[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"breast-neoplasm-malignant-female\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:breast-neoplasm-malignant-female":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,53,91,119],{"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":28,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100651605","supervised-exercise-during-neoadjuvant-chemotherapy-for-breast-cancer-100651605",false,"NCT07764341","Supervised Exercise During Neoadjuvant Chemotherapy for Breast Cancer","Supervised Exercise During Neoadjuvant Chemotherapy for Breast Cancer: Protocol for a Randomized Feasibility Trial","Inclusion Criteria:\n\n1. Histologically confirmed invasive breast carcinoma, clinical stage I-III.\n2. Female, age ≥18 years.\n3. Planned to undergo standard neoadjuvant chemotherapy of ≥4 months duration with curative intent, followed by definitive surgery. This includes common regimens such as taxane- and anthracycline-based chemotherapy or TCHP (docetaxel, carboplatin, trastuzumab, pertuzumab) for HER2-positive disease.\n4. Availability of a baseline CT or PET\u002FCT scan (as part of routine diagnosis or staging) that includes axial images at the third lumbar vertebra (L3) level, performed prior to starting NACT.\n5. Anticipated post-NACT CT or PET\u002FCT scan (e.g. for re-staging) that includes the L3 level, to be performed after completion of NACT and before surgery per standard care practice.\n6. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.\n7. Cleared by treating oncologist and physiotherapist as medically able to participate in a moderate-intensity exercise program (e.g. able to walk independently with or without an assistive device and perform basic resistance exercises).\n8. Able and willing to provide written informed consent.\n9. Able to understand study instructions and complete questionnaires.\n\nExclusion Criteria:\n\n1. Evidence of distant metastatic disease (stage IV) or treatment plan not aiming for curative intent.\n2. Unstable or severe cardiac, pulmonary, or other systemic comorbidities that would make moderate exercise unsafe, such as unstable angina or recent myocardial infarction, decompensated heart failure, uncontrolled severe arrhythmia, uncontrolled severe hypertension, or severe symptomatic lung disease.\n3. Major musculoskeletal or neurological conditions that would preclude safe participation in supervised exercise (e.g. unstable orthopedic injuries, severe neuropathy or neurologic deficit, or recent major surgery not yet recovered).\n4. Current second active malignancy (excluding second localized early breast cancer).\n5. Regular participation in ≥150 minutes per week of moderate-vigorous aerobic activity and ≥2 resistance training sessions per week in the 3 months before cancer diagnosis.\n6. Baseline imaging not available or not including L3, or patient unlikely to have a post-NACT scan including L3 (e.g. if they refuse imaging).\n7. CT images of insufficient quality (e.g. severe artifacts or truncated field of view at L3) that would prevent accurate muscle measurement.\n8. Pregnant or breastfeeding at the time of enrollment.\n9. Significant cognitive impairment, psychiatric disorder, or language barrier that would prevent informed consent or compliance with the protocol.\n10. Any other condition or circumstance that, in the opinion of the investigator, would make participation not in the patient's best interest or would compromise the scientific integrity of the study.","FEMALE","18 Years",{"count":19,"type":20},80,"ESTIMATED","INTERVENTIONAL",[23],"NA","The goal of this clinical trial is to learn whether supervised exercise is practical and safe for women receiving chemotherapy before surgery for breast cancer.\n\nThe main questions it aims to answer are:\n\n* Can participants attend and complete the supervised exercise program during chemotherapy?\n* Is the exercise program safe?\n* Does exercise help maintain muscle mass, strength, quality of life, and chemotherapy delivery?\n\nParticipants will be assigned to either:\n\n* supervised aerobic and strength exercise during chemotherapy, or\n* usual care without a study exercise program. Researchers will compare the two groups before and after chemotherapy.",[26,27],"Breast Cancer Early Stage Breast Cancer (Stage 1-3)","Breast Neoplasm Malignant Female",[29,30,31,32,33,34,35,36,37,38,39],"breast cancer","sarcopenia","neoadjuvant chemotherapy","exercise","resistance training","body composition","physical activity","quality of life","skeletal muscle","pathologic complete response","relative dose intensity","NOT_YET_RECRUITING","2026-08-11",{"date":43,"type":44},"2026-08-13","ACTUAL",{"date":46,"type":20},"2026-09",{"date":48,"type":20},"2027-09",{"name":50,"class":51},"King Hamad University Hospital, Bahrain","OTHER",1,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":61,"targetDuration":4,"studyType":63,"phases":4,"briefSummary":64,"conditions":65,"keywords":71,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":90},"100605450","step-count-and-treatment-response-in-neoadjuvant-breast-cancer-100605450","NCT07162675","Step Count and Treatment Response in Neoadjuvant Breast Cancer","A Multicenter Prospective Study: The Impact of Step Count Measured by Smartwatches on Treatment Response in Non-Metastatic HER2-Negative Breast Cancer Patients Receiving Neoadjuvant Therapy","NEOBRE-STEP","Inclusion Criteria:\n\n* Female patients aged ≥18 years.\n* Pathologically confirmed non-metastatic HER2-negative breast cancer.\n* Candidates scheduled to receive neoadjuvant systemic therapy followed by surgery.\n* ECOG performance status 0-2.\n* Ability to provide informed consent.\n\nExclusion Criteria:\n\n* Metastatic breast cancer at diagnosis.\n* HER2-positive breast cancer.\n* Previous systemic therapy for current breast cancer.\n* Severe comorbidities limiting mobility or physical activity (e.g., advanced neurologic or musculoskeletal disorders).\n* ECOG performance status ≥3.\n* Pregnancy or breastfeeding.\n* Refusal or inability to use a smartwatch device.",{"count":62,"type":20},82,"OBSERVATIONAL","This prospective multicenter observational study (NEOBRE-STEP) investigates the impact of daily step counts, measured by Huawei Fit 2 smartwatches, on treatment response in patients with non-metastatic Human Epidermal Growth Factor Receptor 2 (HER2)-negative breast cancer undergoing neoadjuvant systemic therapy. Patients will wear smartwatches to continuously record step counts, activity intensity, sleep, and heart rate. Patient-reported outcomes, including sleep quality (Pittsburgh Sleep Quality Index, PSQI) and quality of life (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30, EORTC QLQ-C30), will be assessed at baseline and after treatment. The primary outcomes are pathological complete response (pCR) and Miller-Payne score. Secondary outcomes include sleep quality, quality of life, perioperative outcomes, and feasibility of smartwatch monitoring.",[27,66,67,68,69,70],"Exercise","Breast Cancer Females","Wearable Technology","Sleep Quality","Smartwatches",[72,73,74,75,76,77,78],"neoadjuvant therapy","HER2-Negative Breast Cancer","Smartwatch","Step Count","Physical Activity","Patient-Reported Outcomes","Quality of Life (EORTC QLQ-C30)","RECRUITING","2026-02-19",{"date":82,"type":44},"2026-02-20",{"date":84,"type":44},"2025-09-08",{"date":86,"type":20},"2026-08-29",{"name":88,"class":89},"Ankara Etlik City Hospital","OTHER_GOV",2,{"id":92,"slug":93,"hasResults":11,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":97,"eligibilityCriteria":98,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":99,"targetDuration":4,"studyType":21,"phases":101,"briefSummary":103,"conditions":104,"keywords":105,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":52},"100588232","phase-2-omission-of-local-therapies-in-women-patients-with-her2-positive-or-triple-negative-breast-cancer-100588232","NCT06938724","Omission of Local Therapies in Women Patients With HER2-positive or Triple-negative Breast Cancer","Omission of Local Therapies in Women Patients With HER2-positive or Triple-negative Breast Cancer: A Two Arm, Phase 2, Non-inferiority Trial for Surveillance in Maximum Responders to Neoadjuvant Systemic Therapy","OLT","Inclusion Criteria:\n\n* Women ≥ 18y.\n* Initial diagnosis of unifocal HER2-positive (regardless of HR status) or Triple-negative (HR positivity lower than 10% is allowed) T1-2, N0-1, M0 breast cancer.\n* Treated with neoadjuvant systemic treatment according to the center recommendations.\n* Maximum responders and\u002For complete pathological response proved by surgery.\n* Scheduled for breast conservation.\n* Giving specific informed consent.\n\nExclusion Criteria:\n\n* One of the inclusion criteria missed.\n* Residual ductal carcinoma in situ (DCIS) at VABB and\u002For surgery.\n* Bilateral synchronous breast cancer.\n* Previous malignancy within 5 years.\n* BRCA1-2, PALB2 or p53 proven mutation carrier (VUS are exclusion criteria as well).\n* Patients unable to perform regular follow up.",{"count":100,"type":20},152,[102],"PHASE2","HER2-positive and Triple-negative are subtypes of breast cancer more sensitive to systemic therapies, where the complete pathological response rate may be higher than 50%. This gave rise to doubts about the usefulness of traditional local treatments for such responders. Omission of surgery after vacuum assisted breast biopsy (VABB) as well omission of radiotherapy after conservative surgery would now seem to be reasonable alternatives to standard care for highly selected patients, in whom systemic treatments have provided the maximum response.",[27],[106,107,108,109],"Surveillance for breast cancer relapses","Omission of local therapies","Omission of surgery","Omission of radiotherapy","2025-09-12",{"date":112,"type":44},"2025-09-15",{"date":114,"type":44},"2025-07-25",{"date":116,"type":20},"2035-07-25",{"name":118,"class":51},"Fondazione IRCCS Istituto Nazionale dei Tumori, Milano",{"id":120,"slug":121,"hasResults":11,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":4,"eligibilityCriteria":125,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":126,"phases":4,"briefSummary":127,"conditions":128,"keywords":4,"overallStatus":129,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":133,"locationsCount":136},"100449625","expanded-access-protocol-for-subjects-previously-treated-with-gedatolisib-in-b2151009-100449625","NCT05134922","Expanded Access Protocol for Subjects Previously Treated With Gedatolisib in B2151009","Expanded Access Protocol for Subjects Previously Treated With Gedatolisib in a Celcuity-Sponsored Clinical Study (B2151009)","Inclusion Criteria:\n\n1. Currently enrolled in the B2151009 clinical study and benefiting from treatment with gedatolisib in combination with other therapies as determined by the Investigator\n2. Previously demonstrated compliance and are willing and able to comply with scheduled visits, treatment plans, and other study procedures\n3. No evidence of progressive disease, as determined by the Investigator\n4. Provide written informed consent prior to enrolling and receiving treatment\n\nExclusion Criteria:\n\n1. Permanently discontinued from treatment in Study B2151009, or discontinued from Study B2151009 for any reason\n2. Women who are pregnant, intend to become pregnant, or nursing","EXPANDED_ACCESS","Continued access to treatment for subjects who continue benefit from therapy with gedatolisib in combination with palbociclib, and fulvestrant or letrozole.",[27],"AVAILABLE","2025-03-19",{"date":132,"type":44},"2025-03-21",{"name":134,"class":135},"Celcuity Inc","INDUSTRY",5]