[{"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":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,52,83,101],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":31,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100605450","step-count-and-treatment-response-in-neoadjuvant-breast-cancer-100605450",false,"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.","FEMALE","18 Years",{"count":20,"type":21},82,"ESTIMATED","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.",[25,26,27,28,29,30],"Breast Neoplasm Malignant Female","Exercise","Breast Cancer Females","Wearable Technology","Sleep Quality","Smartwatches",[32,33,34,35,36,37,38],"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":42,"type":43},"2026-02-20","ACTUAL",{"date":45,"type":43},"2025-09-08",{"date":47,"type":21},"2026-08-29",{"name":49,"class":50},"Ankara Etlik City Hospital","OTHER_GOV",2,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":60,"targetDuration":4,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":67,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":82},"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":61,"type":21},152,"INTERVENTIONAL",[64],"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.",[25],[68,69,70,71],"Surveillance for breast cancer relapses","Omission of local therapies","Omission of surgery","Omission of radiotherapy","2025-09-12",{"date":74,"type":43},"2025-09-15",{"date":76,"type":43},"2025-07-25",{"date":78,"type":21},"2035-07-25",{"name":80,"class":81},"Fondazione IRCCS Istituto Nazionale dei Tumori, Milano","OTHER",1,{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":4,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":90,"phases":4,"briefSummary":91,"conditions":92,"keywords":4,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":97,"locationsCount":100},"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.",[25],"AVAILABLE","2025-03-19",{"date":96,"type":43},"2025-03-21",{"name":98,"class":99},"Celcuity Inc","INDUSTRY",5,{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":4,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":17,"minAge":108,"maxAge":109,"enrollmentInfo":110,"targetDuration":4,"studyType":62,"phases":112,"briefSummary":114,"conditions":115,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":126},"100511581","safety-and-performance-of-regenera-breast-implant-in-women-affected-by-malignant-breast-lesion-treated-by-lumpectomy-100511581","NCT05941299","Safety and Performance of REGENERA Breast Implant in Women Affected by Malignant Breast Lesion Treated by Lumpectomy","A Pivotal Study of REGENERA Implant in Malignant Breast Lesion Treated by Lumpectomy","Inclusion Criteria:\n\n* Female adult subject aged 40-70 years.\n* Subject diagnosed with malignant breast lesion:\n* monolateral nodular infiltrative carcinoma,\n* without microcalcification,\n* single or multifocal,\n* included in an area with a maximum diameter of 4 cm,\n* non-metastatic (M0).\n* Subject with clinically negative axilla.\n* Subject considered eligible for conservative breast surgery - BCS (Breast-Conserving Surgery, lumpectomy or quadrantectomy), leaving a volume deficit compatible with a REGENERA implant (available in two dried sizes) volume of 70 ml or 100 ml.\n* Confirmation of malignant lesion (pT1, pT2, pN0, pN1) with no discordance between biopsy and radiological imaging.\n* Adequate hematopoietic functions.\n* Good general health and mentally sound.\n* Subject able and willing to give written informed consent form.\n\nExclusion Criteria:\n\n* Subject with actual concomitant benign breast lesion (B2 and B3), unless present in the same mammary quadrant or in the contralateral breast.\n* Subject with actual concomitant malignancies, lobular neoplasm, metastatic breast carcinoma, sarcoma, malignant phyllodes lesions, or Paget's disease.\n* Axillary dissection planned as part of the breast lesion surgery.\n* History of surgery, chemotherapy, neoadjuvant chemotherapy, or irradiation of the breast parenchyma object of the study.\n* Skin retraction at the breast to be operated.\n* Infection of the surgical site confirmed pre-operatively by clinical examination.\n* Abnormal blood sugar and glycosylated hemoglobin.\n* Hard smoker (more than 10 cigarettes a day).\n* Acute or chronic severe renal insufficiency (creatinine values \\>180 μmol\u002Fl).\n* History of severe asthma or allergies (including allergy to anesthetics or contrast media).\n* Autoimmune disease.\n* Subjects who are known to be carriers of BCRA mutation.\n* Inability to undergo MRI or allergy to contrast media.\n* Systemic infections in an active phase.\n* Immunocompromised patients (HIV).\n* Pregnant or breastfeeding woman or woman who has nursed a child within 3 months prior to enrolment in the study.\n* Subject who has participated in another interventional study within the past 3 months.\n* Subject who received immunosuppressant therapy in the last 3 months.\n* History of substance abuse (drug or alcohol).\n* Non-collaborative patients (severe physical disabilities or psychiatric disorders, as per specialist opinion).","40 Years","70 Years",{"count":111,"type":21},92,[113],"NA","The goals of this clinical trial are:\n\n* demonstrate the safety of REGENERA breast implant in patients undergoing lumpectomy of malignant breast lesions\n* demonstrate the safety and performance of REGENERA in terms of investigator's satisfaction, potential interference with current standard-of-care imaging techniques and occurrence of device-related serious adverse events.",[116,25],"Mastectomy, Segmental","2024-11-20",{"date":119,"type":43},"2024-11-22",{"date":121,"type":43},"2023-09-29",{"date":123,"type":21},"2029-12-30",{"name":125,"class":99},"Tensive SRL",3]