other GI conditions the investigator believes may cause bleeding or perforation.\n7. Clinically significant and\u002For uncontrolled cardiac disease, including NYHA Class III or IV heart failure, uncontrolled hypertension (systolic BP \\> 160 mmHg), clinically significant arrhythmia assessed by the investigator to affect study participation safety, or myocardial infarction within 6 months prior to C1D1.\n8. Severe hypersensitivity reaction (≥ Grade 3) to anti-PD-1 monoclonal antibody and\u002For any of its excipients; or prior severe hypersensitivity to biologic therapies that the investigator considers may increase subject risk.\n9. Acute leukemia or chronic lymphocytic leukemia (CLL).\n10. QTcF \\> 470 msec, or history of congenital long QT syndrome, or clinically significant ECG abnormalities (including pericarditis) that the investigator considers may affect subject safety.\n11. Active infection requiring systemic treatment; or active, uncontrolled bacterial, viral, or fungal infection requiring systemic treatment within 7 days prior to C1D1.\n12. History of (non-infectious) pneumonitis\u002Finterstitial lung disease requiring steroid treatment, or current pneumonitis\u002Finterstitial lung disease.\n13. Active autoimmune disease requiring systemic treatment within 2 years prior to C1D1\n14. HIV infection.\n15. Active HBV or HCV infection\n16. Prior major organ transplantation\n17. Prior autologous or allogeneic bone marrow transplantation.\n18. Symptomatic primary CNS malignancy, CNS metastases, or leptomeningeal disease.\n19. Major surgery (excluding diagnostic procedures) or severe trauma within 28 days prior to the first dose of GV20-0251, or currently in recovery that the investigator deems would interfere with the study, or anticipated major surgery during the study.\n20. Received a live or attenuated vaccine within 30 days prior to the first dose.\n21. Requires treatment with interferon-α or related\u002Fsimilar agents within 3 weeks prior to C1D1 or during the entire study period.\n22. Requires more than one paracentesis per 8 weeks to manage ascites; or single ascites drainage volume \\> 1.5 liters within 8 weeks prior to C1D1.\n23. Psychiatric illness or substance abuse disorder (e.g., drug abuse, alcohol dependence) that may interfere with the subject's ability to comply with study requirements.\n24. Other serious non-malignant conditions or laboratory abnormalities that, in the opinion of the investigator and\u002For sponsor, make the subject unsuitable for the study; or other circumstances that the investigator believes may confound study results or prevent the subject from completing the study.\n25. Additional exclusion criteria that applicable to HCC or biliary tract malignancy subjects.","80 Years",{"count":164,"type":20},227,[57],"This is a Phase 2 study of GV20-0251 in combination with anti-PD-1 monoclonal antibodies (including tislelizumab and toripalimab) for the treatment of participants with unresectable, locally advanced, or metastatic solid tumors who are refractory to, intolerant of, or ineligible for standard of care.",[127,27,168,64,169,170,171,130,172,128,173],"Prostatic Neoplasms","Esophageal Squamous Cell Carcinoma","Cholangiocarcinoma","Gallbladder Neoplasms","Pancreatic Ductal Adenocarcinoma","Small Cell Lung Carcinoma","NOT_YET_RECRUITING","2026-06-04",{"date":177,"type":37},"2026-06-08",{"date":179,"type":20},"2026-06-02",{"date":181,"type":20},"2029-08-15",{"name":183,"class":44},"GV20 Therapeutics",2,{"id":186,"slug":187,"hasResults":11,"nctId":188,"briefTitle":189,"officialTitle":190,"acronym":4,"eligibilityCriteria":191,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":192,"targetDuration":4,"studyType":21,"phases":194,"briefSummary":195,"conditions":196,"keywords":204,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":218,"lastUpdatePostDateStruct":219,"startDateStruct":221,"completionDateStruct":223,"leadSponsor":225,"locationsCount":227},"100535064","phase-1-a-study-of-pembrolizumab-and-cryoablation-in-people-with-breast-cancer-100535064","NCT06246968","A Study of Pembrolizumab and Cryoablation in People With Breast Cancer","Does Cryoablation Boost Immune Response Improving the Benefits of Pembrolizumab in Patients With Metastatic or Locally Advanced Triple Negative Breast Cancer?","Inclusion Criteria:\n\n* Patients ≥ 18 years of age\n* Confirmed histologic diagnosis of metastatic TNBC\n* 1 site amenable cryoablation of at least 1.5 cm in size as determined by an Interventional Radiologist. Eligible cryoablation sites include (but not limited to) soft tissue, liver, lung, and bone as determined by an Interventional Radiologist to be safest and most feasible.\n* Physically fit (clinically eligible) to undergo cryoablation as per usual clinical practice\n* Per clinical guidelines, women of childbearing age should use effective contraception during treatment with pembrolizumab and for at least 4 months after the last dose of the drug, which will be assessed and monitored by, and the responsibility of, the patient's medical oncologist (not study investigators or research team) as pembrolizumab is standard of care. Memorial Sloan Kettering Cancer Center Pregnancy Standards will be followed prior to cryoablation. That is, female patients that are 11-50 years of age and of childbearing potential will undergo a pregnancy test within 2 weeks (15 days) before cryoablation. Pregnancy test will not be required in patients with bilateral oophorectomy, bilateral salpingectomy, bilateral salpingectomy-oophorectomy, hysterectomy, menopause (no menses ≥ 1 year prior to treatment or after completion of all treatment), or surgical sterilization (i.e. tubal ligation or blockage), with documentation of permanent exemptions in CIS (\"Pregnancy Testing Exemption\").\n* Pembrolizumab therapy (200 mg every 3 weeks) planned as part of standard of care as first, second, or third line of therapy\n\n  * Eligible for PD-1 inhibitor per the patient's medical oncologist, with planned treatment with PD-1 inhibitor per the patient's medical oncologist. Additional systemic therapy is per the patient's medical oncologist. The following systemic therapy will be accepted (the timing of the systemic therapy relative to pembrolizumab and cryoablation is not restricted):\n\n    * Capecitabine (Xeloda, available as a generic drug)\n    * Carboplatin (Paraplatin, available as a generic drug)\n    * Cisplatin (Platinol, available as a generic drug)\n    * Cyclophosphamide (Cytoxan, available as a generic drug)\n    * Docetaxel (Taxotere)\n    * Doxorubicin (Adriamycin, available as a generic drug)\n    * Pegylated liposomal doxorubicin (Doxil)\n    * Epirubicin (Ellence, available as a generic drug)\n    * Eribulin (Halaven)\n    * Fluorouracil (5-FU, Adrucil, available as a generic drug)\n    * Gemcitabine (Gemzar, available as a generic drug)\n    * Ixabepilone (Ixempra)\n    * Methotrexate (available as a general drug)\n    * Nab-paclitaxel (Abraxane)\n    * Paclitaxel (Taxol, available as a generic drug)\n    * Vinorelbine (Navelbine, available as a generic drug)\n\nExclusion Criteria:\n\n* Patient not eligible for PD-1 inhibitor per the patient's medical oncologist\n* No disease amenable for cryoablation\n* Pembrolizumab therapy not planned as part of standard of care",{"count":193,"type":20},30,[56],"Participants will have a confirmed diagnosis of metastatic breast cancer and will receive pembrolizumab in combination with cryoablation OR pembrolizumab alone. Participants will be randomly assigned.",[197,198,199,200,27,201,202,203],"Metastatic Breast Cancer","Breast Cancer","Breast Cancer Stage IV","Triple Negative Breast Cancer","Metastatic Triple-Negative Breast Carcinoma","Locally Advanced Breast Cancer","Locally Advanced Triple-Negative Breast Carcinoma",[205,206,207,208,209,210,211,212,213,214,215,216,217],"metastatic TNBC","metastatic triple negative breast carcinoma","metastatic breast cancer","breast cancer","breast cancer stage IV","triple negative breast cancer","pembrolizumab","cryoablation","Memorial Sloan Kettering Cancer Center","23-390","locally advanced breast cancer","locally advanced triple negative breast carcinoma","locally advanced triple negative breast cancer","2026-05-18",{"date":220,"type":37},"2026-05-20",{"date":222,"type":37},"2024-01-29",{"date":224,"type":20},"2027-01-29",{"name":213,"class":226},"OTHER",7,{"id":229,"slug":230,"hasResults":11,"nctId":231,"briefTitle":232,"officialTitle":233,"acronym":4,"eligibilityCriteria":234,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":235,"targetDuration":4,"studyType":21,"phases":237,"briefSummary":238,"conditions":239,"keywords":245,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":250,"startDateStruct":252,"completionDateStruct":254,"leadSponsor":256,"locationsCount":258},"100545354","phase-1-a-phase-iii-trial-of-ucb4594-in-participants-with-advanced-cancer-100545354","NCT06380816","A Phase I\u002FII Trial of UCB4594 in Participants With Advanced Cancer","A Cancer Research UK Phase I\u002FII Trial to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of UCB4594 Alone and in Combination With Anti-cancer Treatments in Participants With Advanced Malignancies","Inclusion Criteria:\n\n1. Written (signed and dated) informed consent and capable of co-operating with investigational medicinal product (IMP) administration and follow-up\n2. Participant population: Histologically or cytologically proven advanced solid tumours (as specified below), refractory to conventional treatment, or for which no conventional therapy is considered appropriate by the Investigator or is declined by the participant. Module A (dose escalation): Tumour types which have shown high levels of human HLA-G expression (as reported in the literature): head and neck squamous cell carcinoma, non-small cell lung cancer, colorectal cancer, triple-negative breast cancer, renal cell cancer (clear cell only), oesophago-gastric cancer (excluding gastrointestinal stromal tumour), cervical cancer, ovarian cancer, pancreatic cancer. N.B. Participants with small cell type cancers on histology\u002Fcytology are excluded. Pre-treatment biopsies are mandatory for all participants. Paired biopsies will be mandatory for participants from doses of 30 mg and higher. Participants must have disease amenable to biopsy (excluding bone metastases) as deemed safe by the Investigator\n3. Measurable disease, according to RECIST v1.1\n4. Life expectancy of at least 12 weeks\n5. Eastern Cooperative Oncology Group performance status of 0 or 1\n6. Haematological and biochemical indices within defined ranges. These measurements should be performed to confirm the patient's eligibility to participate in the trial\n7. Aged 18 years or over at the time consent is given. Participants aged 16-17 years may be eligible for recruitment to the backfill cohorts in dose escalation once adequate safety and toxicity data have been established in participants aged 18 years or over. All relevant data will be reviewed and a decision on the inclusion of participants aged 16-17 years will be made by the Trial Management Group\n\nExclusion Criteria:\n\n1. Radiotherapy (except palliative), endocrine therapy (unless for non-malignant disease), chemotherapy, targeted therapy or immunotherapy, or any other IMPs during the previous 4 weeks or 5 half-lives (whichever is shorter) before the first dose of IMP\n2. Ongoing toxicity of previous treatments \\>CTCAE Grade 1 (except alopecia of any grade, stable Grade 2 peripheral neuropathy or hormone-replacement therapy (HRT)-managed endocrine disorders)\n3. Patients with rapidly progressing \u002F symptomatically deteriorating brain\u002Fleptomeningeal metastases\u002Funtreated brain metastases are excluded. Patients with previously treated brain metastases are eligible if they haven't had a seizure or a clinically significant change in neurological status or required steroids in the last 2 weeks\n4. Pregnant or breastfeeding female patients (or planning to breastfeed)\n5. Women of childbearing potential. However, those not already pregnant or breastfeeding (or who discontinue breastfeeding) and meet the following are eligible:\n\n   5.1. Have a negative serum pregnancy test within 7 days before enrolment and either:\n\n   5.2.1. Agree to a form of highly effective contraception plus a barrier method, or\n\n   5.2.2. Agree to sexual abstinence\n\n   Effective from the negative pregnancy test, throughout the trial and for 10 months after the last dose of UCB4594\n6. Male patients with partners of childbearing potential. However, patients who meet the following are eligible:\n\n   6.1. Agree to a barrier method of contraception or sexual abstinence\n\n   6.2. Males with pregnant or breastfeeding partners must use barrier method contraception to prevent exposure of the foetus or neonate\n\n   6.3. Non-vasectomised males must also ensure any partner of childbearing potential uses highly effective contraception or agrees to sexual abstinence\n\n   Effective from the date of the first dose of UCB4594, throughout the trial and for 5 months after the last dose of UCB4594 N.B. Males must refrain from donating sperm for the same period\n7. Surgery from which the patient has not yet recovered\n8. High medical risk because of non-malignant systemic disease, including serious or uncontrolled infection (requiring intravenous antibiotics) or unexplained fever \\>38°C within 2 weeks prior to the first dose of UCB4594\n9. Known to be serologically positive for hepatitis B virus, hepatitis C virus or human immunodeficiency virus\n10. Active or suspected autoimmune disease, or any history of autoimmune condition that required systemic corticosteroids or immunosuppressive agents. Patients who have ever had a transplant are excluded. This does not apply to patients with: vitiligo, alopecia, or type I diabetes mellitus, psoriasis not requiring chronic systemic immunosuppressive treatment within the past 2 years, stable autoimmune-mediated hypothyroidism on HRT, and Raynaud's syndrome\n11. Are being treated with escalating or supraphysiologic doses of corticosteroids or immunosuppressive agents. Participants with immunotherapy-related hypophysitis adequately treated with physiologic doses of steroids are not excluded. Use of topical, ophthalmic, inhaled, intermittent steroid injections, and intranasal corticosteroids are permitted\n12. Hypersensitivity to the ingredients\u002Fexcipients (including polysorbate 80) in UCB4594\n13. History of significant toxicities from treatment of immune checkpoint inhibitors (CPIs) that necessitated permanent discontinuation (Patients who started on combination CPI \\[e.g., ipilimumab\u002Fnivolumab\\] and had toxicity requiring discontinuation of one CPI \\[e.g., continued with nivolumab single agent\\] are not excluded)\n14. History of Grade ≥3 infusion-related reaction to monoclonal antibodies or similar drugs\n15. Prior treatment with HLA-G, immunoglobulin-like transcript (ILT)2 or ILT4-targeting drug\n16. Live, attenuated vaccine within 28 days prior to the first dose of IMP\n17. Increased risk due to tumour flare (e.g., an initial increase in tumour size that may lead to obstruction of airways, etc)\n18. Significant active pulmonary disease or condition at screening, including:\n\n    18.1. Lymphangitis carcinomatosa\n\n    18.2. History of interstitial lung disease or pulmonary fibrosis\n\n    18.3. History of pulmonary inflammatory disease\n19. Evidence of bleeding diathesis\n20. Significant cardiovascular disease, defined as a history of: congestive heart failure requiring therapy or left ventricular ejection fraction \\\u003C40%, unstable angina pectoris or myocardial infarction within 6 months prior to entry, or current poorly controlled angina (symptoms weekly or more), clinically significant cardiac arrhythmia within 6 months prior to entry (asymptomatic atrial fibrillation or asymptomatic first-degree heart block permitted), or myocarditis. Presence of symptomatic or severe valvular heart disease. Baseline QT interval corrected by Fridericia \\>450 msec for males and \\>470 msec for females on triplicate electrocardiogram is ineligible\n21. Participant in or plans to join another interventional trial\n22. Other current malignancies. Cancer survivors who have undergone potentially curative therapy for prior malignancy with no evidence of disease for 3+ years are eligible\n23. Any other condition that, in the Investigator's opinion, means the trial is not in the patient's best interest",{"count":236,"type":20},167,[56,57],"This clinical trial is looking at UCB4594. This is the first time the drug is being tested in humans. UCB4594 is a type of drug called a monoclonal antibody. It has been designed to work by targeting a protein called human leucocyte antigen G (HLA-G) that is found in high levels on some cancer cells. By attaching itself to this protein it may help the immune system to attack and kill the cancer cells.\n\nThe four main aims of the clinical trial are to find out:\n\n1. The best dose of UCB4594 that can be given safely to participants in the trial.\n2. What the side effects of UCB4594 are and how they can be managed.\n3. What happens to UCB4594 inside the body and how it affects cancer cells.\n4. Whether UCB4594 can cause cancer to shrink.",[240,64,128,130,27,241,242,243,127,69,244],"Advanced Solid Tumours","Carcinoma, Renal Cell (Clear Cell Only)","Esophageal Neoplasms","Stomach Neoplasms (Excluding Gastrointestinal Stromal Tumors)","Pancreatic Neoplasms",[246,247,248],"HLA-G","Monoclonal Antibody","Cancer","2026-05-05",{"date":251,"type":37},"2026-05-08",{"date":253,"type":37},"2024-07-09",{"date":255,"type":20},"2029-11",{"name":257,"class":226},"Cancer Research UK",4,{"id":260,"slug":261,"hasResults":11,"nctId":262,"briefTitle":263,"officialTitle":264,"acronym":4,"eligibilityCriteria":265,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":266,"targetDuration":4,"studyType":21,"phases":268,"briefSummary":269,"conditions":270,"keywords":275,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":286,"lastUpdatePostDateStruct":287,"startDateStruct":289,"completionDateStruct":291,"leadSponsor":293,"locationsCount":295},"100455301","phase-1-a-study-of-pf-08046054sgn-pdl1v-in-advanced-solid-tumors-100455301","NCT05208762","A Study of PF-08046054\u002FSGN-PDL1V in Advanced Solid Tumors","A Phase 1 Study of PF-08046054\u002FSGN-PDL1V in Advanced Solid Tumors","Inclusion Criteria:\n\n* Parts A and B:\n\n  * Participants must have one of the following histologically- or cytologically-confirmed metastatic or unresectable solid tumor types\n\n    * Non-small cell lung cancer (NSCLC)\n    * Head and neck squamous cell carcinoma (HNSCC) (except nasopharyngeal cancer)\n    * Esophageal squamous cell carcinoma (SCC)\n    * Triple negative breast cancer (TNBC)\n  * Participants must have disease that is relapsed or refractory, that has progressed on approved therapies, be intolerant to or refused such therapies, or such and therapies are contraindicated and in the judgement of the investigator, should have no appropriate SoC therapeutic option\n  * Participants must have PD-L1 expression based on historical testing\n* Part C:\n\n  * Participants must have disease that is relapsed or refractory or be intolerant to SoC therapies and must have one of the following tumor types\n\n    * HNSCC\n\n      * Participants with HNSCC must have histologically or cytologically-confirmed HNSCC\n    * NSCLC\n\n      * Participants must have histologically or cytologically-confirmed NSCLC. Participants with SCC and non--SCC histology are eligible. Note: Participants with a neuroendocrine component or histology are not eligible.\n    * Esophageal SCC\n    * Pancreatic cancer\n    * Hepatocellular carcinoma\n    * TNBC\n    * Gastric cancer\n    * Endometrial cancer\n  * Participants must have been previously tested for PD-L1 expression and should have PD-L1 expression ≥1 or \\\u003C1 by CPS or TPS based on historical testing\n* Part D and Part E:\n\n  * Participants must have histologically or cytologically-confirmed disease of the HNSCC or NSCLC\n  * Participants must have PD-L1 expression based on historical testing\n  * Participants with NSCLC; PD-L1 expression ≥ 1% by TPS\n  * Participants with HNSCC; PD--L1 expression ≥1 by CPS\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1\n* Measurable disease per RECIST v1.1 at baseline\n\nExclusion Criteria:\n\n* History of another malignancy within 3 years of first dose of study treatment or any evidence of residual disease from a previously diagnosed malignancy.\n* Known active central nervous system metastases. Participants with previously-treated brain metastases may participate provided they:\n\n  * Are clinically stable for at least 4 weeks prior to study entry after brain metastasis treatment\n  * Have no new or enlarging brain metastases\n  * And are off of corticosteroids prescribed for symptoms associate with brain metastases for at least 7 days prior to first dose of study treatment\n* Lepto-meningeal disease\n* Prior treatment with an anti-PD-L1 agent within less than 5 half-lives. This duration of time will vary according to the half-life of the specific agent.\n* Previous receipt of an monomethylauristatin E (MMAE)-containing agent.\n* Pre-existing neuropathy ≥Grade 2 per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.\n\nThere are additional inclusion criteria. The study center will determine if criteria for participations are met.",{"count":267,"type":20},714,[56],"This study will test the safety of a drug called PF-08046054\u002FSGN-PDL1V alone and with pembrolizumab in participants with solid tumors. It will also study the side effects of this drug. A side effect is anything a drug does to your body besides treating your disease.\n\nParticipants will have solid tumor cancer that has spread through the body (metastatic) or cannot be removed with surgery (unresectable).\n\nThis study will have five parts. Parts A and B of the study will find out how much PF-08046054\u002FSGN- PDL1V should be given to participants. Part C will use the dose found in Parts A and B to find out how safe PF-08046054\u002FSGN-PDL1V is and if it works to treat solid tumor cancers. In Part D and E, participants will be given PF-08046054\u002FSGN-PDL1V with pembrolizumab to find out how safe this combination is and if it works to treat solid tumor cancers.",[128,271,169,27,272,273,67,274],"Squamous Cell Carcinoma of the Head and Neck","Gastric Cancer","Endometrial Cancer","Hepatocellular Carcinoma",[276,78,277,75,200,278,279,280,281,282,283,284,285],"Non-small cell lung cancer","Head and neck squamous cell carcinoma","TNBC","Gastric cancer","Seattle Genetics","HCC","PDAC","Esophageal","Pfizer","Endometrial","2026-04-17",{"date":288,"type":37},"2026-04-20",{"date":290,"type":37},"2022-10-25",{"date":292,"type":20},"2029-01-04",{"name":294,"class":44},"Seagen, a wholly owned subsidiary of Pfizer",61,{"id":297,"slug":298,"hasResults":11,"nctId":299,"briefTitle":300,"officialTitle":301,"acronym":4,"eligibilityCriteria":302,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":303,"targetDuration":4,"studyType":21,"phases":305,"briefSummary":306,"conditions":307,"keywords":330,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":337,"lastUpdatePostDateStruct":338,"startDateStruct":340,"completionDateStruct":342,"leadSponsor":344,"locationsCount":346},"100561192","phase-1-a-study-with-nkt3964-for-adults-with-advancedmetastatic-solid-tumors-100561192","NCT06586957","A Study With NKT3964 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 CDK2 Degrader NKT3964 in Adults With Advanced\u002FMetastatic Solid Tumors","Inclusion Criteria:\n\n\\- Must have a pathologically confirmed advanced and unresectable or metastatic solid tumor listed below with documented disease progression on last standard treatment. Part 1 only: subjects must be refractory to, or intolerant of existing therapy(ies) known to provide clinical benefit for their condition.\n\nDose Escalation:\n\n1. Ovarian cancer\n2. Endometrial cancer (only endometrioid subtype will require CCNE1 amplification)\n3. Gastric, gastroesophageal junction (GEJ) or esophageal adenocarcinoma with CCNE1 amplification\n4. Small cell lung cancer (SCLC)\n5. Triple-negative breast cancer (TNBC; HER2, estrogen receptor and progesterone receptor negative)\n6. HR+ (includes estrogen-receptor or progesterone-receptor) and HER2- breast cancer (must have progressed following treatment with a CDK4\u002F6 inhibitor, and is not suitable for endocrine therapy \\[ET\\])\n7. Other solid tumors with CCNE1 amplification\n\nDose Expansion:\n\nPart 2A: HR+ and HER2- breast cancer that is locally advanced and unresectable (Stage III) or metastatic (Stage IV); previously treated with ≥1 line of standard of care (SOC) including CDK4\u002F6 inhibitor plus ET and not suitable for further ET. Subjects must have progressed after receiving therapy for ≥3 months in the metastatic setting or for ≥6 months in the adjuvant setting. Subjects must have received ≤2 lines of systemic cytotoxic therapy (chemotherapy or cytotoxic antibody drug conjugate \\[ADC\\]) in the metastatic setting..\n\nPart 2B: Advanced platinum-based-chemotherapy resistant or refractory epithelial ovarian\u002Ffallopian\u002Fprimary peritoneal carcinoma or clear cell ovarian cancer (defined as recurrence ≤6 months after completing platinum-based regimen) with progression on at least one platinum containing therapy and previously treated with ≤4 prior lines of systemic therapy administered for advanced\u002Fmetastatic disease and with CCNE1 amplification.\n\nPart 2C: Advanced unresectable or metastatic gastric, GEJ or esophageal adenocarcinoma with progression on at least one systemic therapy and previously treated with ≤3 prior lines of systemic therapy administered for advanced\u002Fmetastatic disease, with CCNE1 amplification as determined by NGS by local liquid or tissue test.\n\nPart 2D: Advanced endometrial adenocarcinoma or uterine papillary serous carcinoma previously treated with ≤4 prior lines of systemic therapy administered for advanced\u002Fmetastatic disease with CCNE1 amplification.\n\nPart 2E: Advanced\u002Frecurrent uterine carcinosarcoma previously treated with 1 prior platinum-based chemotherapy regimen and ≤3 prior lines of systemic therapy. Prior bevacizumab or PARP inhibitors are allowed and must be at least 3 weeks prior to the start of study drug.\n\n* Have adequate organ function\n* Subjects with female reproductive organs must be surgically sterile, post-menopausal, or must be willing to use highly effective method(s) of contraception\n* Ability to swallow oral medications.\n* Consent to provide archived tumor tissues and paired tumor biopsy at pretreatment\n\nExclusion Criteria:\n\n* Locally advanced solid tumor that is a candidate for curative treatment through radical surgery and\u002For radiotherapy, or chemotherapy.\n* History of another malignancy with exceptions\n* History of lymphohistiocytic or lymphoid hyperplasia; hemophagocytic lymphohistiocytosis.\n* Failed to recover from effects of prior anticancer treatment therapy to baseline or Grade ≤ 1 severity (per CTCAE)\n* Clinically significant cardiovascular event within 6 months prior to start of NKT3964 treatment\n* Known active CNS metastases and\u002For carcinomatous meningitis\n* Active interstitial lung disease currently requiring treatment\n* History of uveitis, retinopathy or other clinically significant retinal disease\n* Active or chronic corneal disorders, other active ocular conditions requiring ongoing therapy, or any clinically significant corneal disease\n* Active wound healing from major surgery within 1 month or minor surgery within 10 days before the first dose of NKT3964.\n* Known human immunodeficiency virus (HIV), active hepatitis B or C infection\n* Prior investigative treatment with a selective or nonselective CDK2 inhibitor or degrader\n* Childs-Pugh class B or C cirrhosis or any other clinically significant liver disorder\n* Palliative radiation therapy within 14 days or other radiation therapy within 4 weeks prior to C1D1",{"count":304,"type":20},150,[56],"The goal of the Dose Escalation phase of the study is to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity to determine the preliminary recommended dose for expansion (RDE) of NKT3964 in adults with advanced or metastatic solid tumors. The goal of the Expansion phase of the study is to evaluate the preliminary anti-tumor activity of NKT3964 at the RDE based on objective response rate (ORR) and determine the preliminary recommended Phase 2 dose (RP2D).",[308,309,310,311,312,69,313,314,126,315,316,200,317,318,319,272,320,321,322,323,173,27,324,325,326,327,328,329],"Solid Tumor","Advanced Solid Tumor","Solid Tumor, Adult","Metastatic Tumor","Ovarian Cancer","Ovarian Carcinoma","Metastatic Ovarian Carcinoma","Endometrial Diseases","Metastatic Endometrial Cancer","Metastatic Endometrial Carcinoma","Advanced Endometrial Carcinoma","Advanced Ovarian Carcinoma","Advanced Gastric Carcinoma","Metastatic Gastric Cancer","Metastatic Gastric Carcinoma","Small Cell Lung Cancer","Platinum-resistant Ovarian Cancer","Platinum-refractory Ovarian Carcinoma","CCNE1 Amplification","Hormone Receptor Negative Breast Carcinoma","Human Epidermal Growth Factor 2 Negative Carcinoma of Breast","Progesterone-receptor-positive Breast Cancer",[331,332,333,334,335,336],"CDK 2 Inhibitor","CDK 4 Inhibitor","CDK 6 Inhibitor","CDK2 Degrader","Protein Degrader","PROTAC","2026-04-16",{"date":339,"type":37},"2026-04-21",{"date":341,"type":37},"2024-09-19",{"date":343,"type":20},"2029-05",{"name":345,"class":44},"NiKang Therapeutics, Inc.",19,{"id":348,"slug":349,"hasResults":11,"nctId":350,"briefTitle":351,"officialTitle":352,"acronym":353,"eligibilityCriteria":354,"healthyVolunteers":11,"sex":355,"minAge":17,"maxAge":4,"enrollmentInfo":356,"targetDuration":4,"studyType":21,"phases":358,"briefSummary":359,"conditions":360,"keywords":361,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":363,"lastUpdatePostDateStruct":364,"startDateStruct":366,"completionDateStruct":368,"leadSponsor":370,"locationsCount":372},"100544200","phase-2-bicalutamide-and-abemaciclib-in-inoperable-or-metastatic-androgen-receptor-positive-triple-negative-breast-cancer-100544200","NCT06365788","Bicalutamide and Abemaciclib in Inoperable or Metastatic Androgen Receptor-positive Triple-negative Breast Cancer","A Multicenter Single Arm Phase II Study With Bicalutamide in Combination With Abemaciclib in 4 Cohorts of Locoregionally Advanced Inoperable or Metastatic Androgen Receptor-positive Triple-negative Breast Cancer","ABBICAR","Inclusion Criteria:\n\n1. Provision of signed and dated, written informed consent prior to any study specific procedures, sampling and analysis. If a patient declines to participate in any voluntary exploratory research of the study, there will be no loss of benefit to the patient and she will not be excluded from other aspects of the study\n2. Women aged at least 18 years\n3. The patient has a biopsy-confirmed diagnosis of recurrent, unresectable, locally advanced, or metastatic AR+ TNBC\n\n   1. AR+ assessed locally and defined as ≥1% of cells staining on IHC of last recurrent\u002Fmetastatic breast cancer specimen\n   2. Local biopsy confirmation of last recurrent\u002Fmetastatic site with positive IHC for ER and\u002For PR in ≤10% of cells and negative for HER2 per ASCO\u002FCAP-guidelines\n   3. Prior invasive (metastatic) breast cancer with positive IHC for ER and\u002For PR in \\>10% of cells is allowed, provided the last biopsy of recurrent\u002Fmetastatic disease has positive IHC for ER and\u002For PR in ≤10% of cells\n   4. Prior invasive (metastatic) HER2-positive breast cancer per ASCO\u002FCAP-guidelines is not allowed\n   5. The patient has measurable disease per RECIST 1.1 or evaluable bone-only disease with lytic or mixed component that is progressive as evidenced on pre-treatment baseline imaging\n4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 with no deterioration over the previous 2 weeks and minimum life expectancy of 12 weeks\n5. The patient must have had prior treatment with at least 1 prior cytostatic regimen in advanced setting setting unless treatment with a cytostatic regimen is contraindicated as judged by Investigator. There is no upper limit for prior treatment lines in advanced setting.\n\n   * Patients with known germline BRCA1\u002F2 pathogenic variants should have received previous treatment with PARP inhibitors in the early\u002Flocally advanced or metastatic setting, unless contraindicated.\n   * Prior treatment with palbociclib or ribociclib is allowed, provided at least 6 months have elapsed between last administration and start of study treatment\n6. Patients must have recovered (Common Terminology Criteria for Adverse Events \\[CTCAE\\] Grade ≤1) from the acute effects of prior anticancer treatment except for residual Grade 2 alopecia, anemia or peripheral neuropathy prior to randomization. A washout period of at least 21 days is required between last chemotherapy dose and first dose of study drug (provided the patient did not receive radiotherapy).\n7. Patients who received radiotherapy must have completed and fully recovered from the acute effects of radiotherapy. A washout period of at least 14 days is required between end of radiotherapy and randomization.\n8. In females of child-bearing potential, a negative serum or urine pregnancy test within 7 days prior to starting treatment is required. Women of child-bearing potential must agree to use a highly effective method of contraception prior to study entry, for the duration of study participation (in addition to the LHRH-agonist), and for 3 weeks following completion of abemaciclib and for 130 days following completion of bicalutamide.\n\nA female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:\n\n* Has not undergone a hysterectomy or bilateral oophorectomy; or\n* Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).\n\nExclusion Criteria:\n\n1. Treatment with any of the following:\n\n   a. Any experimental treatment in a clinical trial within the last 30 days or 5 half-lives, whichever is longer, prior to randomization.\n\n   b) Currently enrolled in any other type of medical research (for example: medical device) judged by the sponsor not to be scientifically or medically compatible with this study.\n\n   c. Any other chemotherapy, immunotherapy or anticancer agents within 21 days of the first dose of study treatment d. Treatment with palbociclib or ribociclib within 6 months of the first dose of study treatment e. Any prior exposure to abemaciclib f. Any prior exposure to anti-androgen therapy (bicalutamide, abiraterone, and\u002For enzalutamide)\n2. Major surgery (excluding placement of vascular access) within 4 weeks of the first dose of study treatment\n3. Spinal cord compression, leptomeningeal carcinomatosis, or brain metastases - unless asymptomatic, treated, stable at baseline imaging and not requiring corticosteroids \\>10 mg prednisolone daily (or equivalent) for at least 2 weeks prior to start of study treatment\n4. Concurrent use of endocrine therapy (tamoxifen, anastrozole, letrozole, exemestane, oral contraceptive pills)\n5. The patient has serious and\u002For uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, severe renal impairment \\[e.g. estimated creatinine clearance \\\u003C30ml\u002Fmin\\], history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea).\n6. As judged by the investigator, any evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses, or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV). Screening for chronic conditions is not required.\n7. Any of the following cardiac criteria:\n\n   1. Mean resting corrected QT interval (QTc) \\> 470 msec obtained from 3 consecutive electrocardiograms (ECGs)\n   2. Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG (eg, complete left bundle branch block, third degree heart block)\n   3. Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age or any concomitant medication known to prolong the QT interval\n   4. Personal history of syncope of cardiovascular etiology, ventricular arrhythmia (of pathologic origin including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest.\n   5. Experience of any of the following procedures or conditions in the preceding 6 months: coronary artery bypass graft, angioplasty, vascular stent, myocardial infarction, angina pectoris, congestive heart failure NYHA Grade 2 or greater\n   6. Uncontrolled hypotension - Systolic BP \\\u003C90mmHg and\u002For diastolic BP \\\u003C50mmHg\n   7. Known left ventricular ejection fraction (LVEF) below lower limit of normal for site\n8. Prior history of DVT\u002FPE or embolic stroke, unless currently on therapeutic anticoagulation\n9. Inadequate bone marrow reserve or organ function as demonstrated by any of the following laboratory values:\n\n   1. Absolute neutrophil count \\\u003C 1.5 x 109\u002FL\n   2. Platelet count \\\u003C 100 x 109\u002FL\n   3. Hemoglobin \\\u003C 8 g\u002FdL (Patients may receive transfusions to achieve this hemoglobin level at the discretion of the investigator. Initial treatment must not begin earlier than the day after the erythrocyte transfusion.)\n   4. Alanine aminotransferase \\> 3 times the upper limit of normal (ULN)\n   5. Aspartate aminotransferase \\> 3 times ULN\n   6. Total bilirubin \\> 1.5 times ULN (patients with Gilbert's syndrome with a total bilirubin ≤2.0 times ULN and direct bilirubin within normal limits are permitted)\n   7. Creatinine \\>1.5 times ULN concurrent with creatinine clearance \\\u003C 50 ml\u002Fmin (measured or calculated per local institutional practice); confirmation of creatinine clearance is only required when creatinine is \\> 1.5 times ULN\n   8. Known proteinuria 3+ on dipstick analysis or \\>500mg\u002F24 hours\n   9. Sodium or potassium outside normal reference range for site. Grade 1 abnormality of sodium and potassium (as defined by CTCAE v5.0) can be included if judged clinically not significant by the investigator, based on the participant's clinical context and comorbidities.\n10. Liver disease such as cirrhosis, chronic active hepatitis, or chronic persistent hepatitis. Patients who are hepatitis B Core antibody IgG positive are allowed to participate if taking and compliant with daily oral hepatitis B prophylactic medications\n11. Severely impaired lung function defined as spirometry and DLCO that is less than or equal to 50% of the normal predicted value and\u002For 02 saturation that is 89% or less at rest on room air and\u002For serious \u002Funcontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy).\n12. Uncontrolled diabetes as defined by fasting serum glucose \\>1.5 x ULN\n13. Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of abemaciclib and\u002For bicalutamide\n14. Patients with an active bleeding diathesis\n15. The patient has active systemic bacterial infection (requiring intravenous \\[IV\\] antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C \\[for example, hepatitis B surface antigen positive\\]. Screening is not required for enrollment.\n16. History of hypersensitivity or allergic reaction to abemacliclib, bicalutamide or goserelin, or drugs with a similar chemical structure or class\n17. Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements\n18. Co-administration with strong CYP3A4 inducers (e.g., phenytoin, rifampin, carbamazepine, St John's Wort, bosentan, efavirenz, etravirine, modafinil, and nafcillin) or strong CYP3A4 inhibitors (e.g., clarithromycin, indinavir, itraconazole, ketoconazole, lopinavir\u002Fritonavir, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, verapamil, and voriconazole). See Appendix 4 for complete list.\n19. Other invasive malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin.\n20. Female patients who are pregnant or breast feeding\u002Flactating, or females of reproductive potential who are not using effective birth control methods. Hormonal contraceptives are not acceptable as a method of contraception.\n21. Patients with hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption","FEMALE",{"count":357,"type":20},53,[57],"This study has as goal to evaluate the use of abemaciclib and bicalutamide in androgen receptor positive metastatic triple negative breast cancer.",[27],[200,362],"Receptors, Androgen","2026-03-26",{"date":365,"type":37},"2026-04-01",{"date":367,"type":37},"2024-04-08",{"date":369,"type":20},"2028-12",{"name":371,"class":226},"Universitaire Ziekenhuizen KU Leuven",6,{"id":374,"slug":375,"hasResults":11,"nctId":376,"briefTitle":377,"officialTitle":378,"acronym":379,"eligibilityCriteria":380,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":381,"targetDuration":4,"studyType":21,"phases":383,"briefSummary":384,"conditions":385,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":386,"lastUpdatePostDateStruct":387,"startDateStruct":389,"completionDateStruct":391,"leadSponsor":393,"locationsCount":395},"100514083","phase-2-capecitabine-plus-pembrolizumab-in-patients-with-triple-negative-breast-cancer-after-chemo-immunotherapy-and-surgery-100514083","NCT05973864","Capecitabine Plus Pembrolizumab in Patients With Triple Negative Breast Cancer After Chemo-immunotherapy and Surgery","A Phase II Study to Evaluate CAPecitabine Plus Pembrolizumab as Post-operative Adjuvant Therapy for Triple Negative Breast Cancer With Residual Disease After Neoadjuvant Chemo-immunotherapy","CAPPA","• CRITERIA FOR EXPERIMENTAL ARM :\n\nInclusion criteria (for experimental arm):\n\nPatients eligible for this study must meet ALL of the following criteria:\n\n1. Patient must have signed a written informed consent prior to any trial specific procedures. When the patient is physically unable to give their written consent, a trusted person of their choice, independent from the investigator or the sponsor, can confirm in writing the patient's consent;\n2. Subject ≥18 years of age on day of signing informed consent form (ICF);\n3. Histologically proven TNBC defined as follows:\n\n   1. HER2 negativity (ASCO\u002FCAP criteria)\n   2. AND less than 10% of cells stained by immunohistochemistry (IHC) for ER and PgR;\n4. TNBC patients previously treated by standard neoadjuvant chemotherapy with a minimum of 6 cycles of immunochemotherapy containing pembrolizumab, per standard of care (and pembrolizumab label) and anthracyclines and\u002For taxanes (with\u002Fwithout carboplatin). Other drugs may be acceptable following discussion with the sponsor (with the exclusion of capecitabine);\n5. Complete resection of the breast tumor(s) (and of any invaded lymph node);\n6. No complete pathological response, defined as RCB Class I, II or III (per local assessment);\n7. Available representative formalin-fixed paraffin-embedded (FFPE) tumor block from surgery specimen with its histological report;\n8. Eastern Cooperative Oncology Group (ECOG) Performance Status \\\u003C2;\n9. Adequate organ and bone marrow function. All screening lab tests should be performed within 28 days before inclusion;\n10. Resolution to at least grade 1 of all acute toxicities from previous therapies including immune-related toxicity due to pembrolizumab, except alopecia and grade 2 immune-related endocrinopathies controlled by hormone replacement which are allowed;\n11. Minimal\u002Fmaximal period for prior treatments (i.e. minimal delay from last dose of prior treatment to C1D1): breast surgery (the wound must have healed prior to C1D1) ≥2 weeks (maximum 10 weeks); last pembrolizumab injection ≥3 weeks;\n12. Women of child-bearing potential must have a negative serum pregnancy test within 7 days before C1D1;\n13. Women of child-bearing potential and male patients must agree to use 1 effective form of contraception from the time of the negative pregnancy test up to 6 months after the last dose of study drugs;\n14. Patient should be able and willing to comply with study visits and procedures as per protocol;\n15. Patients must be affiliated to a Social Security System (or equivalent).\n\nNon-inclusion criteria (for experimental arm):\n\nPatients eligible for this study must not meet ANY of the following criteria:\n\n1. Radiological or clinical evidence of metastatic disease documented by imaging or clinical examination performed during screening period;\n2. Has received capecitabine or other ICI than pembrolizumab in the NAC regimen;\n3. Has a known additional malignancy, excepted skin basal cell carcinoma, squamous cell carcinoma of the skin, or in situ cervical cancer or previously treated malignancy with no evidence of disease for ≥2 years;\n4. Presents a contraindication to continue pembrolizumab treatment as per respective SmPC including known hypersensitivity;\n5. Previous immune-related adverse event of any grade due to pembrolizumab that led to permanent discontinuation of pembrolizumab;\n6. Presents a contraindication to capecitabine treatment as per SmPC (See EMA website for most recent edition of SmPC);\n7. Complete DPD (Dihydropyrimidine Dehydrogenase) deficiency (a systematic screening of DPD deficiency must be performed);\n8. Patient with active infection ;\n9. Patients with history of uncontrolled or symptomatic cardiac disease ;\n10. Patients having received brivudine within 4 weeks prior to inclusion;\n11. Require the use of one of the following forbidden treatments during the study treatment period:\n\n    * Any investigational anticancer therapy other than the protocol specified treatment;\n    * Any concurrent chemotherapy, immunotherapy, biologic for cancer treatment, other than the ones stated in the protocol;\n12. Pregnant women or women who are breast-feeding;\n13. Patients unwilling or unable to comply with the medical follow-up required by the trial because of geographic, familial, social, or psychological reasons;\n14. Persons deprived of their liberty or under protective custody or guardianship;\n15. Participation in another therapeutic trial within the 30 days prior to randomization.\n\n    * CRITERIA FOR STANDARD OF CARE TREATED EXTERNAL COHORT\n\nInclusion criteria (for standard of care treated external cohort) :\n\nPatients eligible for this cohort must meet ALL of the following criteria:\n\n1. Patient information prior to study entry and non-opposition to data collection\n2. Subject ≥18 years of age ;\n3. Histologically proven TNBC defined as follows:\n\n   1. HER2 negativity (ASCO\u002FCAP criteria)\n   2. AND less than 10% of cells stained by immunohistochemistry (IHC) for ER and PgR;\n4. TNBC patients previously treated by standard neoadjuvant chemotherapy with a minimum of 6 cycles of immunochemotherapy containing pembrolizumab, per standard of care (and pembrolizumab label) and anthracyclines and\u002For taxanes (with\u002Fwithout carboplatin). Other drugs may be acceptable following discussion with the sponsor (with the exclusion of capecitabine);\n5. Complete resection of the breast tumor(s) (and of any invaded lymph node);\n6. No complete pathological response, defined as RCB Class I, II or III (per local assessment);\n7. Patient should have received at least one injection of pembrolizumab as post-surgery treatment (concomitantly or after radiotherapy).\n\nNon-exclusion criteria (for standard of care treated external cohort) :\n\nPatients eligible for this study must not meet ANY of the following criteria:\n\n1. Radiological or clinical evidence of metastatic disease documented by imaging or clinical examination after surgery.\n2. Has received capecitabine or other ICI than pembrolizumab in the NAC regimen;\n3. Has a known additional malignancy, excepted skin basal cell carcinoma, squamous cell carcinoma of the skin, or in situ cervical cancer or previously treated malignancy with no evidence of disease for ≥2 years;\n4. Any investigational anticancer therapy (chemotherapy, immunotherapy, biologic for cancer treatment) other than pembrolizumab only as adjuvant treatment.",{"count":382,"type":20},220,[57],"The goal of this clinical trial is to evaluate the efficacity and safety of pembrolizumab and capecitabine on the invasive disease-free survival, in participants who have triple negative breast cancer (TNBC) with residual disease after neoadjuvant chemotherapy associated with pembrolizumab.",[27],"2025-11-14",{"date":388,"type":37},"2025-11-17",{"date":390,"type":37},"2025-03-11",{"date":392,"type":20},"2028-08",{"name":394,"class":226},"UNICANCER",20,{"id":397,"slug":398,"hasResults":11,"nctId":399,"briefTitle":400,"officialTitle":401,"acronym":4,"eligibilityCriteria":402,"healthyVolunteers":11,"sex":355,"minAge":17,"maxAge":4,"enrollmentInfo":403,"targetDuration":4,"studyType":21,"phases":404,"briefSummary":405,"conditions":406,"keywords":407,"overallStatus":174,"whyStopped":4,"lastUpdateSubmitDate":416,"lastUpdatePostDateStruct":417,"startDateStruct":419,"completionDateStruct":421,"leadSponsor":423,"locationsCount":425},"100596068","phase-2-a-study-of-sacituzumab-govitecan-plus-toripalimab-versus-toripalimab-plus-nab-paclitaxel-in-pd-l1-positive-advanced-tnbc-100596068","NCT07040644","A Study of Sacituzumab Govitecan Plus Toripalimab Versus Toripalimab Plus Nab-Paclitaxel in PD-L1 Positive Advanced TNBC","A Multi-center, Open-label, Randomized, Phase II Trial of Sacituzumab Govitecan Plus Toripalimab Versus Toripalimab Plus Nab-Paclitaxel as First-line Therapy in Patients With Unresectable, Locally Advanced or Metastatic Triple-Negative Breast Cancer","Inclusion Criteria:\n\n* Female patients aged ≥18 years.\n* Histologically or cytologically confirmed triple-negative breast cancer (TNBC).\n* Unresectable locally advanced or metastatic disease.\n* PD-L1 positive (CPS ≥1 as assessed by central laboratory).\n* No prior systemic treatment for advanced or metastatic TNBC.\n* Measurable disease per RECIST v1.1.\n* ECOG performance status of 0 or 1.\n* Adequate hematologic, hepatic, and renal function.\n* Willingness to provide informed consent.\n\nExclusion Criteria:\n\n* Prior treatment with any anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies.\n* Known active central nervous system metastases.\n* Active autoimmune disease or history of autoimmune disorders requiring systemic treatment.\n* Active infection requiring systemic therapy.\n* Pregnancy or lactation.\n* Other active malignancies requiring treatment within the past 5 years.\n* History of severe hypersensitivity reactions to study drugs.",{"count":304,"type":20},[57],"This is a multicenter, open-label, randomized phase II trial evaluating the efficacy and safety of sacituzumab govitecan plus toripalimab versus toripalimab plus nab-paclitaxel in patients with previously untreated, unresectable, locally advanced or metastatic triple-negative breast cancer (TNBC) that is PD-L1 positive.\n\nEligible patients will be randomized in a 1:1 ratio to receive either sacituzumab govitecan plus toripalimab or toripalimab plus nab-paclitaxel. Tumor response will be assessed by investigators according to RECIST v1.1 at baseline, every 6 weeks during the first year, and every 12 weeks thereafter.\n\nThe primary objective is to evaluate progression-free survival (PFS). Secondary endpoints include overall survival (OS), objective response rate (ORR), duration of response (DOR), time to response (TTR), and safety profile according to NCI-CTCAE v5.0.",[27],[408,409,410,411,412,413,414,415],"PD-L1 Positive","Sacituzumab Govitecan","Toripalimab","Nab-Paclitaxel","Advanced Breast Cancer","Metastatic TNBC","Randomized Controlled Trial","Progression-Free Survival","2025-08-29",{"date":418,"type":37},"2025-09-08",{"date":420,"type":20},"2025-09",{"date":422,"type":20},"2028-06",{"name":424,"class":226},"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University",1,{"id":427,"slug":428,"hasResults":11,"nctId":429,"briefTitle":430,"officialTitle":431,"acronym":432,"eligibilityCriteria":433,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":434,"targetDuration":4,"studyType":21,"phases":436,"briefSummary":437,"conditions":438,"keywords":441,"overallStatus":174,"whyStopped":4,"lastUpdateSubmitDate":445,"lastUpdatePostDateStruct":446,"startDateStruct":448,"completionDateStruct":450,"leadSponsor":452,"locationsCount":184},"100604597","phase-2-testing-two-different-drugs-sacituzumab-govitecan-and-trastuzumab-deruxtecan-combinations-prescribed-in-an-alterning-pattern-to-patients-with-metastatic-or-locally-advanced-triple-negative-breast-cancer-100604597","NCT07151586","Testing Two Different Drugs (Sacituzumab-govitecan and Trastuzumab-deruxtecan) Combinations Prescribed in an Alterning Pattern to Patients With Metastatic or Locally Advanced Triple-negative Breast Cancer","A Phase 2, Multicenter, Randomized, Open-label Trial Assessing Sacituzumab-govitecan and Trastuzumab-deruxtecan Combinations in an Alternating Regimen for Patients With Metastatic or Locally Advanced HER2-low Triple-negative Breast Cancer","ALTER","Inclusion Criteria:\n\n* Patient must have signed a written informed consent prior to any trial specific procedures. (Note : When the patient is physically unable to give his\u002Fher written consent, a impartial witness of their choice, independent from the investigator or the sponsor, can confirm in signing the patient's consent)\n* Men or women ≥ 18 years of age\n* Histologically confirmed metastatic or locally advanced and unresectable triple-negative breast cancer, meeting both of the following criteria by local testing:\n\nHER2-low breast cancer, defined as either immunohistochemistry (IHC) 2+ \u002F in situ hybridization (ISH)-negative or IHC 1+ (ISH-negative or untested), on either the primary or any metastatic site\n\nEstrogen receptor (ER) expression \\\u003C10% and progesterone receptor (PR) expression \\\u003C10% (Note: In case of bilateral breast cancer, participation in the study is permitted as long as both tumours correspond to a triple-negative breast cancer meeting the above criteria)\n\n* Patient eligible to receive sacituzumab-govitecan and T-Dxd according to their indication\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤1\n* Women of childbearing potential and male patients must agree to use adequate contraception for the duration of trial participation and up to 7 months after completing treatment for women and up to 4 months for men.\n\nA woman is considered to be of childbearing potential if she is not postmenopausal or has not undergone hysterectomy. Postmenopausal is defined as any of the following:\n\nAge ≥ 60 years Age \\\u003C 60 years and ≥ 12 continuous months of amenorrhea with no identified cause other than menopause Surgical sterilization (bilateral oophorectomy)\n\n\\- Adequate organ and bone marrow function within 28 days before enrollment. The most recent results available must be used for all parameters below:\n\nHemoglobin ≥ 9 g\u002FdL. Red blood cell transfusion is not allowed within 1 week prior to screening assessment\n\nAbsolute neutrophil count (ANC) ≥ 1,500\u002Fmm³. Granulocyte-colony stimulating factor (G-CSF) administration is not allowed within 1 week prior to screening assessment\n\nPlatelet count ≥ 100,000\u002Fmm³. Platelet transfusion is not allowed within 1 week prior to registration\n\nTotal bilirubin ≤ 1.5 × upper limit of normal (ULN) if no liver metastases, or \\\u003C 3 × ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinemia) or liver metastasis at baseline\n\nAlanine transaminase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN, or \\\u003C 5 × ULN in patients with liver metastasis\n\nSerum albumin ≥ 2.5 g\u002FdL\n\nCreatinine clearance (CrCl) ≥ 30 mL\u002Fmin, calculated using the Cockcroft-Gault equation: CrCl (mL\u002Fmin) = \\[(140 - age in years) × weight in kg\\] \u002F \\[72 × serum creatinine in mg\u002FdL\\] (× 0.85 for females)\n\n* Adequate cardiac function, defined as a left ventricular ejection fraction ≥ 55% estimated by echocardiogram or multigated acquisition scintigraphy\n* Women of childbearing potential must have a negative serum or urine pregnancy test done within 7 days before randomization\n* Affiliated to the French Social Security System (or equivalent)\n* Patient willing and able to comply with the protocol for the duration of the trial including undergoing treatment and scheduled visits, and examinations including follow-up.\n\nExclusion Criteria:\n\n* Patient previously treated with any ADC targeting HER2 or TROP2\n* Patient with uncontrolled or significant cardiovascular disease\n* Patients with brain metastases (BM) except for asymptomatic treated BM not requiring ongoing corticosteroid treatment with stable lesions on baseline\u002Fscreening brain MRI. Patients who require treatment of brain metastases are eligible after 14 days post surgery or radiation, if felt to be clinically stable and not requiring ongoing corticosteroid treatment\n* History of (non-infectious) interstitial lung disease (ILD)\u002Fpneumonitis that required steroids, or current ILD\u002Fpneumonitis, or suspected ILD\u002Fpneumonitis that cannot be ruled out by imaging at screening\n* Any medical history or condition that per protocol or in the opinion of the investigator is incompatible with the study\n* Patients with known allergy or severe hypersensitivity to any of the trial drugs or their excipients\n* Other concurrent medical or psychiatric conditions that, in the Investigator's opinion, may cause misleading study interpretation or prevent completion of study procedures and followup examinations\n* Patients with any other disease or illness that requires hospitalisation or is incompatible with the trial treatment are not eligible\n* Patients enrolled in another therapeutic trial within 30 days of inclusion\n* Pregnant or breast-feeding women at the time of randomization or intention to become pregnant during the study and up to 7 months after treatment\n* Person deprived of their liberty or under protective custody or guardianship\n* Patients unwilling or unable to comply with the medical follow-up required by the trial because of geographic, familial, social, or psychological reasons",{"count":435,"type":20},260,[57],"This is a phase II, multicentre, open-label, randomised controlled trial (patients are randomly assigned to one treatment arm or the other) evaluating two treatment strategies (sacituzumab govitecan and trastuzumab deruxtecan in an alternative schema or sacituzumab govitecan alone) in patients with locally advanced or metastatic triple-negative breast cancer.\n\nThe goal is to answer the question: Does alternating sacituzumab goveitecan (SG) and trastuzumab deruxtecan (T-DXd) improve survival in patients with HER2-low metastatic triple-negative breast cancer compared to continuing treatment with SG alone?",[27,439,440],"Neoplasm Metastasis","HER 2 Low-expressing Breast Cancer",[442,443,200,202,444,197],"Antibody-drug conjugates","HER2-low","HER2-negative","2025-08-25",{"date":447,"type":37},"2025-09-03",{"date":449,"type":20},"2025-10",{"date":451,"type":20},"2029-10",{"name":394,"class":226},{"id":454,"slug":455,"hasResults":11,"nctId":456,"briefTitle":457,"officialTitle":458,"acronym":4,"eligibilityCriteria":459,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":460,"targetDuration":4,"studyType":21,"phases":461,"briefSummary":462,"conditions":463,"keywords":468,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":471,"lastUpdatePostDateStruct":472,"startDateStruct":474,"completionDateStruct":476,"leadSponsor":478,"locationsCount":480},"100476579","phase-2-novel-neoadjuvant-and-adjuvant-strategy-for-germline-brca-12-mutated-triple-negative-breast-cancer-100476579","NCT05485766","Novel Neoadjuvant and Adjuvant Strategy for Germline BRCA 1\u002F2 Mutated Triple Negative Breast Cancer","Neoadjuvant and Adjuvant Olaparib Plus Pembrolizumab Following Platinum Based Chemotherapy Plus Pembrolizumab for Germline BRCA Mutated Triple Negative Breast Cancer (WJOG14020B\u002FOPERETTA)","Inclusion Criteria:\n\n* Male\u002Ffemale subjects who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of invasive breast cancer\n* Have histologically confirmed TNBC, as defined by the most recent ASCO\u002FCAP guidelines.\n* Confirmed germline BRCA 1\u002F2 mutated.\n* Have previously untreated locally advanced non-metastatic (M0) TNBC defined as the following combined primary tumor (T) and regional lymph node (N) staging per AJCC for breast cancer staging criteria version 7 as assessed by the investigator based on radiological and\u002For clinical assessment:\n\n  1. T1c, N1-N2\n  2. T2, N0-N2\n  3. T3, N0-N2\n  4. T4a-d, N0-N2\n* It has been confirmed that there is no distant metastasis to each organ by the following tests. Chest: Contrast CT or FDG-PET\u002FCT Abdominal: Contract CT\\* or FDG-PET\u002FCT Bone: Bone scintigraphy or FDG-PET\u002FCT Brain: In the case of no central nervous system symptoms, examination for brain metastasis is not required.\n* The subject (or legally acceptable representative if applicable) provides written informed consent for the trial.\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.\n* Have adequate organ function as defined in the protocol. Specimens must be collected within 10 days prior to the start of study treatment.\n\nExclusion Criteria:\n\n* Subjects who has a positive urine pregnancy test within 72 hours prior to registration\n* Has diagnosed as inflammatory breast cancer.\n* Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor .\n* Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug.\n* Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention.\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.\n* Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years.\n* Has severe hypersensitivity (≥Grade 3) to pembrolizumab and investigational drugs used in this study and\u002For any of their excipients.\n* Has active autoimmune disease that has required systemic treatment in the past 2 years\n* Has a history of (non-infectious) pneumonitis\u002Finterstitial lung disease .\n* Has an active infection requiring systemic therapy.\n* Has a known history of Human Immunodeficiency Virus (HIV) infection.\n* Has a known history of Hepatitis B (defined as Hepatitis B surface antigen \\[HbsAg\\] reactive) or known active Hepatitis C virus (defined as HCV RNA \\[qualitative\\] is detected) infection.\n* Has a known history of active TB (Bacillus Tuberculosis).\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality.\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n* Is pregnant or breastfeeding, or expecting to conceive or father children.\n* Has had an allogenic tissue\u002Fsolid organ transplant.\n* Has received pre-treatment with Olaparib or other PARP inhibitors.\n* Has significant cardiovascular disease\n* Has a resting electrocardiogram (ECG) indicating uncontrolled, potentially reversible cardiac conditions.\n* Subject has myelodysplastic syndrome (MDS)\u002Facute myeloid leukemia (AML) or with features suggestive of MDS\u002FAML.\n* Subject received colony-stimulating factors within 28 days prior to the first dose of study intervention.\n* Subject is considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection.\n* Is either unable to swallow orally administered medication or has a gastrointestinal disorder affecting absorption.\n* Is, in the judgement of the investigator, unlikely to comply with the study procedures, restrictions, and requirements of the study.\n* Is currently receiving either strong or moderate inhibitors of cytochrome P450 (CYP)3A4 that cannot be discontinued for the duration of the study.\n* Is currently receiving either strong or moderate inducers of CYP3A4 that cannot be discontinued for the duration of the study.",{"count":154,"type":20},[57],"This is a Phase II, single-arm, open label study to evaluate Olaparib plus Pembrolizumab following platinum-based chemotherapy plus Pembrolizumab as neoadjuvant therapy for germline BRCA (gBRCA) 1\u002F2 mutated triple negative breast cancer (TNBC).\n\nPembrolizumab in combination with weekly paclitaxel and carboplatin (treatment 1) is followed by Pembrolizumab in combination with Olaparib (treatment 2) in neoadjuvant setting and Pembrolizumab in combination with Olaparib in adjuvant setting will be studied",[27,200,26,198,464,465,466,467],"BRCA1 Mutation","BRCA2 Mutation","BRCA Mutation","BRCA-Associated Breast Carcinoma",[469,470],"BRCA1 protein","BRCA2 protein","2025-03-17",{"date":473,"type":37},"2025-03-20",{"date":475,"type":37},"2024-07-16",{"date":477,"type":20},"2028-09-30",{"name":479,"class":226},"Okayama University",3,{"id":482,"slug":483,"hasResults":11,"nctId":484,"briefTitle":485,"officialTitle":486,"acronym":487,"eligibilityCriteria":488,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":489,"targetDuration":4,"studyType":21,"phases":491,"briefSummary":492,"conditions":493,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":502,"lastUpdatePostDateStruct":503,"startDateStruct":505,"completionDateStruct":507,"leadSponsor":508,"locationsCount":184},"100440865","phase-2-correlation-of-clinical-response-to-pathologic-response-in-patients-with-early-breast-cancer-100440865","NCT05020860","Correlation of Clinical Response to Pathologic Response in Patients With Early Breast Cancer","A Phase II Trial to Correlate Early Clinical Response to Pathologic Outcome With Neoadjuvant Systemic Therapy in Patients With Early Stage Breast Cancer","RESPONSE","Inclusion Criteria:\n\n* At least 18 years of age, and legally able to provide informed consent. Both men and women are eligible.\n* Histologically confirmed, invasive breast cancer. Tumor may be triple negative (as defined by ASCO-CAP guidelines), HER2-positive (as defined by ASCO-CAP guidelines), or high-risk estrogen receptor positive (as defined by ASCO-CAP guidelines).\n\nTo be considered \"high risk,\" at least 2 of the following criteria must be met: 1) histologic grade 3; 2) patient age 50 or less; 3) ER Allred score \\\u003C 6; 4) Ki-67 ≥ 30%.\n\n* Tumors must be at least 2 cm by clinical exam or ultrasound\n* Bilateral breast cancers are allowed if the following criteria are met: 1) A lesion on one side (meeting the criteria above) is designated as the index lesion on which study assessments will be performed, and 2) the same treatment regimen is appropriate for both cancers as determined by the treating physician.\n* ECOG performance status of 0 or 1\n* Left ventricular ejection fraction (LVEF) ≥ the institutional lower limit of normal, as assessed by echocardiogram or Multigated Acquisition (MUGA )scan.\n* Adequate organ function, as determined by the following parameters:\n\n  * Absolute Neutrophil Count (ANC) ≥ 1200\u002Fmm3\n  * Platelets ≥ 100,000\u002Fmm3\n  * Hemoglobin ≥ 9 g\u002FdL\n  * Total bilirubin ≤ institutional upper limit of normal (ULN), unless patient has Gilbert's disease or similar syndrome\n  * Alkaline phosphatase (ALP) ≤ 2.5 x institutional ULN\n  * Aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) ≤ 1.5 x institutional ULN\n  * Serum creatinine ≤ institutional ULN\n* The participant, if of childbearing potential, is willing to use effective, non-hormonal contraception while on treatment.\n* Participation in a concurrent clinical trial is permitted, with Principal Investigator approval.\n\nExclusion Criteria:\n\n* Definitive clinical or radiologic evidence of Stage IV disease\n* Inflammatory breast cancer\n* Participants who are pregnant or lactating\n* History of an excisional biopsy or lumpectomy performed prior to study entry\n* Prior treatment with anthracyclines for any malignancy.\n* Prior treatment for currently diagnosed breast cancer (i.e., endocrine therapy, chemotherapy, targeted therapy, or radiation.\n* History of cardiac disease that would preclude the use of drugs included in these treatment regimens. This includes, but is not limited to:\n\n  * Angina pectoris requiring the use of anti-anginal medication\n  * Ventricular arrhythmias except for benign premature ventricular contractions\n  * Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication\n  * Conduction abnormality requiring a pacemaker\n  * Valvular disease with documented compromise in cardiac function\n  * Symptomatic pericarditis\n  * Documented cardiomyopathy\n  * History of documented congestive heart failure (CHF)\n  * Myocardial infarction documented by elevated cardiac enzymes, or persistent regional wall abnormalities on assessment of left ventricular function.\n* Current HIV, hepatitis B, or hepatitis C infection\n* History of non-breast malignancies (with the exception of in situ cancers treated only by local excision, and basal cell or squamous cell carcinoma of the skin) within 5 years prior to enrollment.\n* Any other non-malignant systemic disease that would preclude treatment with any of the treatment regimens or prevent required follow-up.\n* Any psychiatric or addictive disorders, adverse social situations, or other medical conditions that, in the opinion of the investigator, would preclude the patient from meeting study requirements.",{"count":490,"type":20},185,[57],"The purpose of this study is to learn whether clinical response (the amount a tumor shrinks based on imaging or tumor measurements obtained by physical exam) predicts pathologic response (the amount of tumor remaining when surgery is performed) in participants with breast cancer who are receiving chemotherapy prior to surgery.",[198,494,495,496,497,498,200,499,500,27,501],"Breast Neoplasm","Breast Cancer Female","Breast Cancer Invasive","Breast Cancer Stage II","Breast Cancer Stage III","Hormone Receptor-positive Breast Cancer","HER2-positive Breast Cancer","Estrogen Receptor-positive Breast Cancer","2025-02-25",{"date":504,"type":37},"2025-02-27",{"date":506,"type":37},"2023-04-18",{"date":255,"type":20},{"name":509,"class":226},"Baylor Breast Care Center",{"id":511,"slug":512,"hasResults":11,"nctId":513,"briefTitle":514,"officialTitle":515,"acronym":4,"eligibilityCriteria":516,"healthyVolunteers":11,"sex":355,"minAge":17,"maxAge":517,"enrollmentInfo":518,"targetDuration":4,"studyType":21,"phases":519,"briefSummary":520,"conditions":521,"keywords":522,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":525,"lastUpdatePostDateStruct":526,"startDateStruct":528,"completionDateStruct":530,"leadSponsor":532,"locationsCount":425},"100545752","phase-2-utidelone-utd1-plus-capecitabine-in-non-pcr-tnbc-after-neoadjuvant-therapy-100545752","NCT06385990","Utidelone (UTD1) Plus Capecitabine in Non-pCR TNBC After Neoadjuvant Therapy","Clinical Study of the Efficacy and Safety of Utidelone (UTD1) Combined With Capecitabine as Adjuvant Therapy in Non-pCR Triple-negative Breast Cancer Patients After Neoadjuvant Therapy","Inclusion Criteria:\n\n* Signed informed consent;\n* 18 Years and older;\n* Female;\n* Breast cancer confirmed by pathological histology, ER-negative (\\\u003C1% positive), PR-negative (\\\u003C1% positive), and HER2-negative (IHC: HER2 (0), HER2 (1+), or HER2 (2+) and FISH non-amplification;\n* Patients must receive full course of neoadjuvant chemotherapy before surgery and did not achieve pathological complete response (i. e., pathologically confirmed residual lesion, maximum diameter of 1cm) or \u002F lymph node positive (ypN+);\n* Previous neoadjuvant chemotherapy regimen included anthracycline, taxane, or a combination of both.\n* Patients who clinically require radiotherapy of the affected breast or chest wall and regional lymph node area should receive radiotherapy before or after study medication;\n* All toxicities related to previous antitumor therapy must return to Grade 1 (CTCAE v5.0), except alopecia;\n* Within 1 week before enrollment, the blood routine examination was basically normal (taking the normal value of each study center as the standard): 1) Blood routine: hemoglobin (Hb) \\> 90g \u002F L, White blood cell count (WBC) \\> 3.5\\*10\\^9 \u002F L, Number of neutrophils (ANC) \\* 1.5\\*10\\^9 \u002F L, Platelet count (PLT)\\* 100\\*10\\^9 \u002F L; 2) Renal function: upper limit of normal serum creatinine value; 3) Liver function: for patients without liver metastasis: glutamulate aminotransferase (AST), glutamate aminotransferase (ALT), alkaline phosphatase (ALP) are less than 2.5 times of the upper limit of normal value, and totle bilirubin is less than 1.25 times of the upper limit of normal value; for patients with liver metastasis, AST, ALT, ALP, ALT, ALP, are less than 5 times of the upper limit of normal value, and totle bilirubin is less than 1.25 times of the upper limit of normal value;\n* The ECOG physical status score for patients must be 0 or 1;\n\nExclusion Criteria:\n\n* Metastatic breast cancer at diagnosis;\n* Breast cancer patients who did not completed surgery;\n* History of other malignancies within 5 years prior to randomization, but patients with the following tumors may participate in the study: carcinoma of the cervix in situ, colon in situ, melanoma in situ and basal cell carcinoma of the skin and squamous cell carcinoma;\n* Any other non-malignant systemic disease (cardiovascular, renal, liver, etc.) that hinders the implementation or follow-up of the treatment program;\n* Symptomatic congestive heart failure (New York Heart Association Grade II-IV), symptomatic or poorly controlled arrhythmia, history of congenital long QT syndrome or corrected QTc\\> 500ms at screening, history of uncontrolled hypertension or hypertensive crisis or hypertensive encephalopathy;\n* History of interstitial pneumonia, Need for steroids or evidence of active pneumonia;\n* Suffering from an active autoimmune disease, and required systemic treatment in the past 2 years (i. e., use of disease regulators, corticosteroids, or immunosuppressive drugs);\n* Patients with a known infection with human immunodeficiency virus (HIV);\n* Patients with active infections requiring systemic treatment;\n* Any hormonal medication (such as raloxifene, tamoxifen, or other selective oestrogen receptor modulators) for osteoporosis or breast cancer prophylaxis (only patients who have discontinued these drugs before randomization may participate in the study);\n* The patient received either capecitabine or utiderone before surgery;\n* Pregnant or lactating women;\n* Known or suspected allergy to any study drug or excipients;\n* Prohibition of corticosteroids;\n* Any other condition the investigator considers inappropriate to participate in the trial.","70 Years",{"count":357,"type":20},[57],"This trial is a multicenter, single-arm clinical trial to evaluate the efficacy and safety of UTD1 in combination with capecitabine for the adjuvant treatment of TNBC patients who did not achieve pathologic complete remission after neoadjuvant therapy. TNBC patients who did not achieve pathological complete remission or positive lymph node after neoadjuvant chemotherapy received adjuvant treatment with study drug.\n\nSolution: UTD1 30mg \u002F m², once a day on days 1-5; capecitabine: 1000mg \u002F m², days 1-14, oral, twice \u002F day; 21 days a treatment cycle of 6-8 cycles.",[27],[523,524],"adjuvant chemotherapy","non-pCR","2024-04-23",{"date":527,"type":37},"2024-04-26",{"date":529,"type":37},"2024-03-29",{"date":531,"type":20},"2027-03-29",{"name":533,"class":226},"Hunan Cancer Hospital",{"id":535,"slug":536,"hasResults":11,"nctId":537,"briefTitle":538,"officialTitle":538,"acronym":539,"eligibilityCriteria":540,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":541,"targetDuration":4,"studyType":21,"phases":543,"briefSummary":544,"conditions":545,"keywords":4,"overallStatus":174,"whyStopped":4,"lastUpdateSubmitDate":546,"lastUpdatePostDateStruct":547,"startDateStruct":549,"completionDateStruct":551,"leadSponsor":553,"locationsCount":372},"100444446","phase-2-cyclin-dependent-kinase-in-triple-negative-breast-cancer---a-window-of-opportunity-study-100444446","NCT05067530","Cyclin dEpendent Kinase in tRiple nEGatIVe brEast canceR - a \"Window of Opportunity\" Study","CAREGIVER","Inclusion Criteria:\n\n* females or males \\>18 years old at the time of informed consent signature;\n* diagnosis of potentially resectable or de novo metastatic (stage II-IV) invasive carcinoma of the breast;\n* eligible for standard neoadjuvant or palliative paclitaxel and\u002For carboplatin-based chemotherapy as determined by Investigator;\n* triple negative tumor defined as:\n\n  * hormone receptor-negative (\\\u003C1% ER\u002FPgR expression);\n  * HER2-negative (Immunohistochemistry (IHC) score ≤1 or IHC score =2 and negative for the amplification by in situ hybridization);\n* multicentric\u002Fmultifocal disease is allowed, provided that all lesions have been biopsied and their phenotype has been confirmed pathologically as TNBC;\n* no previous anticancer therapy for this malignancy;\n* clinically or radiographically measurable disease (discrete lesion only, enhancement is not included) within the breast, that can be biopsied, defined as longest diameter \\>2 cm;\n* multicentric or multifocal disease is allowed if at least 1 lesion is \\>2 cm;\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;\n* adequate bone marrow and organ function as defined by the following local laboratory values:\n* hemoglobin ≥9 g\u002FdL;\n* absolute neutrophil count (ANC) ≥1500\u002FμL;\n* platelets ≥100,000\u002FμL;\n* total bilirubin ≤ institutional upper limit of normal (ULN), unless diagnosis of Gilbert syndrome;\n* aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5x ULN;\n* creatinine ≤ ULN OR creatinine clearance ≥50 mL\u002Fmin per Cockcroft-Gault equation for patients with creatinine levels greater than ULN.\n* blood glucose level \\\u003C120 mg\u002FdL after at least 6 hours of fasting;\n* standard 12-lead electrocardiogram (ECG) without clinically significant abnormalities;\n* ability to undergo contrast-enhanced MRI;\n* ability to swallow and retain oral medication;\n* all study participants of child-bearing potential must agree to use adequate contraceptive methods prior to study entry, during the study and for the following 3 weeks (females) or 14 weeks (males);\n* prior chemotherapy, other targeted anticancer therapies, or prior radiation therapy (outside of treated breast) for other malignancy treated with radical intent is allowed, provided the treatment was completed ≥1 year before informed consent signature;\n* prior bisphosphonate therapy is allowed;\n* willing and able to undergo all the procedures required by the study protocol;\n* provision of written informed consent form prior to receiving any study related procedure.\n\nExclusion Criteria:\n\n* inflammatory breast cancer;\n* prior systemic treatment for this malignancy;\n* prior treatment with CDK4\u002F6 inhibitor;\n* known hypersensitivity to study medications or any of their excipients;\n* major surgery or radiotherapy (apart from limited field radiotherapy for symptom control) within 14 days prior to randomization;\n* concurrent invasive malignancy;\n* known HIV, active HBV or HCV infection;\n* active autoimmune disease requiring ongoing immunosuppressive therapy;\n* history of allotransplantation;\n* concurrent treatment with systemic immunosuppressive agents, including steroids, within 3 weeks of enrolment;\n* presence of implants or devices not compatible with MRI;\n* pregnant or nursing female participants;\n* receiving strong inhibitors or inducers of CYP3A4\u002F5 or medications with narrow therapeutic window that are predominantly metabolized through CYP3A4\u002F5;\n* impairment of GI function that may significantly alter the absorption of the oral trial treatments;\n* unwilling or unable to follow protocol requirements, including obligatory biopsies;\n* any condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive study drugs;\n* any other concurrent severe and\u002For uncontrolled medical condition that would, in the Investigator's judgment, contraindicate patient participation in the clinical trial or compromise compliance with the protocol.",{"count":542,"type":20},126,[57],"CAREGIVER is a prospective, randomized, multicenter, open, five-arm study with unequal allocation ratios of 1:1:2:1:2 (palbociclib : paclitaxel : palbociclib + paclitaxel : carboplatin : carboplatin + paclitaxel). Study will be performed in untreated patients with triple-negative breast cancer (TNBC). Potential candidates without previously established diagnosis of TNBC will be included in a Pre-screening Phase, when a biopsy of breast tumor will be taken to confirm the diagnosis of cancer, select patients with TNBC and collect tissue for translational research.",[27],"2021-10-04",{"date":548,"type":37},"2021-10-05",{"date":550,"type":20},"2022-01-01",{"date":552,"type":20},"2026-12-06",{"name":554,"class":226},"Medical University of Gdansk"]