[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hormone-receptor-positive-breast-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hormone-receptor-positive-breast-cancer":29},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,32,0,25,[9,47,78,108,140,165,186,223,249,275,299,325,356,380,402,427,450,480,505,525,559,571,583,618,641],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100053974","phase-2-cdk46-inhibitors-combined-with-endocrine-therapy-for-neoadjuvant-treatment-100053974",false,"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","18 Years","75 Years",{"count":22,"type":23},158,"ESTIMATED","INTERVENTIONAL",[26],"PHASE2","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",[29,30,31,32,33],"Hormone Receptor-Positive Breast Cancer","High-risk Breast Cancer","Early-Stage Breast Cancer","HER2-negative Breast Cancer","ctDNA Monitoring","RECRUITING","2026-07-10",{"date":37,"type":38},"2026-07-13","ACTUAL",{"date":40,"type":38},"2026-04-20",{"date":42,"type":23},"2029-12-31",{"name":44,"class":45},"Peking University People's Hospital","OTHER",1,{"id":48,"slug":49,"hasResults":12,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":55,"targetDuration":4,"studyType":24,"phases":57,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":73,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":77,"locationsCount":46},"100053782","phase-2-ctdna-guided-de-escalation-of-adjuvant-chemotherapy-with-dalpiciclib-in-hr-positiveher2-negative-breast-cancer-100053782","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":56,"type":23},393,[26],"* 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.",[29,30,31,32,33,60],"Breast Cancer Early Stage Breast Cancer (Stage 1-3)",[62,63,64,65,66,67,68,69,70,71,72],"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":37,"type":38},{"date":75,"type":38},"2025-08-01",{"date":42,"type":23},{"name":44,"class":45},{"id":79,"slug":80,"hasResults":12,"nctId":81,"briefTitle":82,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":24,"phases":87,"briefSummary":88,"conditions":89,"keywords":92,"overallStatus":98,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":4},"100645014","phase-2-clinical-study-of-local-and-systemic-biological-impact-of-glp1gip-receptor-agonists-in-patients-with-breast-cancer-the-clara-trial-100645014","NCT07676331","Clinical Study of Local and Systemic Biological Impact of GLP1\u002FGIP-Receptor Agonists in Patients With Breast Cancer: The CLARA Trial","CLARA","Inclusion Criteria:\n\n1. Voluntary written informed consent of the participant has been obtained prior to any screening procedures\n2. Patient is \\>18 years of age\n3. Patient is postmenopausal, as defined per local practice\n4. Tumour size of ≥1 cm\n5. The patient has a biopsy-confirmed diagnosis of GII-III ER+, HER2 - early stage breast cancer scheduled for primary surgery as per standard-of-care\n\n   1. To fulfil the requirement for HR+ disease by local testing on primary disease specimen, tumour must be ER positive defined by immunohistochemistry (IHC) according to American Society of Clinical Oncology (ASCO)\u002FCollege of American Pathologists (CAP) guidelines for hormone receptor testing.\n   2. To fulfil the requirement of HER2- disease by local testing on primary disease specimen, tumour must be HER2- according to ASCO\u002FCAP guidelines for HER2 testing\n   3. All histological subtypes are eligible, including but not limited to invasive breast cancer of no special type (IBC-NST) , invasive lobular carcinoma (ILC) etc.\n6. Have a BMI of\n\n   1. ≥30 kg\u002Fm2 or\n   2. ≥27 kg\u002Fm2 and previously diagnosed with at least 1 of the following weight-related comorbidities:\n\n   i. Hypertension: treated or with systolic blood pressure ≥130 mmHg or diastolic blood pressure ≥80 mmHg ii. Dyslipidaemia: treated or with LDL ≥160 mg\u002FdL (4.1 mmol\u002FL) or triglycerides ≥150 mg\u002FdL (1.7 mmol\u002FL), or HDL iii. Obstructive sleep apnoea iv. Cardiovascular disease, for example, ischemic cardiovascular disease, New York Heart Association Functional Classification Class I-III heart failure\n7. Patient should be able to read\u002Funderstand Dutch, French or English\n8. Willing to commit to the study program and comply with all related protocol procedures\n9. Willing to undergo a new biopsy of the breast lesion in case no formalin-fixed paraffin-embedded (FFPE) block can be made available for the trial.\n\nExclusion Criteria:\n\n1. Have Type 1 or 2 diabetes mellitus, history of ketoacidosis, or hyperosmolar state or coma.\n2. Have at least 1 laboratory value suggestive of diabetes during screening : HbA1c ≥6.5% (≥48 mmol\u002Fmol) or fasting glucose ≥126 mg\u002FdL (≥7.0 mmol\u002FL)\n3. Have a history of BC exceptions are made for:\n\n   1. Contralateral in situ BC without systemic treatment\n   2. Ipsilateral in situ BC without systemic treatment or radiation therapy\n4. Have a history of an additional invasive malignancy that is progressing or that has required active treatment in the 3 years prior to breast cancer diagnosis. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer\n5. Are receiving or has received within 3 months prior to screening systemic glucocorticoid therapy (excluding topical, intraocular, intranasal, intra-articular, or inhaled preparations) or have evidence of a significant, active autoimmune that has required (within the last 3 months) or is likely to require, in the opinion of the investigator, concurrent treatment with systemic treatment (such as glucocorticoids (excluding topical, intraocular, intranasal, intra-articular, or inhaled preparations)) during the course of the study.\n\n   Note: Replacement therapy with thyroxine is not a contraindication for inclusion if patient is already on same dose for 3 months\n6. Have a history of any other condition, such as known drug or alcohol abuse, diagnosed eating disorder, or other psychiatric disorder, that, in the opinion of the investigator, may preclude the participant from following and completing the protocol\n7. Family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)\n8. Have a self-reported change in body weight \\>5 kg within 3 months prior to screening\n9. Have a prior surgical treatment for obesity, excluding liposuction or abdominoplasty\n10. Have endoscopic and\u002For device-based therapy for obesity or have had device removal within the last 6 months prior to screening\n11. Have renal impairment measured as eGFR \\\u003C30L\u002Fmin\u002F1.73m2\n12. Have a known clinically significant gastric emptying abnormality (for example, severe gastroparesis or gastric outlet obstruction) or chronically take drugs that directly affect GI motility\n13. Have a history of chronic or acute pancreatitis\n14. Is treated with insulin or other hypoglycaemic drugs\n15. Participation in another interventional Trial with an investigational medicinal product (IMP) or device in the neoadjuvant setting\n16. Have obesity induced by other endocrinologic disorders, for example, Cushing syndrome, or diagnosed monogenetic or syndromic forms of obesity\n17. Has acute or chronic hepatitis, signs and symptoms of any other liver disease other than NAFLD, or any of the following, as determined by the central laboratory during screening:\n\n    1. Alanine aminotransferase (ALT) level \\>3.0x ULN for the reference range\n    2. Alkaline phosphatase (ALP) level \\>2.0x ULN for the reference range, or\n    3. Total bilirubin level \\>1.5x ULN for the reference range (except for cases of known Gilbert's Syndrome) Note: Participants with non-alcoholic fatty liver disease (NAFLD) are eligible to participate in this trial if their ALT level is ≤3.0x ULN for the reference range\n18. Has used systemic hormonal substitution therapy within 2 months before screening\n19. Has used a GLP1\u002F(GIP)\u002F(GC) Receptor Agonist within 2 months of screening\n20. Has used medications (prescribed or over-the-counter) within 2 months prior to screening that promote weight loss.",{"count":86,"type":23},168,[26],"The CLARA trial is a phase II window-of-opportunity trial evaluating how a commonly used weight-loss medication (tirzepatide, a GLP-1\u002FGIP receptor agonist) affects breast cancer biology, alone and in combination with standard hormone therapy (letrozole).\n\nThe main goal is to determine whether tirzepatide, alone or combined with letrozole, reduces tumor cell growth.",[90,91],"Hormone-receptor-positive Breast Cancer","Early Breast Cancer",[93,94,95,96,97],"GLP-1\u002FGIP receptor agonist","tirzepatide","letrozole","Window-of-opportunity trial","Weight-loss drugs","NOT_YET_RECRUITING","2026-06-23",{"date":101,"type":38},"2026-06-30",{"date":103,"type":23},"2026-08-01",{"date":105,"type":23},"2028-05-01",{"name":107,"class":45},"Universitaire Ziekenhuizen KU Leuven",{"id":109,"slug":110,"hasResults":12,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":4,"eligibilityCriteria":114,"healthyVolunteers":12,"sex":115,"minAge":19,"maxAge":4,"enrollmentInfo":116,"targetDuration":4,"studyType":24,"phases":118,"briefSummary":120,"conditions":121,"keywords":123,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":139},"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.","ALL",{"count":117,"type":23},120,[119],"PHASE1","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.",[90,32,122],"Metastatic Breast Cancer",[124,125,126,127,128],"BGB-21447","BGB-43395","metastatic breast cancer","Bcl-2i","CDK4i","2026-06-17",{"date":131,"type":38},"2026-06-22",{"date":133,"type":38},"2025-02-04",{"date":135,"type":23},"2027-07-30",{"name":137,"class":138},"BeOne Medicines","INDUSTRY",14,{"id":141,"slug":142,"hasResults":12,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":4,"eligibilityCriteria":146,"healthyVolunteers":12,"sex":115,"minAge":19,"maxAge":4,"enrollmentInfo":147,"targetDuration":4,"studyType":24,"phases":149,"briefSummary":150,"conditions":151,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":157,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":164},"100557993","phase-1-study-of-xb010-in-subjects-with-solid-tumors-100557993","NCT06545331","Study of XB010 in Subjects With Solid Tumors","A Dose-Escalation and Expansion Study of XB010 as a Single Agent and Combination Therapy in Subjects With Locally Advanced or Metastatic Solid Tumors","* Age 18 years or older on the day of consent.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.\n* Adequate organ and marrow function.\n* Cytologically or histologically and radiologically confirmed solid tumor that is inoperable, locally advanced, metastatic, or recurrent.\n\n  * The Cohort Expansion stage will enroll subjects with multiple tumor types (non-small cell lung cancer, hormone-receptor-positive breast cancer, head and neck cancer, esophageal squamous cell, triple-negative breast cancer).\n* Capable of understanding and complying with the protocol requirements and must have signed the informed consent document.",{"count":148,"type":23},396,[119],"This is a FIH study is to evaluate the safety, tolerability, PK, immunogenicity, and preliminary antitumor activity of XB010 as a single agent and in combination with pembrolizumab in subjects with locally advanced or metastatic solid tumors for whom alternative therapies do not exist or available therapies are intolerable or no longer effective.",[152,153,154,155,90,156],"Locally Advanced or Metastatic Solid Tumors","Esophageal Squamous Cell Cancer","Head and Neck Squamous Cell Cancer","NSCLC (Non-small Cell Lung Cancer)","Triple Negative Breast Cancer (TNBC)",{"date":131,"type":38},{"date":159,"type":38},"2024-08-06",{"date":161,"type":23},"2027-10-20",{"name":163,"class":138},"Exelixis",20,{"id":166,"slug":167,"hasResults":12,"nctId":168,"briefTitle":169,"officialTitle":170,"acronym":4,"eligibilityCriteria":171,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":172,"targetDuration":4,"studyType":24,"phases":174,"briefSummary":175,"conditions":176,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":179,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":139},"100483291","phase-1-phase-12-study-to-evaluate-ep0062-as-monotherapy-and-in-combination-in-patients-with-advanced-or-metastatic-arher-2-er-breast-cancer-100483291","NCT05573126","Phase 1\u002F2 Study to Evaluate EP0062 as Monotherapy and in Combination in Patients With Advanced or Metastatic AR+\u002FHER-2-\u002FER+ Breast Cancer","A Modular, Open-Label, Multi-Centre Phase 1\u002F2 Dose-Finding, Optimisation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of EP0062 as Monotherapy and in Combination in Patients With Relapsed Locally Advanced or Metastatic AR+\u002FHER-2-\u002FER+ Breast Cancer","Inclusion Criteria:\n\n1. Women 18 years or older at the time of informed consent\n2. Histologically proven diagnosis of breast cancer with evidence of metastatic or locally advanced breast adenocarcinoma as defined by the American Joint Committee on Cancer\u002FUnion for International Cancer Control\u002FTumour Node Metastases (AJCC\u002FUICC TNM) staging classification (8th Ed, 2017) and where no conventional therapy is available or considered appropriate by the Investigator or is declined by the patient\n3. Availability of archival tumour sample (formalin-fixed, paraffin-embedded block(s) or slides from a primary tumour or biopsy of a metastatic tumour lesion or lesions); in the absence of an archival tumour sample, or if only archival bone tissue is available, a fresh biopsy will need to be collected\n4. Biopsy-proven AR+ and ER+ breast cancer\n\n   * For Module A, AR+ breast cancer is defined as ≥ 10% AR nuclei staining by central immunohistochemistry (IHC) using the Ventana assay\n   * For Modules B and C, AR+ breast cancer is defined as ≥ 30% AR nuclei staining by central IHC using the Ventana assay\n5. HER2-negative breast cancer, defined as negative by fluorescence in situ hybridisation (FISH) or IHC score of 0 or 1+. If IHC is equivocal at 2+, a negative FISH test (HER2\u002FAmplification of the centromeric region of chromosome 17)CEP17 ratio of \\\u003C2.0) is required\n6. Postmenopausal, as defined by at least one of the following:\n\n   1. Age over 60 years\n   2. Amenorrhea \\> 12 months at the time of informed consent and an intact uterus, with follicle-stimulating hormone (FSH) and oestradiol in the postmenopausal ranges (as per local practice)\n   3. FSH and oestradiol in the postmenopausal ranges (as per local practice) in women aged \\\u003C55 years who have undergone hysterectomy\n   4. Prior bilateral oophorectomy\n7. Module B arm 1: patients who have progressed on ≤ 2 prior lines of endocrine therapy, including a prior CDK4\u002F6 inhibitor.\n8. Module B arm 2: patients who have progressed on ≤ 2 prior lines of endocrine therapy in advanced\u002Fmetastatic setting, including prior CDK4\u002F6 inhibitor\n9. Module B arm 3: patients who have progressed on treatment with a prior CDK4\u002F6 inhibitor plus an aromatase inhibitor as initial therapy or recurrence on\u002Fafter treatment with a CDK4\u002F6 inhibitor plus endocrine therapy in the adjuvant setting.\n\nExclusion Criteria:\n\nPatients with any of the following will not be included in the study:\n\n1. Prior anti-cancer or investigational drug treatment within the following time windows:\n\n   * Any chemotherapy within 21 days prior to the first dose of study drug\n   * Any non-chemotherapy investigational anti-cancer drug \\\u003C 5 half-lives (28 days for biologics) or \\\u003C 14 days for small-molecule therapeutics or if half-life is not known\n   * Tamoxifen and aromatase inhibitors within 14 days prior to the first dose of study drug\n   * Fulvestrant or other investigational Selective Estrogen Receptor Degraders (SERDs) within 21 days prior to first dose of study drug\n2. Currently taking testosterone, methyltestosterone, oxandrolone, oxymetholone, danazol, fluoxymesterone, testosterone-like agents (e.g., dehydroepiandrosterone, androstenedione, and other androgenic compounds, including herbals), or antiandrogens\n3. Radiation therapy within 14 days prior to the first dose of study drug and scheduled to have radiation therapy during participation in this study. Short courses of palliative radiation therapy during the study might be allowed following discussion with and approval by the Medical Monitor. Palliative radiotherapy within 6 weeks prior to first dose of study drug is permitted\n4. Unresolved or unstable serious toxic side effects of prior chemotherapy or radiotherapy, i.e., ≥ Grade 2 per Common Terminology Criteria for Adverse Events (CTCAE) v5.0, except fatigue, alopecia, and Grade 2 chemotherapy-induced neuropathy\n5. Confirmed Corrected QT Interval by Fridericia (QTcF) \\> 470 ms on screening ECG, or history of torsades de pointes (TdP), or history of congenital long QT syndrome, or immediate family history of long QT syndrome, unexplained sudden death at a young age, or sudden cardiac death\n6. Any other clinically important abnormalities in rhythm, conduction, or morphology on resting ECG (e.g., complete left bundle branch block, third-degree heart block); rate-controlled atrial fibrillation is permitted\n7. Concomitant medications that prolong the corrected QT interval and\u002For increase the risk for TdP that cannot be discontinued or substituted with another drug within 5 half-lives or 14 days before the first dose of study drug, whichever is longer\n8. Congestive heart failure Grades II-IV according to the New York Heart Association at the time of screening\n9. Myocardial infarction or unstable angina within the previous 6 months\n10. Patients receiving medications that are known to be strong inhibitors or inducers of CYP3A4 within 5 half-lives or 14 days, whichever is longer, before the first dose of study drug\n11. Prior treatment with selected combination agent",{"count":173,"type":23},95,[119,26],"The aim of this study is to identify the optimal dose for EP0062 as monotherapy and in combination with standard-of-care therapies to assess its Safety, Tolerability, Pharmacokinetics, and Efficacy in Patients with Relapsed Locally Advanced or Metastatic AR+\u002FHER-2-\u002FER+ Breast Cancer",[177,178,122],"Hormone Receptor-positive Breast Cancer","Hormone Receptor Positive HER-2 Negative Breast Cancer",{"date":131,"type":38},{"date":181,"type":38},"2023-01-11",{"date":183,"type":23},"2028-02",{"name":185,"class":138},"Ellipses Pharma",{"id":187,"slug":188,"hasResults":12,"nctId":189,"briefTitle":190,"officialTitle":191,"acronym":192,"eligibilityCriteria":193,"healthyVolunteers":12,"sex":115,"minAge":19,"maxAge":4,"enrollmentInfo":194,"targetDuration":4,"studyType":24,"phases":196,"briefSummary":197,"conditions":198,"keywords":207,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":214,"lastUpdatePostDateStruct":215,"startDateStruct":217,"completionDateStruct":219,"leadSponsor":221,"locationsCount":46},"100610025","phase-2-phii-randomized-capecitabine--elacestrant-vs-capecitabine-alone-in-er-breast-cancer-capela-100610025","NCT07222215","PhII Randomized CAPecitabine + ELAcestrant vs. Capecitabine Alone in ER+ Breast Cancer (CAPELA)","A Phase II Multi-Center Open-label Randomized Study of CAPecitabine in Combination With ELAcestrant Versus Capecitabine Alone in Advanced Estrogen Receptor-Positive Breast Cancer (CAPELA)","CAPELA","Inclusion Criteria:\n\n* Participants must have histologically confirmed estrogen receptor-positive (ER+), HER2-negative metastatic or locally recurrent unresectable (advanced) invasive breast cancer. ER and HER2 measurements should be performed according to institutional guidelines in a CLIA-approved setting. ER must be ≥ 10% on the most recent biopsy in which receptor testing was performed. 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.\n* Participants must have standard of care ctDNA sequencing testing documenting ESR1 and TP53 mutation status. In patients without ESR1 mutation, this result must be from within 3 months.\n\n  * ESR1 mutations that are considered pathogenic are: E380Q, V422del, S436P, L536H, L536P, L536R, Y537C, Y537D, Y537N, Y537S, D538G\n  * TP53 mutations that are considered pathogenic as determined by a CLIA certified laboratory\n* Women or men age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of capecitabine in combination with elacestrant participants \\\u003C18 years of age are excluded from this study\n* 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 who have been on a GnRH agonist for at least three consecutive months prior to study entry are eligible. Women in this group MUST remain on the GnRH agonist for the duration of protocol treatment.\n  * Status-post bilateral oophorectomy or total hysterectomy after adequate healing post-surgery\n* Must have measurable or evaluable disease by RECIST 1.1. Must have progressed on at least one line of endocrine therapy in the metastatic setting or recurred on or within one year of adjuvant endocrine therapy\n* Unrestricted number of prior endocrine therapies (with or without targeted treatment) are allowed in the advanced disease setting. If a patient recurred on or within one year of adjuvant endocrine therapy, it would be counted as one line of treatment.\n* Prior CDK4\u002F6 inhibition is required (in adjuvant or metastatic disease), unless a CDK4\u002F6 inhibitor is contraindicated (CDK4\u002F6 inhibitor in combination with endocrine treatment is considered as one line of endocrine treatment).\n* Participants must have remained on a prior endocrine treatment alone or in combination with a CDK4\u002F6 inhibitor in the metastatic setting without progression for at least 6 months prior to study entry. This regimen does not need to be the most recent regimen prior to study entry. If patients have progressed on adjuvant endocrine treatment and have not received treatment in the metastatic setting, they must have progressed after at least two years of adjuvant endocrine treatments.\n* Prior alpelisib with endocrine treatment is allowed (considered as a line of endocrine treatment).\n* Prior everolimus with endocrine treatment is allowed (considered a line of endocrine treatment).\n* Prior capivasertib with endocrine treatment is allowed (considered a line of endocrine treatment)\n* Prior fulvestrant is permitted. Prior SERM (tamoxifen, lasofoxifene) is permitted. Neither prior oral SERDs nor other next generation oral endocrine therapies (such as PROTACS) are permitted.\n* No prior chemotherapy regimen or ADC is allowed in the metastatic setting.\n* Participants may have received radiotherapy for palliative purposes but must not be experiencing grade \\>1 treatment-related toxicities at study entry and must have completed treatment \\> 14 days prior to registration.\n* ECOG PS 0-1\n* Adequate hematological, liver, and kidney function, as defined below:\n\n  * Absolute neutrophil count \\> 1,500\u002FµL\n  * Platelets \\> 100,000\u002FµL\n  * Hemoglobin \\> 9 g\u002FdL (transfusion is allowed to meet this criterion) Total bilirubin \\\u003C 1.5 x institutional upper limit or normal (ULN) or \\\u003C 3 institutional ULN in the presence of documented Gilbert's syndrome\n  * AST (SGOT)\u002FALT (SGPT) \\\u003C 2.5 x institutional ULN, or ≤ 5 institutional ULN for subjects with documented metastatic disease to the liver\n  * Creatinine clearance \\> 50 mL\u002Fmin\u002F1.73 m2\n* Women of childbearing age, women who are made postmenopausal through use of GNRH agonists, and men must agree to use adequate contraception for the duration of protocol treatment and for at least 6 months after the last dose of capecitabine.\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:\n\n  * Age \\> 60 years; or\n  * Age \\\u003C 60 with intact uterus and amenorrhea for 12 consecutive months or more AND estrogen (estradiol) and FSH levels are within postmenopausal range; or\n  * Status-post bilateral oophorectomy, total hysterectomy, or bilateral tubal ligation\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* HIV-infected participants must have well-controlled HIV on ART, defined as:\n\n  1. Participants on ART must have a CD4+ T-cell count ≥350 cells\u002Fmm3 at the time of screening.\n  2. Participants on ART must have achieved and maintained virologic suppression defined as confirmed HIV RNA level below 50 or the LLOQ (below the limit of detection) using the locally available assay at the time of screening and for at least 12 weeks before screening.\n  3. It is advised that participants must not have had any AIDS-defining opportunistic infections within the past 12 months.\n  4. Participants on ART must have been on a stable regimen, without changes in drugs or dose modification, for at least 4 weeks before study entry (Day 1) and agree to continue ART throughout the study. The combination ART regimen must not contain any antiretroviral medications that interact with CYP3A4 inhibitors\u002Finducers\u002Fsubstrates.\n\nNote: No HIV testing is required at screening unless mandated by local health Authority.\n\n* 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 before allocation.\n\nNote: Participants should remain on antiviral therapy throughout study intervention and follow local guidelines for HBV antiviral therapy post completion of study intervention.Hepatitis B screening tests are not required unless:\n\n* Known history of HBV infection\n* As mandated by local health authority Participants with history of HCV infection are eligible if HCV viral load is undetectable at screening.\n\nNote: Participants must have completed curative antiviral therapy at least 4 weeks before allocation.\n\nHepatitis C screening tests are not required unless:\n\n* Known history of HCV infection\n* As mandated by local health authority\n\nExclusion Criteria:\n\n* Participants who have had endocrine and\u002For biologic therapy \\\u003C 14 days prior to entering the study or those who have not recovered from any prior treatment-related toxicities (must recover to no more than grade 1; alopecia, sensory neuropathy Grade ≤ 2, or other Grade ≤ 2 toxicity not constituting a safety risk based on investigator's judgment are acceptable). This is to minimize risk of drug-drug interactions and clarify etiology of future toxicities.\n* Participants who are receiving concurrent therapy with other investigational agents. This is to minimize risk of drug-drug interactions and clarify etiology of future toxicities.\n* Rapidly progressive, symptomatic, visceral spread of disease placing participant at risk of life- threatening complications in the short term. It is likely that these patients will not benefit from this regimen.\n* History of dihydropyrimidine dehydrogenase (DPD) deficiency. Patients with this deficiency are prone to significant toxicity from capecitabine.\n* Participants with active brain metastases. Treated brain metastases that are asymptomatic and do not require systemic steroids for management of symptoms are allowed if they have received SRS (7-day washout) or WBRT (14-day washout) or asymptomatic untreated brain metastases measuring \\\u003C1cm. Patients with leptomeningeal disease are not eligible. It is unlikely that these patients will benefit from this regimen.\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. 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. This could increase risk of toxicity from treatment and potentially decrease adherence to study protocol.\n* Individuals with a history of a different malignancy are ineligible except for the following circumstances:\n\n  * (1) Individuals with a history of other malignancies are eligible if they have been disease-free for at least 3 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. These cases should be discussed with the sponsor-investigator prior to enrollment.\n  * (2) 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. History of prior malignancy puts patients at risk of recurrence from their prior malignancy or progression of a second malignancy which would complicate interpretation of the end points of this trial.\n* Ongoing treatment with drugs that are sensitive substrates of P-glycoprotein (dabigatran, digoxin, fexofenadine) or BRCP (rosuvastatin, sulfasalazine). These drugs have potential drug-drug interactions with the study agents.\n* Treatment with strong CYP3A inhibitors within 2 weeks before first study treatment administration or five elimination half-lives, whichever is longest and cannot be replaced.\n* Medical conditions requiring concomitant administration of medications with a narrow therapeutic window metabolized by CYP3A and for which a dose reduction cannot be considered. See Appendix D for a list of medications that are CYP3A substrates. These drugs have potential drug-drug interactions with the study agents.\n* Female participants lactating or nursing. The safety of these medications in pregnancy or breast feeding patients is unknown.\n\nBoth men and women of all races and ethnic groups are eligible for this trial.",{"count":195,"type":23},297,[26],"The goal of this research study is to compare a combination of two drugs, capecitabine and elacestrant to capecitabine alone as a treatment for advanced estrogen receptor-positive (ER+) breast cancer. This study is designed for participants with cancer that has previously stopped responding to medication in the class of therapy called CDK 4\u002F6 inhibitors, including palbociclib, ribociclib, or abemaciclb.\n\nThe names of the study drugs involved in this study are:\n\n* Elacestrant (a type of selective estrogen receptor degrader)\n* Capecitabine (a type of fluoropyrimidine antimetabolite)",[199,122,200,201,202,203,204,205,206],"Estrogen-receptor-positive Breast Cancer","Breast Cancer","Hormone Receptor Positive Breast Cancer","Human Epidermal Growth Factor 2 Negative Carcinoma of Breast","HER2- Breast Cancer","ESR1 Gene Mutation","ER Wildtype","Breast Neoplasms",[208,122,209,210,211,203,212,213],"Advanced Estrogen Receptor-Positive Breast Cancer","Breast cancer","Hormone receptor positive breast cancer","Advanced Human Epidermal Growth Factor Receptor 2 negative breast cancer","ESR1 gene mutation","ER wildtype","2026-06-10",{"date":216,"type":38},"2026-06-12",{"date":218,"type":38},"2026-01-16",{"date":220,"type":23},"2030-10-01",{"name":222,"class":45},"Kristina A. Fanucci",{"id":224,"slug":225,"hasResults":12,"nctId":226,"briefTitle":227,"officialTitle":228,"acronym":229,"eligibilityCriteria":230,"healthyVolunteers":12,"sex":115,"minAge":231,"maxAge":4,"enrollmentInfo":232,"targetDuration":4,"studyType":234,"phases":4,"briefSummary":235,"conditions":236,"keywords":237,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":240,"lastUpdatePostDateStruct":241,"startDateStruct":242,"completionDateStruct":244,"leadSponsor":246,"locationsCount":46},"100642562","everst--everolimus-after-alpelisib-in-women-with-hormone-receptor-positive-hr-metastatic-breast-cancer-mbc-100642562","NCT07646171","EVERST- Everolimus After Alpelisib in Women With Hormone Receptor-positive (HR+) Metastatic Breast Cancer (MBC)","EVERST- Everolimus After Alpelisib in Women With HR+ MBC- This Phase II, Open-label, Single-arm, Study Investigates the Clinical Benefit of Everolimus Combined With Endocrine Therapy. in Hormone Receptor-positive (HR+), Metastatic Breast Cancer Patients Who Progressed on Prior PI3K Inhibitor Therapy With Endocrine Therapy. The Trial Aims to Determine if Sequential Inhibition of the PI3K\u002FAKT\u002FmTORC1 Pathway Retains Efficacy Post-PI3K Inhibitor Resistance, Hypothesizing That Everolimus Will Demonstrate a Response Rate Exceeding the Historical 9.5% Observed in the BOLERO2 Trial.","MBC","Inclusion Criteria:\n\n* HR+MBC with PI3Kmut Post CDK 4\u002F6+ET Post PI3K inhibitor+ET\n\nExclusion Criteria:\n\n* Women who didn't receive anti-PI3K","21 Years",{"count":233,"type":23},19,"OBSERVATIONAL","This phase II, open-label, single-arm, study investigates the clinical benefit of everolimus combined with endocrine therapy (ET) in hormone receptor-positive (HR+), metastatic breast cancer (MBC) patients who progressed on prior PI3K inhibitor therapy (+ ET). The trial aims to determine if sequential inhibition of the PI3K\u002FAKT\u002FmTORC1 pathway retains efficacy post-PI3K inhibitor resistance, hypothesizing that everolimus will demonstrate a response rate exceeding the historical 9.5% observed in the BOLERO2 trial.",[201],[238,210,239],"mTOR inhibitor","PI3K inhibitor","2026-06-09",{"date":216,"type":38},{"date":243,"type":38},"2022-09-01",{"date":245,"type":23},"2027-12-31",{"name":247,"class":248},"Tel-Aviv Sourasky Medical Center","OTHER_GOV",{"id":250,"slug":251,"hasResults":12,"nctId":252,"briefTitle":253,"officialTitle":254,"acronym":4,"eligibilityCriteria":255,"healthyVolunteers":12,"sex":115,"minAge":19,"maxAge":4,"enrollmentInfo":256,"targetDuration":4,"studyType":24,"phases":258,"briefSummary":259,"conditions":260,"keywords":264,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":266,"lastUpdatePostDateStruct":267,"startDateStruct":269,"completionDateStruct":271,"leadSponsor":273,"locationsCount":46},"100533350","phase-2-arx788-for-treating-patients-with-her2-low-locally-advanced-unresectable-or-metastatic-breast-cancer-100533350","NCT06224673","ARX788 for Treating Patients With HER2-low Locally Advanced Unresectable or Metastatic Breast Cancer","Phase II Open-label Study of ARX788 (Anti-HER2 Antibody Drug Conjugate (ADC)) for Patients With HER2-low Locally Advanced Unresectable or Metastatic Breast Cancer","Inclusion Criteria:\n\n* Male or female participants age 18 years or greater with ability to provide written informed consent for the study.\n* Eastern Cooperative Oncology Group (ECOG) score of 0-2.\n* Estimated life expectancy of at least at 6 months per investigator assessment.\n* Ability to understand and the willingness to sign a written informed consent document.\n* Pathologically documented HER2-low locally advanced unresectable or metastatic breast cancer (MBC). NOTE: human epidermal growth factor receptor 2 (HER2)-low status determined by HER2 immunohistochemistry (IHC) 1+ or 2+ and no evidence of HER2 gene amplification by in situ hybridization (ISH)\u002Ffluorescence in situ hybridization (FISH), which can be documented from any tumor sample during the patient's cancer treatment history (early-stage or metastatic).\n\n  * Cohort 1: Participants with hormone receptor positive (HR+)\u002FHER2-low locally advanced unresectable or MBC. HR+ status defined as estrogen receptor \\>= 10% and\u002For progesterone receptor ≥ 10% and HER2 low.\n  * Cohort 2: Participants with hormone receptor negative (HR-)\u002FHER2-low locally advanced unresectable or MBC. Considered HR- if estrogen receptor (ER) and progesterone receptor (PR) \\\u003C 10% and HER2-low.\n* Presence of at least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. NOTE: Participant's with at least one measurable lytic bone lesion are eligible.\n* Availability of tumor block or formalin-fixed paraffin-embedded (FFPE) tissue as 10 precut unstained slides will be collected for the HER2 status evaluation and biomarker analysis based on the most recent tumor tissue sample. NOTE: New pretreatment biopsy tissue is preferred as HER2 status may change, but a fresh biopsy is not required. The study team and investigator will make every attempt to get archival tissue. Participants who do not have archival or new tumor tissue available may be eligible after discussion with the study principal investigator (PI).\n* Participants with stable and treated brain metastases are eligible if the participants meet the following criteria:\n\n  * Prior stereotactic radiosurgery (SRS) should be completed \\>=7 days before study treatment initiation.\n  * Prior whole-brain radiation therapy should be completed \\>=14 days before study treatment initiation.\n  * Any ongoing use of systemic corticosteroids does not exceed 2 mg of dexamethasone (or equivalent) daily.\n* Participants must have received at least one prior line of chemotherapy or ADC therapy for locally advanced unresectable or metastatic disease. Prior checkpoint inhibitor therapy is allowed.\n* Hemoglobin ≥ 8.0 g\u002FdL\n* Absolute neutrophil count ≥ 1.0 x 10\\^9\u002FL\n* Platelets ≥ 100,000 x 10\\^9\u002FL\n* Total bilirubin ≤ 1.5 x institutional upper limit of normal, unless elevated due to Gilbert's syndrome and direct bilirubin is within normal limits\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase (SGOT)) \\\u003C 3 x institutional upper limit of normal. In participants with liver metastases, \\\u003C= 5 x institutional upper limit of normal is allowed.\n* Alanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase (SGPT)) \\\u003C 3 x institutional upper limit of normal. In participants with liver metastases, \\\u003C=5 x institutional upper limit of normal is allowed.\n* Creatinine ≤ 1.5 x within institutional upper limit of normal OR creatinine clearance glomerular filtration rate (GFR) ≥ 50 mL\u002Fmin\u002F1.73 m, calculated using the Cockcroft-Gault equation\n* Adequate cardiac function as assessed by left ventricular ejection fraction ≥ 50% or institutional lower limit of normal.\n* Human immunodeficiency virus (HIV)-infected individuals on effective antiretroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n* For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy.\n* Individuals with a history of hepatitis C virus (HCV) infection must have been treated without detectable HCV RNA.\n* Participants must have recovered from all acute toxicities from prior therapies to ≤ grade 1 or baseline (except for alopecia and neuropathy) per the National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) v 5.0.\n* Male and female subjects of reproductive\u002Fchildbearing potential must agree to use a highly effective form of contraception or total sexual abstinence during and upon completion of the study; and for at least 3 months after the last dose of study drug for women of childbearing potential (WOCBP) and at least 5 months after the last dose of study drug for men whose partners are WOCBP.\n* Male subjects must agree to not freeze or donate sperm starting at Screening and throughout the study period, and at least 5 months after the final study drug administration.\n* Female subjects must agree to not donate, or retrieve for their own use, ova from the time of screening and throughout the study treatment period, and for at least 3 months after the final study drug administration.\n\nExclusion Criteria:\n\n* Has a prior history of treatment with ARX-788 or auristatin analogues.\n* Has a history of allergic reaction to any component of ARX788.\n* Has exposure to any other investigational or commercial anti-cancer agents or therapies administered with the intention to treat malignancy within 14 days before the first dose of study treatment. NOTE: Anti-hormonal therapy may be administered up to 7 days prior to the first dose of study treatment.\n* Radiotherapy outside of the brain administered \\\u003C7 days prior to first dose of ARX788\n* Prior or current history of interstitial lung disease (ILD), pneumonitis, or other clinically significant lung disease with the exception of disease that is directly attributable to the presence of lung metastases from their underlying cancer.\n* Participants with significant pulmonary conditions, defined as any of the following:\n\n  * Any prior history of drug-induced immune-mediated pneumonitis.\n  * Prior history of radiation therapy to the chest of \\> 18 gray (Gy) with residual sequelae considered clinically significant by investigator assessment.\n  * Radiographic evidence of radiation fibrosis involving \\> 15% of the lung parenchyma associated with clinical symptoms.\n  * Any requirement for supplemental oxygen.\n* Clinically-significant ocular findings including history of keratitis, keratopathy, and\u002For active eye disease (excluding glaucoma).\n* History of congestive heart failure, unstable angina pectoris, unstable cardiac arrhythmia, or myocardial infarction within 6 months prior to enrollment. QTcF prolongation of \\>470 msec (females) or \\>450 msec (males) based screening ECG.\n* Has a diagnosis of leptomeningeal carcinomatosis. NOTE: Stable brain metastases are allowed.\n* Has an active systemic or psychiatric illness that would impact the patient's ability to receive study therapy.\n* Has an uncontrollable intercurrent illness, infection (including participants with active, symptomatic Coronavirus disease of 2019 (COVID-19) infections), or other conditions that could limit study compliance or interfere with study assessments.\n* Has a history of an additional malignancy that is progressing or has required active treatment within the past 3 years. NOTE: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ (excluding carcinoma in situ of the bladder or high-grade cervical dysplasia in the last three years), and thyroid cancer not requiring cytotoxic agents that have undergone potentially curative therapy are not excluded.\n* Pregnancy or breastfeeding.\n* Has an active, uncontrolled hepatitis B, hepatitis C, and\u002For human immunodeficiency virus (HIV) infection. Participants with adequately controlled hepatitis B, hepatitis C, and\u002For HIV are allowed. NOTE: HIV and hepatitis B and C testing are not required for screening. Testing will only be done if clinically indicated.",{"count":257,"type":23},36,[26],"This phase II trial tests how well ARX788 works in treating patients diagnosed with HER2-low, locally advanced unresectable or metastatic breast cancer. ARX788 is an antibody-drug conjugate (ADC) that is given by infusion (diluted and injected slowly into veins). Antibodies are proteins which are naturally produced by the body's immune system to help fight infections. ARX788 consists of antibodies that have been attached to a toxin that has the potential to kill cancer cells. ARX788 sticks to a protein called human epidermal growth factor receptor (HER2), which is found on some breast cancer cells. Giving ARX788 may be safe and effective in treating patients with HER2-low locally advanced unresectable metastatic breast cancer.",[261,262,90,263],"HER2 Low Breast Carcinoma","Triple Negative Breast Cancer","Hormone Receptor Positive Breast Carcinoma",[265],"Antibody-drug Conjugate","2026-06-08",{"date":268,"type":38},"2026-06-11",{"date":270,"type":38},"2026-06-05",{"date":272,"type":23},"2029-11-30",{"name":274,"class":45},"Laura Huppert, MD, BA",{"id":276,"slug":277,"hasResults":12,"nctId":278,"briefTitle":279,"officialTitle":279,"acronym":4,"eligibilityCriteria":280,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":281,"targetDuration":4,"studyType":234,"phases":4,"briefSummary":283,"conditions":284,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":290,"lastUpdatePostDateStruct":291,"startDateStruct":293,"completionDateStruct":295,"leadSponsor":297,"locationsCount":46},"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":282,"type":23},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.",[32,90,122,285,286,287,288,263,289],"Anatomic Stage II Breast Cancer AJCC v8","Anatomic Stage III Breast Cancer AJCC v8","Anatomic Stage IV Breast Cancer AJCC v8","HER2 Negative Breast Carcinoma","Metastatic Breast Carcinoma","2026-05-28",{"date":292,"type":38},"2026-06-01",{"date":294,"type":38},"2024-04-30",{"date":296,"type":23},"2031-06-15",{"name":298,"class":45},"Mayo Clinic",{"id":300,"slug":301,"hasResults":12,"nctId":302,"briefTitle":303,"officialTitle":304,"acronym":4,"eligibilityCriteria":305,"healthyVolunteers":12,"sex":115,"minAge":19,"maxAge":4,"enrollmentInfo":306,"targetDuration":4,"studyType":24,"phases":308,"briefSummary":309,"conditions":310,"keywords":314,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":317,"lastUpdatePostDateStruct":318,"startDateStruct":319,"completionDateStruct":321,"leadSponsor":323,"locationsCount":324},"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":307,"type":23},28,[119],"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.",[122,311,200,312,313,32,288,90],"Stage IV Breast Cancer","Breast Cancer Stage IV","Breast Cancer Metastatic",[122,311,200,312,313,32,288,90,315,316],"Memorial Sloan Kettering Cancer Center","24-138","2026-05-26",{"date":290,"type":38},{"date":320,"type":38},"2024-11-15",{"date":322,"type":23},"2028-11-30",{"name":315,"class":45},7,{"id":326,"slug":327,"hasResults":12,"nctId":328,"briefTitle":329,"officialTitle":330,"acronym":4,"eligibilityCriteria":331,"healthyVolunteers":12,"sex":115,"minAge":19,"maxAge":4,"enrollmentInfo":332,"targetDuration":4,"studyType":24,"phases":334,"briefSummary":335,"conditions":336,"keywords":341,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":317,"lastUpdatePostDateStruct":348,"startDateStruct":350,"completionDateStruct":352,"leadSponsor":354,"locationsCount":355},"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":333,"type":23},399,[119],"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.",[337,338,122,90,263,339,32,178,340],"Advanced Solid Tumor","Advanced Breast Cancer","Hormone Receptor Positive Malignant Neoplasm of Breast","Non-small Cell Lung Cancer",[342,343,344,345,346,178,125,347],"breast cancer","advanced solid tumor","advanced breast cancer","hormone receptor positive breast cancer","HER2-negative breast cancer","non-small cell lung cancer",{"date":349,"type":38},"2026-05-27",{"date":351,"type":38},"2023-12-01",{"date":353,"type":23},"2028-11",{"name":137,"class":138},63,{"id":357,"slug":358,"hasResults":12,"nctId":359,"briefTitle":360,"officialTitle":361,"acronym":4,"eligibilityCriteria":362,"healthyVolunteers":12,"sex":115,"minAge":19,"maxAge":4,"enrollmentInfo":363,"targetDuration":4,"studyType":24,"phases":365,"briefSummary":366,"conditions":367,"keywords":369,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":370,"lastUpdatePostDateStruct":371,"startDateStruct":373,"completionDateStruct":375,"leadSponsor":377,"locationsCount":379},"100448132","phase-2-study-of-screening-brain-mris-in-stage-iv-breast-cancer-100448132","NCT05115474","Study of Screening Brain MRIs in Stage IV Breast Cancer","Phase II Study of Screening Brain MRIs in Stage IV Breast Cancer","Inclusion Criteria:\n\n* Histologic diagnosis of breast cancer with documentation of ER\u002FPR\u002FHER2 status\n* Radiographic evidence of stage IV extracranial diease having progressed past first line therapy in HR+\u002FHER2- patients\n* Radiographic evidence of stage IV extracranial disease in TN and HER2+ patients\n* Age ≥ 18\n* Life expectancy ≥ 6 months\n* Eastern Cooperative Oncology Group performance status 0 to 2\n* Patients must be able to understand and the willingness to sign an informed consent for study procedures\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n\nExclusion Criteria:\n\n* Prior diagnosis or treatment of brain metastases or leptomeningeal disease\n* Patients with prior history of non-breast cancer malignancies should have no evidence of disease ≥ 2 years\n* Neurologic symptoms warranting standard screening brain MRI in the judgement of the treating physician at time of enrollment\n* Indications warranting brain MRI for other neurologic conditions at time of study entry\n* Contraindication towards MRI imaging with contrast\n* Chronic kidney disease stage IV or V or end stage renal disease",{"count":364,"type":23},170,[26],"The study is a single arm, nonrandomized phase II prospective study, with the goal of investigating the role of screening brain MRIs in neurologically asymptomatic patients with metastatic breast cancer.",[262,368,177],"HER2-positive Breast Cancer",[311],"2026-05-14",{"date":372,"type":38},"2026-05-18",{"date":374,"type":38},"2021-12-21",{"date":376,"type":23},"2026-10",{"name":378,"class":45},"H. Lee Moffitt Cancer Center and Research Institute",2,{"id":381,"slug":382,"hasResults":12,"nctId":383,"briefTitle":384,"officialTitle":385,"acronym":4,"eligibilityCriteria":386,"healthyVolunteers":12,"sex":115,"minAge":19,"maxAge":4,"enrollmentInfo":387,"targetDuration":4,"studyType":24,"phases":388,"briefSummary":389,"conditions":390,"keywords":391,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":392,"lastUpdatePostDateStruct":393,"startDateStruct":395,"completionDateStruct":397,"leadSponsor":399,"locationsCount":401},"100485990","phase-1-vs-6766abemafulv-in-met-hrher--bc-100485990","NCT05608252","VS-6766+Abema+Fulv in Met HR+\u002FHER- BC","A Single Arm Phase 1\u002F2 Trial of Abemaciclib + Avutometinib (VS-6766) + Fulvestrant in Metastatic HR+\u002FHER2- Breast Cancer","Inclusion Criteria:\n\n* Participants must have histologically or cytologically confirmed hormone receptor positive (HR+), HER2 negative metastatic or locally recurrent unresectable invasive breast cancer. ER, PR and HER2 measurements should be performed according to institutional guidelines, in a CLIA-approved setting. Cut-off values for positive\u002Fnegative staining should be in accordance with current ASCO\u002FCAP (American Society of Clinical Oncology\u002FCollege of American Pathologists) guidelines.\n* Participants may have measurable or non-measurable disease according to RECIST v1.1.\n* Men and pre- and postmenopausal women are eligible. Ongoing monthly GNRH agonist is required in pre-menopausal women or male participants for at least 4 weeks prior to study entry. If men or pre-menopausal women have not received regular GNRH agonist for at least 4 weeks prior to study entry, these patients will be excluded.\n* Participants must have radiological or objective evidence of progression on any CDK 4\u002F6 inhibitor-containing regimen in the metastatic setting, and\u002For relapse\u002Fprogression during or within 12 months of completion of any CDK4\u002F6 inhibitor-containing regimen in the adjuvant setting.\n\n  * It is not mandatory to have a CDK4\u002F6 inhibitor-containing regimen as the most recent treatment.\n* Participants must have radiological or objective evidence of progression on fulvestrant (as a single agent or as a component of any multi-drug regimen) in the metastatic setting.\n\n  * It is not mandatory to have a fulvestrant-containing regimen as the most recent treatment.\n* Prior therapy:\n\n  * No more than two prior chemotherapy regimens in the metastatic setting.\n  * For both the phase I and phase II portions of this trial, there is no limit on prior lines of endocrine therapy in the adjuvant or metastatic setting.\n* For phase 2 cohort only: Willing to undergo pre- and on-treatment tumor biopsies. Patients are exempt from this requirement if, in the opinion of the investigator, the biopsy procedure would pose a significant risk. Biopsies are optional in the phase 1 cohort.\n* ECOG performance status \\\u003C2.\n* Participants must have normal organ and marrow function as defined below:\n\n  * absolute neutrophil count ≥ 1.5 x 109\u002FL\n  * platelets ≥100,000\u002Fμl\n  * hemoglobin ≥9 g\u002FdL (If red blood cell transfusion has been administered, hemoglobin must remain stable and ≥9 g\u002FdL without further transfusion for at least 1 week prior to first dose of study therapy).\n  * total bilirubin ≤1.5mg\u002FdL (≤3.0mg\u002FdL in patients with known Gilbert syndrome and direct bilirubin within normal limits)\n  * AST(SGOT)\u002FALT(SGPT) ≤2.5 × institutional ULN.\n  * Adequate renal function with a creatinine clearance rate of ≥ 50 mL\u002Fmin as calculated by the Cockcroft-Gault formula.\n  * International normalized ratio (INR) ≤ 1.5 and partial thromboplastin time (PTT) ≤ 1.5 x ULN in the absence of anticoagulation or therapeutic levels in the presence of anticoagulation.\n  * Creatine phosphokinase (CPK) ≤ 2.5 x ULN.\n  * Adequate cardiac function with left ventricular ejection fraction ≥ 50% by echocardiography (ECHO) or multiple-gated acquisition (MUGA) scan.\n  * Baseline QTc interval \\\u003C 480 ms (average of triplicate readings) using Fredericia's QT correction formula. NOTE: This criterion does not apply to patients with a complete or incomplete right or left bundle branch block.\n* Adequate recovery from toxicities related to prior systemic treatments, surgery, or radiotherapy to at least Grade 1 by CTCAE v 5.0. Exceptions include alopecia and peripheral neuropathy grade ≤ 2.\n* Age \\>18 years. Because no dosing or adverse event data are currently available on the use of study agents in participants \\\u003C18 years of age, children are excluded from this study.\n* Women of childbearing potential, women who are made postmenopausal through use of GNRH agonists, and men must agree to use adequate contraception for the duration of protocol treatment. Women meeting these criteria will need to use adequate contraception for at least 30 days after the last dose of abemaciclib or VS-6766 and for one year after the last dose of fulvestrant. Men will need to use adequate contraception for 90 days after the last dose of abemaciclib or VS-6766 and for one year after the last dose of fulvestrant. Additionally, males must agree not to donate sperm for the duration of protocol treatment and for at least 90 days after the last dose of protocol therapy. Childbearing potential for this purpose is defined as: those who have not been surgically sterilized and\u002For have had a menstrual period in the past 12 months. Adequate contraception is defined as one highly effective non-hormonal form of contraception or two effective forms of non-hormonal contraception by the participant and\u002For partner:\n\nHighly Effective Non-Hormonal Contraception Methods of birth control which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly are considered highly-effective forms of contraception.\n\nThe following non-hormonal methods of contraception are acceptable:\n\n* True abstinence when this is in line with the preferred and usual lifestyle of the participant. \\[Periodic abstinence (e.g., calendar, ovulation, symptothermal post-ovulation methods) and withdrawal are not acceptable methods of contraception\\].\n* Male sterilization (with appropriate post-vasectomy documentation of the absence of sperm in the ejaculate). For female participants, the vasectomized male partner should be the sole partner. OR Effective Non-Hormonal Contraception\n\nAlternatively two of the following effective forms of contraception may be used instead:\n\n* Placement of non-hormonal or progesterone-coated intrauterine device (IUD) or intrauterine system (IUS). Consideration should be given to the type of device being used, as there are higher failure rates quoted for certain types, e.g., steel or copper wire.\n* Condom with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository.\n* Occlusive cap (diaphragm or cervical\u002Fvault caps) with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository.\n* The use of barrier contraceptives should always be supplemented with the use of spermicide. The following should be noted:\n* Failure rates indicate that, when used alone, the diaphragm and condom are not highly effective forms of contraception. Therefore, the use of additional spermicides does confer additional theoretical contraceptive protection.\n* However, spermicides alone are ineffective at preventing pregnancy when the whole ejaculate is spilled. Therefore, spermicides are not a barrier method of contraception and should not be used alone.\n\nIt should be noted that two forms of effective contraception are required. A double barrier method is acceptable, which is defined as condom and occlusive cap (diaphragm or cervical\u002Fvault caps) with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository.\n\n* A female of childbearing potential, as defined above in section 3.1.12, must have a negative serum pregnancy test performed within 7 days of C1D1. A positive urine test must be confirmed by a serum test. Pregnancy testing does not need to be pursued in female participants who are:\n\n  * Age \\>60 years; or\n  * Age \\\u003C60 years with intact uterus and amenorrhea for 12 consecutive months or more AND estrogen (estradiol) levels within postmenopausal range; or\n  * Status post bilateral oophorectomy, total hysterectomy, or bilateral tubal ligation\n* Participant must be able to swallow and retain oral medication.\n* Ability to understand and willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Participants with active brain metastases or with known carcinomatous meningitis. Stable, treated brain metastases are allowed (this includes participants who have documented radiologic stability at least 4 weeks after radiotherapy, and do not require systemic steroids for management of symptoms from CNS metastatic lesions). Any patients with documented brain metastasis not meeting above criteria for stable treated brain metastasis are considered to have active brain metastases.\n* Phase I: Participants who have discontinued prior abemaciclib for toxicity, at any dose. Phase II: Participants who have discontinued prior abemaciclib for toxicity, if that toxicity occurred at or above the RP2 dose level for abemaciclib that is incorporated into phase II of this trial.\n* Participants who have discontinued prior fulvestrant for toxicity.\n* Prior treatment with any MEK inhibitor.\n* The subject has received another investigational agent within at least 30 days or 5 half-lives of the first dose of study drug, whichever is longer, or is currently enrolled in any medical device research or other research that is judged by the sponsor to not be scientifically or medically compatible with this study.\n* The subject has received a chemotherapy agent or immunotherapy within 21 days of the first dose of study drug.\n* The subject has received an endocrine or biologic agent within 14 days of the first dose of study drug.\n* The subject has completed radiation within 14 days of registration. Patients who received radiotherapy must have completed and fully recovered from the acute effects of radiotherapy.\n* The subject has had major surgery within 14 days of registration.\n* Participants with the following pre-existing ocular pathology are excluded:\n* Patients with history of glaucoma, history of retinal vein occlusion (RVO), predisposing factors for RVO, including uncontrolled hypertension, uncontrolled diabetes.\n* Patient with history of retinal pathology or evidence of visible retinal pathology that is considered a risk factor for RVO, intraocular pressure \\> 21 mm Hg as measured by tonometry, or other significant ocular pathology, such as anatomical abnormalities that increase the risk for RVO.\n* Patients with a history of corneal erosion (instability of corneal epithelium), corneal degeneration, active or recurrent keratitis, and other forms of serious ocular surface inflammatory conditions.\n* History of rhabdomyolysis or neuromuscular disorders that are associated with elevated CK (eg inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy).\n* The patient has an uncontrolled intercurrent illness including, but not limited to, uncontrolled hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmia, congestive heart failure (New York Heart Association Class III or IV), active ischemic heart disease, myocardial infarction within the previous six months, syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), uncontrolled diabetes mellitus, severe obstructive pulmonary disease, or severe chronic liver or renal disease, or sudden cardiac arrest.\n* Individuals with a history of a second malignancy are ineligible except for the following circumstances. Individuals with a history of other malignancies are potentially eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years and there is no evidence of disease recurrence for 1 year or more since completion of appropriate therapy: cervical cancer in situ, and non-melanoma cancer of the skin. Patients with other cancers diagnosed within the past 5 years and felt to be at low risk of recurrence should be discussed with the overall study PI to determine eligibility.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to VS-6766 (including inactive ingredients mannitol, magnesium stearate, HPMC (hydroxypropylmethylcellulose) shells), abemaciclib, or fulvestrant.\n* Known history of testing positive for HIV with history of an AIDS-defining opportunistic infection within the past 12 months, or need to receive combination antiretroviral therapy for HIV that are strong CYP3A4 inhibitors or inducers.\n* Known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection (for example, hepatitis B surface antigen positive). Screening is not required for enrollment. Patients with chronic HBV infection who meet criteria for anti-HBV therapy should be on suppressive antiviral therapy prior to initiation of study therapy. Patients with a history of HCV infection will need to have completed curative antiviral treatment with HCV viral load below the limit of quantification. Patients with untreated HCV may be enrolled if the HCV is stable and if the patient is not at risk for hepatic decompensation. Patients that need to receive antiviral therapy for HBV or HCV that are strong CYP3A4 inhibitors or inducers will be excluded.\n* Patients exposed to strong CYP3A4 inhibitors or inducers within 14 days prior to the first dose of study drugs (see Appendix C). Concurrent use of strong CYP3A4 inhibitors (see Appendix C), such as ketoconazole and erythromycin, or inducers (see Appendix C), such as St. John's wort, should be avoided during the study treatment.\n* Pregnant women are excluded from this study because effect of combination VS-766, abemaciclib, and fulvestrant on a developing fetus is unknown. Breastfeeding should be discontinued prior to entry onto the study.\n* Patients with the inability to swallow oral medications, impaired gastrointestinal absorption due to gastrectomy or other major surgical resection involving the stomach or small bowel, preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea, or other medical issue that would impact absorption of oral medication in the opinion of the investigator.\n* Patients with active systemic bacterial infection (requiring intravenous \\[IV\\] antibiotics at time of initiating study treatment), or fungal infection (requiring IV antifungal treatment at time of initiating study treatment), or severe acute respiratory syndrome from coronavirus 2 (SARS-Cov2) infection ≤28 days prior to first dose of study treatment.\n* Patients on treatment with warfarin. Individuals on treatment with warfarin must be transitioned to anticoagulation instead with low-molecular-weight heparin or a direct oral anticoagulant prior to first dose of study treatment.\n* Any other serious and\u002For uncontrolled preexisting medical condition(s) (e.g. interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, other cardiac, gastrointestinal, pulmonary, psychiatric, neurological, or genetic conditions, etc.) that in the opinion of the Investigator would place the patient at unacceptably high risk for toxicity and therefore preclude participation in this study.",{"count":355,"type":23},[119,26],"This research is being done to evaluate the safety and effectiveness of a drug currently known as VS-6766 in combination with the drugs abemaciclib and fulvestrant in HR+\u002FHER2-negative breast cancer.\n\nThe names of the study drugs involved in this study are:\n\n* VS-6766\n* Abemaciclib\n* Fulvestrant",[200,177,178],[200,177,178],"2026-04-27",{"date":394,"type":38},"2026-04-30",{"date":396,"type":38},"2023-02-23",{"date":398,"type":23},"2028-12-31",{"name":400,"class":45},"Adrienne G. Waks",3,{"id":403,"slug":404,"hasResults":12,"nctId":405,"briefTitle":406,"officialTitle":407,"acronym":4,"eligibilityCriteria":408,"healthyVolunteers":12,"sex":409,"minAge":19,"maxAge":4,"enrollmentInfo":410,"targetDuration":4,"studyType":24,"phases":412,"briefSummary":413,"conditions":414,"keywords":417,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":392,"lastUpdatePostDateStruct":419,"startDateStruct":420,"completionDateStruct":422,"leadSponsor":424,"locationsCount":426},"100477802","phase-2-ethan---et-for-male-bc-100477802","NCT05501704","ETHAN - ET for Male BC","ETHAN: A Phase II Study Comparing Different Endocrine THerapies for mAle Breast caNcer","Inclusion Criteria:\n\n* Men aged 18 years or older, with diagnosis of invasive breast cancer who have not undergone surgical resection of the primary tumor and axillary nodes.\n* Stage I, II, or III per American Joint Committee on Cancer (AJCC) staging 8th edition (112).\n* Breast cancer must be hormone receptor-positive and HER2-negative according to definition below assessed by local pathology.\n\n  * Hormone receptor-positive is defined as: positivity for at least one of the hormone receptors (estrogen receptor \\[ER\\] or progesterone receptor \\[PR\\]) by IHC. ER and PR assays are considered positive if there are \\> 1% positive tumor nuclei in the samples.\n  * HER2-negative is defined per the current American Society of Clinical Oncology\u002FCollege of American Pathologists Clinical Practice Guideline (113).\n* Patients with multifocal or multicentric disease are eligible if the treating investigator has determined the patient should be treated as ER-positive and HER2-negative.\n* Bilateral breast cancers are allowed if the treating investigator has determined the patient should be treated as ER-positive and HER2-negative.\n* Patients with a history of ipsilateral or contralateral DCIS or LCIS are eligible.\n* ECOG performance status ≤ 2.\n* Required laboratory values demonstrating adequate organ function:\n\n  * ANC ≥ 1000\u002Fmm3\n  * Hemoglobin ≥ 8 g\u002Fdl\n  * Platelets ≥ 50,000\u002Fmm3\n  * Serum creatinine ≤ 3.0 x ULN (institutional)\n  * Total bilirubin ≤ 2.0 x ULN (institutional).\n  * AST and ALT ≤ 5.0 x ULN (institutional)\n* Men with partners of childbearing potential must be willing to use one highly effective form of non-hormonal contraception or two effective forms of non-hormonal contraception by the patient and\u002For partner and continue its use for the duration of the study treatment and for 6 months after the last dose of study treatment.\n* Non-English-speaking patients are eligible but will be exempt from patient-completed questionnaires.\n* Willing and able to sign informed consent.\n* Willing to undergo breast biopsy after completion of window phase.\n* Patient is able to swallow oral medications.\n\nExclusion Criteria:\n\n* Prior endocrine therapy, chemotherapy, radiation therapy, or investigational therapy for the current breast cancer diagnosis.\n* Prior endocrine therapy, systemic therapy, radiation therapy, or investigational therapy for any other malignancy within the past 12 months.\n* Diagnosis of inflammatory breast cancer (T4d).\n* Other concurrent serious diseases that may interfere with planned treatment, including severe cardiac disease, congestive heart failure (CHF) of New York Heart Association (NYHA) Class III or higher, severe pulmonary conditions\u002Fillness, uncontrolled infections.\n* The patient has serious and\u002For uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, severe renal impairment \\[e.g. estimated creatinine clearance \\\u003C30ml\u002Fmin\\], history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea).\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.","MALE",{"count":411,"type":23},60,[26],"This research study is looking to see how well male breast cancer responds to preoperative treatment with endocrine therapy and which endocrine therapy regimen is the most effective treatment for male breast cancer.\n\nThe drugs used in this study are:\n\n* Tamoxifen\n* Anastrozole\n* Degarelix\n* Abemaciclib",[415,177,416],"Male Breast Cancer","Hormone Receptor Negative Breast Carcinoma",[415,177,418],"Hormone Receptor Negative Breast Cancer",{"date":394,"type":38},{"date":421,"type":38},"2023-10-11",{"date":423,"type":23},"2036-04-01",{"name":425,"class":45},"Jose Pablo Leone",8,{"id":428,"slug":429,"hasResults":12,"nctId":430,"briefTitle":431,"officialTitle":432,"acronym":433,"eligibilityCriteria":434,"healthyVolunteers":12,"sex":115,"minAge":19,"maxAge":4,"enrollmentInfo":435,"targetDuration":4,"studyType":24,"phases":437,"briefSummary":438,"conditions":439,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":441,"lastUpdatePostDateStruct":442,"startDateStruct":444,"completionDateStruct":446,"leadSponsor":448,"locationsCount":164},"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":436,"type":23},200,[26],"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.",[440,177,32],"Locoregional Recurrence","2026-04-02",{"date":443,"type":38},"2026-04-08",{"date":445,"type":38},"2022-09-13",{"date":447,"type":23},"2029-08-15",{"name":449,"class":45},"Oana Danciu",{"id":451,"slug":452,"hasResults":12,"nctId":453,"briefTitle":454,"officialTitle":455,"acronym":4,"eligibilityCriteria":456,"healthyVolunteers":12,"sex":115,"minAge":19,"maxAge":20,"enrollmentInfo":457,"targetDuration":4,"studyType":234,"phases":4,"briefSummary":458,"conditions":459,"keywords":465,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":471,"lastUpdatePostDateStruct":472,"startDateStruct":474,"completionDateStruct":476,"leadSponsor":478,"locationsCount":46},"100613316","observational-study-of-gut-microbiota-in-abemaciclib-treated-patients-with-and-without-diarrhea-100613316","NCT07264998","Observational Study of Gut Microbiota in Abemaciclib-Treated Patients With and Without Diarrhea","Gut Microbiota Changes in Breast Cancer Patients Treated With Abemaciclib and Correlation With Drug-Induced Diarrhea: An Observational Cohort Study","Inclusion Criteria:\n\n1. Aged 18 to 75 years.\n2. Diagnosed with hormone receptor-positive (HR⁺) breast cancer.\n3. Currently receiving treatment with Abemaciclib (either as monotherapy or in combination with endocrine therapy) for a duration of at least 2 weeks.\n4. Willing and able to provide written informed consent for participation in the study.\n\nExclusion Criteria:\n\n1. History of major gastrointestinal diseases, such as inflammatory bowel disease, Crohn's disease, ulcerative colitis, or intestinal obstruction, or having undergone major gastrointestinal surgery.\n2. Recent use (within 1 month) of antibiotics, probiotics, or traditional Chinese medicine that may alter gut function.\n3. Pregnant or lactating women.\n4. Unwilling to provide informed consent or considered by the investigator to be unsuitable for the study for any other reason.",{"count":411,"type":23},"Why is this study being done? Many patients with a type of breast cancer (called HR-positive) take a medicine called Abemaciclib. While this medicine is effective, a very common side effect is diarrhea, which can be severe enough to disrupt treatment and reduce quality of life. The reason why some patients get diarrhea and others do not is not well understood. This study aims to investigate whether the natural bacteria living in the gut (known as the gut microbiome) play a role in this side effect. Researchers will compare the gut bacteria of patients who develop diarrhea with those who do not.\n\nWhat will happen in the study? This is an observational study, which means that patients will receive their normal cancer treatment and will not be given any new or experimental drugs as part of this initial phase.\n\n* Patients who are already being treated with Abemaciclib will be invited to join.\n* They will be placed into one of two groups: those who experience diarrhea and those who do not.\n* Participants will be asked to provide stool (feces) samples and may also provide optional blood samples at specific times during their treatment.\n* Researchers will analyze these samples in the lab to study the types and functions of the gut bacteria.\n\nWho can participate?\n\n* Adult women (aged 18-75) diagnosed with HR-positive breast cancer.\n* Currently receiving treatment with Abemaciclib for at least 2 weeks.\n* Must be willing to provide informed consent and follow the study procedures.\n\nWhat are the potential benefits? Participants will not receive any direct medical benefit from taking part in this study. However, the information learned may help researchers better understand why diarrhea occurs and, in the future, could lead to new ways to prevent or treat this side effect for other cancer patients.\n\nHow is privacy protected? All personal information and samples collected will be de-identified using a unique code. This means that the data used for analysis cannot be directly linked back to the participant's identity. All data is stored securely according to strict ethical guidelines.",[206,29,460,461,462,463,464],"Abemaciclib","Abemaciclib-related Diarrhea","Drug-induced Diarrhea","Gastrointestinal Microbiome (Focus)","Microbiome",[460,466,467,464,468,469,470],"Hormone receptor-positive breast cancer","Drug-induced diarrhea","Gastrointestinal microbiome","Microbiome biomarkers","Abemaciclib-related diarrhea","2026-04-01",{"date":473,"type":38},"2026-04-03",{"date":475,"type":38},"2025-12-21",{"date":477,"type":23},"2026-07",{"name":479,"class":45},"Hubei Cancer Hospital",{"id":481,"slug":482,"hasResults":12,"nctId":483,"briefTitle":484,"officialTitle":485,"acronym":486,"eligibilityCriteria":487,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":488,"targetDuration":4,"studyType":24,"phases":489,"briefSummary":491,"conditions":492,"keywords":495,"overallStatus":98,"whyStopped":4,"lastUpdateSubmitDate":498,"lastUpdatePostDateStruct":499,"startDateStruct":501,"completionDateStruct":502,"leadSponsor":504,"locationsCount":46},"100615571","a-randomized-controlled-trial-of-acupuncture-for-the-management-of-hot-flashes-in-patients-with-hormone-receptor-positive-breast-cancer-100615571","NCT07294339","A Randomized Controlled Trial of Acupuncture for the Management of Hot Flashes in Patients With Hormone Receptor-Positive Breast Cancer","针刺治疗激素受体阳性乳腺癌患者潮热的随机对照试验研究，A Randomized Controlled Trial of Acupuncture for the Management of Hot Flashes in Patients With Hormone Receptor-Positive Breast Cancer","ACU-HRBC-HF","Inclusion Criteria Female patients aged 18 to 75 years. Histopathologically confirmed breast cancer, currently receiving endocrine therapy (e.g., selective estrogen receptor modulators and\u002For aromatase inhibitors, CDK4\u002F6 inhibitors), with or without ovarian function suppression, for at least 4 weeks and ongoing at the time of enrollment.\n\nExpected survival time \\> 6 months. Experiencing persistent hot flashes for at least 4 weeks, with a frequency of ≥14 episodes per week (≥2 per day) during the week prior to enrollment, and a Hot Flash Composite Score (HFCS) of 3-4.\n\nEastern Cooperative Oncology Group (ECOG) performance status of 0 or 1:\n\n0: Fully active, able to carry on all pre-disease performance without restriction;\n\n1. Restricted in physically strenuous activity but ambulatory and able to carry out light work (e.g., housework, office work);\n2. Ambulatory and capable of all self-care but unable to carry out any work activities; up and about more than 50% of waking hours;\n3. Capable of only limited self-care; confined to bed or chair more than 50% of waking hours;\n4. Completely disabled; cannot carry on any self-care; totally confined to bed or chair;\n5. Dead. Willing and able to participate in the study and sign the informed consent form.\n\nExclusion Criteria Evidence of tumor metastasis, currently undergoing radiotherapy, chemotherapy, or having a planned surgery.\n\nUse of selective serotonin reuptake inhibitors (SSRIs) and\u002For anticonvulsants or other pharmacologic agents for hot flash management within 4 weeks prior to study entry.\n\nUnstable cardiac disease or myocardial infarction within 6 months prior to study initiation.\n\nRecent initiation or modification of endocrine therapy within 1 week, or planned initiation or modification within 14 weeks.\n\nHistory or risk of seizure of unclear etiology. Prior acupuncture treatment for hot flashes within 6 months before enrollment. Contraindications to MRI scanning. Pregnant or lactating women. Presence of uncontrolled active infection. Severe psychiatric disorders or family history of psychiatric or neurological diseases.\n\nWithdrawal Criteria Failure to complete acupuncture treatment per protocol, making efficacy evaluation impossible.\n\nUse of medications or treatments during the trial that may affect study outcomes.\n\nVoluntary withdrawal from the study during treatment.\n\nDiscontinuation Criteria Serious adverse events, complications, or physiological changes during treatment that make continuation unsafe or impractical.\n\nLoss to follow-up or death after enrollment. Participant's voluntary withdrawal at any stage of treatment.",{"count":411,"type":23},[490],"NA","Hot flashes are among the most common and distressing adverse effects experienced by patients receiving endocrine therapy for hormone receptor-positive breast cancer. Hormone replacement therapy (HRT) and non-hormonal medications can alleviate symptoms but are limited by side effects and safety concerns, leading to poor adherence. Acupuncture, a traditional Chinese medical therapy involving percutaneous stimulation of specific acupoints, has shown potential to reduce the frequency and severity of hot flashes with minimal adverse events.\n\nThis randomized, parallel-controlled clinical trial aims to evaluate the efficacy and safety of acupuncture in managing hot flashes in postoperative breast cancer patients undergoing endocrine therapy. Sixty eligible patients with stage I-III hormone receptor-positive breast cancer will be randomly assigned in a 1:1 ratio to receive either true acupuncture or sham acupuncture, three times per week for eight weeks, followed by a 16-week follow-up period without acupuncture. Functional magnetic resonance imaging (fMRI) will be employed to explore neural mechanisms underlying acupuncture's effects, alongside assessments of hot flash frequency, quality of life (FACT-B+ES), sleep quality (PSQI), and serum biomarkers related to endocrine and neuropeptide regulation. The results are expected to provide evidence for the efficacy and central mechanisms of acupuncture in managing hot flashes in breast cancer patients.",[493,29,494],"Acupuncture Treatment","Hot Flashes",[29,494,496,497],"Acupuncture","Randomized Controlled Trial","2026-03-18",{"date":500,"type":38},"2026-03-19",{"date":471,"type":23},{"date":503,"type":23},"2027-10-01",{"name":44,"class":45},{"id":506,"slug":507,"hasResults":12,"nctId":508,"briefTitle":509,"officialTitle":510,"acronym":4,"eligibilityCriteria":511,"healthyVolunteers":12,"sex":115,"minAge":19,"maxAge":4,"enrollmentInfo":512,"targetDuration":4,"studyType":24,"phases":513,"briefSummary":514,"conditions":515,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":516,"lastUpdatePostDateStruct":517,"startDateStruct":519,"completionDateStruct":521,"leadSponsor":523,"locationsCount":46},"100479561","phase-2-anastrazole-fulvestrant--abemaciclib-for-hrher2--metastatic-breast-cancer-100479561","NCT05524584","Anastrazole, Fulvestrant & Abemaciclib for HR+HER2- Metastatic Breast Cancer","Phase II, Open-Labeled, Single-Armed Combination Treatment With Anastrozole, Fulvestrant and Abemaciclib for Hormone Receptor Positive, HER2(-) Metastatic Breast Cancer","Inclusion Criteria:\n\n* Patients must have a diagnosis of HR+ breast cancer. To fulfill the requirement of HR+ disease, a breast cancer must express, by immunohistochemistry (IHC), at least one of the hormone receptors (ER, progesterone receptor \\[PgR\\]) as defined in the relevant American Society of Clinical Oncology\u002FCollege of American Pathologists Guidelines: For ER and PgR assays to be considered positive, ≥1% of tumor cell nuclei must be immunoreactive by immunohistochemistry (IHC)\n* Patients must have newly diagnosed metastatic regional breast cancer (Stage IV per AJCC 8th edition criteria for staging of breast cancer) or local-regional advanced or recurrent cancer not amenable to curative treatment\n\n  1\\. Relapse \\> 12 months from completion of (neo)adjuvant endocrine and\u002For chemotherapy with no treatment for advanced or metastatic disease (patients with no early stage breast cancer neoadjuvant or adjuvant systemic treatment may qualify)\n* Age ≥ 18 years\n* ECOG performance status 0-2\n* Have post-menopausal status as defined by following: Prior bilateral oophorectomy. Age ≥ 60 years, Age \\\u003C 60 and amenorrheic (non-treatment-induced amenorrhea secondary to tamoxifen, toremifene, ovarian suppression, or chemotherapy) for at least 12 months. Follicle-stimulating hormone (FSH) and estradiol must be in the postmenopausal range. If patients are pre-menopausal ovarian function suppression will be initiated.\n* Have at least one measurable disease as defined per RECIST 1.1\n* Adequate organ and marrow function as defined below:\n\n  1. Hemoglobin \\>8 g\u002FdL. Patients may receive transfusion of packed red blood cells (PRBC) to achieve this hemoglobin level at the discretion of the investigator; however, initial study drug treatment must not begin earlier than the day after the PRBC transfusion\n  2. Absolute neutrophil count ≥1,500\u002FmcL\n  3. Platelets ≥ 100,000\u002Fmcl\n  4. Total bilirubin ≤ 1.5 X institutional ULN. Patients with Gilbert's syndrome with a total bilirubin ≤2.0 times ULN and direct bilirubin within normal limits are permitted\n  5. AST (SGOT)\u002FALT (SPGT) ≤ 2.5 X institutional ULN\n  6. Creatinine ≤ 1.5 X institutional ULN\n* Able to swallow oral medications\n* Patients who received chemotherapy or curative radiotherapy must have recovered (Common Terminology Criteria for Adverse Events \\[CTCAE\\] Grade ≤1) from the acute effects of chemotherapy and curative radiotherapy except for residual alopecia (of any grade) or Grade 2 peripheral neuropathy prior to enrollment.\n* Person of child bearing potential (POCBP) (ie. premenopausal) and men must agree to use ovarian or testicular suppression prior to study entry, for the duration of study participation, and for 90 days following completion of therapy.\n\n  1. A post-menopausal female patient is defined by one of the following for female patients: prior bilateral oophorectomy, age ≥ 60 years, age \\\u003C 60 and amenorrheic (non-treatment-induced amenorrhea secondary to tamoxifen, toremifene, ovarian suppression, or chemotherapy) for at least 12 months.\n  2. If follicle-stimulating hormone (FSH) and estradiol labs were performed as standard practice within the screening window and the patient is post-menopausal, those lab results must be in the postmenopausal range. These labs are not required to be performed for the study.\n* POCBP are required to initiate effective contraception by study intervention start. Effective contraception is per the investigator's discretionhild. A POCBP (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) is someone who meets at least one of the following criteria:\n\n  1. Has not undergone a hysterectomy or bilateral oophorectomy; or\n  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* Must be able to sign a written informed consent, are reliable, willing to be available for the duration of the study and are willing to follow study procedures.\n* Both men and women and members of all races and ethnic groups are eligible for this trial. Non-English speaking, deaf, hard of hearing and illiterate individuals are eligible for this trial.\n\nExclusion Criteria:\n\n* Localized breast cancer which is curable with surgery or radiation, with or without chemotherapy. This study will utilize the American Joint Committee on Cancer (AJCC) staging system, eight edition that provides a strategy for grouping patients with respect to prognosis. The AJCC has designated staging by TNM classification.\n* Current diagnosis of inflammatory breast cancer\n* Patients who have had chemotherapy or radiotherapy within 12 months prior to entering the study.\n\n(Note: Palliative radiotherapy is does not require a washout Note: For current diagnosis, CDK 4\u002F6 inhibitor and\u002For endocrine therapy within 8 weeks prior to starting study treatment is allowed).\n\n* Prior treatment with Fulvestrant (Note: For the current diagnosis, fulvestrant initiated within 8 weeks prior to starting study intervention is allowed)\n* Patients are currently receiving an investigational drug in a clinical trial or participating in any other type of medical research judged by the investigator not to be scientifically or medically compatible with this study. If a patient is currently enrolled in a clinical trial involving non-approved use of a device, then agreement with the principal investigator is required to establish eligibility\n* Have serious pre-existing medical conditions that, in the judgment of the investigator, would preclude participation in this study (for example, history of major surgical resection involving the stomach or small bowel or preexisting Crohn's disease or ulcerative colitis , interstitial lung disease, severe dyspnea at rest, any pre-existing chronic condition resulting in baseline grade 2 or higher diarrhea, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements)\n* Have a personal history of any of the following conditions: syncope or cardiovascular etiology, ventricular tachycardia, ventricular fibrillation or sudden cardiac arrest\n* Have a history of any other cancer (except for non-melanoma skin cancer or carcinoma in situ of the cervix) unless in complete remission with no therapy for a minimum of three years or have received an autologous or allogeneic stem-cell transplant ((\\> 5 years from stem cell transplant is acceptable). (Patients with non-active cancer not requiring treatment are allowed to be enrolled on the study)\n* Have an active bacterial or fungal infection or a detectable viral infection (for example HIV or viral hepatitis). Screening is not required for enrollment\n* Recent therapy with a biologic agent or a monoclonal therapy is excluded. Wash out of at least three half-lives of monoclonal antibody would be required to be enrolled.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to CDK4\u002F6 inhibitors or other agents used in study.\n* Patients who are pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.",{"count":164,"type":23},[26],"This is a phase 2, open-label, singled-arm clinical trial determining efficacy of combination therapy with anastrozole, fulvestrant and abemaciclib in subjects with breast cancer. These are subjects who are newly diagnosed advanced or metastatic hormone receptor positive breast cancer or subjects who have progressed following treatment free interval of more than 12 months following adjuvant or neoadjuvant treatment.",[200,122,177,32],"2026-03-09",{"date":518,"type":38},"2026-03-11",{"date":520,"type":38},"2022-08-31",{"date":522,"type":23},"2031-12-31",{"name":524,"class":45},"University of California, Irvine",{"id":526,"slug":527,"hasResults":12,"nctId":528,"briefTitle":529,"officialTitle":530,"acronym":4,"eligibilityCriteria":531,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":532,"targetDuration":4,"studyType":24,"phases":533,"briefSummary":535,"conditions":536,"keywords":544,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":551,"lastUpdatePostDateStruct":552,"startDateStruct":554,"completionDateStruct":556,"leadSponsor":558,"locationsCount":324},"100596217","phase-4-a-study-of-revaree-plus-in-people-with-breast-cancer-100596217","NCT07042581","A Study of Revaree Plus in People With Breast Cancer","Evaluation of Revaree Plus in Women With Breast Cancer","Inclusion Criteria:\n\n* ≥18 years of age at the time of signing informed consent.\n* Stage 0-3 hormone-receptor positive breast cancer confirmed at MSKCC\n* Able to complete study questionnaires in English or Spanish\n* Breast cancer patients must have completed primary therapy (surgery, and\u002For chemotherapy, and\u002For radiation therapy) or currently on maintenance therapy\n* Currently on an aromatase inhibitor or tamoxifen or Selective Estrogen Receptor Modulators (SERM)\n* Currently have no clinical evidence of disease\n* Reporting being bothered by vaginal symptoms of estrogen deprivation (i.e., vaginal dryness, dyspareunia, or discomfort \\[pain with intercourse or examination\\])\n* A total score of 4 or greater in VAS\n* Without history of other cancers (excluding non-melanoma skin cancer)\n* Must sign an informed consent indicating that the participant understands the purpose of, and procedures required for the study and is willing to participate in the study\n\nExclusion Criteria:\n\n* Inability to provide informed consent\n* Vaginal bleeding of unknown etiology within 12 months of study entry\n* Currently taking hormone replacement therapy \\[local or systemic\\] (Patients must discontinue for 4 weeks in order to be eligible prior to study enrollment)\n* Existing use of external estrogens or nonhormonal moisturizers (Patients must discontinue for 4 weeks in order to be eligible prior to study enrollment)\n* No known allergies to any ingredients in 10mg HLA suppository",{"count":411,"type":23},[534],"PHASE4","The purpose of this study is to find out whether Revaree Plus is effective at improving vaginal health for people who are having symptoms of vaginal dryness during breast cancer treatment.",[200,537,538,539,540,541,542,543,90,263,339],"Stage 0 Breast Cancer","Stage I Breast Cancer","Stage II Breast Cancer","Stage III Breast Cancer","Stage 0 Breast Carcinoma","Stage II Breast Carcinoma","Stage III Breast Carcinoma",[200,537,538,539,540,545,546,547,548,549,550,315],"Stage 0 hormone receptor positive breast cancer","Stage I hormone receptor positive breast cancer","Stage II hormone receptor positive breast cancer","Stage III hormone receptor positive breast cancer","Revaree","24-374","2026-02-04",{"date":553,"type":38},"2026-02-06",{"date":555,"type":38},"2025-06-20",{"date":557,"type":23},"2029-06-20",{"name":315,"class":45},{"id":560,"slug":4,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":561,"targetDuration":4,"studyType":24,"phases":562,"briefSummary":27,"conditions":563,"keywords":4,"overallStatus":98,"whyStopped":4,"lastUpdateSubmitDate":564,"lastUpdatePostDateStruct":565,"startDateStruct":567,"completionDateStruct":569,"leadSponsor":570,"locationsCount":4},"100621091",{"count":22,"type":23},[26],[29,30,31,32,33],"2026-01-18",{"date":566,"type":38},"2026-01-26",{"date":568,"type":23},"2026-02-01",{"date":42,"type":23},{"name":44,"class":45},{"id":572,"slug":4,"hasResults":12,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":573,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":574,"targetDuration":4,"studyType":24,"phases":575,"briefSummary":58,"conditions":576,"keywords":577,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":564,"lastUpdatePostDateStruct":578,"startDateStruct":580,"completionDateStruct":581,"leadSponsor":582,"locationsCount":46},"100590706","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-3N0M0 with high-risk factors (Grade 3, or Grade 2 with Ki67 ≥20%);\n  2. 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":56,"type":23},[26],[29,30,31,32,33,60],[62,63,64,65,66,67,68,69,70,71,72],{"date":579,"type":38},"2026-01-21",{"date":75,"type":38},{"date":42,"type":23},{"name":44,"class":45},{"id":584,"slug":585,"hasResults":12,"nctId":586,"briefTitle":587,"officialTitle":588,"acronym":589,"eligibilityCriteria":590,"healthyVolunteers":12,"sex":115,"minAge":19,"maxAge":4,"enrollmentInfo":591,"targetDuration":4,"studyType":24,"phases":593,"briefSummary":594,"conditions":595,"keywords":597,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":610,"lastUpdatePostDateStruct":611,"startDateStruct":612,"completionDateStruct":614,"leadSponsor":616,"locationsCount":324},"100555957","phase-2-tirzepatide-for-weight-loss-intervention-in-early-stage-hormone-receptor-positiveher2-negative-breast-cancer-100555957","NCT06518837","Tirzepatide for Weight Loss Intervention in Early-Stage Hormone Receptor Positive\u002FHER2 Negative Breast Cancer","FITWISE: Feasibility Study of Tirzepatide for Weight Loss Intervention in Early-Stage Hormone Receptor Positive\u002FHER2 Negative Breast Cancer","FITWISE","Inclusion Criteria:\n\n* Consent: Be willing and able to provide written informed consent for the trial.\n* Age: Male or Female patients aged 18 years or older.\n* Breast Cancer Diagnosis: Have hormone receptor-positive (HR+), HER2-negative (HER2-) breast cancer previously diagnosed by biopsy. HR status is defined as estrogen receptor (ER) \\>10% and\u002For progesterone receptor (PR) \\>10%; HER2 status is defined as immunohistochemistry (IHC) 0 or 1+ or IHC 2+, fluorescence in situ hybridization (FISH) negative.\n* Stage: Have previously untreated early-stage, clinical or anatomic stage I, II, or III hormone receptor-positive breast cancer.\n* Definitive Treatment: Have had definitive treatment with curative intent for breast cancer, including surgery, chemotherapy, and radiotherapy as indicated.\n* Body Mass Index (BMI): Have a BMI of 30 kg\u002Fm² or more, or a BMI of 27 kg\u002Fm² or more with one weight-related complication (e.g., hypertension, type 2 diabetes, dyslipidemia, obstructive sleep apnea, or cardiovascular disease).\n* Performance Status: Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n* Cardiac Function: Have a left ventricular ejection fraction (LVEF) of 50% or greater, or greater than the institution's lower limit of normal (LLN), as assessed by echocardiogram (ECHO) or multigated acquisition (MUGA) scan performed at screening.\n* Organ Function: Demonstrate adequate organ function in screening labs.\n* Tumor Specimens: Have archived biopsy or surgical tumor specimens available as tumor blocks or unstained slides.\n\nExclusion Criteria:\n\n* Other Clinical Studies: Is currently enrolled, or will enroll in, a different clinical study in which investigational therapeutic procedures are performed or investigational therapies are administered while participating in this study.\n* Stage IV Breast Cancer: Have stage IV, metastatic breast cancer.\n* Cancer Type: Have HER2-positive or triple-negative breast cancer.\n* Active Malignancy: Have a concomitant active malignancy.\n* Performance Status: Have an Eastern Cooperative Oncology Group (ECOG) performance status greater than 2.\n* Body Mass Index: Have a BMI of less than 27 kg\u002Fm².\n* Type 1 Diabetes Mellitus: Have type 1 diabetes mellitus.\n* Gastric Emptying Abnormality: Have a known clinically important gastric emptying abnormality (e.g., severe gastroparesis or gastric outlet obstruction) or chronically took drugs that directly affect gastrointestinal motility.",{"count":592,"type":23},40,[26],"This clinical trial aims to evaluate the effectiveness of tirzepatide in achieving a 5% or more body weight reduction in patients undergoing adjuvant treatment for hormone receptor-positive, HER2-negative (HR+\u002FHer2-) breast cancer. The study will also assess the safety and tolerability of tirzepatide, its feasibility based on discontinuation rates, and completion of treatment. Secondary objectives include evaluating 3-year invasive disease-free survival (IDFS) and distant relapse-free survival (DRFS), changes in BMI and body fat distribution, metabolic markers, and circulating tumor DNA (ctDNA).",[29,596],"HER2-Negative Breast Cancer",[598,599,600,601,602,603,604,605,606,607,608,609],"Weight Loss","Body Weight Reduction","Feasibility of Weight Loss Intervention","invasive Disease-Free Survival (IDFS)","Body Mass Index (BMI)","Body Fat Distribution","Metabolic Markers","Circulating Tumor DNA (ctDNA)","Tirzepatide","GIP and GLP-1 dual agonist","Black patients","distant relapse-free survival (DRFS)","2026-01-17",{"date":579,"type":38},{"date":613,"type":38},"2024-10-30",{"date":615,"type":23},"2027-09-30",{"name":617,"class":45},"Rutgers, The State University of New Jersey",{"id":619,"slug":620,"hasResults":12,"nctId":621,"briefTitle":622,"officialTitle":623,"acronym":624,"eligibilityCriteria":625,"healthyVolunteers":12,"sex":115,"minAge":19,"maxAge":4,"enrollmentInfo":626,"targetDuration":4,"studyType":24,"phases":628,"briefSummary":629,"conditions":630,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":632,"lastUpdatePostDateStruct":633,"startDateStruct":635,"completionDateStruct":637,"leadSponsor":639,"locationsCount":401},"100536339","phase-2-sequencing-antibody-drug-conjugates-in-erher2-lowultra-low-mbc-100536339","NCT06263543","Sequencing Antibody Drug Conjugates in ER+\u002FHER2 LOW\u002FULTRA LOW MBC","SERIES: SEquencing Sacituzumab Govitecan AfteR T-DXd In ER+\u002FHER2 LOW\u002FULTRA LOW MetaStatic Breast Cancer","SERIES","Inclusion Criteria:\n\n* Provision of signed and dated informed consent form.\n* Stated willingness to comply with all study procedures and availability for the duration of the study.\n* Individuals ≥ 18 years of age.\n* 4\\. Histologically confirmed metastatic or advanced and unresectable breast cancer that is HER2 LOW\u002FULTRA LOW by local testing on either the primary or any metastatic site. HER2 LOW is defined as: (IHC 2+\u002FISH- or IHC 1+ (ISH- or untested)) and HER2 ULTRA LOW is defined as: IHC0+ (faint membrane staining up to 10%)\n* Histologically confirmed metastatic or advanced and unresectable breast cancer that is hormone receptor positive (estrogen receptor and\u002For progesterone receptor positive) defined as \\>1% on any metastatic site or the primary tumor.\n* Endocrine-refractory (as per investigator judgement) and may have received any number of prior endocrine therapies (alone or in combination with cyclin-dependent kinase (CDK)4\u002F6 inhibitor, everolimus, alpelisib, acapivasertib or inavolisib).\n* Received a CDK4\u002F6 inhibitor either alone or in combination with endocrine therapy (in the adjuvant or metastatic setting) with any duration of therapy permitted.\n* Received at least 1 but no more than 4 prior systemic chemotherapy regimens in the metastatic setting. Prior ADCs count as a line of systemic chemotherapy. Prior PARP inhibitor use counts as a line of systemic therapy.\n* Prior treatment with T-DXd (discontinued for progression and\u002For intolerance), which does not have to be the treatment immediately prior to enrollment on trial.\n* Documented clinical and\u002For radiographic disease progression after most recent therapy, unless immediate prior therapy was T-DXd which was discontinued for toxicity.\n* Measurable disease, as per RECIST V1.1 - a. If a patient has bone-only disease, they are eligible as long as there is a lytic lesion that is considered measurable. Blastic-only bone lesions are not allowed.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2.\n* Adequate organ and bone marrow function within 28 days before enrollment. For all parameters listed below, the most recent results available must be used:\n\n  1. Hemoglobin ≥ 9 g\u002FdL. Note: Red blood cell transfusion is not allowed within 1 week prior to screening assessment.\n  2. Absolute neutrophil count (ANC) ≥ 1500\u002Fmm\\^3. Note: Granulocyte-colony stimulating factor (G-CSF) administration is not allowed within 1 week prior to screening assessment.\n  3. Platelet count ≥ 100,000\u002Fmm\\^3. Note: Platelet transfusion is not allowed within 1 week prior to registration.\n  4. Total bilirubin (TBL) ≤ 1.5 × upper limit of normal (ULN) if no liver metastases or \\\u003C 3 × ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinemia) or liver metastasis at baseline.\n  5. Alanine transaminase (ALT) and aspartate aminotransferase (AST) ≤ 3 ×ULN or \\\u003C 5 × ULN in patients with liver metastasis.\n  6. Serum albumin ≥ 2.5 g\u002FdL.\n  7. Creatinine clearance (CrCl) ≥ 30 mL\u002Fmin (calculated using the Cockcroft and Gault equation). Cockcroft-Gault equation: CrCl (mL\u002Fmin) = \\[140 - age (years)\\] × weight (kg) 72 × serum creatinine (mg\u002FdL) {× 0.85 for females}\n  8. International normalized ratio (INR) or prothrombin time (PT) and either partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN.\n* Adequate treatment washout period before randomization, defined as:\n\n  1. Major surgery: ≥ 3 weeks\n  2. Radiation therapy including palliative and\u002For stereotactic radiation therapy ≥ 2 weeks\n  3. Hormonal therapy: ≥ 2 weeks\n  4. Targeted therapy (CDK4\u002F6i, PARP inhibitor, AKTinhibitor, mTOR inhibitor, PIK3CA inhibitor): ≥ 2 weeks\n  5. Immunotherapy (non-antibody-based therapy): ≥ 2 weeks\n  6. T-DXd: ≥ 3 weeks\n* Evidence of post-menopausal status or for individuals of childbearing potential must have a negative serum beta-human chorionic gonadotropin (ß-hCG) at screening or baseline. Individuals of childbearing potential are defined as those who are not surgically sterile (i.e., underwent bilateral tubal occlusion, bilateral salpingectomy, bilateral oophorectomy, or complete hysterectomy) or post-menopausal.\n* Individuals of childbearing potential who are sexually active with a non-sterilized male partner must agree to use at least one highly effective method of contraception from the time of registration through final study treatment. Not all methods of contraception are highly effective.\n* Non-sterilized male patients who are sexually active with a partner of childbearing potential must agree to use a condom with spermicide from registration and throughout duration of the study treatment.\n\nThe following are acceptable measures to prevent pregnancy:\n\n* Abstinence (not having sexual relations with a person who can get you pregnant)\n* Non-hormonal Intrauterine Device (IUD)\n* Vasectomy\n* Sterilization\n* Bilateral tubal occlusion\n\nExclusion Criteria:\n\n* Locally advanced MBC (stage IIIc) in individuals who are candidates for curative intent therapy at the time of study enrollment.\n* Patients with brain metastases (BM) except for asymptomatic treated BM not requiring ongoing corticosteroid treatment with stable lesions on baseline\u002Fscreening brain MRI. Patients who require treatment of brain metastases are eligible after 14 days post receipt of surgery or radiation, if felt to be clinically stable and not requiring ongoing corticosteroid treatment.\n* Active serious infection requiring ongoing antibiotics.\n* History of an anaphylactic reaction to irinotecan.\n* Pregnant or breastfeeding.\n* Ongoing treatment with another investigational drug or other interventional trial.\n* Other concurrent medical or psychiatric conditions that, in the Investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.\n* Any other condition that may put a participant at higher risk, at the discretion of the investigator.",{"count":627,"type":23},75,[26],"The purpose of this research study is to see if the medication sacituzumab govitecan (SG) is effective at the currently approved dose and schedule in people who have previously received trastuzumab deruxtecan (T-DXd) for the treatment of metastatic, hormone receptor positive (HR+)\u002Fhuman epidermal growth factor 2 low (HER2 low) breast cancer. Although SG is approved to treat metastatic HR+\u002FHER2 negative breast cancer, the aim of this study is to determine if SG is still effective specifically in people who have already received T-DXd.",[200,122,338,90,631],"Human Epidermal Growth Factor 2 Low Breast Cancer","2025-12-23",{"date":634,"type":38},"2025-12-26",{"date":636,"type":38},"2024-06-17",{"date":638,"type":23},"2026-12",{"name":640,"class":45},"Reshma L. Mahtani, D.O.",{"id":642,"slug":643,"hasResults":12,"nctId":644,"briefTitle":645,"officialTitle":646,"acronym":4,"eligibilityCriteria":647,"healthyVolunteers":12,"sex":115,"minAge":19,"maxAge":4,"enrollmentInfo":648,"targetDuration":4,"studyType":234,"phases":4,"briefSummary":649,"conditions":650,"keywords":654,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":659,"lastUpdatePostDateStruct":660,"startDateStruct":662,"completionDateStruct":664,"leadSponsor":665,"locationsCount":46},"100598612","real-world-study-of-post-resistance-treatment-strategies-in-advanced-breast-cancer-following-cdk46i-pik3ca-inhibitors-or-t-dxd-100598612","NCT07073755","Real-World Study of Post-Resistance Treatment Strategies in Advanced Breast Cancer Following CDK4\u002F6i, PIK3CA Inhibitors, or T-DXd","A Real-World Observational Study on Post-Resistance Treatment Outcomes in Advanced Breast Cancer Patients After CDK4\u002F6 Inhibitors, PIK3CA Inhibitors, or Trastuzumab Deruxtecan Therapy","Inclusion Criteria:\n\n1. Adults (≥18 years old) with histologically or cytologically confirmed advanced or metastatic breast cancer\n2. Received prior treatment with at least one of the following: CDK4\u002F6 inhibitors, PIK3CA inhibitors, trastuzumab deruxtecan (T-DXd), or other targeted therapies\n3. Documented disease progression following prior targeted therapy\n4. Initiated a subsequent line of systemic therapy (chemotherapy, endocrine therapy, targeted therapy, or combination) after resistance\n5. Available clinical data including baseline characteristics and treatment details\n6. At least one follow-up evaluation after initiation of post-resistance therapy\n\nExclusion Criteria:\n\n1. Incomplete medical records or missing key clinical follow-up data\n2. Concurrent diagnosis of other active malignancies (except non-melanoma skin cancer or in situ cervical cancer)\n3. Known central nervous system disease requiring immediate local treatment (unless clinically stable)\n4. Poor general condition with an Eastern Cooperative Oncology Group (ECOG) performance status ≥2\n5. Life expectancy estimated to be less than 6 months based on clinical judgment",{"count":436,"type":23},"This is a real-world observational study aiming to evaluate the effectiveness of post-progression treatment strategies in patients with advanced breast cancer who have developed resistance to prior targeted therapies, including CDK4\u002F6 inhibitors, PIK3CA inhibitors, trastuzumab deruxtecan (T-DXd), or other targeted agents commonly used in clinical practice. As resistance to these therapies becomes increasingly common, optimal sequencing strategies for subsequent treatment remain unclear.\n\nThis study will collect clinical information on post-resistance systemic treatments and their outcomes, including progression-free survival, overall survival, and response rate. Baseline patient and tumor characteristics will also be collected to explore potential prognostic and predictive factors and to develop outcome prediction models that may help guide future clinical decision-making.\n\nThis is a non-interventional study based on retrospective and prospective data from routine medical care. The results are expected to provide real-world evidence to inform personalized treatment strategies for patients with advanced breast cancer following resistance to targeted therapies.",[122,651,29,368,652,653],"Drug Resistance","Triple-Negative Breast Cancer (TNBC)","Treatment Decisions",[655,656,657,122,658],"Real-World Study","Treatment Resistance","Post-Progression Therapy","Predictive Factors","2025-07-09",{"date":661,"type":38},"2025-07-18",{"date":663,"type":38},"2023-01-01",{"date":292,"type":23},{"name":666,"class":45},"Hunan Cancer Hospital"]