[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"locally-advanced-breast-cancer-labc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:locally-advanced-breast-cancer-labc":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,51,94,124,149,176,196],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100648669","phase-2-smp-656-for-her2-positive-advanced-breast-cancer-100648669",false,"NCT07726342","SMP-656 for HER2-Positive Advanced Breast Cancer","A Randomized, Open-Label, Dose-Optimization Phase II Clinical Trial to Evaluate the Efficacy and Safety of Single-Agent SMP-656 in Patients With HER2-Positive Locally Advanced or Metastatic Breast Cancer Who Progressed After Prior Treatment With HER2-Targeted Topoisomerase Inhibitor ADCs","Inclusion Criteria:\n\n1. Voluntarily participate in this clinical trial, understand and comply with study procedures, and provide written informed consent voluntarily;\n2. Female patients aged ≥ 18 years at the time of signing the informed consent form;\n3. Patients with histologically or cytologically confirmed unresectable HER2-positive locally advanced or metastatic breast cancer, regardless of hormone receptor (HR) status;\n4. HER2-positive status confirmed by testing at the study center or an accredited laboratory, where HER2 positivity is defined as IHC 3+, or IHC 2+ with positive fluorescence in situ hybridization (FISH+) results;\n5. Patients with HER2-positive locally advanced or metastatic breast cancer who have received prior treatment with one TOP inhibitor ADC targeting HER2 (e.g., DS-8201 and other ADCs with topoisomerase inhibitor payloads), and have experienced disease progression after no more than three lines of standard therapy for recurrent or metastatic disease; 1) Endocrine monotherapy is excluded from the abovementioned standard therapy lines; 2) Disease recurrence occurring within 12 months following neoadjuvant or adjuvant chemotherapy will be regarded as progression after first-line standard therapy;\n6. Have at least one measurable target lesion per the Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) ;\n7. ECOG performance status 0-1;\n8. Expected survival ≥ 3 months;\n9. Bone marrow, hepatic, renal and coagulation function shall be deemed adequate based on laboratory tests performed within 7 days prior to the first dose of the investigational product. Blood transfusion or growth factor supportive therapy is prohibited within 14 days before the first administration of the investigational product：\n\n   * Bone marrow function: absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL; platelet count (PLT) ≥ 80 × 10⁹\u002FL; hemoglobin (Hb) ≥ 90 g\u002FL;\n   * Hepatic function: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal (ULN); total serum bilirubin (TBIL) ≤ 1.5 × ULN, with the following exceptions;\n   * For participants with confirmed liver metastases: AST and\u002For ALT ≤ 5 × ULN;\n   * For participants diagnosed with Gilbert's syndrome: TBIL ≤ 3 × ULN;\n   * Serum albumin ≥ 30 g\u002FL;\n   * Renal function: Creatinine clearance (CrCL) ≥ 50 mL\u002Fmin (calculated via the Cockcroft-Gault formula), OR serum creatinine ≤ 1.5 × ULN;\n   * Coagulation function: International Normalized Ratio (INR) ≤ 1.5 × ULN, and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN;\n10. Women of childbearing potential (WOCBP) must agree to use highly effective contraception or maintain abstinence from the time of informed consent signature through 6 months after the last administration of the investigational product；For WOCBP, serum pregnancy testing performed within 7 days prior to the first dose of the investigational product must yield a negative result.\n\nExclusion Criteria:\n\n1. Patients with inflammatory breast cancer;\n2. Have received eribulin in prior lines of therapy;\n3. Have received prior treatment with ADCs carrying tubulin inhibitor payloads for recurrent or metastatic disease;\n4. Prior anti-tumor therapy consisting of utidelone or vinca alkaloids as the last regimen;\n5. Patients with a known history of severe hypersensitivity to inetetamab, SMP-656, or any of their excipients;\n6. Patients with meningeal metastases;\n7. Patients with active central nervous system (CNS) metastases are excluded, with the following exception: symptomatic CNS metastases limited to supratentorial region and\u002For cerebellum (i.e., no midbrain, pons, medulla oblongata or spinal cord metastases) that have received local therapy, with neurological symptoms stabilized for at least 2 weeks prior to the first dose of investigational product, and no requirement for steroid therapy or receiving prednisone ≤10 mg\u002Fday (or equivalent corticosteroids) ;\n8. Patients diagnosed with any other malignancy (other than the study tumor type) within 5 years prior to the first dose of the investigational product, except curatively treated localized malignancies such as basal cell carcinoma of the skin;\n9. Previous, current or suspected interstitial lung disease (ILD), drug-induced interstitial lung disease; or clinically significant active pneumonia identified at screening; or radiation pneumonitis, or other severe pulmonary disorders impairing respiratory function, which in the Investigator's judgment may interfere with the detection or management of investigational product-related pulmonary toxicity;\n10. Patients with a clinically significant history of cardiovascular disease, including but not limited to： (1) Left ventricular ejection fraction (LVEF) \\\u003C 50%; congestive heart failure with New York Heart Association (NYHA) functional class \\> 2; (2) Have experienced myocardial infarction, unstable angina, severe pericardial disease or severe myocardial disease within the previous 6 months; (3) Presence of cardiac valve regurgitation or stenosis requiring therapeutic intervention; (4) Any supraventricular or ventricular arrhythmia requiring treatment or intervention; poorly controlled malignant arrhythmias despite medication; complete left bundle branch block, second-degree or third-degree atrioventricular block; (5) QTc interval \\> 470 ms at screening (for female participants), or known family history of long QT syndrome; (6) Uncontrolled hypertension (defined as systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg despite antihypertensive medication, or prior history of hypertensive crisis or hypertensive encephalopathy) ;\n11. History of arterial or venous thromboembolic events within 6 months prior to the first dose of the investigational product, such as cerebrovascular accident, deep vein thrombosis and pulmonary embolism;\n12. Participants with uncontrollable pleural effusion, pericardial effusion or ascites as judged by the Investigator, which requires repeated drainage once every two weeks or more frequently. Participants with indwelling pleural catheters are permitted to enroll;\n13. Have received live attenuated vaccines within 4 weeks prior to the first dose of the investigational produc, or plan to receive live attenuated vaccines during the study;\n14. Patients with severe infection within 4 weeks prior to the first dose of the investigational product, including but not limited to bacteremia or severe pneumonia requiring hospitalization; or active infection with CTCAE Grade ≥2 requiring systemic antibiotic therapy within 2 weeks before the first dose (prophylactic antibiotics excluded) ;\n15. Patients meeting any of the following criteria will be excluded: patients with active hepatitis B or hepatitis C；For patients positive for hepatitis B surface antigen (HBsAg) and\u002For hepatitis B core antibody (HBcAb), enrollment is permitted only if quantitative hepatitis B virus DNA (HBV-DNA) is below the upper limit of normal (ULN) of the study site laboratory；For patients positive for hepatitis C antibody (HCV-Ab), enrollment is permitted only if HCV RNA is below the ULN of the study site laboratory；Positive human immunodeficiency virus (HIV) antibody test; active syphilis infection; active tuberculosis infection;\n16. Patients with unresolved prior anti-tumor treatment-related toxicities (alopecia excluded) remaining at Grade \\>1 or not recovered to baseline, except adverse events (AEs) deemed not to pose a safety risk by the Investigator;\n17. Patients with Grade ≥2 peripheral neuropathy; or prior history of Grade ≥3 neurotoxicity \u002F peripheral neuropathy; or permanent discontinuation of previous anti-tumor treatment due to neurotoxicity or peripheral neuropathy;\n18. Patients with a history of allogeneic stem cell transplantation or solid organ transplantation, or those planning to receive allogeneic stem cell transplantation or solid organ transplantation during the study;\n19. Patients who have participated in any other clinical trial within 4 weeks or 5 half-lives prior to the first dose of the investigational product, whichever is shorter;\n20. Patients who received radiotherapy within 4 weeks prior to the first dose of the investigational product are excluded, except palliative radiotherapy administered for symptom control within 2 weeks before the first dose of investigational product;\n21. Patients who received systemic anti-tumor therapy within 4 weeks prior to the first dose of the investigational product are excluded, except for the following： 1) Enrollment is permitted only if at least 6 weeks have elapsed between the completion of prior nitrosourea or mitomycin chemotherapy and the first dose of the investigational product; 2) Enrollment is allowed only if a minimum of 1 week has passed between the discontinuation of prior small-molecule targeted therapy and the first dose of the investigational product; 3) Enrollment is permitted only if a minimum of 2 weeks have elapsed between discontinuation of prior traditional Chinese medicine with anti-tumor effects and the first dose of the investigational product;\n22. articipants who have undergone major surgery within 4 weeks prior to the first dose of the investigational product, or are expected to receive major surgery during the study period (diagnostic surgery excluded); those who received diagnostic or minimally invasive surgery within 1 week before the first dose are also excluded;\n23. Patients requiring long-term treatment with corticosteroids or immunosuppressive agents (e.g., active autoimmune diseases requiring systemic therapy). Replacement therapies such as thyroxine, insulin, or physiological corticosteroid replacement for adrenal or pituitary insufficiency are permitted;\n24. Prior documented history of neurological or psychiatric disorders, including epilepsy or dementia;\n25. Female Patients who are pregnant, breastfeeding, or planning to become pregnant during the study;\n26. Patients with severe concomitant diseases that may compromise patient safety or interfere with study completion as judged by the Investigator (e.g., severe hypertension, diabetes mellitus, thyroid disorders), or any other conditions deemed inappropriate for study participation by the Investigator .","ALL","18 Years",{"count":19,"type":20},60,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The goal of this clinical trial is to learn if single-agent SMP-656 works to treat patients with HER2-positive locally advanced or metastatic breast cancer who have progressed after prior HER2-targeted topoisomerase inhibitor antibody-drug conjugate (ADC) treatment. It will also evaluate the safety of SMP-656 and identify the optimal dose for future trials. The main questions it aims to answer are:\n\nWhat is the objective tumor response rate (DOR, PFS, DCR, OS) of two different dose regimens of intravenous SMP-656? What are the side effects and safety risks of these two SMP-656 dose regimens? Which dose level achieves the best balance of anti-cancer activity and tolerability? This is a randomized, open-label, dose-optimization Phase II clinical trial. Participants will be randomly assigned 1:1 to receive one of two fixed doses of SMP-656 given intravenously once every 3 weeks.\n\nParticipants will:\n\nComplete screening tests within 28 days before the first SMP-656 infusion to confirm eligibility Receive study treatment every 3 weeks until cancer progression, intolerable side effects, withdrawal, or other stopping criteria Have regular tumor imaging scans, physical exams, vital sign checks, and blood tests to monitor tumor response and safety Attend a safety follow-up visit 30 days after the last dose of SMP-656 Complete longer-term survival follow-up after the 30-day safety check Provide optional blood and tumor tissue samples for additional research studies",[26,27,28],"HER2-positive Breast Cancer","Metastatic Breast Cancer","Locally Advanced Breast Cancer (LABC)",[30,31,32,33,34,35,36,37,27],"SMP-656","Randomized Open-Label Trial","HER2","Antibody-Drug Conjugate","Trastuzumab Deruxtecan resistant","Phase II Trial","Dose Optimization","Topoisomerase Inhibitor","NOT_YET_RECRUITING","2026-07-22",{"date":41,"type":42},"2026-07-24","ACTUAL",{"date":44,"type":20},"2026-07-16",{"date":46,"type":20},"2027-10-20",{"name":48,"class":49},"Chengdu SciMount Pharmatech Co., Ltd.","INDUSTRY",15,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":58,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":4,"studyType":21,"phases":63,"briefSummary":65,"conditions":66,"keywords":70,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":4},"100636798","targeting-stress-driven-inflammatory-and-angiogenic-pathways-with-brief-act-to-enhance-neoadjuvant-chemotherapy-response-in-locally-advanced-breast-cancer-100636798","NCT07570368","Targeting Stress-Driven Inflammatory and Angiogenic Pathways With Brief ACT to Enhance Neoadjuvant Chemotherapy Response in Locally Advanced Breast Cancer","Effect of Brief Acceptance and Commitment Therapy on Neoadjuvant Chemotherapy Response in Locally Advanced Breast Cancer Through Modulation of Inflammatory and Angiogenic Biomarkers.","Inclusion Criteria:\n\n* Female patients aged 40-65 years\n* Histologically confirmed locally advanced breast cancer\n* Planned to undergo neoadjuvant chemotherapy\n* ECOG performance status 0-2\n* Able to provide informed consent\n* Willing to participate in psychological intervention sessions\n\nExclusion Criteria:\n\n* Severe psychological distress defined as Perceived Stress Scale (PSS-10) score ≥27\n* Active infection or inflammatory disease\n* Known autoimmune disease\n* Cognitive impairment or psychiatric condition interfering with participation\n* Concurrent participation in another interventional study","FEMALE","40 Years","65 Years",{"count":62,"type":20},54,[64],"NA","This clinical trial aims to learn whether a brief psychological therapy called Brief Acceptance and Commitment Therapy (Brief-ACT) can improve the effectiveness of neoadjuvant chemotherapy in patients with locally advanced breast cancer. It will also examine how this therapy affects stress levels and certain blood markers related to inflammation and tumor growth.\n\nThe main questions this study aims to answer are:\n\nDoes Brief-ACT improve the rate of pathological complete response (pCR) after chemotherapy? Does Brief-ACT reduce levels of inflammatory and angiogenic biomarkers such as C-reactive protein (CRP), interleukin-6 (IL-6), neutrophil-to-lymphocyte ratio (NLR), and vascular endothelial growth factor (VEGF)? Does Brief-ACT reduce psychological stress in patients undergoing chemotherapy?\n\nResearchers will compare patients who receive Brief-ACT in addition to standard chemotherapy with those who receive standard chemotherapy alone to see if there are differences in treatment response, stress levels, and biomarker levels.\n\nParticipants will:\n\nReceive neoadjuvant chemotherapy according to standard treatment protocols Be assigned to receive Brief-ACT sessions or no additional psychological intervention Attend regular clinic visits for treatment and monitoring Provide blood samples at specific time points for laboratory analysis Complete questionnaires to assess psychological stress",[67,68,28,69],"Breast Cancer","Breast Neoplasm Female","Locally Advanced Breast Cancer",[71,72,73,74,75,76,77,78,79,80,81,82,83],"breast cancer","Locally advanced breast cancer","brief acceptance and commitment therapy","acceptance and commitment therapy","neoadjuvant chemotherapy","clinical chemotherapy response","inflammatory biomarkers","angiogenic biomarkers","interleukin-6","neutrophil to lymphocyte ratio","vascular endothelial growth factor","psychological stress","psycho-oncology","2026-04-29",{"date":86,"type":42},"2026-05-06",{"date":88,"type":20},"2026-04-28",{"date":90,"type":20},"2027-01",{"name":92,"class":93},"Universitas Airlangga","OTHER",{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":100,"eligibilityCriteria":101,"healthyVolunteers":11,"sex":58,"minAge":17,"maxAge":4,"enrollmentInfo":102,"targetDuration":4,"studyType":104,"phases":4,"briefSummary":105,"conditions":106,"keywords":107,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":123},"100632664","patient-derived-organoids-to-functionally-characterize-chemotherapy-resistance-in-breast-cancer-100632664","NCT07516626","Patient-Derived Organoids to Functionally Characterize Chemotherapy Resistance in Breast Cancer","Functional Characterization of Neoadjuvant Chemotherapy Resistance in Breast Cancer Using Patient-Derived Organoid Models and Development of Drug Repurposing Strategies With Next-Generation Small Molecules","BC-PDO","Inclusion Criteria:\n\n* Female patients aged 18 years or older\n* Histologically confirmed locally advanced breast cancer\n* Planned to receive neoadjuvant chemotherapy\n* Availability of tumor tissue obtained during routine diagnostic or therapeutic procedures\n* Availability of clinical and pathological treatment data\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Age under 18 years\n* Metastatic breast cancer\n* Prior systemic chemotherapy or targeted therapy for the current diagnosis\n* Presence of another active malignancy\n* Severe comorbid conditions that may interfere with study participation\n* Insufficient biological sample for organoid generation or analysis\n* Inability or unwillingness to provide informed consent",{"count":103,"type":20},40,"OBSERVATIONAL","This prospective observational study aims to functionally characterize chemotherapy resistance in patients with locally advanced breast cancer undergoing neoadjuvant chemotherapy. Despite standard molecular classification, significant heterogeneity in treatment response exists, and the biological mechanisms underlying chemoresistance remain incompletely understood.\n\nIn this study, patient-derived organoid (PDO) models will be established from tumor tissues obtained during routine clinical care. These three-dimensional models preserve the biological characteristics of individual tumors and enable ex vivo functional assessment of drug response. Chemotherapy sensitivity and resistance will be evaluated using quantitative parameters including Half-Maximal Inhibitory Concentration (IC50) values, cell viability, and apoptotic response.\n\nFunctional data obtained from PDO models will be correlated with clinical and pathological treatment outcomes, particularly pathological complete response (pCR), to assess the predictive value of PDO-based assays. In addition, apoptotic biomarkers such as Caspase-3\u002F7 will be measured in serum samples collected during routine clinical evaluation and analyzed in relation to treatment response.\n\nFurthermore, selected Food and Drug Administration (FDA) and European Medicines Agency (EMA) approved small molecules will be tested in PDO models to evaluate their potential to reverse chemotherapy resistance, supporting drug repurposing strategies. This study aims to establish a functional, patient-specific platform for assessing chemoresistance and to contribute to the development of personalized therapeutic approaches in breast cancer.",[67,28],[108,109,110,111,112,113,69],"Neoadjuvant Chemotherapy","Chemotherapy Resistance","Patient-Derived Organoids","Drug Repurposing","Pathological Complete Response","Ex Vivo Drug Testing","2026-04-07",{"date":116,"type":42},"2026-04-13",{"date":118,"type":20},"2026-06",{"date":120,"type":20},"2029-06",{"name":122,"class":93},"Atlas University",1,{"id":125,"slug":126,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":4,"eligibilityCriteria":130,"healthyVolunteers":131,"sex":58,"minAge":17,"maxAge":132,"enrollmentInfo":133,"targetDuration":4,"studyType":21,"phases":135,"briefSummary":136,"conditions":137,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":123},"100625261","preoperative-shoulder-exercises-and-postoperative-inflammation-pain-and-function-after-modified-radical-mastectomy-100625261","NCT07420335","Preoperative Shoulder Exercises and Postoperative Inflammation, Pain, and Function After Modified Radical Mastectomy","The Effect of Preoperative Shoulder Range-of-Motion Exercises on C-Reactive Protein (CRP) Levels, Pain, and Shoulder Joint Dysfunction, as Well as Quality of Life in Patients With Locally Advanced Breast Cancer After Modified Radical Mastectomy","Inclusion Criteria:\n\n* Patients with clinically locally advanced breast cancer (stage IIIA-IIIC according to the American Joint Committee on Cancer staging system) who have been scheduled to undergo modified radical mastectomy.\n* Age ≥ 18 years at the time of diagnosis\n* Willing to undergo preoperative rehabilitation for 6-8 weeks and to perform the recommended home-based exercise program.\n* Willing to participate in follow-up via telephone.\n\nExclusion Criteria:\n\n* Inability to understand verbal or written communication, resulting in difficulty following exercise instructions.\n* Intraoperative complications, such as injury to or transection of the thoracodorsal nerve, long thoracic nerve, and\u002For intercostobrachial nerve.\n* Postoperative complications leading to delayed wound healing, defined as incomplete wound healing at one month after surgery, including wound dehiscence, wound infection, or abscess formation.\n* Pre-existing shoulder joint motion limitation diagnosed prior to surgery (e.g., preoperative frozen shoulder).\n* Presence of inflammatory conditions in other body regions at the start of or during the study that may result in elevated leukocyte counts, such as diarrhea, urinary tract infection, or skin infection.\n* Requirement for nonsteroidal anti-inflammatory drugs (NSAIDs) or systemic corticosteroids for the management of inflammation.\n\nDrop out criteria:\n\n* incomplete follow up\n* Unwillingness to undergo repeated blood sampling during the study period.",true,"70 Years",{"count":134,"type":20},52,[64],"This study evaluates whether preoperative shoulder range-of-motion exercises influence postoperative inflammatory response, pain, shoulder function, and quality of life in patients with locally advanced breast cancer undergoing modified radical mastectomy.",[28,138,139],"Postoperative Inflammation","Prehabilitation","2026-02-12",{"date":142,"type":42},"2026-02-19",{"date":144,"type":20},"2026-01-21",{"date":146,"type":20},"2026-12-03",{"name":148,"class":93},"Indonesia University",{"id":150,"slug":151,"hasResults":11,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":4,"eligibilityCriteria":155,"healthyVolunteers":11,"sex":58,"minAge":17,"maxAge":156,"enrollmentInfo":157,"targetDuration":4,"studyType":21,"phases":159,"briefSummary":161,"conditions":162,"keywords":4,"overallStatus":166,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":123},"100593110","phase-1-a-phase-ibii-study-to-evaluate-multiple-combination-therapies-of-fwd1802-in-patients-with-erher2--bc-100593110","NCT07002177","A Phase Ib\u002FII Study to Evaluate Multiple Combination Therapies of FWD1802 in Patients With ER+\u002FHER2- BC","An Open-label, Multicenter, Phase Ib\u002FII Clinical Study to Evaluate the Safety and Efficacy of Multiple Combination Therapies With FWD1802 in Subjects With ER-positive\u002FHER2-negative Unresectable Locally Advanced or Metastatic Breast Cancer","Inclusion Criteria:\n\n* Subjects consent to provide blood samples for centralized laboratory testing of ESR1 mutation status and other biomarkers.\n* Histologically or cytologically confirmed ER-positive\u002FHER2-negative locally advanced or metastatic breast cancer\n* Subjects must meet at least one of the following criteria: postmenopausal or prior bilateral oophorectomy, or postmenopausal or Premenopausal\u002Fperimenopausal women must agree to receive and maintain approved luteinizing hormone-releasing hormone (LHRH) agonist therapy during study treatment\n* Prior Therapy Requirements:Subjects must meet all of the following criteria:\n\n  1. Progression during\u002Fafter, intolerance to, ineligibility for, or refusal of standard therapy\n  2. Endocrine therapy history:\n\n     Recurrence during or within 1 year after completing ≥2 years of adjuvant endocrine therapy;OR progression after ≥1 line of endocrine therapy for advanced breast cancer(ABC) with ≥6 months of maintenance therapy (no restriction on the number of prior endocrine therapy lines).\n  3. ≤2 prior lines of chemotherapy for ABC\n  4. No prior SERD (selective estrogen receptor degrader) therapy except fulvestrant\n  5. Everolimus combination arm: Prior CDK4\u002F6 inhibitor therapy requiredf) CDK4\u002F6 inhibitor combination arm:Permitted ≤1 line of prior non-investigational CDK4\u002F6 inhibitor therapy;If only received adjuvant CDK4\u002F6 inhibitor therapy, recurrence must occur \\>12 months after treatment completion Note: Antibody-drug conjugates (ADCs) are classified as chemotherapy in this study.\n* Phase Ib: At least one evaluable lesion per RECIST v1.1, allowed subjects with osteolytic bone lesion(s) confirmed by CT\u002FMRI.Phase II: At least one measurable lesion per RECIST v1.1.\n\nSubject must have sufficient organ and bone marrow functions at screening.\n\nExclusion Criteria:\n\n* Leptomeningeal metastasis (carcinomatous meningitis)；Spinal cord compression；Symptomatic or clinically unstable central nervous system (CNS) metastases；\n* History or any persistent chronic gastrointestinal disorders or other conditions of impaired absorption that may interfere with oral absorption of the investigational drug\n* Symptomatic visceral metastases , or clinically symptomatic and unstable effusions;Pleural effusion;Ascites;Pericardial effusion or Pulmonary lymphangitis carcinomatosa. Prior intracavitary infusion therapy should have more than 14 days of stabilization,\n* Prior therapy with any selective estrogen receptor degrader (SERD) or similar agents other than fulvestrant\n* Inadequate washout period for prior anticancer therapies.\n* Type 1 diabetes mellitus; Type 2 diabetes mellitus with poor glycemic control at screening(applies only to the everolimus combination arm).\n* Subjects will be excluded if they meet any of the following:\n\n  1. Interstitial lung disease or drug-induced ILD history, OR evidence of active pneumonitis on chest CT scan within 4 weeks prior to first study treatment.\n  2. Severe pulmonary disease at screening, including but not limited to:Severe asthma;Severe chronic obstructive pulmonary disease (COPD) Idiopathic\n* Uncontrolled hypertension despite antihypertensive therapy, defined as:Systolic blood pressure (SBP) \\>150 mmHg OR Diastolic blood pressure (DBP) \\>95 mmHg.\n* Active cardiac disease or history of cardiac dysfunction","75 Years",{"count":158,"type":20},196,[160,23],"PHASE1","This is a Study to Evaluate the Efficacy and Safety of Multiple Combination Therapies with FWD1802 in Subjects with ER-positive\u002FHER2-negative Unresectable Locally Advanced or Metastatic Breast Cancer",[27,163,164,28,165],"Breast Cancer Stage I","Breast Cancer Stage II","ER+ Breast Cancer","RECRUITING","2026-01-05",{"date":169,"type":42},"2026-01-07",{"date":171,"type":42},"2025-06-01",{"date":173,"type":20},"2028-11-01",{"name":175,"class":49},"Forward Pharmaceuticals Co., Ltd.",{"id":177,"slug":178,"hasResults":11,"nctId":179,"briefTitle":180,"officialTitle":181,"acronym":4,"eligibilityCriteria":182,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":183,"targetDuration":4,"studyType":21,"phases":184,"briefSummary":185,"conditions":186,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":123},"100618834","phase-1-jskn016-in-combination-with-d-0502-for-locally-advanced-or-metastatic-hr-positive-her2-negative-breast-cancer-100618834","NCT07336771","JSKN016 in Combination With D-0502 for Locally Advanced or Metastatic HR-Positive, HER2-Negative Breast Cancer","A Multicenter, Open-Label, Phase Ib\u002FII Randomized Study of JSKN016 in Combination With D-0502 in Patients With Locally Advanced or Metastatic Hormone Receptor-Positive, HER2-Negative Breast Cancer","Inclusion Criteria:\n\n* Age ≥18 years\n* Histologically or cytologically confirmed locally advanced or metastatic HR-positive, HER2-negative breast cancer\n* HR-positive defined as ER and\u002For PR ≥1% by IHC\n* HER2-negative per ASCO\u002FCAP guidelines\n* At least one measurable extracranial lesion per RECIST v1.1\n* ECOG performance status 0-1\n* Prior progression on CDK4\u002F6 inhibitor plus endocrine therapy\n* Adequate organ and cardiac function\n* Postmenopausal women, or premenopausal women receiving ovarian function suppression\n\nExclusion Criteria:\n\n* Active or untreated CNS metastases\n* Prior treatment with ADCs containing topoisomerase I inhibitor payloads\n* Active interstitial lung disease or pneumonitis\n* Uncontrolled cardiovascular disease or active infection\n* Prior malignancy within 5 years (with specific exceptions)\n* Pregnancy or breastfeeding",{"count":19,"type":20},[160,23],"This is a multicenter, open-label, Phase Ib\u002FII randomized study designed to evaluate the safety, tolerability, dose-limiting toxicities (DLTs), and preliminary antitumor activity of JSKN016 in combination with the oral selective estrogen receptor degrader (SERD) D-0502 in patients with locally advanced or metastatic hormone receptor-positive (HR+), HER2-negative breast cancer who have previously progressed on CDK4\u002F6 inhibitor-based endocrine therapy.\n\nApproximately 60 patients will be randomized in a 1:1 ratio to receive JSKN016 administered intravenously every 2 weeks (Q2W) or every 3 weeks (Q3W), in combination with daily oral D-0502. Each dosing cohort will include a safety lead-in phase to assess DLTs prior to cohort expansion. Tumor response will be assessed according to RECIST v1.1.",[27,28],"2026-01-04",{"date":189,"type":42},"2026-01-13",{"date":191,"type":20},"2026-01",{"date":193,"type":20},"2028-06",{"name":195,"class":49},"Jiangsu Alphamab Biopharmaceuticals Co., Ltd",{"id":197,"slug":198,"hasResults":11,"nctId":199,"briefTitle":200,"officialTitle":201,"acronym":4,"eligibilityCriteria":202,"healthyVolunteers":11,"sex":58,"minAge":17,"maxAge":156,"enrollmentInfo":203,"targetDuration":4,"studyType":21,"phases":205,"briefSummary":206,"conditions":207,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":209,"startDateStruct":211,"completionDateStruct":213,"leadSponsor":215,"locationsCount":4},"100607540","phase-1-pyrotinib-maleate-tablets-in-combination-with-dalpiciclib-isethionate-tablets-and-standard-endocrine-therapy-100607540","NCT07189884","Pyrotinib Maleate Tablets in Combination With Dalpiciclib Isethionate Tablets and Standard Endocrine Therapy","A Single-arm, Exploratory Clinical Study of Pyrotinib in Combination With Darcilib and Standard Endocrine Neoadjuvant Therapy for the Treatment of HR+HER2 Low-expression Breast Cancer","Inclusion Criteria:\n\n1. Female patients aged ≥18 years and ≤75 years old, who have just been treated for breast cancer;\n2. Pathological examination confirmed that HR was positive (ER≥10%) and HER2 was low (immunohistochemical staining ICH++ and FISH negative);\n3. Patients with invasive breast cancer confirmed by pathological examination (T≥3 or N≥1) who are eligible for neoadjuvant therapy;\n4. ECOG score 0\\~1 points;\n5. Planned to undergo definitive surgical resection of breast cancer, i.e., breast-conserving surgery or total mastectomy, sentinel lymph node (SN) biopsy, or axillary lymph node dissection (ALND);\n6. Normal function of major organs, i.e. meeting the following criteria:\n\n(1) Blood routine examination standards must meet: ANC ≥1.5×109\u002FL; PLT ≥90×109\u002FL； Hb ≥90g\u002FL； (2) Biochemical examination must meet the following criteria: TBIL ≤upper limit of normal (ULN); ALT and AST ≤ 1.5 times the upper limit of normal (ULN), alkaline phosphatase ≤ 2.5 times the upper limit of normal (ULN), BUN and Cr ≤ 1.5× ULN and creatinine clearance ≥ 50 mL\u002Fmin (CockcroftGault formula); (3) Cardiac color ultrasound and echocardiography: left ventricular ejection fraction (LVEF≥55%); (4) 18-lead ECG corrected by Fridericia's QT interval (QTcF) in women\\\u003C 470 ms; 7. For female patients who are not menopausal or surgically sterilized: agree to abstain from sexual activity or use an effective contraceptive method during the treatment period and for at least 7 months after the last dose of study treatment; 8. Volunteer to join this study and sign the informed consent form.\n\nExclusion Criteria:\n\n1. Those who have a known history of allergy to the drug components of this regimen;\n2. Previous anti-tumor therapy or radiotherapy for any malignant tumor (except for cured cervical carcinoma in situ and basal cell carcinoma);\n3. Underwent major surgical procedures unrelated to breast cancer within 4 weeks, or patients have not fully recovered from such surgical procedures;\n4. Patients with stage IV (metastatic) breast cancer;\n5. Inability to swallow, intestinal obstruction, or other factors affecting drug intake and absorption;\n6. Severe heart disease or discomfort that cannot be treated;\n7. Suffering from mental illness or psychotropic substance abuse and unable to cooperate;\n8. Pregnant or lactating female patients;\n9. Patients with severe liver and kidney function diseases and hematological diseases;\n10. Those who are not suitable for enrollment in the investigator's opinion: such as a history of drug abuse, blood products, anticoagulant drugs and immunological drugs in the past year; Those with poor compliance and refusal to cooperate with treatment; Doctors with severe hypertension and diabetes are not suitable for the study.",{"count":204,"type":20},33,[160,23],"This study is a prospective, exploratory clinical study design, and plans to enroll 33 patients with HR+HER2 low expression breast cancer who received pyrotinib combined with darcili and standard endocrine neoadjuvant therapy to evaluate the efficacy of this regimen in HR+HER2 low expression breast cancer. Imaging evaluation was performed according to RECIST 1.1 criteria, and tumor imaging evaluation was performed by the participating center. The pathological evaluation after surgery of neoadjuvant patients was the pCR assessed by the pathologist of the participating center.",[28],"2025-09-17",{"date":210,"type":42},"2025-09-24",{"date":212,"type":20},"2025-09-23",{"date":214,"type":20},"2028-12-31",{"name":216,"class":93},"The First Affiliated Hospital of Xiamen University"]