[{"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":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,57,88,113,143,165],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":46,"lastUpdatePostDateStruct":47,"startDateStruct":50,"completionDateStruct":52,"leadSponsor":54,"locationsCount":4},"100636798","targeting-stress-driven-inflammatory-and-angiogenic-pathways-with-brief-act-to-enhance-neoadjuvant-chemotherapy-response-in-locally-advanced-breast-cancer-100636798",false,"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":20,"type":21},54,"ESTIMATED","INTERVENTIONAL",[24],"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",[27,28,29,30],"Breast Cancer","Breast Neoplasm Female","Locally Advanced Breast Cancer (LABC)","Locally Advanced Breast Cancer",[32,33,34,35,36,37,38,39,40,41,42,43,44],"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","NOT_YET_RECRUITING","2026-04-29",{"date":48,"type":49},"2026-05-06","ACTUAL",{"date":51,"type":21},"2026-04-28",{"date":53,"type":21},"2027-01",{"name":55,"class":56},"Universitas Airlangga","OTHER",{"id":58,"slug":59,"hasResults":11,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":11,"sex":16,"minAge":65,"maxAge":4,"enrollmentInfo":66,"targetDuration":4,"studyType":68,"phases":4,"briefSummary":69,"conditions":70,"keywords":71,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":87},"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","18 Years",{"count":67,"type":21},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.",[27,29],[72,73,74,75,76,77,30],"Neoadjuvant Chemotherapy","Chemotherapy Resistance","Patient-Derived Organoids","Drug Repurposing","Pathological Complete Response","Ex Vivo Drug Testing","2026-04-07",{"date":80,"type":49},"2026-04-13",{"date":82,"type":21},"2026-06",{"date":84,"type":21},"2029-06",{"name":86,"class":56},"Atlas University",1,{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":4,"eligibilityCriteria":94,"healthyVolunteers":95,"sex":16,"minAge":65,"maxAge":96,"enrollmentInfo":97,"targetDuration":4,"studyType":22,"phases":99,"briefSummary":100,"conditions":101,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":87},"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":98,"type":21},52,[24],"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.",[29,102,103],"Postoperative Inflammation","Prehabilitation","2026-02-12",{"date":106,"type":49},"2026-02-19",{"date":108,"type":21},"2026-01-21",{"date":110,"type":21},"2026-12-03",{"name":112,"class":56},"Indonesia University",{"id":114,"slug":115,"hasResults":11,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":4,"eligibilityCriteria":119,"healthyVolunteers":11,"sex":16,"minAge":65,"maxAge":120,"enrollmentInfo":121,"targetDuration":4,"studyType":22,"phases":123,"briefSummary":126,"conditions":127,"keywords":4,"overallStatus":132,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":87},"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":122,"type":21},196,[124,125],"PHASE1","PHASE2","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",[128,129,130,29,131],"Metastatic Breast Cancer","Breast Cancer Stage I","Breast Cancer Stage II","ER+ Breast Cancer","RECRUITING","2026-01-05",{"date":135,"type":49},"2026-01-07",{"date":137,"type":49},"2025-06-01",{"date":139,"type":21},"2028-11-01",{"name":141,"class":142},"Forward Pharmaceuticals Co., Ltd.","INDUSTRY",{"id":144,"slug":145,"hasResults":11,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":4,"eligibilityCriteria":149,"healthyVolunteers":11,"sex":150,"minAge":65,"maxAge":4,"enrollmentInfo":151,"targetDuration":4,"studyType":22,"phases":153,"briefSummary":154,"conditions":155,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":87},"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","ALL",{"count":152,"type":21},60,[124,125],"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.",[128,29],"2026-01-04",{"date":158,"type":49},"2026-01-13",{"date":160,"type":21},"2026-01",{"date":162,"type":21},"2028-06",{"name":164,"class":142},"Jiangsu Alphamab Biopharmaceuticals Co., Ltd",{"id":166,"slug":167,"hasResults":11,"nctId":168,"briefTitle":169,"officialTitle":170,"acronym":4,"eligibilityCriteria":171,"healthyVolunteers":11,"sex":16,"minAge":65,"maxAge":120,"enrollmentInfo":172,"targetDuration":4,"studyType":22,"phases":174,"briefSummary":175,"conditions":176,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"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":173,"type":21},33,[124,125],"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.",[29],"2025-09-17",{"date":179,"type":49},"2025-09-24",{"date":181,"type":21},"2025-09-23",{"date":183,"type":21},"2028-12-31",{"name":185,"class":56},"The First Affiliated Hospital of Xiamen University"]