[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"her2-negative-breast-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:her2-negative-breast-cancer":30},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,62,0,25,[9,51,88,111,137,215,236,268,296,315,342,366,394,425,451,473,499,522,548,570,594,623,648,667,690],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":32,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100545518","phase-3-elacestrant--everolimus-in-patients-erher2--esr1mut-advanced-breast-cancer-progressing-to-et-and-cdk46i-100545518",false,"NCT06382948","Elacestrant + Everolimus in Patients ER+\u002FHER2-, ESR1mut, Advanced Breast Cancer Progressing to ET and CDK4\u002F6i.","A Randomized Phase 3, Double-Blind, Placebo-Controlled Study of Elacestrant Plus Everolimus Versus Elacestrant in Patients With ER+\u002FHER2-, ESR1mut Advanced Breast Cancer Progressing to Endocrine Therapy and CDK4\u002F6 Inhibitors","ADELA","Inclusion Criteria:\n\nPatients will be included in the study only if they meet ALL of the following criteria:\n\n1. Patient must be capable to understand the purpose of the study and have signed written informed consent form (ICF) prior to beginning specific protocol procedures.\n2. Female or male patients ≥ 18 years of age at the time of signing ICF.\n3. Pre- or perimenopausal women, who do not meet the criteria for post-menopausal status (defined in continuation) and men must be concurrently receiving a LHRH analogue for at least 28 days (if shorter, post-menopausal levels of serum estradiol\u002Ffollicle-stimulating hormone \\[FSH\\] must be confirmed analytically) prior to study randomization and are planning to continue LHRH agonist treatment during the study.\n\n   Post-menopausal women as defined by any of the following criteria:\n   1. Age ≥ 60 years;\n   2. Age \\\u003C 60 years and cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and serum estradiol and\u002For FSH levels within the laboratory's reference range for post-menopausal females;\n   3. Documented bilateral surgical oophorectomy.\n4. Histologically- or cytologically proven diagnosis of adenocarcinoma of the breast with evidence of either unresectable locally recurrent or metastatic disease confirmed by computerized tomography (CT) scan or magnetic resonance imaging (MRI) that is not amenable to resection with curative intent.\n5. Documentation of ER\\[+\\] (≥10% positive stained cells) and HER2\\[-\\] (0-1+ by immunohistochemistry \\[IHC\\] or 2+ and negative by in situ hybridization \\[ISH\\] test) tumor according to the most recent American Society of Clinical Oncology (ASCO)\u002FCollege of American Pathologists (CAP) guidelines as per local assessment. ER\\[+\\]\u002FHER2\\[-\\] status should be confirmed in metastatic setting, with exception of patients with bone and lung only disease.\n6. Patients with ESR1 mutational status will be determined before patient randomization using Guardant360 CDx (Guardant Health) test.\n\n   Note: Patients with previously determined ESR1 mutation using appropriately validated tests (Guardant360 CDx \\[Guardant Health\\], FoundationOne CDx, FoundationOne Liquid \\[Foundation Medicine Inc\\]) will be eligible for inclusion. This local determination can be performed either in blood or tumor samples.\n7. Radiological or objective evidence of disease progression on prior treatment with a CDK4\u002F6 inhibitor in combination with endocrine therapy for advanced disease after at least 6 months of treatment. Patients receiving CDK4\u002F6 inhibitor-based therapy in the adjuvant setting are also eligible provided that disease progression is confirmed after at least 12 months of treatment but no more than 12 months following CDK4\u002F6 inhibitor treatment completion in this scenario.\n8. Patients must have previously received at least one and no more than two lines of endocrine therapy for ABC. Progression during or within 12 months of adjuvant endocrine therapy is considered as a line of endocrine therapy for advanced disease.\n9. No prior elacestrant or other investigational SERDs, proteolysis targeting chimera (PROTAC), complete estrogen receptor antagonist (CERAN), or novel SERM, and\u002For PI3K\u002FAKT\u002FmTOR inhibitors, including everolimus, for advanced disease are permitted.\n\n   Note: Fulvestrant is permitted if treatment was completed administered at least 28 days before randomization.\n10. No prior chemotherapy for advanced disease is allowed.\n11. Evidence of measurable disease as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v.1.1), or non-measurable, but evaluable, disease, including bone-only disease with at least one lytic or mixed lytic-blastic bone lesion.\n12. Willingness and ability to provide the most recently available formalin-fixed paraffin-embedded (FFPE) tumor tissue or block. If a newly obtained baseline biopsy of an accessible tumor lesion is not possible to be obtained prior randomization, an archival tissue sample will be accepted.\n13. Fasting serum cholesterol ≤ 300 mg\u002FdL or 7.75 mmol\u002FL and fasting triglycerides ≤ 2.5 times the upper limit of normal (x ULN).\n14. Adequate bone marrow and organ function:\n\n    1. Hematological (without platelet, red blood cell transfusion, and\u002For granulocyte colony-stimulating factor support within seven days before randomization): absolute neutrophil count (ANC) ≥ 1.5 x 109\u002FL; platelet count ≥ 100.0 x109\u002FL; and hemoglobin ≥ 9.0 g\u002FdL.\n    2. Hepatic: Serum albumin ≥ 2.5 g\u002FdL; total serum bilirubin \\\u003C 1.5 x ULN except for patients with Gilbert's syndrome who may be included if the total serum bilirubin is ≤ 3 x ULN or direct bilirubin ≤ 1.5 x ULN; alkaline phosphatase (ALP) ≤ 2.5 x ULN (≤ 3 x ULN in patients with liver and\u002For bone metastases); aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 1.5 x ULN (≤ 3 x ULN in patients with liver metastases).\n    3. Renal: Serum creatinine ≤ 1.5 x ULN or estimated creatinine clearance ≥ 50 mL\u002Fmin as calculated by Cockcroft- Gault equation.\n    4. Coagulation: International normalized ratio (INR) ≤ 1.5 x ULN, unless that the patient meets the exception described in the exclusion criteria 16.\n15. Resolution of all acute toxic effects of prior anti-cancer therapy to grade ≤ 1 as determined by the National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) v.5.0 (except for toxicities not considered a safety risk for the patient at Investigator's discretion).\n\n    Note: Patients with grade 2 alopecia are allowed.\n16. Women of childbearing potential who are sexually active with a non-sterilized male partner must have a negative serum pregnancy test within 7 days before randomization. In addition, they agree to use one highly effective method of birth control 28 days prior to start of treatment until 120 days after the last dose of study treatments. Female patients must refrain from egg cell donation and breastfeeding during this same time period.\n17. Male participants with a female partner of childbearing potential must be surgically sterile or using a highly effective method of contraception 28 days prior to treatment until 120 days after the last dose of study treatments to prevent pregnancy in a partner. Male participants must not donate or bank sperm during this same time period. Not engaging in heterosexual activity (sexual abstinence) for the duration of the study and 120 days after the last dose of study treatments is an acceptable practice if this is the preferred usual lifestyle of the participant.\n18. ECOG performance status of 0-1.\n19. Minimum life expectancy of ≥ 12 weeks at screening.\n\nExclusion Criteria:\n\nAny patient meeting ANY of the following criteria will be excluded from the study:\n\n1. Inability to comply with study and follow-up procedures.\n2. Formal contraindication to endocrine therapy defined as visceral crisis and\u002For rapidly or symptomatic progressive visceral disease.\n3. Current participation in another therapeutic clinical trial.\n4. Treatment with approved or investigational cancer therapy within 14 days prior to randomization except for fulvestrant that must be administered completed at least 28 days before randomization.\n5. Known active uncontrolled or symptomatic central nervous system (CNS) metastases and\u002For leptomeningeal disease as indicated by clinical symptoms, cerebral edema, and\u002For progressive growth. Patients with a history of CNS metastases are eligible if they have been previously treated with local therapy, are clinically stable, and off anticonvulsants and steroids for at least 14 days before randomization.\n6. Intact uterus with a history of endometrial intraepithelial neoplasia (atypical endometrial hyperplasia or higher-grade lesion).\n7. Concurrent malignancy or malignancy within three years before randomization with the exception of carcinoma in situ of the cervix, non-melanoma skin carcinoma, or stage I uterine cancer. For other cancers considered to have a low risk of recurrence, discussion with the Medical Monitor is required.\n8. Known allergy or hypersensitivity reaction to any investigational medicinal products (IMPs) or their incorporated substances.\n9. History of malabsorption syndrome or other condition that would interfere with enteral absorption (ongoing gastrointestinal obstruction\u002Fmotility disorder, malabsorption syndrome, or prior gastric bypass) or results in the inability or unwillingness to swallow pills.\n10. Palliative radiotherapy with a limited field of radiation within two weeks or with wide field of radiation or to more than 30% of the bone marrow within four weeks prior to randomization.\n11. Major surgical procedure or significant traumatic injury within 14 days before randomization or anticipation of need for major surgery within the course of the study treatment.\n12. Clinically relevant cardiovascular\u002Fcerebrovascular disease and\u002For cardiac dysfunction or conduction abnormalities including, but not confined, to any of the following:\n\n    a. Symptomatic pericarditis, unstable angina pectoris, documented myocardial infarction, coronary\u002Fperipheral artery bypass graft, symptomatic cardiac heart failure (CHF) (New York Heart Association \\[NYHA\\] Class II-IV), or cerebrovascular accident including transient ischemic attack within six months before study randomization.\n13. Concurrent uncontrolled atrial fibrillation, other ongoing cardiac dysrhythmias grade ≥ 2 as determined by NCI-CTCAE v.5.0, or prolonged QT Interval Corrected by Fridericia's formula (\\[QTcF\\] \\> 480 msec).\n14. Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited, to any of the following:\n\n    1. Massive lung metastatic involvement (e.g., pleural effusion, lymphangitic carcinomatosis, etc.).\n    2. Any underlying pulmonary disorder (e.g., severe asthma, severe chronic obstructive pulmonary disease \\[COPD\\], restrictive lung disease, post Coronavirus disease (COVID-19) pulmonary fibrosis, etc.).\n    3. Any autoimmune, connective tissue, or inflammatory disorders with pulmonary involvement (e.g., rheumatoid arthritis, Sjogren's syndrome, sarcoidosis, etc.).\n    4. Prior pneumonectomy.\n15. History of non-infectious interstitial lung disease (ILD)\u002Fpneumonitis that required steroids, has current ILD\u002Fpneumonitis, or has suspected ILD\u002Fpneumonitis that cannot be ruled out by imaging at screening.\n16. Coagulopathy or any history of coagulopathy within six months before study enrollment, including history of deep vein thrombosis or pulmonary embolism. However, patients with the following conditions will be allowed to participate:\n\n    1. Adequately treated catheter-related venous thrombosis occurring more than 28 days prior to randomization.\n    2. Treatment with an anticoagulant (e.g., warfarin or heparin) for a thrombotic event occurring more than six months before randomization, or for an otherwise stable and allowed medical condition (e.g., well controlled atrial fibrillation), provided dose and coagulation parameters (as defined by local standard of care) are stable for at least 28 days prior to randomization.\n17. Concomitant treatment with immunosuppressive agents or chronic corticosteroids use before randomization with the following exceptions: topical applications, inhaled sprays, eye drops, mouthwash, or local injections are allowed. Patients on stable low dose of corticosteroids ( ≤ 10 mg\u002Fday of prednisone or equivalent) for at least two weeks before randomization are also permitted.\n18. Unable or unwilling to avoid prescription medications, over-the-counter medications, dietary\u002Fherbal supplements (e.g., St. John's wort), and\u002For foods (e.g., grapefruit, pomelos, star fruit, Seville oranges and their juices) that are moderate\u002Fstrong inhibitors or inducers of CYP3A4 activity. Participation will be allowed if the medication, supplements, and\u002For foods are discontinued for at least five half-lives or 14 days (whichever is shorter) prior to randomization and for the duration of the study.\n19. Pregnant or lactating women or patients not willing to apply highly effective contraception as defined in the protocol.\n20. Current known infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV). Patients with past HBV infection or resolved HBV infection (defined as having a negative hepatitis B surface antibody \\[HBsAg\\] test and a positive hepatitis B core antibody \\[HBcAb\\] test, accompanied by a negative HBV DNA test) are eligible. Patients positive for HCV antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA. Any other active uncontrolled infection at the time of screening is not allowed.\n21. Known substance abuse or any other concurrent severe and\u002For uncontrolled psychiatric or medical condition that would, in the Investigator's judgment, contraindicate patient participation.","ALL","18 Years",{"count":21,"type":22},300,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","This trial will study a type of advanced breast cancer (ABC) defined as endocrine receptor (ER)-positive\u002Fhuman epidermal growth factor receptor 2(HER2)-negative and estrogen receptor 1 (ESR1)-mutated. Patients will be treated with elacestrant, a compound that acts as a selective estrogen receptor degrader, and everolimus (or placebo), a kinase inhibitor indicated for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer.\n\nThe main purpose of the study is to analyze the efficacy (to find out how effective a treatment is) of elacestrant plus everolimus therapy in patients who have ER-positive\u002FHER2-negative, ESR1-mutated, ABC progressing to endocrine therapy and cyclin-dependent kinase 4\u002F6 (CDK4\u002F6) inhibitor. The efficacy of elacestrant plus everolimus combination will be determined by assessing the period from elacestrant plus everolimus (or placebo) treatment initiation until to the first occurrence of disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason, whichever occurs first, defined as progression free survival.\n\nRigorous eligibility criteria based on specific co-morbidities and clinicopathologic features of their disease have been designed to minimize the risk of patients participating in this study. The anticipated favorable clinical benefits of elacestrant combined with everolimus are projected to outweigh the risks of this treatment. This study will be performed in full compliance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and all applicable local Good Clinical Practice (GCP) and regulations.",[28,29,30,31],"Advanced Breast Cancer","ER-positive Breast Cancer","HER2-negative Breast Cancer","ESR1 Gene Mutation",[33,34,35,36,37],"ER-positive","HER22-negative","ESR1-mutation","CDK4\u002F6-inhibitor","Selective endocrine receptor degrader (SERD)","RECRUITING","2026-08-18",{"date":41,"type":42},"2026-08-20","ACTUAL",{"date":44,"type":42},"2024-12-05",{"date":46,"type":22},"2028-04",{"name":48,"class":49},"MedSIR","OTHER",104,{"id":52,"slug":53,"hasResults":12,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":23,"phases":60,"briefSummary":62,"conditions":63,"keywords":71,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":5},"100525326","phase-1-bgb-43395-alone-or-as-part-of-combination-therapies-in-participants-with-breast-cancer-and-other-advanced-solid-tumors-100525326","NCT06120283","BGB-43395 Alone or as Part of Combination Therapies in Participants With Breast Cancer and Other Advanced Solid Tumors","A Phase 1a\u002F1b Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of the CDK4 Inhibitor BGB-43395, Alone or as Part of Combination Therapies in Patients With Metastatic HR+\u002FHER2- Breast Cancer and Other Advanced Solid Tumors","Inclusion Criteria:\n\n* Phase 1a (Dose Escalation): Participants with histologically or cytologically confirmed advanced, metastatic, or unresectable solid tumors associated with dependency on CDK4, including HR+ breast cancer, ovarian cancer, endometrial cancer, non-small cell lung cancer, and others. For combination with elacestrant, participants must have received at least 1 prior line of treatment for advanced\u002Fmetastatic disease including prior endocrine therapy and CDK4\u002F6 inhibitor in either the adjuvant or advanced\u002Fmetastatic setting.\n* Phase 1a Safety Expansion: For combination with fulvestrant in regions where approved and available, participants with HR+ breast cancer must have received at least 1 prior line of treatment including endocrine therapy and a CDK4\u002F6 inhibitor. For combination with letrozole, participants must be CDK4\u002F6 inhibitor treatment naïve and have not received any previous systemic treatment for advanced disease.\n* Phase 1b: Participants with HR+\u002FHER2- breast cancer.\n* Phase 1b: For combination with fulvestrant, participants with HR+\u002FHER2- breast cancer enrolled in regions where CDK4\u002F6 inhibitors are approved and available must have received 1-2 lines of therapy for advanced\u002Fmetastatic disease including endocrine therapy and a CDK4\u002F6 inhibitor. Participants can have received up to 2 lines of prior cytotoxic chemotherapy for advanced disease. Prior cytotoxic treatment is prohibited. For combination cohorts with letrozole, participants must be CDK4\u002F6 inhibitor treatment naïve and have not received any previous systemic treatment for advanced disease.\n* Stable Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.\n* Female participants with metastatic HR+\u002FHER2- breast cancer must be postmenopausal or receiving ovarian function suppression treatment.\n* Adequate organ function without symptomatic visceral disease.\n\nExclusion Criteria:\n\n* Known leptomeningeal disease or uncontrolled, untreated brain metastases.\n* Any malignancy ≤ 3 years before the first dose of study treatment(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast).\n* Uncontrolled diabetes.\n* Infection requiring systemic antibacterial, antifungal, or antiviral therapy ≤ 28 days before the first dose of study drug(s), or symptomatic COVID-19 infection.\n* Participants with untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers with HBV DNA ≥ 500 IU\u002FmL (or ≥ 2500 copies\u002FmL) at screening.\n* Participants with active hepatitis C infection.\n* Prior allogeneic stem cell transplantation, or organ transplantation.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":59,"type":22},399,[61],"PHASE1","This is a dose escalation and dose expansion study to compare how well BGB-43395, a selective cyclin-dependent kinase 4 (CDK4) inhibitor, works as monotherapy or in combination with fulvestrant, letrozole, or elacestrant in participants with hormone receptor positive (HR+) and human epidermal growth factor 2 negative (HER2-) breast cancer (BC) and other advanced solid tumors. The main purpose of this study is to explore the recommended dosing for BGB-43395.",[64,28,65,66,67,68,30,69,70],"Advanced Solid Tumor","Metastatic Breast Cancer","Hormone-receptor-positive Breast Cancer","Hormone Receptor Positive Breast Carcinoma","Hormone Receptor Positive Malignant Neoplasm of Breast","Hormone Receptor Positive HER-2 Negative Breast Cancer","Non-small Cell Lung Cancer",[72,73,74,75,76,69,77,78],"breast cancer","advanced solid tumor","advanced breast cancer","hormone receptor positive breast cancer","HER2-negative breast cancer","BGB-43395","non-small cell lung cancer",{"date":80,"type":42},"2026-08-19",{"date":82,"type":42},"2023-12-01",{"date":84,"type":22},"2028-11",{"name":86,"class":87},"BeOne Medicines","INDUSTRY",{"id":89,"slug":90,"hasResults":12,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":4,"eligibilityCriteria":94,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":95,"targetDuration":4,"studyType":97,"phases":4,"briefSummary":98,"conditions":99,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":110},"100592444","real-world-study-of-skb264-monotherapy-or-combination-therapy-in-recurrent-or-metastatic-her2-negative-breast-cancer-100592444","NCT06993506","Real-world Study of SKB264 Monotherapy or Combination Therapy in Recurrent or Metastatic HER2-negative Breast Cancer","Sacituzumab Tirumotecan Monotherapy or Combination Therapy in Patients With Unresectable Locally Advanced, Recurrent or Metastatic HER2-Negative Breast Cancer: A Real-World Study","Inclusion Criteria:\n\n1. Aged ≥ 18 years old at the time of signing the informed consent form, regardless of gender;\n2. Patient must meet one of the following pathological diagnoses and classifications:\n\n   2.1) For TNBC Cohort: -Histological\u002Fcytological confirmed of triple-negative breast cancer (TNBC) from the most recent pre-SKB264 biopsy\u002Fpathological report, with: HER2 negative: immunohistochemistry (IHC) of 0 or 1+; if is 2+ by IHC, negative HER2 expression must be confirmed by fluorescence in situ hybridization (FISH); Estrogen and progesterone receptor negative means that less than 1% of the cells express hormone receptors as indicated by IHC; -Locally advanced, recurrent, or metastatic disease (locally advanced disease should be confirmed by investigators as ineligible for curative resection); 2.2) For HR+\u002FHER2- BC Cohort: -Histological\u002Fcytological confirmed of HR+\u002FHER2- breast cancer from the most recent pre-SKB264 biopsy\u002Fpathological report, with: HER2 negative: IHC of 0 or 1+; if is 2+ by IHC, negative HER2 expression must be confirmed by FISH; HR positive: Hormone receptor-positive (HR, ER, or PR status) was defined as ≥1% expression by IHC.-Locally advanced, recurrent, or metastatic disease (locally advanced disease should be confirmed by investigators as ineligible for curative resection);\n3. Plan to receive SKB264 monotherapy or combination therapy;\n4. Prior treatment lines: -For TNBC Cohort: ≤2 lines of systemic antitumor therapy for unresectable locally advanced, recurrent, or metastatic disease; -For HR+\u002FHER2- BC Cohort: ≤2 lines of systemic antitumor therapy (excluding endocrine therapy) for unresectable locally advanced, recurrent, or metastatic disease;\n5. Voluntarily participate in the study, sign the informed consent form and demonstrate good compliance.\n\nExclusion Criteria:\n\n1. Patients with other malignancies, except cured basal or squamous cell skin cancer or in situ cancer of cervix; and patients with other malignancies must have a tumor-free period of at least 5 years;\n2. Patients who are currently participating in other interventional clinical studies;\n3. Known allergy to the investigational drug or any of its components;\n4. Pregnant or lactating women;\n5. Any situation that the researchers consider to interfere with the evaluation of the study drug or the safety of the subjects or the analysis of the study results, or any other situation that the researchers consider inappropriate to participate in this study.",{"count":96,"type":22},500,"OBSERVATIONAL","This study is a multi-center observational real-world study, with a total of 500 patients planned to be enrolled. This study is divided into two cohorts: the triple-negative breast cancer (TNBC) cohort and the hormone receptor-positive\u002Fhuman epidermal growth factor receptor 2-negative breast cancer (HR+\u002F HER2-BC) cohort. The aim of this study is to assess the efficacy and safety of Sacituzumab Tirumotecan (SKB264) monotherapy or combination therapy in patients with unresectable locally advanced, recurrent or metastatic HER2-negative breast cancer in the real-world setting.",[30,100,101],"Recurrence","Metastasis","2026-08-16",{"date":39,"type":42},{"date":105,"type":42},"2026-05-28",{"date":107,"type":22},"2027-10-31",{"name":109,"class":49},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences",19,{"id":112,"slug":113,"hasResults":12,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":117,"eligibilityCriteria":118,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":119,"targetDuration":4,"studyType":23,"phases":121,"briefSummary":122,"conditions":123,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":136},"100478622","elacestrant-for-treating-erher2--breast-cancer-patients-with-ctdna-relapse-treat-ctdna-100478622","NCT05512364","Elacestrant for Treating ER+\u002FHER2- Breast Cancer Patients With ctDNA Relapse (TREAT ctDNA)","Elacestrant for Treating ER+\u002FHER2- Breast Cancer Patients With ctDNA Relapse","TREAT ctDNA","Inclusion Criteria:\n\n1. ctDNA screening phase:\n\n   Main inclusion criteria:\n\n   • Female (both pre- and postmenopausal) or male patients with histologically confirmed ER positive (regardless of PR),\n\n   HER2 negative breast cancer, according to local pathologist:\n   * ER-positive defined as ≥ 10% of cells staining positive for ER or Allred proportion score ≥3\n   * HER2-negative defined as a score of 0, 1+ by immunohistochemistry (IHC) or a negative in situ hybridization (ISH) based on single-probe average HER2 copy number, as per American Society of Clinical Oncology guidelines\n   * Intermediate to high risk of recurrence after definitive treatment for early breast cancer, defined as:\n\n   FOR PATIENTS TREATED WITH PRIMARY SURGERY:\n   * Any patient with ≥ 4 positive axillary lymph nodes (stage pN2-3).\n   * 1-3 positive axillary lymph nodes (stage pN1) and either:\n   * Tumour size ≥ 5 cm or\u002Fand\n   * Histologic grade 3 or\u002Fand\n   * Ki67≥20% or\u002Fand\n   * High genomic risk defined as Oncotype Dx Recurrence Score \\>=26, Mammaprint high risk, Prosigna score \\>40 or EPclin risk score \\>=4.0.\n   * Negative axillary lymph nodes (stage pN0) and tumour size ≥ 2 cm and either\n   * Histologic grade 3 a or\u002Fand\n   * Ki67≥20% and\u002For\n   * High genomic risk defined as Oncotype Dx Recurrence Score \\>=26, Mammaprint high risk, Prosigna score \\>60 or EPclin risk score \\>=4.0. FOR PATIENTS TREATED WITH NEOADJUVANT\n\n   SYSTEMIC TREATMENT FOLLOWED BY SURGERY:\n   * Patient may have received neoadjuvant endocrine therapy or neoadjuvant chemotherapy provided that:\n   * The initial tumour and\u002For the tumour after surgery meet the criteria above defined for patients treated with primary surgery or the initial tumour was staged as cT4anyN and\n   * There is no pathological complete response, defined as no invasive disease in the breast and axilla (ypT0\u002Fis ypN0).\n   * Age ≥18 years\n   * Patients must have received at least 1 year and up to 7.5 years of ET and planned to continue adjuvant ET during ctDNA screening phase\n   * Previous adjuvant CDK4\u002F6 inhibitor or PARP-inhibitor treatment is allowed provided it is completed\n   * Invasive multicentric \u002F multifocal disease is allowed provided that all the tested foci are ER+ HER2-. A sample from the highest-risk one, according to the investigator decision based on the size and grade, should be sent to Natera to build the patient ctDNA assay.\n   * Available tumour sample from resected or biopsied tissue, with a tumour content of ≥20% (30% preferred) either before or after macro dissection (if performed) and a cell viability of a minimum 100 cells.\n   * Core Needle Biopsies (CNB): recommended minimum of four (4) cores per block\n   * Fine Needle Aspirates (FNA) are not accepted\n   * The following sample types are acceptable:\n   * 6-10 unstained slides (charged and unbaked) of 10μm each (or 12-19 unstained slides at 5 μm each), PLUS one contiguous H\\&E slide. Minimum total tissue thickness must be 60μm OR\n   * FFPE tissue block with 25mm2 minimum surface area\n   * Written informed consent must be given according to ICH\u002FGCP, and national\u002Flocal regulations.\n\n   Main exclusion criteria:\n   * Suspected recurrent disease or known conflicts with the inclusion and exclusion criteria for the randomised trial\n   * Prior treatment with any SERD or investigational ER antagonist\n   * Previous history of invasive breast cancer\n   * Previous history of any other malignancy within the last 5 years, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ.\n   * Previous history of bone marrow and\u002For organ transplant\n   * Bilateral invasive breast cancer\n   * Participation in another clinical study, with the exception of the SURVIVE study and observational (non-interventional) and non-drug intervention clinical studies. Note: patients participating in interventional studies may participate once they enter the follow-up period of the study\n   * Blood transfusion within 3 months prior to registration or during the screening.\n2. Randomised trial:\n\nMain inclusion criteria:\n\n* ctDNA positive according to the Signatera ctDNA assay (main study ctDNA test) or other ctDNA assay approved for diagnostic purposes.\n* Patients must meet the eligibility criteria for the screening phase, with the exception of the tissue sample requirements.\n* Patients must receive adjuvant ET at the time of the ctDNA positive test\n* Absence of locoregional and\u002For metastatic disease and\u002For new malignancy, as investigated by:\n* Mammogram (unilateral in case of mastectomy; not required in patients having undergone bilateral mastectomy) NOTE: if local investigator plans to use MRIs instead of mammograms during the study, MRI will have to be performed at baseline.\n* CT thorax and abdomen\u002Fpelvis with IV contrast. In case of any contra-indications (medical or regulatory): CT thorax without contrast + MRI abdomen\u002Fpelvis.\n* Technetium-99m bone scintigraphy\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1\n* Adequate organ function\n* Women of childbearing potential (WOCBP) must have a negative highly sensitive serum or urine pregnancy test within 7 days prior to randomisation.\n\nMain exclusion criteria:\n\n* Any unresolved toxic effect of prior therapies or surgical procedures of Grade ≥ 2 according to Common Terminology Criteria of Adverse Events (CTCAE) v5.0, with the exception of alopecia, peripheral neuropathy and other toxicities not considered a safety risk for the participant at investigator's discretion\n* Unable or unwilling to avoid over-the-counter medications, dietary\u002Fherbal supplements, and\u002For foods that are moderate\u002Fstrong inhibitors or inducers of CYP3A4 activity\n* Known difficulty in tolerating oral medications or conditions which would impair absorption of oral medications\n* Any of the following cardiovascular disorders within 3 months before enrolment:\n* myocardial infarction\n* stroke\n* severe\u002Funstable angina\n* symptomatic cardiac arrhythmia\n* prolonged QTcF ≥ Grade 3 (i.e., \\> 500 msec)\n* heart failure ≥ Class III as defined by the New York Heart Association (NYHA) guidelines\n* CTCAE version 5.0 grade 3 or 4 dyslipidemia at the time of screening, defined as cholesterol\\>400 mg\u002FdL or \\>10.34 mmol\u002FL and\u002For triglycerides\\>500 mg\u002FdL or \\>5.7 mmol\u002FL.\n* Child-Pugh Score greater than Class A\n* Uncontrolled significant active infections (≥ grade 3 according to CTCAE version 5), including active hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency Virus (HIV)\n* Coagulopathy or any history of coagulopathy within the past 6 months, including history of deep vein thrombosis or pulmonary embolism",{"count":120,"type":22},220,[25],"This is an international, multi-center, randomised, open label, superiority phase III trial of elacestrant vs standard endocrine therapy in patients with ER+\u002FHER2- breast cancer and ctDNA relapse.\n\nDuring the ctDNA screening phase, patients will be tested at different timepoints to detect the presence of ctDNA in their blood.\n\nPatients who are found to be ctDNA-positive and have no evidence of distant metastasis, will be randomised 1:1 between standard endocrine treatment (the same they were receiving when tested ctDNA positive) versus elacestrant, provided they meet all eligibility criteria. After completion of the protocol treatment period, treatment will be left at the discretion of the treating physician.",[29,30,124,125],"Stage IIB Breast Cancer","Stage III Breast Cancer","2026-08-07",{"date":128,"type":42},"2026-08-10",{"date":130,"type":42},"2023-12-15",{"date":132,"type":22},"2035-11-01",{"name":134,"class":135},"European Organisation for Research and Treatment of Cancer - EORTC","NETWORK",111,{"id":138,"slug":139,"hasResults":12,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":4,"eligibilityCriteria":143,"healthyVolunteers":12,"sex":18,"minAge":144,"maxAge":4,"enrollmentInfo":145,"targetDuration":4,"studyType":23,"phases":146,"briefSummary":148,"conditions":149,"keywords":178,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":207,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":214},"100407463","the-evaluation-of-pc14586-in-patients-with-advanced-solid-tumors-harboring-a-tp53-y220c-mutation-pynnacle-100407463","NCT04585750","The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)","A Phase 1\u002F2 Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of PC14586 in Patients With Locally Advanced or Metastatic Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)","Inclusion Criteria:\n\n* At least 18 years of age or 12 to 17 years of age after Safety Review Committee approval.\n* Locally advanced or metastatic solid malignancy with a TP53 Y220C mutation\n* Eastern Cooperative Oncology Group (ECOG) status of 0 or 1\n* Previously treated with one or more lines of anticancer therapy and progressive disease\n* Adequate organ function\n* Measurable disease per RECIST v1.1 (Phase 2)\n\nAdditional Criteria for Inclusion in Phase 1b (rezatapopt) + pembrolizumab combination)\n\n* Anti-PD-1\u002FPD-L1 naive or must have progressed on treatment\n* Measurable disease\n\nExclusion Criteria:\n\n* Anti-cancer therapy within 21 days (or 5 half-lives) of receiving the study drug\n* Radiotherapy within 14 days of receiving the study drug\n* Primary CNS tumor\n* History of leptomeningeal disease or spinal cord compression\n* Brain metastases, unless neurologically stable and do not require steroids to treat associated neurological symptoms\n* Stroke or transient ischemic attack within 6 months prior to screening\n* Heart conditions such as unstable angina within 6 months prior to screening, uncontrolled hypertension, a heart attack within 6 months prior to screening, congestive heart failure, prolongation of QT interval, or other rhythm abnormalities\n* Strong CYP3A4 inducers and strong CYP2C9 inhibitors\u002Finducers within 14 days of first dose of rezatapopt\n* History of gastrointestinal (GI) disease that may interfere with absorption of study drug or patients unable to take oral medication\n* History of prior organ transplant\n* Known, active malignancy, except for treated cervical intraepithelial neoplasia, or non-melanoma skin cancer\n* Known, active uncontrolled Hepatitis B, Hepatitis C, or human immunodeficiency virus infection\n\nAdditional Criteria for Exclusion from Phase 2 (rezatapopt monotherapy)\n\n* Known KRAS mutation, defined as a single nucleotide variant (SNV) (Phase 2)\n\nAdditional Criteria for Exclusion from Phase 1b (rezatapopt) + pembrolizumab combination)\n\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 co-inhibitory T-cell receptor and discontinued from that treatment due to a Grade 3 or higher immune-related AE (irAE)\n* Received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention\n* Diagnosis of immunodeficiency or receiving chronic systemic steroid therapy within 7 days prior to the first dose of study drug\n* Hypersensitivity (≥ Grade 3) to pembrolizumab and\u002For any of its excipients\n* Active autoimmune disease that has required systemic treatment in past 2 years\n* History of radiation pneumonitis\n* History of (non-infectious) or active pneumonitis \u002F interstitial lung disease that required steroids\n* Active infection requiring systemic therapy\n* Known history of HIV infection\n* Has previously received rezatapopt","12 Years",{"count":21,"type":22},[61,147],"PHASE2","The Phase 2 monotherapy portion of this study is currently enrolling and will evaluate the efficacy and safety of PC14586 (INN rezatapopt) in participants with locally advanced or metastatic solid tumors harboring a TP53 Y220C mutation. The Phase 1 portion of the study will assess the safety, tolerability and preliminary efficacy of multiple dose levels of rezatapopt as monotherapy and in Phase 1b in combination with pembrolizumab.",[64,150,151,152,153,154,155,156,157,158,159,160,161,162,163,164,165,166,167,168,169,170,171,172,173,174,175,176,30,177],"Advanced Malignant Neoplasm","Metastatic Cancer","Metastatic Solid Tumor","Lung Cancer","Ovarian Cancer","Endometrial Cancer","Prostate Cancer","Colorectal Cancer","Breast Cancer","Other Cancer","Locally Advanced","Head and Neck Cancer","Gall Bladder Cancer","Small Cell Lung Cancer","Small Cell Lung Cancer ( SCLC )","Small Cell Lung Carcinoma","NSCLC","NSCLC (Non-small Cell Lung Cancer)","SCLC","Non-Small Cell Lung Carcinoma","Triple Negative Breast Cancer","TNBC","HER2+ Breast Cancer","Non-Small Cell Lung Cancer","ER\u002FPR Positive Breast Cancer","HER2- Breast Cancer","HER2-positive Breast Cancer","ER\u002FPR(+), Her2(-) Breast Cancer",[179,180,181,182,183,184,185,186,187,188,189,190,191,192,193,194,195,196,197,198,199,200,201,202,203,204,205,206],"PC14586","p53","Y220C","Phase 1","Phase 1\u002F2","PMV","PMV Pharma","p53 mutation","TP53","TP53 mutation","p53 mutant","p53 reactivator","pembrolizumab","Keytruda","combination","PD-1","PD-L1","anti-PD-1","Merck","MSD","IgG4","mAb","Phase 1b","NGS","Next Generation Sequencing","precision","Phase 2","Rezatapopt",{"date":128,"type":42},{"date":209,"type":42},"2020-10-29",{"date":211,"type":22},"2027-12-31",{"name":213,"class":87},"PMV Pharmaceuticals, Inc",77,{"id":216,"slug":217,"hasResults":12,"nctId":218,"briefTitle":219,"officialTitle":219,"acronym":4,"eligibilityCriteria":220,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":221,"targetDuration":4,"studyType":23,"phases":223,"briefSummary":224,"conditions":225,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":227,"startDateStruct":229,"completionDateStruct":231,"leadSponsor":233,"locationsCount":235},"100637333","phase-2-metronomic-oral-paclitaxel-monotherapy-and-combined-immunotherapy-for-advanced-her2-negative-breast-cancer-a-two-stage-dose-exploration-and-expansion-trial-100637333","NCT07602907","Metronomic Oral Paclitaxel Monotherapy for Advanced HER2-Negative Breast Cancer: A Two-Stage Dose-Finding and Expansion Study","Inclusion Criteria:\n\n1.Age ≥ 18 years, male or female. 2.Histologically confirmed unresectable locally advanced, recurrent, or metastatic HER2-negative breast cancer, regardless of hormone receptor (HR) status. For patients with HR+\u002FHER2-negative subtype: prior treatment with at least 1 line of CDK4\u002F6 inhibitor plus endocrine therapy is required, and the patient is considered no longer suitable for further endocrine therapy by the investigator.\n\n3.Patients have received 1-4 prior lines of systemic anti-tumor therapy for recurrent or metastatic disease.\n\n1. Line of therapy is defined as a systemic treatment regimen for recurrent or metastatic disease. First-line therapy is the first regimen used in the recurrent\u002Fmetastatic setting; any subsequent regimen that adds a new drug class (e.g., anti-angiogenic, immunotherapy) is considered a new line.\n2. Neoadjuvant or adjuvant therapy is not counted as a treatment line.\n3. Disease recurrence \\>6 months after neoadjuvant therapy is counted as first-line; recurrence ≤6 months is considered continuation of prior therapy and not a new line.\n4. Disease recurrence \\>12 months after adjuvant therapy is counted as first-line; recurrence ≤12 months is considered continuation of prior therapy, and subsequent regimens start at second-line.\n\n4.Prior treatment with taxane is allowed if both criteria are met:\n\n1. Interval from last dose of taxane to first study dose ≥ 4 weeks;\n2. No unresolved taxane-related Grade ≥3 toxicity in the past. 5.Body surface area (BSA): 1.38 m² ≤ BSA ≤ 1.87 m². 6.ECOG performance status 0-1. 7.At least one measurable lesion per RECIST 1.1. 8.Expected survival ≥ 12 weeks. 9.Adequate bone marrow function: ANC ≥ 1.5 × 10⁹\u002FL Platelets ≥ 100 × 10⁹\u002FL Hemoglobin ≥ 90 g\u002FL 10.Adequate hepatic function: Total bilirubin ≤ 1.5 × ULN ALT\u002FAST ≤ 2.5 × ULN (no liver metastasis) ALT\u002FAST ≤ 5 × ULN (with liver metastasis) 11.Adequate renal function: Serum creatinine ≤ 1.5 mg\u002FdL Or creatinine clearance (Ccr) ≥ 60 mL\u002Fmin (calculated by Cockcroft-Gault formula) if serum creatinine \\>1.5 mg\u002FdL.\n\n12.Pre-existing peripheral neuropathy \\\u003C Grade 2 (CTCAE v6.0). 13.Known CNS metastases are allowed only if all of the following are met:\n\n1. CNS lesions stable for ≥4 weeks before enrollment, per RANO-BM criteria (no new lesions, target lesion volume change \\\u003C20%, no clear progression of non-target lesions on baseline and follow-up MRI).\n2. No corticosteroid use, or current dexamethasone ≤4 mg\u002Fday (or equivalent), with no dose increase within 7 days before enrollment.\n3. For patients with prior local CNS treatment: no imaging progression after treatment completion; neurologic symptoms stable for ≥2 weeks before first study dose; no steroid or ≤4 mg\u002Fday dexamethasone (or equivalent).\n4. No leptomeningeal disease.\n5. Whole-brain radiotherapy completed \\>14 days before enrollment.\n6. Prior stereotactic radiosurgery is allowed.\n7. Prior CNS surgery completed \\>28 days before enrollment with full recovery. 14.Voluntary participation and signed written informed consent.\n\nExclusion Criteria:\n\n1. Patients with suspected major infectious diseases, neurological disorders, or intestinal obstruction.\n2. Patients with a diagnosis of other cancer types (except non-melanoma skin cancer, cervical carcinoma in situ, or other cancers with no recurrence or metastasis for ≥5 years and considered cured).\n3. Patients who have undergone major surgery, including organ resection within 4 weeks before enrollment, or radiotherapy within 2 weeks before enrollment.\n4. Disease progression during prior taxane salvage therapy (at least 2 cycles completed), or recurrence\u002Fmetastasis within 12 months after neoadjuvant\u002Fadjuvant therapy.\n5. Patients requiring long-term concomitant use of P-glycoprotein (P-gp) inhibitors or immunosuppressive agents during the study.\n6. Patients receiving long-term treatment with steroids or other immunosuppressive agents (except oral, topical, or local injection).\n7. Patients with myocardial infarction, congestive heart failure, rapidly changing arrhythmia on ECG, severe or unstable angina pectoris, or other serious heart diseases.\n8. Patients with other severe medical diseases (uncontrolled diabetes mellitus and hypertension, chronic obstructive pulmonary disease (COPD), or dyspnea at rest due to any cause).\n9. Patients with a history of drug or alcohol abuse within the past 3 months.\n10. Pregnant or breastfeeding women, or patients who cannot or will not use effective contraceptive methods.\n11. Patients with or suspected of having bile acid excretion disorders.\n12. Active tendency of gastrointestinal bleeding or use of oral vitamin K antagonists (low-dose warfarin and acetylsalicylic acid are allowed as long as INR ≤2.0).\n13. Patients with severe hypersensitivity to the active ingredients or excipients of the study drugs.\n14. History of HIV seropositivity (HIV testing is not mandatory).\n15. Gastrointestinal dysfunction or diseases that may significantly alter the absorption of study drugs (e.g., ulcerative diseases, poorly controlled nausea, vomiting, diarrhea, malabsorption syndrome), except patients with prior gastrectomy.\n16. Patients receiving enteral feeding (e.g., via nasogastric tube, nasointestinal tube, gastrostomy, or jejunostomy).\n17. Patients with visceral crisis, or patients with excessive tumor burden, rapid disease progression who urgently require rapid tumor shrinkage (e.g., conventional maximum tolerated dose chemotherapy) to relieve severe clinical symptoms per investigator assessment.\n18. Patients considered inappropriate for the clinical trial by the investigator.",{"count":222,"type":22},73,[147],"The goal of this clinical trial is to evaluate the safety, tolerability, and preliminary anti-tumor activity of metronomic oral paclitaxel solution in patients with advanced HER2-negative breast cancer who have previously received systemic anti-cancer treatments.\n\nThe main questions this study aims to answer are:\n\nWhat doses of metronomic oral paclitaxel solution can be safely administered to patients with advanced HER2-negative breast cancer? How well does metronomic oral paclitaxel solution control tumor growth? What side effects and treatment-related medical problems occur during treatment?\n\nThis study will include two stages. In the first stage, researchers will evaluate different dosing schedules of oral paclitaxel solution to identify a dose（OTD） with an acceptable balance between safety and potential anti-tumor activity. In the second stage, additional participants will receive the selected dose（OTD） to further evaluate its effectiveness and safety.\n\nParticipants will:\n\nReceive metronomic oral paclitaxel solution according to the assigned dose schedule.\n\nVisit the study clinic regularly for physical examinations, laboratory tests, tumor imaging assessments, and safety evaluations.\n\nComplete assessments of treatment response, side effects, and quality of life during the study.\n\nContinue follow-up after treatment to collect information about disease status and survival.",[28,30],"2026-08-06",{"date":228,"type":42},"2026-08-11",{"date":230,"type":22},"2026-08-04",{"date":232,"type":22},"2029-08-20",{"name":234,"class":49},"Zhejiang Cancer Hospital",1,{"id":237,"slug":238,"hasResults":12,"nctId":239,"briefTitle":240,"officialTitle":241,"acronym":242,"eligibilityCriteria":243,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":244,"targetDuration":4,"studyType":23,"phases":246,"briefSummary":247,"conditions":248,"keywords":250,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":230,"lastUpdatePostDateStruct":259,"startDateStruct":261,"completionDateStruct":263,"leadSponsor":265,"locationsCount":267},"100614610","phase-3-phase-iii-study-to-evaluate-the-safety-efficacy-and-impact-on-quality-of-life-of-capivasertib-alongside-standard-of-care-endocrine-treatment-in-patients-with-hrher2--advanced-breast-cancer-and-progression-on-prior-endocrine-based-treatment-100614610","NCT07281833","Phase III Study to Evaluate the Safety, Efficacy, and Impact on Quality of Life of Capivasertib Alongside Standard-of-care Endocrine Treatment in Patients With HR+\u002FHER2- Advanced Breast Cancer and Progression on Prior Endocrine-based Treatment","An Interventional, Open-label, Phase III Study to Evaluate the Safety, Efficacy, and Impact on Quality of Life of Capivasertib Alongside Standard-of-care Endocrine Treatment in Patients With HR+\u002FHER2- Advanced Breast Cancer and Progression on Prior Endocrine-based Treatment","CAPIcorn","Inclusion Criteria:\n\n1. Females (≥18 years, pre-, peri- or post-menopausal) and males (≥18 years) at the time of signing the informed consent form\n\n   a. Pre-menopausal (and peri-menopausal, i.e., those that do not meet the criteria for post menopausal defined below) women can be enrolled if amenable to treatment with an GNRH agonist. Patients are to have commenced concomitant treatment with GNRH agonist prior to or on Cycle 1, Day 1 and must be willing to continue it for the duration of the study.\n\n   b. Post-menopausal women are defined as: i. aged ≥60 years of age, OR ii. aged \\\u003C60 years of age and amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatments\u002Fchemotherapy\u002Fovarian suppression\u002Ftamoxifen or similar. These patients should also have serum oestradiol and follicle stimulating hormone (FSH) levels confirmed as being within the standard laboratory reference range for post-menopausal females, OR iii. documented bilateral oophorectomy.\n2. Histologically confirmed HR+\u002FHER2- breast cancer determined from the most recent tumour sample (primary or metastatic) as per WHO classification. To fulfil the requirement of HR+ disease, a breast cancer must express ER with or without co-expression of progesterone receptor.\n\n   Therefore, tumours must be:\n\n   a. ER+ defined as ≥1% of tumour cells stain positive for ER on immunohistochemistry (IHC) or, if no percentage is available, then an Allred IHC score of ≥3\u002F8, b. Progesterone receptor positive defined as ≥1% of tumour cells stain positive for progesterone receptor on IHC or, if no percentage is available, then an Allred IHC score of ≥3\u002F8; or progesterone receptor negative defined as \\\u003C1% of tumour cells stain positive for progesterone receptor on IHC or, if no percentage is available, then an Allred IHC score of ≤2\u002F8; or progesterone receptor unknown, and c. HER2- defined as 0 or 1+ intensity on IHC, or 2+ intensity on IHC and no evidence of amplification on in situ hybridisation (ISH), or if IHC not done, no evidence of amplification on ISH.\n3. Metastatic or locally advanced disease with radiological or objective evidence of recurrence or progression (the cancer should have shown progression during or after most recent therapy); locally advanced disease must not be amenable to resection with curative intent (patients who are considered suitable for surgical or ablative techniques following potential down-staging with study treatment are not eligible).\n4. Patients are to have received treatment with an ET (endocrine-based therapy) containing regimen (single agent or in combination) and have:\n\n   a. Radiological evidence of breast cancer recurrence or progression while on, or within 12 months of the end of (neo)adjuvant treatment with an ET, OR b. Radiological evidence of progression while on prior ET administered as a treatment line for locally advanced or metastatic breast cancer (this does not need to be the most recent therapy).\n5. Presence of one or more of the PIK3CA\u002FAKT1\u002FPTEN biomarkers, preferably determined in tumour tissue\\*\n6. Decision to newly initiate capivasertib\n7. Informed consent provided by patient prior to participation in the trial and before initiation of any study-specific measures\n8. A. Female patients of childbearing potential at inclusion must have a negative pregnancy test (serum) and additionally, - surgically sterile, - carry an intrauterine device (combined with a barrier method),\n\n   * having received a bilateral tubal ligation\u002Focclusion (combined with a barrier method),\n   * or using a highly effective method of contraception for the duration of the study (from the time they sign consent) and for 3 months after the last dose of capivasertib \u002F GNRH and for 2 years after the last dose of fulvestrant to prevent pregnancy.\n   * Total\u002Ftrue abstinence When the patient refrains from any form of sexual intercourse and this is in line with their usual and\u002For preferred lifestyle; this must continue for the duration of the study and for 3 months after the last dose of capivasertib\u002F GNRH and for 2 years after the last dose of fulvestrant to prevent pregnancy.\n   * Vasectomised sexual partner (with participant assurance that partner received post-vasectomy confirmation of azoospermia) combined with a barrier method or sexual partner with bilateral orchiectomy\n   * Hormonal contraception is not acceptable.\n\n8\\. B. Male patients must either be\n\n* surgically sterile\n* or using an highly effective method of contraception for the duration of the study (from the time they sign consent) and for 4 months after the last dose of capivasertib\u002F GNRH and for 2 years after the last dose of fulvestrant to prevent pregnancy in a partner.\n* Sexually abstinent men (i.e., refraining from heterosexual intercourse during the entire study duration) must continue for 4 months after the last dose of capivasertib\u002F GNRH and for 2 years after the last dose of fulvestrant to prevent pregnancy in a partner.\n* Male patients who intend to be sexually active with a woman of childbearing potential, must use a condom plus spermicide upon entering the study and until 4 months after the last dose of capivasertib and for 2 years after the last dose of fulvestrant to prevent pregnancy in a partner.\n* Highly effective methods of contraception should be considered in female partners of men taking capivasertib plus fulvestrant who are of childbearing potential.\n\n  9\\. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 with no deterioration over the previous 2 weeks and life expectancy of ≥12 weeks\n\n  \\*A list of eligible alterations and test procedures is provided in the protocol.\n\nExclusion Criteria:\n\n* Patients eligible for inclusion in this study must not meet any of the following criteria:\n\n  1. Absence of an alteration in the PIK3CA\u002FAKT1\u002FPTEN biomarkers\n  2. Previous enrolment in the present study\n  3. Participation in another clinical study with any investigational medicinal product and still on IMP treatment or have participated in an interventional study that remains blinded\n  4. A disease burden that makes the patient ineligible for endocrine-based therapy per the investigator's best judgement (e.g., symptomatic visceral disease that is potentially life threatening in the short-term)\n  5. Known history of drug or alcohol abuse within 1 year of screening\n  6. Except for alopecia, any unresolved toxicities from prior therapy CTCAE Grade ≥2 at the time of starting study treatment\n  7. Leptomeningeal metastases\n  8. Spinal cord compression or brain metastases unless asymptomatic, treated and stable, and not requiring steroids within 4 weeks prior to study treatment initiation\n  9. Clinically significant abnormalities of glucose metabolism as defined by any of the following:\n\n     a. HbA1c ≥8.0% (63.9 mmol\u002Fmol) at screening. Note: for any patient with evidence of impaired glucose control or insulin resistance refer to the Capivasertib Toxicity Management Guidelines.\n  10. Inadequate bone marrow reserve or organ function as demonstrated by any of the following laboratory values:\n\n      1. Absolute neutrophil count \\\u003C1.5 × 109\u002FL\n      2. Platelet count \\\u003C100 × 109\u002FL\n      3. Haemoglobin \\\u003C9 g\u002FdL (\\\u003C5.59 mmol\u002FL). \\[NOTE: any blood transfusion must be \\>14 days prior to the determination of a haemoglobin ≥9 g\u002FdL (≥5.59 mmol\u002FL)\\]\n      4. Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) \\>2.5 times upper limit of normal (ULN) if no demonstrable liver metastases or \\>5 × ULN in the presence of liver metastases\n      5. Total bilirubin \\>1.5 × ULN (Patients with confirmed Gilbert's syndrome may be included in the study)\n      6. Creatinine \\>1.5 × ULN concurrent with creatinine clearance \\\u003C50 mL\u002Fmin (measured or calculated by Cockcroft and Gault equation); creatinine clearance is only required when creatinine is \\>1.5 × ULN\n  11. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, or active infection including tuberculosis, hepatitis B, hepatitis C, and human immunodeficiency virus (HIV), including those who have confirmed COVID 19 and any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in the investigator's opinion, gives reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, may affect the interpretation of the results, render the patient at high risk from treatment complications or interferes with obtaining informed consent. Screening for chronic conditions is not required.\n\n      Note: Known active hepatitis B or C infection, positive hepatitis C antibody, positive hepatitis B virus surface antigen. Participants positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA. Patients receiving antiretroviral therapies which are strong inhibitors or inducers of CYP3A4 will be excluded due to the potential for drug-drug interaction with capivasertib\n  12. Known abnormalities in coagulation such as bleeding diathesis, or treatment with anticoagulants precluding intramuscular injections of fulvestrant or subcutaneous injections of GNRH agonist (if applicable)\n  13. Refractory nausea and vomiting, malabsorption syndrome, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection, or other condition that would preclude adequate absorption of capivasertib\n  14. Previous allogenic bone marrow or solid organ transplant\n  15. History of another primary malignancy\n  16. Known immunodeficiency syndrome\n  17. Mean resting corrected QT interval \\>470 ms, obtained from triplicate ECGs performed at screening. History of QT prolongation associated with other medications that required discontinuation of that medication \\[Congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age in first-degree relatives.\\]\n  18. Medical history significant for arrhythmia (e.g., multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia), which is symptomatic or requires treatment (CTCAE Grade 3), symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. Participants with atrial fibrillation controlled by medication or arrhythmias controlled by pacemakers may be permitted to enter the study based on the Investigator judgement with cardiologist consultation recommended.\n  19. Any factors that increase the risk of QTc prolongation or risk of arrhythmic events, hypokalaemia of Grade \\>1, potential for Torsades de Pointes, congenital long QT syndrome\n  20. Experience of any of the following procedures or conditions in the preceding 3 months: coronary artery bypass graft, angioplasty, myocardial infarction, unstable angina pectoris. Congestive heart failure New York Heart Association (NYHA) ≥grade 2.\n  21. History of hypersensitivity to active or inactive excipients of capivasertib, fulvestrant and GNRH agonists (if applicable, i.e., concomitant GNRH agonist required in this study) or drugs with a similar chemical structure or class to capivasertib, fulvestrant or GNRH agonists (if applicable)\n  22. Radiotherapy within 14 days prior to first dose of capivasertib\n  23. Major surgical procedure (excluding placement of vascular access) or significant traumatic injury within 4 weeks of the first dose of study intervention or an anticipated need for major surgery during the study.\n  24. Evidence of dementia altered mental status or any psychiatric condition that would prohibit understanding or rendering of informed consent\n  25. Pregnancy or breastfeeding\n  26. Patients who at time of data collection for this study are participating in or have participated in an interventional study that remains blinded\n  27. More than 2 lines of endocrine-based therapy for inoperable locally advanced or mBC\n  28. More than 1 line of chemotherapy for inoperable locally advanced or mBC. Adjuvant and neoadjuvant chemotherapy are not classed as lines of chemotherapy for mBC\n  29. Prior treatment with any of the following:\n\n      1. AKT, PIK3 and mTOR inhibitors\n      2. ngSERD (Note: prior treatment with fulvestrant (=SERD) is allowed!)\n      3. Nitrosourea or mitomycin C within 6 weeks prior to study treatment initiation\n      4. Any other chemotherapy, immunotherapy, immunosuppressant medication (other than corticosteroids) or anticancer agents within 3 weeks prior to study treatment initiation. A longer washout period may be required for drugs with a long half-life (e.g., biologics) as agreed by the sponsor\n      5. Potent inhibitors or inducers of CYP3A4 within 2 weeks prior to the first dose of study treatment (3 weeks for St John's wort) or drugs that are sensitive to CYP3A4 inhibition within 1 week prior to study treatment initiation.\n      6. Any concomitant medication that may interfere with capivasertib or fulvestrant safety and efficacy based on the Investigator´s Brochure of capivasertib and the prescribing information of fulvestrant and local clinical guidelines, e.g., that are known to be associated with Torsade de Pointes or potent inducers of cytochrome P450 3A4 (CYP3A4).",{"count":245,"type":22},250,[25],"This is a multicentre phase-III-trial to evaluate the use of capivasertib in patients with HR+\u002FHER2- advanced breast cancer and progression on prior endocrine-based treatment.\n\nThe goal of this study is\n\n1. To evaluate benefit of capivasertib regarding time to next treatment (TTNT1) - i.e., time \"on treatment\" with capivasertib.\n2. To evaluate the benefits of patient reported outcome(PRO)-adherence regarding the deterioration of quality of life (DQoL)-free interval.\n\nThere is no active comparison group but a historical control group consisting of data of patients treated within the CAPItello-291-study..\n\nParticipants will take capivasertib accompanied by standard of care endocrine treatment and are asked to document ther quality of life on standardised questionnaires. Optionally, patients can use eHealth support via their own smart phones.",[158,249,28,65,30],"HR-positive Breast Cancer",[72,251,252,253,254,255,256,257,258],"advanced, metastatic","metastatic","progression","HR+","HER2-","capivasertib","eHealth","ePRO",{"date":260,"type":42},"2026-08-05",{"date":262,"type":42},"2025-11-27",{"date":264,"type":22},"2030-03",{"name":266,"class":49},"Women's Cancer Study Group GmbH",16,{"id":269,"slug":270,"hasResults":12,"nctId":271,"briefTitle":272,"officialTitle":273,"acronym":4,"eligibilityCriteria":274,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":275,"targetDuration":4,"studyType":23,"phases":277,"briefSummary":278,"conditions":279,"keywords":285,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":230,"lastUpdatePostDateStruct":288,"startDateStruct":289,"completionDateStruct":291,"leadSponsor":293,"locationsCount":295},"100529629","phase-2-dato-base-datopotamab-deruxtecan-for-breast-cancer-brain-metastases-100529629","NCT06176261","DATO-BASE: DATOpotamab-deruxtecan for Breast Cancer Brain metAstaSEs","DATO-BASE: A Phase 2 Trial of DATOpotamab-deruxtecan for Breast Cancer Brain metAstaSEs","Inclusion Criteria :\n\n* Metastatic breast cancer that is pathologically confirmed to be HER2-negative according to 2018 ASCO\u002FCAP guidelines 55.\n* Radiological confirmation of metastatic disease.\n* Cohorts A and B: Presence of newly diagnosed brain metastases or brain metastases progressing after prior local and\u002For systemic therapy.\n* Cohorts A and B: Participants must have a baseline MRI of the brain performed with and without gadolinium contrast, and must have central nervous system metastases with at least one measurable brain metastasis ≥ 1.0 cm in size (per RANO-BM) that has not been irradiated, or has progressed despite prior radiation therapy and\u002For systemic therapy (in the opinion of the treating physician). For cohorts A and B, head CT with contrast may be used in place of MRI at baseline and throughout the trial if MRI is contraindicated and the participant's CNS metastases are clearly measurable by head CT.\n* Cohorts C: Radiological evidence of evaluable leptomeningeal disease and clinical diagnosis of LMD per treating investigator. A positive CSF cytology is not required.\n* Cohort A: prior progression to treatment with at least one line of endocrine treatment (with or without CDK4\u002F6 inhibition) in the metastatic setting is mandatory. Patients experiencing recurrence during adjuvant endocrine treatment will be also considered eligible for the trial. There is no limit on the number of prior lines acceptable for the purpose of enrollment in this study.\n* Cohort B and C: no prior treatment is required (i.e., previously untreated patients are eligible). There is no limit on the number of prior lines of therapy acceptable for the purpose of enrollment in this study.\n* Participants may have measurable or non-measurable extracranial disease. Participants are NOT required to have extracranial disease, but must have imaging done to document disease status at baseline.\n* Age ≥ 18 years.\n* ECOG Performance Status 0-2\n* Participants must have adequate treatment washout period before registration, defined as \\> 4 weeks from major surgery, \\> 2 weeks from radiation treatment. For weekly chemotherapy regimens, \\> 2 weeks from chemotherapy; for every 3 weekly regimens, \\> 3 weeks from chemotherapy. At least 2 weeks from other systemic or targeted or investigational therapies (other than endocrine therapy) for breast cancer. No washout is required for endocrine therapy (e.g. aromatase inhibitors, tamoxifen, fulvestrant) but patients should discontinue prior to start of protocol therapy. Patients on ovarian suppression are allowed (but not required) to continue ovarian suppression at the discretion of their treating provider.\n* Left ventricular ejection fraction (LVEF) ≥ 50% by echocardiogram (ECHO) or multigated acquisition (MUGA) scan.\n* Adequate organ function as defined by the following values:\n\n  * Hemoglobin ≥ 9.0 g\u002FdL. Red blood cell\u002Fplasma transfusion is not permitted within 1 week prior to screening assessment.\n  * Absolute neutrophil count ≥1,500\u002Fmm3. Granulocyte colony-stimulating factor administration is not permitted within 1 week prior to screening assessment.\n  * Platelets ≥100,000\u002Fmm3. Platelet transfusion is not permitted within 1 week prior to screening assessment.\n  * Total bilirubin ≤ 1.5 institutional ULN if no liver metastases; or ≤ 3 x ULN in the presence of documented Gilbert's syndrome (unconjugated hyperbilirubinemia) or liver metastases at baseline.\n  * AST(SGOT)\u002FALT(SGPT) ≤ 2.5 × institutional ULN OR ≤ 5.0 x institutional ULN for patients with documented liver metastases\n  * Serum creatinine ≤ 1.5 mg\u002FdL (or glomerular filtration rate ≥ 30 ml\u002Fmin as determined by the Cockcroft-Gault equation)\n* Participants with a history of chronic viral conditions such as HIV, Hepatitis B\u002FC, should not be systemically excluded but have thoughtful consideration of inclusion, unless safety is a concern. Testing for these conditions is not required at baseline.\n* Female subjects of childbearing potential must have a negative serum or urine pregnancy test within 14 days of initiating protocol therapy.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Visceral crisis or impending visceral crisis\n* CNS complications for whom urgent neurosurgical intervention is indicated (i.e., resection, shunt placement)\n* Indication for immediate local therapy to CNS lesion(s) as defined by local standard\n* Evidence of significant (i.e., symptomatic) intracranial hemorrhage\n\n  -\\> 2 seizures within 4 weeks prior to study entry (registration)\n* Ongoing\u002Fpersistent toxicities caused by previous anti-cancer therapy (except alopecia) not yet improved to Grade ≤ 1 OR baseline prior to study entry (registration)\n* Known contraindication to MRI (e.g., due to pacemaker, ferromagnetic implants, claustrophobia, extreme obesity, hypersensitivity). However, for cohorts A and B, head CT with contrast may be used in place of MRI at baseline and throughout the trial if MRI is contraindicated and the participant's CNS metastases are clearly measurable by head CT.\n* Concurrent administration of other anti-cancer therapy during the course of this study is not allowed. Concurrent use of supportive care medications is allowed, and certain medications are required (see Section 5.1).\n* Uncontrolled intercurrent illness, including (but not limited to) active infection, severely compromised pulmonary function, unstable angina pectoris, uncontrolled cardiac arrhythmia, active ischemic heart disease, myocardial infarction within the previous six months, gastric or duodenal ulceration diagnosed within the previous six months, chronic liver or renal disease, or severe malnutrition. Note that if a patient has controlled diabetes mellitus, but is unable to monitor blood glucose at home, they will be excluded from the trial.\n* Participants must not have a condition requiring ongoing systemic treatment with corticosteroids (\\>4 mg daily dexamethasone (or bioequivalent)) or other immunosuppressive medications within 7 days prior to the baseline MRI. Corticosteroids administration must be stable and planned to remain ≤ 4 mg daily for the duration of protocol treatment. However, use of corticosteroids for clinical symptoms is allowed based upon treating physician discretion.\n* History of non-infectious interstitial lung disease (ILD)\u002Fpneumonitis that required steroids, current ILD\u002Fpneumonitis, or suspected ILD\u002Fpneumonitis that cannot be ruled out by imaging at screening.\n* A history of uncontrolled seizures, CNS disorders, or psychiatric disability judged by the investigator to be clinically significant and adversely affecting compliance to study drugs.\n* A history of malignancy other than breast cancer, except (a) adequately resected non-melanoma skin cancer, (b) curatively treated in situ disease, or (c) other solid tumors curatively treated, with no evidence of disease for ≥ 3 years.\n* Major surgery, open biopsy, or significant traumatic injury within 28 days prior to the initiation of protocol therapy, or anticipation of need for a major surgical procedure during the study.\n* Clinically significant corneal disease.\n* Has a history of severe hypersensitivity reactions to either the drug or inactive ingredients (including but not limited to polysorbate 80) of datopotamab deruxtecan.\n* History of severe hypersensitivity reactions to other monoclonal antibodies\n* Negative pregnancy test (urine and\u002For serum) is required for women of childbearing potential. Pregnant or lactating women are excluded from participation due to potential teratogenic effects of study drug.\n* Female participants must be either:\n\n  * post-menopausal for at least 1 year\n  * surgically sterile, or\n  * if of childbearing potential and sexually active with a non-sterilized male partner, must agree to use one highly effective form of birth control for the entire treatment period and for at least 7 months after the last dose of datopotamab deruxtecan (see Section 5.4 for complete list of highly effective birth control methods).\n* Female participants must not donate, or retrieve for their own use, ova at any time during this study and for at least 7 months after the last dose of datopotamab deruxtecan.\n* Female participants must refrain from breastfeeding while on study and for at least 7 months after the last dose of datopotamab deruxtecan.\n* Male participants who intend to be sexually active with a female partner of childbearing potential must be surgically sterile or using an acceptable method of contraception (see Section 5.4 for complete list of highly effective birth control methods) from the time of screening throughout the total duration of the study and the drug washout period (at least 4 months after the last dose of study intervention) to prevent pregnancy in a partner. Male participants must not donate or bank sperm during this same time period.",{"count":276,"type":22},58,[147],"The purpose of this study is to test the safety and effectiveness of the study drug datopotamab deruxtecan in participants with metastatic breast cancer that has spread to the brain.\n\nThe name of the study drug used in this research study is:\n\nDatopotamab deruxtecan (a type of antibody-drug conjugate)",[158,280,281,282,30,283,284],"Breast Cancer Female","Metastatic Triple-Negative Breast Carcinoma","ER Positive Breast Cancer","HER2 Negative Breast Carcinoma","ER-negative Breast Cancer",[158,280,281,282,286,283,287],"HER2 Negative Breast Cancer","ER Negative Breast Cancer",{"date":226,"type":42},{"date":290,"type":42},"2024-01-08",{"date":292,"type":22},"2029-01-01",{"name":294,"class":49},"Nancy Lin, MD",3,{"id":297,"slug":298,"hasResults":12,"nctId":299,"briefTitle":300,"officialTitle":301,"acronym":4,"eligibilityCriteria":302,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":303,"targetDuration":4,"studyType":23,"phases":305,"briefSummary":306,"conditions":307,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":230,"lastUpdatePostDateStruct":308,"startDateStruct":309,"completionDateStruct":311,"leadSponsor":313,"locationsCount":235},"100406500","phase-2-evaluation-of-psma-in-her2--ar-metastatic-breast-cancer-100406500","NCT04573231","Evaluation of PSMA in HER2- AR+ Metastatic Breast Cancer","Evaluation of Prostate Specific Membrane Antigen (PSMA) in HER2-negative, Androgen Receptor (AR)-Positive Metastatic Breast Cancer With 18F-DCFPyL PSMA-based PET\u002FCT","Inclusion Criteria:\n\n* Patients diagnosed with metastatic HER2-negative breast cancer AR expression of ≥ 10%\n\nExclusion Criteria:\n\n* Other (non-breast) known active malignancy. Participants with previously treated cancers which are in remission or have no evidence of disease are eligible.\n* Unable to lie flat during or tolerate PET\u002FCT\n* Participants with any medical condition or other circumstances that, in the opinion of the investigator, compromise the safety or compliance of the subject to produce reliable data or completing the study\n* Women of childbearing potential must not be pregnant or breast feeding (pregnancy test negative within 7 days prior to PET\u002FCT",{"count":304,"type":22},13,[147],"The purpose of this research is to determine the expression of prostate specific membrane antigen (PSMA) in human epidermal growth factor receptor 2 (HER2)-negative, androgen receptor (AR)-positive metastatic breast cancer, and to determine its role in resistance to the anti-androgen, bicalutamide. The investigators hypothesize that PSMA expression will correlate with resistance to anti-androgen therapies, as has been documented in prostate cancer, and this can be used to select patients most likely to benefit from these therapies in future clinical trials. 15 people with HER2-negative, AR-positive metastatic breast cancer will be enrolled and be on study for about 3 days.",[158,30,65],{"date":126,"type":42},{"date":310,"type":42},"2021-05-24",{"date":312,"type":22},"2026-08",{"name":314,"class":49},"University of Wisconsin, Madison",{"id":316,"slug":317,"hasResults":12,"nctId":318,"briefTitle":319,"officialTitle":320,"acronym":321,"eligibilityCriteria":322,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":323,"targetDuration":4,"studyType":23,"phases":325,"briefSummary":326,"conditions":327,"keywords":331,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":332,"lastUpdatePostDateStruct":333,"startDateStruct":335,"completionDateStruct":337,"leadSponsor":339,"locationsCount":341},"100380170","phase-2-sacituzumab-govitecan-in-tnbc-100380170","NCT04230109","Sacituzumab Govitecan In TNBC","A Phase 2 Study of Response-guided Neoadjuvant Sacituzumab Govitecan (IMMU-132) in Patients With Localized Triple-Negative Breast Cancer (NeoSTAR)","NeoSTAR","Inclusion Criteria:\n\n* Female or male patients ≥ 18 years of age.\n* Histologically confirmed diagnosis of invasive breast cancer, previously untreated.\n* Pre-and postmenopausal women are eligible to participate if not pregnant, not breastfeeding, and at least one of the following conditions applies:\n\n  * Not a woman of childbearing potential (WOCBP) OR\n  * A WOCBP who agrees to use effective contraceptive measures that have a failure rate of less than 1% per year from the initiation of treatment through at least 6 months b. after the last dose of study treatment. WOCBP must agree to 1 of the following contraceptive methods:\n\n    * Complete abstinence from intercourse of reproductive potential, or\n    * Consistent and correct use of 1 of the following methods of birth control:\n\n      * Nonhormonal intrauterine device (IUD); Hormonal IUD in conjunction with a barrier method; Female sterilization (have had surgical bilateral oophorectomy with or; without hysterectomy), total hysterectomy, or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment; Vasectomy in the male partner (upon medical assessment of surgical success)\n* Male patients with female partners of childbearing potential must practice\n\n  * Complete abstinence from intercourse of reproductive potential\n  * Have a surgically successful vasectomy upon medical assessment, or\n  * Use condoms plus partner use of a contraceptive method with a failure rate of \\\u003C1% per year during treatment and until 3 months after last dose of study drug.\n* ECOG performance status = 0, 1 (Karnofsky ≥60%, see Appendix A)\n* Ability to understand and the willingness to sign a written informed consent form (ICF). Patient has signed the ICF prior to any screening procedures being performed and is able to comply with protocol requirements, including research biopsy.\n* Patient has adequate bone marrow and organ function as defined by the following laboratory values at screening:\n\n  * Absolute neutrophil count (ANC) ≥ 1,500 per mm3\n  * Platelets ≥ 100,000 per mm3\n  * Hemoglobin ≥9.0 g\u002FdL\n  * PT-INR ≤1.5 x institutional ULN unless participant is receiving anticoagulant therapy as long as PT or aPPT is within therapeutic range of intended use of anticoagulants (for patients receiving pembrolizumab only).\n  * Serum creatinine \\\u003C1.5 mg\u002FdL or creatinine clearance ≥50 mL\u002Fmin (via the Cockcroft-Gault formula) for participants with creatinine levels above institutional upper limit of normal (ULN)\n  * Adequate hepatic function (bilirubin ≤ 1.5 ULN, AST and ALT ≤ 2.5 X ULN and serum albumin \\> 3 g\u002FdL).\n\nExclusion Criteria:\n\n* Participants currently receiving systemic therapy for any malignancy or having received systemic therapy for a malignancy in the preceding 3 years. (Concurrent endocrine therapy allowed in the adjuvant setting. Concurrent GnRH agonists allowed in any setting. Concurrent CDK4\u002F6 inhibitor not allowed in any setting.)\n* Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Clinically significant, uncontrolled heart disease and\u002For cardiac repolarization abnormality including any of the following:\n\n  * History of angina pectoris, symptomatic pericarditis, coronary artery bypass graft (CABG) or myocardial infarction within 6 months prior to study entry.\n  * History of cardiac failure, known cardiomyopathy (LVEF \\\u003C 50%; new LVEF assessment is not specifically required for this trial), significant\u002Fsymptomatic bradycardia, Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome or any of the following: ---Known risk to prolong the QT interval or induce Torsade's de Pointes.; Uncorrected hypomagnesemia or hypokalemia; Systolic Blood Pressure (SBP) \\>160 mmHg or \\\u003C90 mmHg. Higher blood pressure is permissible per discretion of treating physician; Bradycardia (heart rate \\\u003C50 at rest), by ECG or pulse; On screening, inability to determine the QTcF interval on the ECG (i.e.: unreadable or not interpretable) or QTcF \\>470 screening ECG\n* Pregnant or breast-feeding women are excluded from this study because the safety of study medications is not established.\n* HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months prior to enrollment are eligible for this trial. Participants who are HBsAg positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to registration. Participants should remain on anti-viral therapy throughout study intervention and follow local guidelines for HBV anti-viral therapy post completion of study intervention. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n* Participants who are not good candidates for the study (as per investigator judgement)\n* History of hypersensitivity reactions attributed to compounds of similar chemical or biologic composition to sacituzumab govitecan.",{"count":324,"type":22},239,[147],"This research study is studying to evaluate sacituzumab govitecan for individuals with localized triple negative breast cancer (TNBC)\n\nThe names of the study drugs involved in this study is:\n\n* Sacituzumab govitecan (SG)\n* Pembrolizumab (combination therapy with SG)",[328,170,329,330,30],"Invasive Breast Cancer","ER-Negative Breast Cancer","PR-Negative Breast Cancer",[328,170,329,330,30],"2026-07-16",{"date":334,"type":42},"2026-07-17",{"date":336,"type":42},"2020-07-14",{"date":338,"type":22},"2029-10",{"name":340,"class":49},"Massachusetts General Hospital",5,{"id":343,"slug":344,"hasResults":12,"nctId":345,"briefTitle":346,"officialTitle":347,"acronym":348,"eligibilityCriteria":349,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":350,"targetDuration":4,"studyType":23,"phases":352,"briefSummary":353,"conditions":354,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":357,"lastUpdatePostDateStruct":358,"startDateStruct":359,"completionDateStruct":361,"leadSponsor":363,"locationsCount":365},"100475205","phase-2-ribociclib-and-endocrine-treatment-of-physicians-choice-for-locoregional-recurrent-resected-hormone-receptor-positive-her2-negative-breast-cancer-100475205","NCT05467891","Ribociclib And Endocrine Treatment of Physician's Choice for Locoregional Recurrent, Resected Hormone Receptor Positive HER2 Negative Breast Cancer","A Phase II Study of Ribociclib And Endocrine Treatment of Physician's Choice for Locoregional Recurrent, Resected Hormone Receptor Positive HER2 Negative Breast Cancer","RaPhLRR","Eligibility Criteria to Collect Optional Correlative Blood and Tissue at Local Recurrence\n\n* Written informed consent (stage I) and HIPAA authorization for release of personal health information obtained prior to performing any study-specific procedures. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.\n* Male or female age ≥ 18 years at the time of consent.\n* Patient has a histologically and\u002For cytologically confirmed diagnosis of estrogen-receptor positive and\u002For progesterone receptor positive breast cancer based on the most recently analyzed tissue sample and all tested by local laboratory.\n* Patient has HER2-negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test is required by local laboratory testing and based on the most recently analyzed tissue sample. If there is insufficient tissue from the most recently collected sample, earlier tissue may be used on a case-by-case basis if permission is granted by the sponsor investigator.\n* Patient has locoregional recurrence of breast cancer: locoregional recurrence is defined as invasive recurrence in the ipsilateral breast, axilla, regional nodes, or chest wall.\n\nInclusion Criteria for Treatment Phase:\n\nSubject must meet all of the following applicable inclusion criteria to participate in this study:\n\n* Written informed consent (stage II\u002F main consent) and HIPAA authorization for release of personal health information obtained prior to performing any study-specific screening procedures. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.\n* Male or female age ≥ 18 years at the time of consent. NOTE: Both pre- and post-menopausal women are eligible. Post-menopausal status is defined as:\n\n  * Prior bilateral oophorectomy\n  * Age ≥60\n  * Age \\\u003C60 and amenorrhea for the last 12 or more months(in the absence of chemotherapy, tamoxifen, toremifen, or ovarian suppression) and FSH and estradiol in the postmenopausal range per local normal range.\n* ECOG Performance Status of 0-1 within 28 days prior to registration.\n* If patient is receiving tamoxifen or toremifene, a washout period of 5 half-lives (i.e. 35 days) prior to registration is required (during that period the participant can take AI).\n* Patient has a histologically and\u002For cytologically confirmed diagnosis of estrogen-receptor positive and\u002For progesterone receptor positive breast cancer based on the most recently analyzed tissue sample and all tested by local laboratory.\n* Patient has HER2-negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test is required by local laboratory testing and based on the most recently analyzed tissue sample. If there is insufficient tissue from the most recently collected sample, earlier tissue may be used on a case-by-case basis if permission is granted by the sponsor investigator.\n* Patients have had adequate local treatment for locoregional recurrence (LRR) of breast cancer.\n\n  * Locoregional recurrence is defined as recurrence in the ipsilateral breast, axilla, regional lymph nodes, or chest wall.\n  * Local treatment is defined as either surgery, radiation therapy, or a combination of both if indicated.\n  * Adequate local therapy is surgery with negative microscopic margins. Radiation therapy is mandated for patients with microscopically involved margins and recommended for all patients who had not received radiotherapy as part of their primary treatment.\n  * Patients who have distant metastatic disease will not be eligible.\n  * Prior treatment with neoadjuvant and adjuvant chemotherapy and ET is allowed.\n* Patients must enroll within 6 months of the last local treatment, either local surgery or radiation; or systemic chemotherapy (if patient is receiving chemotherapy), whichever occurred last. Chemotherapy after local therapy is allowed. ET for recurrent disease is allowed for up to 12 months prior to enrollment.\n* Patient has no contraindication to the adjuvant ET in the trial and is planned to be treated or continue treatment with ET.\n* Demonstrate adequate organ function as defined below; all screening labs to be obtained within 28 days prior to registration.\n\n  * Hematological\n\n    * Absolute Neutrophil Count (ANC): ≥ 1.5 x 109\u002FL\n    * Platelets: ≥ 100 x 109\u002FL\n    * Hemoglobin (Hgb): ≥ 9.0 g\u002FdL\n  * Renal\n\n    ---Estimated glomerular filtration rate (eGFR): ≥ 30 mL\u002Fmin\u002F1.73m2 according to the Modification of Diet in Renal Disease (MDRD) formula\n  * Hepatic\n\n    * Bilirubin: ≤ upper limit of normal (ULN) except for patients with Gilbert's syndrome who may only be included if the total bilirubin is ≤ 3.0 × ULN or direct bilirubin ≤ 1.5 × ULN\n    * Aspartate aminotransferase (AST): ≤ 2.5 × ULN except for patients with liver metastasis, who are only included if the AST is \\\u003C 5 × ULN\n    * Alanine aminotransferase (ALT): ≤ 2.5 × ULN except for patients with liver metastasis, who are only included if the ALT is \\\u003C 5 × ULN\n  * Coagulation\n\n    ---International Normalized Ratio (INR) : ≤ 1.5 × ULN (unless is receiving anticoagulants and the INR is within the therapeutic range of intended use for that anticoagulant within 7 days prior to the first dose of study drug)\n  * Electrolytes ---Potassium, Magnesium, and Total Calcium (corrected for serum albumin): Within normal limits or corrected to within normal limits with supplements.\n* Standard 12-lead ECG values defined as\n\n  * QTcF interval at screening \\\u003C 450 msec (QT interval using Fridericia's correction)\n  * Resting heart rate 50-90 bpm (determined from the ECG)\n* Females of childbearing potential who are sexually active with a male able to father a child must have a negative pregnancy test (serum or urine) within 14 days prior to registration and must be willing to use a highly effective method of contraception that does not contain estrogen and\u002For progesterone. See the protocol for definition of childbearing potential.\n* As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study.\n* Ability to swallow and retain oral medication.\n\nExclusion Criteria for Treatment Phase:\n\nSubjects meeting any of the criteria below may not participate in the study:\n\n* Patient with a known hypersensitivity to any of the excipients of ribociclib.\n* Patient who has received prior CDK4\u002F6 inhibitor for recurrent disease. Patients who received a CDK4\u002F6 inhibitor in the adjuvant setting may participate if they have been off therapy for at least 1 year prior to diagnosis of recurrent disease.\n* Patient has had major surgery within 14 days prior to starting study drug or has not recovered from major side effects.\n* Pregnant or breastfeeding or planning to become pregnant during the trial (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).\n* Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen are not eligible for this trial.\n* Patients with distant metastases of breast cancer beyond regional lymph nodes as defined by AJCC (8th edition).\n* Treatment with any investigational drug within 30 days prior to registration or participation in any other type of medical research judged not to be scientifically or medically compatible with this study. Enrollment or planned enrollment in another study that does not involve an investigational drug will be allowed at the discretion of the treating investigator.\n* Patient has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs (e.g., uncontrolled ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).\n* Patient has any other concurrent severe and\u002For uncontrolled medical condition that would, in the investigator's judgment, cause unacceptable safety risks, contraindicate patient participation in the clinical study or compromise compliance with the protocol: (e.g., chronic pancreatitis, chronic active hepatitis, HIV, active untreated or uncontrolled fungal, bacterial or viral infections, etc.). Testing to be done at investigator's discretion.\n* Clinically significant, uncontrolled heart disease and\u002For cardiac repolarization abnormality, including any of the following:\n\n  * History of documented myocardial infarction (MI), angina pectoris, symptomatic pericarditis, or coronary artery bypass graft (CABG) within 6 months prior to study entry\n  * Documented cardiomyopathy\n  * History of Left Ventricular Ejection Fraction (LVEF) \\\u003C 50%\n  * Long QT syndrome or family history of idiopathic sudden death or congenital long QT syndrome, or any of the following:\n\n    * Risk factors for Torsades de Pointe (TdP) including uncorrected hypocalcemia, hypokalemia or hypomagnesemia, history of cardiac failure, or history of clinically significant\u002Fsymptomatic bradycardia\n    * Concomitant medication(s) with a known risk to prolong the QT interval and\u002For known to cause Torsades de Pointe that cannot be discontinued or replaced by safe alternative medication (e.g., within 5 half-lives or 7 days prior to starting study drug)\n    * Inability to determine the QTcF interval\n  * Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia), complete left bundle branch block, high-grade AV block (e.g., bifascicular block, Mobitz type II and third-degree AV block)\n  * Systolic Blood Pressure (SBP) \\>160 or \\\u003C90 mmHg\n* Patient is currently receiving any of the following substances and cannot be discontinued 7 days prior to Cycle 1 Day 1:\n\n  * Concomitant medications, herbal supplements, and\u002For fruits (e.g., grapefruit, pummelos, star fruit, Seville oranges) and their juices that are strong inducers or inhibitors of CYP3A4\u002F5,\n  * Medications that have a narrow therapeutic window and are predominantly metabolized through CYP3A4\u002F5.\n* Patient is currently receiving or has received systemic corticosteroids ≤ 2 weeks prior to starting study drug, or who have not fully recovered from side effects of such treatment. Note: The following uses of corticosteroids are permitted: a short duration (\\\u003C5 days) of systemic corticosteroids; any duration of topical applications (e.g. for rash), inhaled sprays (e.g., for obstructive airways diseases), eye drops or local injections (e.g., intra-articular).\n* Patient with an uncontrolled psychiatric condition that, in the investigator's judgment, may cause unacceptable safety risks, impede research integrity and compliance, or interfere with the objectives of the study.",{"count":351,"type":22},200,[147],"This is an open label, multicenter, single arm phase II study to evaluate the efficacy and safety of ribociclib and ET in patients with locoregional recurrence of HR-positive, HER2-negative breast cancer.",[355,356,30],"Locoregional Recurrence","Hormone Receptor-positive Breast Cancer","2026-07-15",{"date":332,"type":42},{"date":360,"type":42},"2022-09-13",{"date":362,"type":22},"2029-08-15",{"name":364,"class":49},"Oana Danciu",21,{"id":367,"slug":368,"hasResults":12,"nctId":369,"briefTitle":370,"officialTitle":371,"acronym":372,"eligibilityCriteria":373,"healthyVolunteers":12,"sex":374,"minAge":19,"maxAge":375,"enrollmentInfo":376,"targetDuration":4,"studyType":23,"phases":378,"briefSummary":379,"conditions":380,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":385,"lastUpdatePostDateStruct":386,"startDateStruct":388,"completionDateStruct":390,"leadSponsor":392,"locationsCount":235},"100621091","phase-2-cdk46-inhibitors-combined-with-endocrine-therapy-for-neoadjuvant-treatment-100621091","NCT07366112","CDK4\u002F6 Inhibitors Combined With Endocrine Therapy for Neoadjuvant Treatment","CDK4\u002F6 Inhibitors Combined With Endocrine Therapy for Neoadjuvant Treatment of Breast Cancer: ctDNA-Guided Personalized Therapy","DNACDKHR","Inclusion Criteria:\n\n* 1.Female breast cancer patients aged ≥18 years and ≤75 years, either postmenopausal or premenopausal\u002Fperimenopausal; 2.Pathologically confirmed hormone receptor-positive (HR+), HER2-negative invasive breast cancer:\n\n  1. ER-positive and\u002For PR-positive defined as: ≥10% of tumor cells showing positive staining;\n  2. HER2-negative defined as: standard immunohistochemistry (IHC) result of 0\u002F1+; or IHC 2+ with negative in situ hybridization (ISH) (confirmed by the central pathology laboratory); 3. At least one evaluable lesion per RECIST 1.1, with clinical staging meeting:\n\n  \u003C!-- -->\n\n  1. T1c-2N0M0 with high-risk factors (Grade 3, or Grade 2 with Ki67 ≥20%);\n  2. T3N0M0;\n  3. Any TN+M0; 4.Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1; 5.Willing to participate in the study and voluntarily sign informed consent; 6.Agree to undergo ctDNA testing during treatment; 7.Adequate organ and bone marrow function defined as:\n\n  \u003C!-- -->\n\n  1. Absolute neutrophil count (ANC) ≥1,500\u002Fmm³ (1.5 × 10⁹\u002FL) (without granulocyte colony-stimulating factor \\[G-CSF\\] treatment within 14 days);\n  2. Platelet count (PLT) ≥100,000\u002Fmm³ (100 × 10⁹\u002FL) (without corrective therapy within 7 days);\n  3. Hemoglobin (Hb) ≥9 g\u002FdL (90 g\u002FL) (without corrective therapy within 7 days);\n  4. Serum creatinine ≤1.5× upper limit of normal (ULN) or creatinine clearance ≥60 mL\u002Fmin (without corrective therapy within 7 days);\n  5. Total bilirubin (TBIL) ≤1.5×ULN (without corrective therapy within 7 days);\n  6. Aspartate aminotransferase (AST\u002FSGOT) and alanine aminotransferase (ALT\u002FSGPT) ≤1.5×ULN (without corrective therapy within 7 days);\n  7. Cardiac function: left ventricular ejection fraction (LVEF) ≥55%; QTc interval corrected by Fridericia's formula (QTcF) \\\u003C470 msec on 12-lead ECG; Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to randomization and agree to use non-hormonal contraception from informed consent signing until 2 months after the last treatment.\n\nExclusion Criteria:\n\n* 1.Bilateral breast cancer; 2.Prior history of breast cancer (including ductal carcinoma in situ or invasive breast cancer); 3.Any prior antitumor therapy for the current breast cancer, including systemic therapies (endocrine, chemotherapy, immunotherapy, biological therapy) or local therapies (radiotherapy, vascular embolization, axillary lymph node biopsy); 4.Diagnosis of any malignancy within 5 years prior to randomization, except cured cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma of the skin; 5.History of severe pulmonary diseases (e.g., interstitial pneumonia); 6. HIV infection, acquired immunodeficiency syndrome (AIDS), active hepatitis B (HBV DNA ≥500 IU\u002FmL), hepatitis C (HCV antibody-positive with HCV RNA above the lower limit of detection), or co-infection with HBV and HCV; 7.Within 6 months prior to randomization: myocardial infarction, severe\u002Funstable angina, NYHA Class ≥II heart failure, ≥Grade 2 persistent arrhythmia (per NCI CTCAE v5.0), atrial fibrillation of any grade, coronary\u002Fperipheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident (including transient ischemic attack), or symptomatic pulmonary embolism; 8.Severe active infection within 4 weeks prior to randomization (requiring intravenous antibiotics, antifungals, or antivirals) or unexplained fever \\>38.5°C during screening\u002Fbefore first dose; 9.Known allergy to any component of the study drugs; 10.Current participation in another interventional drug clinical study; 11.Pregnancy or lactation; 12.Refusal to comply with follow-up; 13.Other severe physical\u002Fmental illnesses or laboratory abnormalities that may increase study risk, interfere with results, or render the patient unsuitable per investigator judgment.","FEMALE","75 Years",{"count":377,"type":22},158,[147],"Exploring the dynamics of ctDNA following neoadjuvant therapy with CDK4\u002F6 inhibitors combined with endocrine treatment, and its potential to guide de-escalation of adjuvant chemotherapy",[381,382,383,30,384],"Hormone Receptor-Positive Breast Cancer","High-risk Breast Cancer","Early-Stage Breast Cancer","ctDNA Monitoring","2026-07-10",{"date":387,"type":42},"2026-07-13",{"date":389,"type":42},"2026-04-20",{"date":391,"type":22},"2029-12-31",{"name":393,"class":49},"Peking University People's Hospital",{"id":395,"slug":396,"hasResults":12,"nctId":397,"briefTitle":398,"officialTitle":399,"acronym":400,"eligibilityCriteria":401,"healthyVolunteers":12,"sex":374,"minAge":19,"maxAge":375,"enrollmentInfo":402,"targetDuration":4,"studyType":23,"phases":404,"briefSummary":405,"conditions":406,"keywords":408,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":385,"lastUpdatePostDateStruct":420,"startDateStruct":421,"completionDateStruct":423,"leadSponsor":424,"locationsCount":235},"100590706","phase-2-ctdna-guided-de-escalation-of-adjuvant-chemotherapy-with-dalpiciclib-in-hr-positiveher2-negative-breast-cancer-100590706","NCT06970912","ctDNA-Guided De-Escalation of Adjuvant Chemotherapy With Dalpiciclib in HR-Positive\u002FHER2-Negative Breast Cancer","A Prospective, Multicenter, Randomized, Open-Label Phase II Study of ctDNA-Guided De-Escalation of Adjuvant Chemotherapy With Dalpiciclib in HR-Positive\u002FHER2-Negative Breast Cancer","DNADalHR","Inclusion Criteria:\n\n* Female breast cancer patients aged ≥18 years and ≤75 years, either postmenopausal or premenopausal\u002Fperimenopausal;\n* Pathologically confirmed hormone receptor-positive (HR+), HER2-negative invasive breast cancer:\n\n  1. ER-positive and\u002For PR-positive defined as: ≥10% of tumor cells showing positive staining;\n  2. HER2-negative defined as: standard immunohistochemistry (IHC) result of 0\u002F1+; or IHC 2+ with negative in situ hybridization (ISH) (confirmed by the central pathology laboratory);\n* At least one evaluable lesion per RECIST 1.1, with clinical staging meeting:\n\n  1. T1c-2N0M0 with high-risk factors (Grade 3, or Grade 2 with Ki67 ≥20%);\n  2. T3N0M0;\n  3. Any TN+M0;\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;\n* Willing to participate in the study and voluntarily sign informed consent;\n* Agree to undergo ctDNA testing during treatment;\n* Adequate organ and bone marrow function defined as:\n\n  1. Absolute neutrophil count (ANC) ≥1,500\u002Fmm³ (1.5 × 10⁹\u002FL) (without granulocyte colony-stimulating factor \\[G-CSF\\] treatment within 14 days);\n  2. Platelet count (PLT) ≥100,000\u002Fmm³ (100 × 10⁹\u002FL) (without corrective therapy within 7 days);\n  3. Hemoglobin (Hb) ≥9 g\u002FdL (90 g\u002FL) (without corrective therapy within 7 days);\n  4. Serum creatinine ≤1.5× upper limit of normal (ULN) or creatinine clearance ≥60 mL\u002Fmin (without corrective therapy within 7 days);\n  5. Total bilirubin (TBIL) ≤1.5×ULN (without corrective therapy within 7 days);\n  6. Aspartate aminotransferase (AST\u002FSGOT) and alanine aminotransferase (ALT\u002FSGPT) ≤1.5×ULN (without corrective therapy within 7 days);\n  7. Cardiac function: left ventricular ejection fraction (LVEF) ≥55%; QTc interval corrected by Fridericia's formula (QTcF) \\\u003C470 msec on 12-lead ECG;\n* Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to randomization and agree to use non-hormonal contraception from informed consent signing until 2 months after the last treatment.\n\nExclusion Criteria:\n\n* HER2-positive breast cancer confirmed by current pathological diagnosis;\n* Inflammatory breast cancer;\n* Stage IV (metastatic) breast cancer;\n* Bilateral breast cancer;\n* Prior history of breast cancer (including ductal carcinoma in situ or invasive breast cancer);\n* Any prior antitumor therapy for the current breast cancer, including systemic therapies (endocrine, chemotherapy, immunotherapy, biological therapy) or local therapies (radiotherapy, vascular embolization, axillary lymph node biopsy);\n* Diagnosis of any malignancy within 5 years prior to randomization, except cured cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma of the skin;\n* History of severe pulmonary diseases (e.g., interstitial pneumonia);\n* HIV infection, acquired immunodeficiency syndrome (AIDS), active hepatitis B (HBV DNA ≥500 IU\u002FmL), hepatitis C (HCV antibody-positive with HCV RNA above the lower limit of detection), or co-infection with HBV and HCV;\n* Within 6 months prior to randomization: myocardial infarction, severe\u002Funstable angina, NYHA Class ≥II heart failure, ≥Grade 2 persistent arrhythmia (per NCI CTCAE v5.0), atrial fibrillation of any grade, coronary\u002Fperipheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident (including transient ischemic attack), or symptomatic pulmonary embolism;\n* Severe active infection within 4 weeks prior to randomization (requiring intravenous antibiotics, antifungals, or antivirals) or unexplained fever \\>38.5°C during screening\u002Fbefore first dose;\n* Known allergy to any component of the study drugs;\n* Current participation in another interventional drug clinical study;\n* Pregnancy or lactation;\n* Refusal to comply with follow-up;\n* Other severe physical\u002Fmental illnesses or laboratory abnormalities that may increase study risk, interfere with results, or render the patient unsuitable per investigator judgment.",{"count":403,"type":22},393,[147],"* This is a Phase II, multicenter, randomized clinical trial evaluating a ctDNA-guided approach to de-escalate adjuvant chemotherapy in patients with hormone receptor (HR)-positive, HER2-negative early-stage breast cancer. The study aims to determine if combining the CDK4\u002F6 inhibitor Dalpiciclib with endocrine therapy can reduce the need for chemotherapy while maintaining clinical benefits.\n* Key Details ：\n\n  1. Participants: 393 women (aged 18-75) with early-stage HR+\u002FHER2- breast cancer at high risk of recurrence (e.g., tumor size ≥2 cm, lymph node involvement, or high-grade tumors).\n  2. Design: Patients are randomized 1:4 to two groups:\n\n     Group A (Chemotherapy) : Receives 4 cycles of taxane-based chemotherapy before surgery.\n\n     Group B (Experimental) : Receives Dalpiciclib + aromatase inhibitor (AI) for 4 cycles pre-surgery.\n\n     Post-surgery, treatment is adjusted based on ctDNA results.\n  3. Primary Goals ： Assess ctDNA clearance rate (conversion from detectable to undetectable ctDNA) after neoadjuvant therapy in Group B.\n\n     Evaluate 3-year event-free survival (EFS) in Group B (e.g., freedom from cancer recurrence, progression, or death).\n\n     Secondary Goals ： Safety of Dalpiciclib + endocrine therapy. Tumor response rates (e.g., complete cell cycle arrest, pathological remission).\n\n     Correlation between ctDNA clearance and long-term outcomes.\n* Why This Matters ： Current guidelines recommend chemotherapy for high-risk HR+ breast cancer, but it often causes significant side effects. This study explores a personalized approach using ctDNA-a blood-based biomarker-to identify patients who may safely avoid chemotherapy without compromising survival. If successful, it could shift clinical practice toward less toxic, targeted therapies for eligible patients.",[381,382,383,30,384,407],"Breast Cancer Early Stage Breast Cancer (Stage 1-3)",[409,410,411,412,413,414,415,416,417,418,419],"HR-positive HER2-negative breast cancer","Early-stage breast cancer","Dalpiciclib","CDK4\u002F6 inhibitor","ctDNA-guided therapy","Adjuvant chemotherapy de-escalation","Circulating tumor DNA (ctDNA)","Event-free survival (EFS)","Chemotherapy sparing","Personalized therapy","Biomarker-guided therapy",{"date":387,"type":42},{"date":422,"type":42},"2025-08-01",{"date":391,"type":22},{"name":393,"class":49},{"id":426,"slug":427,"hasResults":12,"nctId":428,"briefTitle":429,"officialTitle":430,"acronym":4,"eligibilityCriteria":431,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":432,"targetDuration":4,"studyType":23,"phases":434,"briefSummary":435,"conditions":436,"keywords":437,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":442,"lastUpdatePostDateStruct":443,"startDateStruct":445,"completionDateStruct":447,"leadSponsor":449,"locationsCount":450},"100574257","phase-1-bgb-21447-bcl-2-inhibitor-combinations-for-adults-with-hormone-receptor-positive-hrhuman-epidermal-growth-factor-receptor-2-negative-her2--metastatic-breast-cancer-100574257","NCT06756932","BGB-21447 (Bcl-2 Inhibitor) Combinations for Adults With Hormone-Receptor Positive (HR+)\u002FHuman Epidermal Growth Factor Receptor 2 Negative (HER2-) Metastatic Breast Cancer","A Phase 1 Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BGB-21447 (a Bcl-2 Inhibitor) Combinations for Patients With HR+\u002FHER2- Metastatic Breast Cancer","Inclusion Criteria:\n\n* Histologically or cytologically confirmed HR+\u002FHER2- metastatic breast cancer. Part 1A and 1B: Participants must have received ≥ 1 prior line(s) of treatment for advanced\u002Fmetastatic disease, including prior endocrine therapy and CDK4\u002F6 inhibitor in either the adjuvant or advanced\u002Fmetastatic setting. Part 2: Participants must have received 1-3 prior line(s) of treatment for advanced\u002Fmetastatic disease, including prior endocrine therapy and CDK4\u002F6 inhibitor in either the adjuvant or advanced\u002Fmetastatic setting.\n* Female participants will be required (either continue ongoing or initiate as soon as feasible) to have ovarian function suppression using gonadotropin-releasing hormone (GnRH) agonists (such as goserelin) or be postmenopausal.\n* Male participants may be required to use GnRH agonists when being treated with fulvestrant at the discretion of the investigator.\n* Participants must have a stable Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1.\n* Adequate organ function.\n* Female participants of childbearing potential and nonsterile male participants with female partners of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study and for 7 days after the last dose of BGB-21447, 6 months after the last dose of BGB-43395, and 2 years after the last dose of fulvestrant.\n* Food effect substudy only: Participants who are able and willing to fast overnight (≥ 10 hours) and consume a high-fat meal.\n\nExclusion Criteria:\n\n* Prior Bcl-2 inhibitor exposure. For triplet combination cohorts only: Prior therapy selectively targeting CDK4.\n* Known leptomeningeal disease or uncontrolled, untreated brain metastases.\n* Any malignancy ≤ 3 years before the first dose of study treatment(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent (eg, treated papillary thyroid carcinoma, resected basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast).\n* For Part 1B: Uncontrolled diabetes.\n* History of hepatitis B or active Hepatitis C infection\n* China Only: Untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers with HBV DNA \\> 500 IU\u002Fml (or \\> 2500 copies\u002Fml) at screening.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":433,"type":22},120,[61],"This is a dose escalation and dose expansion study to assess the safety and tolerability of BGB-21447 (a B-cell leukemia\u002Flymphoma 2 inhibitor, Bcl-2i) in combination with fulvestrant, with or without BGB-43395 (cyclin-dependent kinase 4 inhibitor, CDK4i), in adults with HR+\u002FHER2- metastatic breast cancer.",[66,30,65],[438,77,439,440,441],"BGB-21447","metastatic breast cancer","Bcl-2i","CDK4i","2026-06-17",{"date":444,"type":42},"2026-06-22",{"date":446,"type":42},"2025-02-04",{"date":448,"type":22},"2027-07-30",{"name":86,"class":87},14,{"id":452,"slug":453,"hasResults":12,"nctId":454,"briefTitle":455,"officialTitle":456,"acronym":4,"eligibilityCriteria":457,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":458,"enrollmentInfo":459,"targetDuration":4,"studyType":23,"phases":461,"briefSummary":462,"conditions":463,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":464,"lastUpdatePostDateStruct":465,"startDateStruct":466,"completionDateStruct":468,"leadSponsor":470,"locationsCount":472},"100441563","phase-1-cd40-agonist-flt3-ligand-and-chemotherapy-in-her2-negative-breast-cancer-100441563","NCT05029999","CD40 Agonist, Flt3 Ligand, and Chemotherapy in HER2 Negative Breast Cancer","Phase 1 Pilot Study With Dose Expansion of Chemotherapy in Combination With CD40 Agonist and Flt3 Ligand in Metastatic HER2 Negative Breast Cancer","Inclusion Criteria:\n\n* Unresectable Stage III or Stage IV HER2 negative breast cancer (either triple negative or hormone receptor positive)\n\n  * Triple negative breast cancer for this study is defined as estrogen receptor \\\u003C10%, progesterone receptor \\\u003C10% by immunohistochemistry, and HER2- negative by Herceptest (0 or 1+) or not amplified by in situ hybridization as per routine clinical testing.\n  * Hormone receptor positive breast cancer for this study is defined as either estrogen receptor ≥10% or progesterone receptor ≥10% by immunohistochemistry, and HER2- negative by Herceptest (0 or 1+) or not amplified by in situ hybridization as per routine clinical testing.\n* Age 18 years or older\n* Performance status ECOG 0-2\n* Life expectancy ≥ 12 weeks\n* Documented progressive disease, based on radiographic, clinical or pathologic assessment, during or subsequent to last anticancer therapy. Patients who need to change systemic therapy for other indications such as toxicity that are otherwise eligible for this study may enroll with approval of the lead principal investigator.\n* For triple negative breast cancer patients, subject is in first to fourth line setting of treatment for metastatic or unresectable disease, and have received 0 to 3 prior regimens for metastatic or unresectable disease.\n* For hormone receptor positive breast cancer patients, subjects must have received prior cyclin dependent kinase inhibitor in the metastatic setting. They may have received up to 3 prior lines of chemotherapy and\u002For antibody drug conjugates for metastatic or unresectable disease.\n* Among triple negative breast cancer patients enrolled in the first line treatment setting, subjects must be PD-L1 negative by 22C3 assay and not be eligible for FDA approved standard of care chemotherapy and anti-PD-1\u002FPD-L1 combination therapy as alternative to this clinical trial. This does not apply if patients have previously received PD-1 or PD-L1 blockade as part of neoadjuvant or adjuvant therapy regimen.\n* Screening laboratory values must meet the following criteria:\n\n  * Neutrophils ≥ 1500\u002FuL\n  * Platelets ≥ 100 x10(9)\u002FL\n  * Hemoglobin ≥ 8 g\u002FdL Patients may receive erythrocyte 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  * Creatinine ≤ 2 mg\u002FdL\n  * Creatinine clearance \\>30 mL\u002Fminute\n  * AST ≤ 2.5 X ULN without, and ≤ 5 x ULN with hepatic metastasis\n  * ALT ≤ 2.5 X ULN without, and ≤ 5 x ULN with hepatic metastasis\n  * Total Bilirubin ≤ 1.5 X ULN (except patients with Gilbert's syndrome or liver involvement, who must have a total bilirubin ≤ 2 X ULN)\n  * Alkaline phosphatase ≤ 2.5 X ULN without, and ≤ 5 x ULN with hepatic metastasis\n* All men as well as women of child bearing potential enrolled in this trial must agree to use effective contraception during the course of the trial and for at least 6 months after discontinuing study treatment. Patients and\u002For partners who are surgically sterile or postmenopausal are exempt from this requirement.\n\n  * A female of child-bearing potential is any woman (regardless of sexual orientation, marital status, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: ( 1) has not undergone a hysterectomy or bilateral oophorectomy OR (2) 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* Provision of consent for pre-treatment and on-treatment biopsies. Biopsy sites must be soft tissue tumor lesions or accessible visceral diseases that can be biopsied with acceptable clinical risk (as judged by the investigator); are large enough to allow for the collection of tumor tissue for proposed correlative studies (e.g., anticipated goal of 6-8 cores preferred when feasible using a ≥ 18 gauge needle with an expected core sample length of 5 mm); and have not been irradiated prior to entry. This does not include bone lesions. This may exclude many lung lesions and small lesions.\n* Measurable disease allowing for serial assessment of at least one target lesion(s) by RECIST 1.1 criteria \\[100\\]. Target lesions selected for tumor measurements should be those where additional (e.g., palliative) treatments are not indicated or anticipated.\n* All residual toxicity related to prior anticancer therapies (excluding alopecia, grade 2 fatigue, vitiligo, endocrinopathies on stable replacement therapy, grade 2 neuropathy from taxanes or platinum and grade 2 hearing loss from platinum) must resolve to grade 1 severity or less (or returned to baseline) prior to receipt of study treatment.\n* Read, understood, and provided written informed consent, and if applicable, Health Insurance Portability and Accountability Act (HIPAA) authorization, after the nature of the study has been fully explained, and must be willing to comply with all study requirements and procedures.\n\nExclusion Criteria:\n\n* Among any patients enrolled in the first line treatment setting, tumors should not be PD-L1+ by 22C3 assays or eligible for FDA approved standard of care chemotherapy and anti-PD-1\u002FPD-L1 combination therapy as alternative to this clinical trial. This does not apply if patients have previously received PD-1 or PD-L1 blockade as part of neoadjuvant or adjuvant therapy regimen.\n* History of severe hypersensitivity reactions to mAbs.\n* Prior treatment with any anti-CD40 antibody or rhuFlt3L product.\n* Treatment with anthracycline in the metastatic setting.\n* Prior progression while on anthracycline based therapy or within 6 months of completing neoadjuvant or adjuvant anthracycline.\n* Prior history of acute myeloid leukemia (AML), or tumor with known Flt3 mutation\u002Famplification\n* Receipt of any antibody targeting T cell check point or co-stimulation pathways within 4 weeks, use of any other monoclonal based therapies within 4 weeks, and all other immunotherapy (tumor vaccine, cytokine, or growth factor given to control the cancer) within 2 weeks prior to the planned start of study treatment.\n* Prior T-cell or other cell-based therapies within 12 weeks (or 2 weeks if patient experienced disease progression on the prior treatment)\n* Systemic radiation therapy within 4 weeks, prior focal radiotherapy within 2 weeks, or radiopharmaceuticals (strontium, samarium) within 8 weeks prior to the first dose of study treatment.\n* Chemotherapy or antibody drug conjugate within 21 days or at least 5 half-lives (whichever is shorter) prior to the planned start of study treatment.\n* Any kinase inhibitors within 2 weeks prior to the first dose of study treatment.\n* Major surgery within 4 weeks prior to the first dose of study treatment. Surgery requiring local\u002Fepidural anesthesia must be completed at least 72 hours before study drug administration and patients should be recovered.\n* Use of other investigational drugs within 4 weeks or 5 half-lives (whichever is longer) prior to study treatment administration.\n* Use of immunosuppressive medications within 4 weeks or systemic corticosteroids within 2 weeks prior to first dose of study treatment. Topical, inhaled or intranasal corticosteroids (with minimal systemic absorption) may be continued if the patient is on a stable dose. Non-absorbed intraarticular corticosteroid and replacement steroids (≤ 10 mg\u002Fday prednisone or equivalent) will be permitted.\n* Other prior malignancy, except for adequately treated basal or squamous cell skin cancer or in situ cancers; or any other cancer from which the patient has been disease-free for at least 3 years.\n* Active, untreated central nervous system metastases.\n* Patients with known treated brain metastases should be neurologically stable for 4 weeks post-treatment and prior to study enrollment. Continued use of steroids and\u002For anticonvulsants (in the absence of any suspicion of progressive brain metastases) is acceptable if ≤ equivalent of prednisone 10 mg daily. Brain MRI required on screening to document lack of progression.\n* Women who are pregnant or nursing. All female patients with reproductive potential must have a negative pregnancy test prior to starting treatment.\n* Active autoimmune disease or history of autoimmune disease or syndrome that required systemic steroids or immunosuppressive medications within the preceding 6 months, except for patients with vitiligo, endocrinopathies, or type 1 diabetes, Patients with mild asthma who require intermittent use of bronchodilators (such as albuterol) who have not been hospitalized for asthma in the preceding 6 months will not be excluded from this study.\n* Significant cardiovascular disease including unstable angina pectoris, uncontrolled hypertension or arrhythmia, congestive heart failure (New York Heart Association Class III or IV or EF\\\u003C50%) related to primary cardiac disease, uncontrolled ischemic or severe valvular heart disease or any of the following within 6 months prior to the first dose of study treatment: myocardial infarction, severe\u002Funstable angina, coronary artery bypass graft, congestive heart failure, cerebrovascular accident, transient ischemic attack.\n* For patients with triple negative breast cancer- prior anthracycline therapy with a cumulative doxorubicin-equivalent dose greater than 240 mg\u002Fm2. 240 mg\u002Fm2 anthracycline is equivalent to 4 doses of anthracycline-based chemotherapy in the localized setting (generally 60 mg\u002Fm2 per dose). Notes from physicians demonstrating 4 prior cycles\u002Fdoses of anthracycline or if less than 60 mg\u002Fm2 specifying as such to estimate the total anthracycline dose is sufficient. Exact calculation based on mg received originally is not required.\n* For patients with hormone receptor positive breast cancer who have received a prior anthracycline therapy with a cumulative doxorubicin-equivalent dose exceeding 240 mg\u002Fm2 (as was part of standard-of-care regimens in the past), a cardiology evaluation is recommended to minimize potential risks of heart damage.\n* Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed. The COVID-19 vaccines available in the United States are not live vaccines and are allowed if the final vaccine dose (of a regimen that requires more than 1 dose) is received at least 1 week prior to study enrollment.\n* History of (non-infectious) pneumonitis or has current pneumonitis. This includes asymptomatic infiltrates on screening chest CT scan that are felt by the investigator to potentially be an inflammatory process (i.e. grade 1 pneumonitis).\n* Active infection requiring systemic therapy, known HIV infection, or positive test for hepatitis B surface antigen or hepatitis C (antibody screen and if positive confirmed by RNA analysis). If positive results are not indicative of a true active or chronic infection, the patient can be enrolled after discussion with and agreement by the Investigator.\n* Any other acute or chronic medical or psychiatric condition or laboratory abnormality that could increase the risk associated with trial participation or trial drug administration or could interfere with the interpretation of trial results and, in the judgment of the investigator, would make the patient inappropriate for entry into the trial.\n* Evidence of acute or chronic infection on screening chest radiography.","99 Years",{"count":460,"type":22},30,[61],"This research study is being done to find out if the immunotherapy drugs called CDX-301 and CDX-1140 in combination with the standard chemotherapy treatment pegylated liposomal doxorubicin (PLD, Doxil) are safe and effective at controlling the cancer in patients with metastatic triple Human Epidermal Growth Factor Receptor 2 (HER2) negative breast cancer, and to determine a safe dose and treatment schedule of the three drugs. This research study will also test how your immune system responds to these treatments alone and in combination.",[30,65],"2026-06-15",{"date":442,"type":42},{"date":467,"type":42},"2022-04-20",{"date":469,"type":22},"2029-04-20",{"name":471,"class":49},"University of Texas Southwestern Medical Center",7,{"id":474,"slug":475,"hasResults":12,"nctId":476,"briefTitle":477,"officialTitle":477,"acronym":478,"eligibilityCriteria":479,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":480,"targetDuration":4,"studyType":23,"phases":482,"briefSummary":483,"conditions":484,"keywords":486,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":490,"lastUpdatePostDateStruct":491,"startDateStruct":493,"completionDateStruct":495,"leadSponsor":497,"locationsCount":235},"100608220","phase-1-eradicate-a-phase-ibii-study-of-elacestrant-plus-trastuzumab-deruxtecan-in-patients-with-cdk46-inhibitor-and-endocrine-resistant-hrher2-low-or-her2-ultralow-metastatic-breast-cancer-100608220","NCT07198724","ERADICATE: A Phase Ib\u002FII Study of Elacestrant Plus Trastuzumab Deruxtecan in Patients With CDK4\u002F6 Inhibitor and Endocrine-resistant HR+\u002FHER2-low or HER2-ultralow Metastatic Breast Cancer","ERADICATE","Inclusion Criteria:\n\n* Participants must have a histologically or cytologically confirmed diagnosis of HR+\u002FHER2-low metastatic or unresectable locally advanced breast cancer, defined as ER ≥ 10%, any PR in the most recent sample and HER2-low (IHC 1+ or IHC 2+ and ISH non-amplified) or HER2-ultralow (IHC 0 and any membranous staining on any prior primary or metastatic sample). Cutoff values for positive\u002Fnegative HER2 staining should be in accordance with current ASCO\u002FCAP (American Society of Clinical Oncology\u002FCollege of American Pathologists) guidelines.76\n* Participants must have had prior CDK4\u002F6 inhibitor and may have any number of prior endocrine based therapies in the metastatic setting.\n* Participants may have progressed on up to 1 prior line of prior chemotherapy or ADC in the metastatic setting.\n* Participants must have measurable disease per RECIST 1.1 criteria. See Section 11 for the definition of measurable disease. Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm (≥2 cm) by chest x-ray or as ≥10 mm (≥1 cm) with CT scan, MRI, or calipers by clinical exam. See Section 12 (Measurement of Effect) for the evaluation of measurable disease.\n* Participants must have known ESR1 mutation status in tumor or ctDNA within 6 months of enrollment to the trial. Participants must have Guardant360 CDx testing for ESR1-mutation status if status has not been validated within 60 days of registration.\n* Women or men age ≥18 years are eligible.\n* ECOG performance status ≤ 2.\n* Participants must have adequate organ and marrow function as defined below:\n\n  * Absolute neutrophil count ≥ 1,500\u002FµL\n  * Platelets ≥ 100,000\u002FµL\n  * Hemoglobin ≥ 9.0 g\u002FdL\n  * Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (or ≤ 2 x ULN in patients with documented Gilbert's syndrome)\n  * AST(SGOT)\u002FALT(SGPT) ≤ 2.5 x institutional ULN (or \\\u003C 5 x ULN in patients with liver metastases)\n  * Creatinine ≤ 1.5 x institutional ULN OR\n  * Calculated creatinine clearance ≥ 45 mL\u002Fmin via the Cockcroft-Gault formula for participants with creatinine levels above institutional ULN\n  * Baseline LVEF ≥ 50% prior to registration, as measured by echocardiogram (or multiple-gated acquisition \\[MUGA\\] scan if an echocardiogram cannot be performed or is inconclusive).\n  * Participants with a history of central nervous system (CNS) metastases are eligible if: Stable or untreated, asymptomatic brain metastases not needing immediate local therapy. For patients with untreated CNS lesions \\> 2.0 cm on screening contrast brain MRI, discussion with and approval from the Sponsor Investigator is required prior to enrollment.\n\n    1. Brain metastases previously treated with local therapy may either be stable since treatment or may have progressed since prior local CNS therapy, provided that there is no clinical indication for immediate re-treatment with local therapy in the opinion of the investigator\n    2. Patients treated with CNS local therapy for newly identified lesions may be eligible to enroll if all of the following criteria are met: Time since WBRT is ≥ 14 days prior to first dose of treatment, time since SRS is ≥ 7 days prior to first dose of treatment, and time since surgical resection is ≥ 14 days\n* Postmenopausal women must be postmenopausal, which is defined as any of the following:\n\n  * Age ≥ 60 years\n  * Age \\\u003C 60 and amenorrhea for 12 or more months (in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression) and FSH, and estradiol in the postmenopausal range per local normal range\n  * Premenopausal women made postmenopausal through the use GnRH agonist prior to study entry are eligible and MUST remain on the GnRH agonist for the duration of protocol treatment.\n  * Status-post bilateral oophorectomy - After adequate healing post-surgery\n* Premenopausal women must have a negative serum or urine pregnancy test. Pregnancy testing does not need to be pursued in female participants who are postmenopausal according to the definition in 3.1.10.\n* Women of child-bearing potential and men must agree to use adequate contraception at time of enrollment and for 4 months after the last dose of elacestrant or 7 months after the last dose of trastuzumab deruxtecan, whichever is later.\n* Participants must be able to swallow and retain oral medication.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Prior treatment with aatopoisomerase inhibitor antibody drug conjugate in any setting.\n* Prior treatment with an oral novel estrogen receptor degrader or modulator in the metastatic setting (SERD, SERM, PROTAC, or CERAN). Prior fulvestrant is allowed. A washout period of 7 days is required for any endocrine or targeted therapy. A washout period of 14 days is required for any chemotherapy.\n* Patients with known brain metastases that are symptomatic or that require therapy for symptom control are not eligible. Patients with stable or asymptomatic brain metastases are allowed. Participants with CNS metastases treated by neurosurgical resection or brain biopsy performed within 4 weeks before day 1 of study therapy will be excluded.\n* Receipt of any other investigational compound or device within 2 weeks of the first dose of treatment in this study.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to elacestrant or T-DXd.\n* History of (non-infectious) pneumonitis that required steroids or current ILD by imaging at screening.\n* Patients who are pregnant or breastfeeding, or who expect to become pregnant within the projected duration of the study.\n* Patients with active tuberculosis.\n* Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection requiring systemic therapy, clinically significant cardiovascular disease including: cerebral vascular accident\u002Fstroke (\\\u003C 6 months prior to enrollment), myocardial infarction (\\\u003C 6 months prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication, uncontrolled diabetes mellitus, gastrointestinal disorders potentially affecting the absorption of elacestrant, inflammatory bowel disease or chronic diarrhea, short bowel syndrome, or total gastric resection, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements. Moderate or severe hepatic impairment (Child-Pugh B or C). Active hepatitis B or active hepatitis C infection. Ability to comply with study requirements is to be assessed by each investigator at the time of screening for study participation. History of myocardial infarction, acute coronary syndrome or coronary angioplasty\u002Fstenting\u002Fbypass grafting within the last six months OR congestive heart failure (CHF) New York Heart Association (NYHA) Class II-IV or history of CHF NYHA Class III or IV.\n* Patients with a history of different malignancy are ineligible, except for those who have been disease-free for at least three years and are deemed by the investigator to be at low risk for recurrence of the prior malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: ductal carcinoma in situ of the breast, cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin.",{"count":481,"type":22},65,[61,147],"The goal of this study is to evaluate the safety and efficacy of elacestrant in combination with trastuzumab deruxtecan (T-DXd) in participants with hormone receptor-positive (HR+), HER2-low or HER2-ultralow, metastatic breast cancer that is resistant to prior CDK4\u002F6 inhibitor and endocrine therapy.\n\nThe names of the study drugs involved in this study are:\n\n* Elacestrant (a type of selective estrogen receptor degrader)\n* Trastuzumab deruxtecan (a type of standard of care antibody drug conjugate)",[65,485,30,158,280],"HER2 Low Breast Carcinoma",[65,485,30,158,280,487,488,489],"HR+\u002FHER2-low Breast Cancer","HR+\u002FHER2-ultralow Breast Cancer","Endocrine-resistant Breast Cancer","2026-06-08",{"date":492,"type":42},"2026-06-10",{"date":494,"type":42},"2025-11-17",{"date":496,"type":22},"2038-06-01",{"name":498,"class":49},"Kristina A. Fanucci",{"id":500,"slug":501,"hasResults":12,"nctId":502,"briefTitle":503,"officialTitle":504,"acronym":4,"eligibilityCriteria":505,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":506,"targetDuration":4,"studyType":23,"phases":508,"briefSummary":509,"conditions":510,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":513,"lastUpdatePostDateStruct":514,"startDateStruct":516,"completionDateStruct":518,"leadSponsor":520,"locationsCount":295},"100489973","phase-2-alpelisibinos-inhibitornab-paclitaxel-in-patients-with-her2-negative-metaplastic-breast-cancer-mpbc-100489973","NCT05660083","Alpelisib\u002FiNOS Inhibitor\u002FNab-paclitaxel in Patients With HER2 Negative Metaplastic Breast Cancer (MpBC)","Phase II Trial of Alpelisib With iNOS Inhibitor and Nab-paclitaxel in Patients With HER2 Negative Metastatic or Locally Advanced Metaplastic Breast Cancer (MpBC)","Inclusion Criteria:\n\n1. The patient (or legally acceptable representative if applicable) provides written informed consent for the study.\n2. At least 18 years of age on the day of informed consent signing.\n3. Histologically confirmed HER2 negative MpBC and\u002For Triple Negative Breast Cancer (TNBC) with squamous and\u002For sarcomatoid elements, including osseous, chondroid, and spindle morphology.\n4. HER2 negative status as defined by the current American Society of Clinical Oncology and College of American Pathologists guidelines at time of study entry.\n5. Locally advanced inoperable or metastatic MpBC with measurable disease by RECIST 1.1 Both first- and second-line patients will be eligible for this trial. Patients may have received prior immunotherapy, per standard of care.\n6. Eastern Cooperative Oncology Group performance status of 0 or 1.\n7. Adequate organ and marrow function as defined below:\n\n   * Hemoglobin ≥9.0 g\u002Fdl (without blood transfusion within 2 weeks of laboratory test used to determine eligibility)\n   * Absolute neutrophil count ≥1000\u002FμL (without granulocyte colony stimulating factor support within 2 weeks of laboratory test used to determine eligibility)\n   * Platelet count ≥100,000\u002FμL (without transfusion within 2 weeks of laboratory test used to determine eligibility)\n   * Serum total bilirubin (TB) ≤1.5 x institutional upper limit of normal (ULN; In the case of known Gilbert's syndrome, a higher serum TB \\[\\>1.5 x ULN\\] is allowed),\n   * Aspartate transaminase\u002Falanine transaminase ≤5 x institutional ULN\n   * Creatinine ≤1.5X the ULN or measured creatinine clearance ≥ 60 mL\u002Fmin\u002F1.\n8. Fasting blood glucose of ≤140 mg\u002Fdl and HgbA1c ≤7.0.\n9. Ability to swallow oral medication.\n10. Ability to take aspirin.\n11. Women of childbearing potential must agree to use contraception for the duration of the study through 90 days after the last dose of study treatment. A condom is required for all sexually active male participants to prevent them from fathering a child AND to prevent delivery of study treatment via seminal fluid to their partner. In addition, male participants must not donate sperm during the study and up to the time period as specified in labels of study drugs.\n12. If patient received major surgery, they must have recovered adequately from the toxicity and\u002For complications from the intervention prior to starting the study treatment.\n13. Willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations.\n\nExclusion Criteria:\n\n1. Concomitant use of strong inhibitors or strong inducers of cytochrome P450 (CYP)3A4. The patient must have discontinued strong CYP3A4 inhibitors or strong CYP3A4 inducers for at least 1 week prior to study treatment initiation (Examples included in Appendix 2).\n2. Currently receiving warfarin or other coumarin-derived anticoagulant for treatment, prophylaxis, or otherwise. Therapy with DOACs, heparin, low molecular weight heparin, direct oral anticoagulants or fondaparinux is allowed.\n3. Concurrent use of medications that interact with nitrate\u002Fnitrite levels (Examples included in Appendix 3).\n4. Received previous treatment with nab-paclitaxel, Pl3K inhibitor, AKT inhibitor, or mTOR inhibitor.\n5. Known history of Steven Johnson's syndrome or toxic epidermal necrolysis.\n6. Since HAART agents are metabolized by CYP3A4, HIV positive patients will be excluded from this trial.\n7. Poorly controlled hypertension at baseline (defined as systolic blood pressure \\>150 mm Hg). Isolated, unconfirmed systolic BP elevations will NOT exclude participation. Patients with medication-controlled hypertension are allowed provided they have been on their current medications for at least 4 weeks prior to Cycle 1, Day 1.\n8. Has any of the following cardiac abnormalities:\n\n   * Symptomatic congestive heart failure\n   * History of documented congestive heart failure (New York Heart Association functional classification III-IV)\n   * Documented cardiomyopathy\n   * Left ventricular ejection fraction \\\u003C50% as determined by multigated acquisition scan or echocardiogram\n   * Myocardial infarction \\~6 months prior to enrollment\n   * Unstable angina pectoris\n   * Serious uncontrolled cardiac arrhythmia\n   * Symptomatic pericarditis\n   * History of congenital QT prolongation\n   * Absolute corrected QT interval of \\>480 msec in the presence of potassium \\>4.0 mEq\u002FL and magnesium \\>1.8 mg\u002Fdl.\n9. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 3 weeks prior to study treatment administration. NOTE: Patients who have entered the follow-up phase of an investigational study may participate as long as it has been 3 weeks after the last dose of the previous investigational agent.\n10. Known or suspected hypersensitivity to any component or excipient of the proposed regimen (nab-paclitaxel, alpelisib, iNOS inhibitor, aspirin).\n11. Known additional malignancy that requires active treatment.\n12. Pneumonitis\u002F interstitial lung disease on baseline CT scan of the chest or moderate to severe chronic lung disease\n13. Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.\n14. Manifestations of malabsorption due to prior gastrointestinal surgery, gastrointestinal surgery disease, or an unknown reason.\n15. Symptomatic\u002Funtreated metastatic central nervous system disease.\n16. Type I diabetes mellitus irrespective of Hgb A1c OR uncontrolled type II diabetes mellitus defined as hemoglobin A1c \\>7%.\n17. Uncontrolled gastric ulcer\n18. ≥ Grade 2 sensory neuropathy\n19. Osteonecrosis of jaw\n20. Pancreatitis\n21. Pregnant, breastfeeding or expecting to conceive children within the projected duration of the study, starting with the prescreening or screening visit through 30 days after the last dose of study treatment.",{"count":507,"type":22},36,[147],"This is a research study to test the safety and effectiveness of using the drug alpelisib together with chemotherapy (nab-paclitaxel) and a drug called L-NMMA in patients with HER2 negative metastatic or locally advanced metaplastic breast cancer, who have not responded to previous treatments.\n\nParticipants in this study in addition to the standard care chemotherapy will also receive the drug alpelisib and L-NMMA. The therapies will be administered every 3 weeks (1 cycle) until disease progression, toxicity or until the participant withdraws from the study. The nab-paclitaxel chemotherapy will be administered intravenously on Day 1 of the 3 week cycles. Participants will take the drug alpelisib by mouth once daily at a dose determined by a safety study and the drug L-NMMA will be given intravenously on days 1 to 5 of the 3 week cycles.",[30,65,511,512],"Metaplastic Breast Carcinoma","TNBC - Triple-Negative Breast Cancer","2026-06-03",{"date":515,"type":42},"2026-06-04",{"date":517,"type":42},"2023-01-12",{"date":519,"type":22},"2028-12-02",{"name":521,"class":49},"The Methodist Hospital Research Institute",{"id":523,"slug":524,"hasResults":12,"nctId":525,"briefTitle":526,"officialTitle":527,"acronym":4,"eligibilityCriteria":528,"healthyVolunteers":12,"sex":374,"minAge":529,"maxAge":4,"enrollmentInfo":530,"targetDuration":4,"studyType":23,"phases":532,"briefSummary":533,"conditions":534,"keywords":537,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":541,"lastUpdatePostDateStruct":542,"startDateStruct":543,"completionDateStruct":545,"leadSponsor":547,"locationsCount":472},"100630102","phase-2-a-study-of-the-impact-of-endocrine-therapy-on-surgical-outcomes-in-people-with-lobular-breast-cancer-100630102","NCT07483307","A Study of the Impact of Endocrine Therapy on Surgical Outcomes in People With Lobular Breast Cancer","Impact of Neoadjuvant Endocrine Therapy on Surgical Outcomes in Patients With Stage 2 to 3 Invasive Lobular Carcinoma: A Prospective Study","Inclusion Criteria:\n\n* Written informed consent by participant or legally authorized representative\n* Postmenopausal women aged ≥50 years with biopsy-proven cT2-T3 N0-1 ILC who opt to undergo and are medically fit to undergo BCS at enrollment.\n* Tumors of the ER+\u002FHER2- subtype, defined as:\n\n  1. ER+: Positive for ER staining as indicated by ≥10% immunoreactive tumor nuclei.\n  2. HER2-: Immunohistochemistry assay demonstrating no or faint staining in ≤10% of tumor cells (IHC 0 or 1+) or negative by dual probe in situ hybridization assay.\n\nExclusion Criteria:\n\n* Patients with prior ipsilateral breast cancer.\n* Patients with advanced regional disease (cN2\u002FcN3) or stage 4 disease.\n* Patients who would benefit from neoadjuvant chemotherapy, per the treating medical oncologist.\n* Patients who are not candidates for definitive breast surgery (inoperable or stage 4 disease).\n* Patients with gadolinium allergy, precluding the use of breast MRI.","50 Years",{"count":531,"type":22},176,[147],"The purpose of this study is to look at how effective neoadjuvant (before surgery) endocrine therapy (NET) is in participants with invasive lobular carcinoma (ILC) who have breast-conserving surgery (BCS). The main purpose of the study is to see if NET reduces the chance of having cancer cells at the edges of tissue removed during surgery (positive margins).",[158,30,283,535,536],"ER+ Breast Cancer","Lobular Breast Carcinoma",[158,30,283,535,538,539,540],"26-095","Memorial Sloan Kettering Cancer Center","Lobular Breast Cancer","2026-06-02",{"date":515,"type":42},{"date":544,"type":42},"2026-03-13",{"date":546,"type":22},"2030-03-13",{"name":539,"class":49},{"id":549,"slug":550,"hasResults":12,"nctId":551,"briefTitle":552,"officialTitle":552,"acronym":4,"eligibilityCriteria":553,"healthyVolunteers":12,"sex":374,"minAge":19,"maxAge":4,"enrollmentInfo":554,"targetDuration":4,"studyType":97,"phases":4,"briefSummary":556,"conditions":557,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":562,"startDateStruct":564,"completionDateStruct":566,"leadSponsor":568,"locationsCount":235},"100545914","divitumtka-a-biomarker-assay-for-efficacy-in-hr-breast-cancer-patients-100545914","NCT06388122","DiviTum®TKa: A Biomarker Assay for Efficacy in HR+ Breast Cancer Patients","Inclusion Criteria:\n\n* Pre- or post-menopausal HR+ metastatic breast cancer patients who are:\n\n  * Group 1: scheduled to initiate 1st line combination therapy with an FDA-approved CDK4\u002F6 inhibitor (palbociclib, ribociclib, or abemaciclib) and an FDA-approved endocrine therapy for pre- or post-menopausal HR+ metastatic breast cancer (mBC).\n  * Group 2: scheduled to initiate second or later lines of therapy with an FDA-approved CDK4\u002F6 inhibitor (palbociclib, ribociclib, or abemaciclib) with or without an FDA-approved endocrine therapy for pre- or post-menopausal HR+ mBC.\n  * Group 3: currently receiving 1st line therapy with an FDA-approved CDK4\u002F6 inhibitor (palbociclib, ribociclib, or abemaciclib) and an FDA-approved endocrine therapy for pre- or post-menopausal HR+ mBC.\n  * Group 4: scheduled to initiate, or are currently receiving, 1st or 2nd line therapy of an FDA approved endocrine therapy (single agent) for pre- or post-menopausal HR+ mBC.\n  * Group 5: scheduled to initiate or are currently receiving 1st line therapy of an FDA-approved CDK4\u002F6 inhibitor (ribociclib or abemaciclib) with an FDA approved endocrine therapy for stage 2 or stage 3 adjuvant HR+ BC\n\nNOTE: Patients that meet eligibility criteria for any of the above groups that are already enrolled in an ongoing clinical trial are eligible for co-enrollment to this observational study.\n\nExclusion Criteria:\n\n* Treatment including investigational agent or therapies\n* Early breast cancer diagnosis\n* Male breast cancer\n* Currently receiving treatment for other active malignancy at time of registration\n\n  * EXCEPTIONS: Nonmelanoma skin cancer or carcinoma-in-situ (e.g. of cervix, prostate)\n* Inability to give written informed consent",{"count":555,"type":22},100,"This study is being done to determine if there is a pattern associated with response to endocrine therapy alone and in combination with CDK4\u002F6 inhibitor used for hormone receptor positive HER2 negative breast cancer.",[30,66,65,558,559,560,283,67,561],"Anatomic Stage II Breast Cancer AJCC v8","Anatomic Stage III Breast Cancer AJCC v8","Anatomic Stage IV Breast Cancer AJCC v8","Metastatic Breast Carcinoma",{"date":563,"type":42},"2026-06-01",{"date":565,"type":42},"2024-04-30",{"date":567,"type":22},"2031-06-15",{"name":569,"class":49},"Mayo Clinic",{"id":571,"slug":572,"hasResults":12,"nctId":573,"briefTitle":574,"officialTitle":575,"acronym":4,"eligibilityCriteria":576,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":577,"targetDuration":4,"studyType":23,"phases":579,"briefSummary":580,"conditions":581,"keywords":585,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":587,"lastUpdatePostDateStruct":588,"startDateStruct":589,"completionDateStruct":591,"leadSponsor":593,"locationsCount":472},"100568211","phase-1-a-study-of-abemaciclib-and-radiation-therapy-in-people-with-metastatic-breast-cancer-100568211","NCT06678269","A Study of Abemaciclib and Radiation Therapy in People With Metastatic Breast Cancer","A Phase I Study of Concurrent Abemaciclib and Radiation Therapy (RT) for Patients With Metastatic Hormone Receptor Positive (HR+), HER2 Negative (HER2-) Breast Cancer","Inclusion Criteria:\n\n* Aged ≥18 years at signing of informed consent.\n* Both male and female patients are allowed\n* Histologically confirmed metastatic breast cancer (mBC), current stage IV.\n* Plan for ablative radiotherapy (SBRT) to a bone metastasis.\n* Documented estrogen receptor (ER) positive and\u002For progesterone receptor (PgR) positive by immunohistochemistry. The threshold to qualify as ER or PgR positive is ≥1% per ASCO\u002FCAP guidelines.\n* HER2 negative tumor status confirmed by immunohistochemistry or FISH per ASCO\u002FCAP guidelines.\n* Any line of prior treatments (hormonal therapy and chemotherapy) is permitted including prior abemaciclib, palbociclib and ribociclib.\n* At the time of enrollment, treating physician has intent to resume abemaciclib (at any dose) following radiotherapy.\n* Patients who received chemotherapy must have recovered (Common Terminology Criteria for Adverse Events \\[CTCAE\\] Grade ≤1) from the acute effects of chemotherapy except for residual alopecia or Grade 2 peripheral neuropathy prior to enrollment. A washout period of at least 21 days is required between last chemotherapy dose and enrollment (provided the patient did not receive radiotherapy).\n* 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 enrollment. No prior radiotherapy to the current intended target site is permitted (ie. reirradiation is excluded from this study).\n* The patient must be able to swallow oral medications.\n* The patient must have adequate organ function per the following criteria (as defined in Table 2):\n\nTable 2: Laboratory Value Guidance to Establish Adequate Organ Function Hematologic ANC: ≥1.5 x 10\\^9\u002FL Platelets: ≥100 x 10\\^9\u002FL Hemoglobin: ≥8 g\u002FdL Participants may receive erythrocyte 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\nHepatic Total bilirubin: ≤1.5 x ULN Patients with Gilbert's syndrome with a total bilirubin ≤2.0 times ULN and direct bilirubin within normal limits are permitted ALT and AST: ≤3 x ULN\n\n* Patient may remain on hormonal therapy and abemaciclib before enrollment.\n* Patients must discontinue other CDK4\u002F6 inhibitor (palbociclib or ribociclib) for at least 7 days and recover from the acute effects of therapy (until the toxicity resolves to ≤Grade 1) except for residual alopecia and peripheral neuropathy.\n* Measurable or non-measurable disease is permitted as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).\n* Patients must have an Eastern Cooperative Oncology Group (ECOG) status of ≤2 or Karnofsky Performance Status (KPS) ≥60.\n* Negative β-human chorionic gonadotropin (hCG) pregnancy test for premenopausal women of reproductive capacity (those who are biologically capable of having children) and for women less than 12 months after menopause.\n* Women of childbearing potential must agree and commit to the use of a highly effective method of contraception as determined to be acceptable by the investigator, from the time of informed consent until 28 days after the last dose of the investigational product. Men must agree and commit to use a barrier method of contraception while on treatment and for 4 weeks after last dose of investigational products.\n* Patients (or their legally authorized representative) must provide written, informed consent to participate in the study and follow the study procedures\n* At the discretion of the treating radiation oncologist, radiation to a metastatic bone lesion is indicated inclusive of bone lesions in the spinal column.\n\nExclusion Criteria:\n\n* Treatment to bone lesions in the calvarium are not eligible for the dose-finding or expansion portions of the study. Patients who otherwise have calvarial lesions not undergoing treatment on this protocol are eligible to enroll.\n* Patients currently enrolled in a clinical trial involving an investigational product or non-approved use of a drug or device (other than the study drug\u002Fdevice used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.\n* The patient has received an experimental treatment in a clinical trial within the last 30 days or 5 half-lives, whichever is longer, prior to the start of study intervention, or is 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* Patients who received radiation therapy ≤14 days prior to initiation of investigational agents are excluded.\n* Patients are ineligible if they have 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).\n* Females who are pregnant or lactating.\n* 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.\n* The patient has a personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest.\n* Significant chronic gastrointestinal disorder with diarrhea as a major symptom (e.g., Crohn's disease, malabsorption, or Grade ≥2 diarrhea of any etiology screening).\n* Malignant spinal cord compression (ESCC2 or above)\n* Prior radiation therapy to the current target site.",{"count":578,"type":22},28,[61],"The purpose of this study is to test different doses of abemaciclib to find the best dose in participants while receiving hormone therapy and radiation therapy.",[65,582,158,583,584,30,283,66],"Stage IV Breast Cancer","Breast Cancer Stage IV","Breast Cancer Metastatic",[65,582,158,583,584,30,283,66,539,586],"24-138","2026-05-26",{"date":105,"type":42},{"date":590,"type":42},"2024-11-15",{"date":592,"type":22},"2028-11-30",{"name":539,"class":49},{"id":595,"slug":596,"hasResults":12,"nctId":597,"briefTitle":598,"officialTitle":599,"acronym":600,"eligibilityCriteria":601,"healthyVolunteers":12,"sex":374,"minAge":19,"maxAge":602,"enrollmentInfo":603,"targetDuration":4,"studyType":23,"phases":605,"briefSummary":606,"conditions":607,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":615,"lastUpdatePostDateStruct":616,"startDateStruct":617,"completionDateStruct":619,"leadSponsor":621,"locationsCount":235},"100484012","phase-2-fudan-university-shanghai-cancer-center-breast-cancer-precision-platform-series-study--neoadjuvant-therapy-100484012","NCT05582499","Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy","Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy (FASCINATE-N)","FASCINATE-N","Inclusion Criteria:\n\n* Histologically confirmed invasive breast cancer of clinical stage T1-4N1-3M0 or cT2-4N0M0;\n* Age between18-70 years;\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1;\n* ER, PR and HER2 status were measured by immunohistochemistry (IHC);\n* LVEF≥55%；\n* Definition of SNF subtypes: SNF subtypes confirmed by digital pathology of H\\&E slices;\n* Triple negative subtyping: On the basis of triple-negative pathological diagnosis, AR, cluster of differentiation 8 (CD8) and Forkhead Box C1 (FOXC1) were combined to define the subtyping;\n* At least one measurable lesion according to RECIST version 1.1\n* Normal organ and marrow function: Hemoglobin (HB) ≥90 g\u002FL (No blood was transfused within 14 days), Absolute neutrophil count ≥ 1500\u002FμL, Platelets ≥ 75,000\u002FμL, Total bilirubin ≤ 1.5 x ULN), aspartate aminotransferase (AST) (SGOT) and alanine aminotransferase (ALT) (SGPT) ≤ 3 x ULN, creatinine \\\u003C 1 x ULN, endogenous creatinine clearance \\> 50 ml\u002Fmin (Cockcroft-Gault formula);\n* Non-pregnant and non-lactating, fertile female subjects were required to use a medically approved contraceptive method for the duration of the study treatment and at least 3 months after the last use of the study drug;\n* Ability to understand and willingness to sign a written informed consent\n\nExclusion Criteria:\n\n* Previous cytotoxic chemotherapy, endocrine therapy, biological therapy or radiotherapy for any reason;\n* Patients with New York Heart Association (NYHA) grade II or above heart disease (including grade II);\n* Patients with severe systemic infections or other serious diseases;\n* Patients with known allergy or intolerance to the study drug or its excipients;\n* Other malignant tumors in the past 5 years, except cured cervical carcinoma in situ and non-melanoma skin cancer;\n* Pregnant or lactating patients of childbearing age who refused to take appropriate contraceptive measures during the course of the study;\n* Participated in other trial studies within 30 days before the administration of the first dose of the study drug;\n* Patients who were judged by the investigator to be unsuitable for this study.","70 Years",{"count":604,"type":22},716,[147],"The purpose of this study is to establish a prospective, single-center platform research based on clinical subtypes to explore precision neoadjuvant therapy in patients with operable breast cancer who met the indications for neoadjuvant chemotherapy and by the update of basic translational research in the center, especially the refinement of typing, the discovery of new targets and the development of novel targeted drugs, verified the effectiveness of new targeted drugs in neoadjuvant therapy.",[608,158,609,610,176,30,611,612,613,614],"Breast Neoplasm","Breast Tumors","Triple-Negative Breast Cancer (TNBC)","Hormone Receptor Positive Tumor","Hormone Receptor Negative Tumor","Early-stage Breast Cancer","Locally Advanced Breast Cancer","2026-05-22",{"date":105,"type":42},{"date":618,"type":42},"2022-11-01",{"date":620,"type":22},"2029-09",{"name":622,"class":49},"Fudan University",{"id":624,"slug":625,"hasResults":12,"nctId":626,"briefTitle":627,"officialTitle":628,"acronym":629,"eligibilityCriteria":630,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":631,"targetDuration":4,"studyType":23,"phases":633,"briefSummary":634,"conditions":635,"keywords":636,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":640,"lastUpdatePostDateStruct":641,"startDateStruct":642,"completionDateStruct":644,"leadSponsor":646,"locationsCount":235},"100589397","phase-2-impact-of-omitting-chemo-based-on-patients-selection-for-er-positive-her2-negative-breast-cancer-with-ribociclib-and-endocrine-therapy-100589397","NCT06953882","Impact of Omitting Chemo Based on Patient's Selection for ER-Positive, HER2-Negative Breast Cancer With Ribociclib and Endocrine Therapy","SELECT: A Phase II Adjuvant Trial Evaluating the Impact of Omitting Chemotherapy Based on Patient's Selection for Moderate to High-Anatomical Risk, Low-Genomic Risk, ER-Positive, HER2- Negative Breast Cancer With a Combination Regimen of Ribociclib and Optimized Endocrine Therapy","SELECT","Inclusion Criteria:\n\n1. Female or male age ≥ 18 years old and have the ability to understand and the willingness to sign a written informed consent document.\n2. Participants may have ipsilateral or contralateral synchronous breast cancer if the highest stage tumor meets entry criteria, and the other sites of disease would not require chemotherapy or HER2-directed therapy.\n3. Participants may have multicentric or multifocal breast cancer if the highest stage tumor meets entry criteria, and the other sites of disease would not require chemotherapy or HER2-directed therapy.\n4. Participants underwent a total mastectomy, skin-sparing mastectomy, nipple-sparing mastectomy, or a lumpectomy.\n5. Participants must have undergone axillary staging with sentinel node biopsy (SNB), targeted axillary dissection (TAD), or axillary lymph node dissection (ALND).\n6. The following staging criteria must be met postoperatively according to AJCC 8th edition criteria: men or premenopausal women T2-3N0 and RS 16-25, or T1-3N1-2 and RS ≤ 25, and postmenopausal women T2-3N0 and RS 26-30, or T1-3N1 and RS 26-30, or T1-3N2 and RS ≤ 25.\n7. The tumor must be ER-positive (≥ 10%), HER2-negative, by current ASCO\u002FCAP guidelines based on testing results. HER2-negative breast cancer is defined as a negative in situ hybridization test or an immunohistochemistry (IHC) status of 0 or 1+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test is required to confirm the participant's HER2-negative status (based on the most recently analyzed tissue sample tested by a local laboratory).\n8. Participants with known menopausal status at the time of screen.\n\n   a. Postmenopausal status is defined as: i. Participant underwent bilateral oophorectomy, or ii. Age ≥ 60 years, or Age \\\u003C 60 years and amenorrhea for 12 or more months (in the absence of chemotherapy, tamoxifen, toremifene or ovarian suppression) and Follicle-stimulating hormone (FSH) and plasma estradiol are in the postmenopausal ranges per local normal ranges. Note: All women who do not meet the criteria for postmenopausal status are considered premenopausal for the purpose of this trial.\n9. HIV-infected participants with undetectable viral load within 6 months and in long term anti-retroviral therapy that would not have a significant drug-drug interaction with ribociclib are eligible for this trial.\n10. Radiation therapy should be used according to standard guidelines.\n11. Participants must have an ECOG performance status of 0 to 1 within 28 days prior to registration of the study.\n12. Participant is able to swallow oral medications.\n13. Participants must have adequate organ and marrow function as defined below. All laboratory values must be obtained within 28 days prior to registration of the study.\n\n    1. Absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL.\n    2. Platelets ≥ 100 × 109\u002FL.\n    3. Hemoglobin ≥ 9.0 g\u002FdL.\n    4. Estimated glomerular filtration rate (eGFR) ≥ 30 mL\u002Fmin\u002F1.73m2 according to the Modification of Diet in Renal Disease (MDRD) formula.\n    5. Alanine transaminase (ALT) \\\u003C 2.5 × Upper Limit Normal (ULN).\n    6. Aspartate transaminase (AST) \\\u003C 2.5 × ULN.\n    7. Total serum bilirubin \\\u003C ULN; or total bilirubin ≤ 3.0 × ULN or direct bilirubin ≤ 1.5 × ULN in patients with well documented Gilbert's Syndrome.\n    8. Patient must have the following laboratory values within normal limits or corrected to within normal limits with supplements (the local laboratory value should be documented within normal limits after the correction) before enrollment:\n\n       * Potassium.\n       * Magnesium.\n       * Total Calcium (corrected for serum albumin).\n14. Standard 12-lead ECG values assessed as: QTcF interval (using Fridericia's correction) at screening \\\u003C 450 msec. Resting heart rate 50-90 beats per minute (determined from the ECG).\n15. Participant must be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other trial procedures.\n16. Participants must adhere to the following reproductive and contraceptive requirements while on study treatment and within three months after receiving the last dose of the treatment drugs.\n\n    a. General requirements: i. Participants must not be pregnant or breastfeeding. ii. Participants must not donate or freeze eggs for future use related to assisted reproduction during the course of this study or within three months after receiving the last dose of the treatment drugs.\n\n    b. For participants of childbearing potential: i. A participant of childbearing potential is defined as an individual who is premenopausal and capable of becoming pregnant. This includes individuals using contraception, those who are sexually inactive, and those with partners who have undergone a vasectomy. A participant is considered of childbearing potential if they have reached menarche, have not yet met the criteria for postmenopause (defined as more than 12 consecutive months of amenorrhea without any other medical cause), and have not undergone surgical sterilization (such as hysterectomy or oophorectomy).\n\n    ii. A negative highly sensitive serum pregnancy test (for β-hCG) must be obtained within two weeks of starting the treatment drug administration.\n\n    iii. Participants must practice at least one highly effective method of contraception.\n\n    c. Highly effective methods of contraception include, but are not limited to: i. Total abstinence (no sexual relations), when this is in line with your preferred and usual lifestyle. Periodic abstinence like calendar, ovulation, symptothermal, post-ovulation methods, and withdrawal are not acceptable methods of contraception.\n\n    ii. Total hysterectomy (surgical removal of the uterus and cervix) or tubal ligation (getting your \"tubes tied\") at least six weeks before taking study treatment.\n\n    iii. Your male partner has already been sterilized with the appropriate documentation. The sterilized male partner should be your sole partner.\n\n    iv. Placement of an intrauterine device (IUD) v. The use of oral (estrogen and progesterone), injected or implanted hormonal methods of contraception or intrauterine system (IUS) or any other form of hormonal contraception (e.g., hormone vaginal ring, hormonal-based IUD or transdermal hormone contraception) is not allowed in this study.\n17. Participant has no contraindication for the adjuvant ET in the trial and is planned to be treated with ET for five years or more.\n\nExclusion Criteria:\n\nParticipants who meet any of the following criteria will be excluded from study entry:\n\n1. Definitive clinical or radiologic evidence of distant metastases of breast cancer beyond regional lymph nodes (stage IV according to AJCC 8th edition) and\u002For evidence of recurrence after curative surgery.\n2. T4 tumors, including inflammatory breast cancer.\n3. N3 tumors.\n4. Participants that have received neoadjuvant chemotherapy or biotherapy.\n5. Participant is concurrently using hormone replacement therapy.\n6. Participants with a known hypersensitivity to any of the excipients of ribociclib and\u002For ET (e.g. rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, glucose-galactose malabsorption, and soy allergy).\n7. Participant has received any CDK4\u002F6 inhibitor.\n8. Participant has a concurrent invasive malignancy or a prior invasive malignancy that requires systemic therapy or place them at more than minimal risk of mortality in the next 5 years.\n9. Participant has known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection (testing is not mandatory, unless required by local regulation).\n10. Life expectancy of \\\u003C5 years due to co-morbid conditions in the opinion of the treating investigator.\n11. Non-epithelial breast malignancies such as sarcoma or lymphoma.\n12. Hormonally based contraceptive measures must be discontinued prior to registration (including progestin\u002Fprogesterone IUDs).\n13. Pregnancy or lactating women or women who plan to become pregnant or breast-feed during the trial.\n\n    a. Note: Pregnancy testing according to institutional standards for women of childbearing potential must be performed at screening.\n14. Clinically significant, uncontrolled heart disease and\u002For cardiac repolarization abnormality, including any of the following:\n\n    1. History of documented myocardial infarction (MI), angina pectoris, symptomatic pericarditis, or coronary artery bypass graft within six months prior to screening\n    2. Documented cardiomyopathy\n    3. Long QT syndrome or family history of idiopathic sudden death or congenital long QT syndrome, or any of the following:\n\n    i. Risk factors for Torsades de Pointes (TdP) including uncorrected hypokalemia or hypomagnesemia, history of cardiac failure, or history of clinically significant\u002Fsymptomatic bradycardia ii. Concomitant medication(s) with a known risk to prolong the QT interval and\u002For known to cause TdP that cannot be discontinued or replaced by safe alternative medication (e.g. within five half-lives or seven days prior to starting trial treatment) iii. Inability to determine the QTcF interval d. Clinically significant cardiac arrhythmias (e.g. ventricular tachycardia), complete left bundle branch block, high-grade Atrioventricular (AV) block (e.g. bifascicular block, Mobitz type II- and third-degree AV block) e. Uncontrolled arterial hypertension.\n15. Participant is currently receiving any of the following substances within 7 days before registration:\n\n    1. Concomitant medications, herbal supplements, and\u002For fruits (e.g. grapefruit, pummelos, starfruit, Seville oranges) and their juices that are known as strong inhibitors or inducers of CYP3A4\u002F5.\n    2. Medications that have a narrow therapeutic window and are predominantly metabolized through CYP3A4\u002F5.\n16. Participant is currently receiving or has received systemic corticosteroids ≤ 2 weeks prior to starting trial treatment or has not fully recovered from side effects of such treatment. Note: The following uses of corticosteroids are permitted: a short duration (\\\u003C5 days) of systemic corticosteroids, any duration of topical applications (e.g. for rash), inhaled sprays (e.g. for obstructive airways diseases), eye drops or local injections (e.g. intra-articular).\n17. Participant has impairment of GI function or GI disease that may significantly alter the absorption of the oral trial treatments (e.g. uncontrolled ulcerative diseases, uncontrolled nausea, vomiting or diarrhea, malabsorption syndrome, or small bowel resection).\n18. Participant has any other concurrent severe and\u002For uncontrolled medical condition that would, in the principal investigator's judgment, cause unacceptable safety risks, contraindicate patient participation in the clinical trial or compromise compliance with the protocol (e.g. chronic pancreatitis, chronic active hepatitis, liver cirrhosis or any other significant liver disease, active untreated or uncontrolled fungal, bacterial or viral infections, active infection requiring systemic anti-bacterial therapy, etc.).\n19. Participation in other studies involving investigational drug(s) within 30 days prior to registration or within 5 half-lives of the investigational drug(s) (whichever is longer), or participation in any other type of medical research judged not to be scientifically or medically compatible with this trial. If the participant is enrolled or planned to be enrolled in another study that does not involve an investigational drug, the agreement of the Sponsor-Investigator is required to establish eligibility.",{"count":632,"type":22},140,[147],"This is a Phase II, two-arm, single center, patient preference study designed to evaluate the impact of omitting adjuvant chemotherapy in moderate to high-anatomical risk, low-genomic risk (men or premenopausal women T2-3N0 and RS 16-25, or T1-3N1-2 and RS ≤ 25, and postmenopausal women T2-3N0 and RS 26-30, or T1-3N1 and RS 26-30, or T1-3N2 and RS ≤ 25),",[286],[637,638,639,33],"premenopausal women T1-3N1-2","postmenopausal women T3N1","postmenopausal women T3N2","2026-05-20",{"date":587,"type":42},{"date":643,"type":42},"2025-07-09",{"date":645,"type":22},"2030-09",{"name":647,"class":49},"Yale University",{"id":649,"slug":650,"hasResults":12,"nctId":651,"briefTitle":652,"officialTitle":653,"acronym":4,"eligibilityCriteria":654,"healthyVolunteers":12,"sex":374,"minAge":19,"maxAge":4,"enrollmentInfo":655,"targetDuration":4,"studyType":23,"phases":657,"briefSummary":658,"conditions":659,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":640,"lastUpdatePostDateStruct":661,"startDateStruct":662,"completionDateStruct":664,"leadSponsor":666,"locationsCount":235},"100515272","phase-1-study-to-evaluate-biomarkers-and-safety-of-dapagliflozin-concomitant-with-neoadjuvant-therapy-100515272","NCT05989347","Study to Evaluate Biomarkers and Safety of Dapagliflozin Concomitant With Neoadjuvant Therapy","A Pilot Study to Evaluate Biomarkers and Safety of Dapagliflozin Concomitant With Neoadjuvant Therapy for Patient With HER2-negative Early-stage Breast Cancer and Hyperinsulinemia","Inclusion Criteria:\n\n* Women \\> 18 years of age with newly diagnosed, histologically confirmed, clinical stage I-III, HER2-negative - either ER+ or triple negative - invasive breast cancer as defined by ASCO CAP guidelines for whom neoadjuvant chemotherapy would be indicated. The following chemotherapy regimens are acceptable:\n\n  1. Weekly or dose dense paclitaxel, followed by dose dense doxorubicin plus cyclophosphamide\n  2. Docetaxel plus cyclophosphamide\n  3. Docetaxel plus carboplatin plus or minus pembrolizumab\n  4. Paclitaxel plus carboplatin concurrent with every 3 week pembrolizumab followed by dose dense doxorubicin plus cyclophosphamide concurrent with every 3 week pembrolizumab (KEYNOTE-522 regimen; only for participants with triple negative breast cancer)\n* BMI ≥ 25 kg\u002Fm2\n* Hyperinsulinemia defined as HOMA-IR ≥ 2.5.\n* Willing and able to provide written informed consent for the trial.\n* Has at least one (1) physical 4-5-micron single H\\&E slide from diagnostic biopsy available\n* Female participants of childbearing potential should have a negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n* Female participants must be 1 year post-menopausal orsurgically sterile, Women of childbearing potential who are sexually active with a non-sterilized male partner must agree to follow their chemotherapy provider's instructions for birth control.\n* Participants should have adequate organ function to tolerate chemotherapy, as defined by:\n\n  1. peripheral granulocyte count of \\> 1,500\u002Fmm3\n  2. platelet count \\> 100,000\u002Fmm3\n  3. hemoglobin \\>9 g\u002FdL\n  4. total bilirubin \\\u003C 1.5 x upper limit of normal (ULN)\n  5. aspartate aminotransferase (AST) and alanine aminotransferase (ALT) each \\\u003C 1.5 x ULN\n  6. serum creatinine \\\u003C 1.5 x ULN\n  7. INR\u002FPT\u002FPTT each \\\u003C 1.5 x ULN\n* Able to swallow oral formulation of the study agent\n* Subjects should not donate blood while participating in this study, or for at least 90 days following the last dose of chemotherapy\n\nExclusion Criteria:\n\n* Participants who underwent partial excisional biopsy or lumpectomy, segmental mastectomy or modified radical mastectomy or sentinel node biopsy and therefore cannot be assessed accurately for pathologic response, are not eligible.\n* Participants currently pregnant or breastfeeding.\n* Participants for whom any of the planned chemotherapies are contraindicated.\n* Participants with currently diagnosed type I or II diabetes mellitus.\n* Participants taking any antidiabetic medication that would affect insulin resistance or hyperinsulinemia (i.e. TZD, GLP-1RA, DPP-4i, SGLT2i, metformin) in the past one month.\n* Participants with history of hypersensitivity reaction to dapagliflozin.\n* Participants with eGFR \\\u003C 25.\n* History of recurrent (three or more occurrences within 12 months, or two or more occurrences within 6 months) urinary tract infections.\n* Currently participating in weight loss programs or weight change in the past 3 months (\\> 5% current body weight) or have a history of gastrointestinal surgery.\n* Live vaccines within 30 days prior to the first dose of trial treatment and while participating in the trial. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, intranasal influenza, rabies, BCG, and typhoid vaccine.\n* Judgement by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements.",{"count":656,"type":22},20,[61],"The primary objective of the study is to assess metabolic plasma markers of insulin resistance in patients with early-stage HER2-negative breast cancers receiving dapagliflozin concomitant with neoadjuvant therapy.",[158,660,30],"Hyperinsulinism",{"date":615,"type":42},{"date":663,"type":42},"2024-10-15",{"date":665,"type":22},"2027-12",{"name":647,"class":49},{"id":668,"slug":669,"hasResults":12,"nctId":670,"briefTitle":671,"officialTitle":672,"acronym":673,"eligibilityCriteria":674,"healthyVolunteers":12,"sex":374,"minAge":19,"maxAge":4,"enrollmentInfo":675,"targetDuration":4,"studyType":23,"phases":676,"briefSummary":678,"conditions":679,"keywords":4,"overallStatus":680,"whyStopped":4,"lastUpdateSubmitDate":681,"lastUpdatePostDateStruct":682,"startDateStruct":684,"completionDateStruct":686,"leadSponsor":688,"locationsCount":4},"100637935","shared-decision-making-for-patients-with-her2-negative-metastatic-breast-cancer-sdm-01-100637935","NCT07578415","Shared Decision Making for Patients With HER2-negative Metastatic Breast Cancer (SDM-01)","Implementing Shared Decision Making (SDM) For HER2 Negative Metastatic Breast Cancer Patients (SDM-01 Study)","SDM-01","Inclusion Criteria:\n\nConfirmed diagnosis of metastatic breast cancer (MBC).\n\nHER2-negative status (as per ASCO\u002FCAP guidelines).\n\nPatients scheduled to receive or currently receiving their first-line therapy for metastatic disease.\n\nAge ≥ 18 years.\n\nWillingness to participate in the study and provide written informed consent.\n\nExclusion Criteria:\n\nDiagnosis of early-stage breast cancer (non-metastatic).\n\nHER2-positive metastatic breast cancer.\n\nAge \\\u003C 18 years.\n\nRefusal to sign the study-specific informed consent form.",{"count":433,"type":22},[677],"NA","Background and Purpose:\n\nDeciding on the best treatment for HER2-negative metastatic breast cancer (MBC) is a complex process. Patients often have unique values and preferences regarding their care and quality of life. Shared Decision Making (SDM) is a communication process where doctors and patients work together to make healthcare choices. This study aims to evaluate whether providing specific SDM training to oncologists and educational materials to patients can improve the quality of these conversations and make the treatment process feel more focused on patient goals.\n\nStudy Design and Procedures:\n\nThis is a prospective, randomized multicenter study involving oncology centers in Italy. A total of 120 patients starting their first-line therapy for HER2-negative metastatic breast cancer will participate. Participants and their oncologists will be assigned to one of two main study arms:\n\nThe SDM Trained Group: This group includes different approaches, such as formal SDM training for oncologists, providing educational materials (booklet and video) to patients, or a combination of both.\n\nThe Usual Care Group: In this group, patients and oncologists follow standard care processes without specific SDM training or additional educational materials.\n\nWhat to Expect:\n\nPatients in all groups will be asked to complete standardized questionnaires (such as CollaboRATE, SURE, and SDM-Q-9) at two time points: on Day 1 after the first encounter with the oncologist and at a 6-month follow-up. These surveys will measure the patient's perception of the decision-making process, their satisfaction with the treatment choice, and their overall quality of life.\n\nGoal:\n\nThe researchers hypothesize that educational training for patients and\u002For physicians will improve the quality of conversations about MBC therapy. If successful, this study may provide tools to enhance patient adherence to treatment and overall well-being.",[158,286,65],"NOT_YET_RECRUITING","2026-05-05",{"date":683,"type":42},"2026-05-11",{"date":685,"type":22},"2026-06",{"date":687,"type":22},"2029-01",{"name":689,"class":49},"Federico II University",{"id":691,"slug":692,"hasResults":12,"nctId":693,"briefTitle":694,"officialTitle":695,"acronym":696,"eligibilityCriteria":697,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":698,"targetDuration":4,"studyType":23,"phases":700,"briefSummary":701,"conditions":702,"keywords":705,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":718,"lastUpdatePostDateStruct":719,"startDateStruct":721,"completionDateStruct":723,"leadSponsor":725,"locationsCount":727},"100136130","phase-2-i-spy-trial-neoadjuvant-and-personalized-adaptive-novel-agents-to-treat-breast-cancer-100136130","NCT01042379","I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer","I-SPY Trial (Investigation of Serial Studies to Predict Your Therapeutic Response With Imaging And moLecular Analysis 2)","I-SPY","Inclusion Criteria:\n\n* Histologically confirmed invasive cancer of the breast\n* Clinically or radiologically measureable disease in the breast after diagnostic biopsy, defined as longest diameter greater than or equal to 25 mm (2.5cm)\n* No prior cytotoxic regimens are allowed for this malignancy. Patients may not have had prior chemotherapy or prior radiation therapy to the ipsilateral breast for this malignancy. Prior bis-phosphonate therapy is allowed\n* Age ≥18 years\n* ECOG performance status 0-1\n* Willing to undergo core biopsy of the primary breast lesion to assess baseline biomarkers\n* Non-pregnant and non-lactating\n* No ferromagnetic prostheses. Patients who have metallic surgical implants that are not compatible with an MRI machine are not eligible.\n* Ability to understand and willingness to sign a written informed consent (I-SPY TRIAL Screening Consent)\n* Eligible tumors must meet one of the following criteria: Stage II or III, or T4, any N, M0, including clinical or pathologic inflammatory cancer or Regional Stage IV, where supraclavicular lymph nodes are the only sites metastasis\n* Any tumor ER\u002FPgR status, any HER-2\u002Fneu status as measured by local hospital pathology laboratory and meets any tumor assay profile described in protocol section 4.1.2F\n* Normal organ and marrow function: Leukocytes ≥ 3000\u002FμL, Absolute neutrophil count ≥ 1500\u002FμL, Platelets ≥ 100,000\u002FμL, Total bilirubin within normal institutional limits, unless patient has Gilbert's disease, for which bilirubin must be ≤ 2.0 x ULN, AST(SGOT)\u002FALT (SGPT) ≤ 1.5 x institutional ULN, creatinine \\\u003C 1.5 x institutional ULN\n* No uncontrolled or severe cardiac disease. Baseline ejection fraction (by nuclear imaging or echocardiography) must by ≥ 50%\n* No clinical or imaging evidence of distant metastases by PA and Lateral CXR, Radionuclide Bone scan, and LFTs including total bilirubin, ALT, AST, and alkaline phosphatase\n* Tumor assay profile must include on of the following: MammaPrint High, any ER status, any HER2 status, or MammaPrint Low, ER negative (\\\u003C5%), any HER2 status, or MammaPrint Low, ER positive, HER2\u002Fneu positive by any one of the three methods used (IHC, FISH, TargetPrint™)\n* Ability to understand and willingness to sign a written informed consent document (I-SPY 2 TRIAL Consent #2)\n\nExclusion Criteria:\n\n* Use of any other investigational agents within 30 days of starting study treatment\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study agent or accompanying supportive medications.\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements",{"count":699,"type":22},5000,[147],"The purpose of this study is to further advance the ability to practice personalized medicine by learning which new drug agents are most effective with which types of breast cancer tumors and by learning more about which early indicators of response (tumor analysis prior to surgery via magnetic resonance imaging (MRI) images along with tissue and blood samples) are predictors of treatment success.",[703,158,609,704,512,176,30,611,612,613,614],"Breast Neoplasms","Angiosarcoma",[706,707,708,709,710,711,712,713,714,715,716,717],"Neoadjuvant","Breast","Cancer","Neoplasm","Adaptive","pCR","Pathologic Complete Response","Biomarkers signature","MRI Volume","Endocrine Therapy","Chemotherapy","Immunotherapy","2026-05-04",{"date":720,"type":42},"2026-05-06",{"date":722,"type":42},"2010-03-01",{"date":724,"type":22},"2031-12",{"name":726,"class":49},"QuantumLeap Healthcare Collaborative",42]