[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"empgliflozin-cardioprotective-effect\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:empgliflozin-cardioprotective-effect":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"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":27,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":5},"100655625","phase-3-cardioprotective-effect-of-empagliflozin-in-breast-cancer-patients-100655625",false,"NCT07815808","Cardioprotective Effect of Empagliflozin in Breast Cancer Patients","Effects of Empagliflozin Versus Metformin in Women With Breast Cancer Receiving Doxorubicin-Based Chemotherapy: A Prospective Randomized Controlled Cardio-Oncology Trial","Inclusion Criteria:\n\n1. Adult females (≥18 years) with histologically confirmed breast cancer.\n2. Scheduled to receive doxorubicin-based chemotherapy regimens (e.g., AC regimen: Doxorubicin + Cyclophosphamide every 2 or 3 weeks for 4 cycles).\n3. Baseline LVEF ≥ 55 on transthoracic echocardiography with normal baseline GLS.\n4. Estimated Glomerular Filtration Rate (eGFR) \\\u003C 45 mL\u002Fmin\u002F1.73 m2\n5. Written informed consent provided\n\nExclusion Criteria:\n\n1. Prior exposure to anthracyclines, mediastinal radiation, or anti-HER2 therapy.\n2. Pre-existing heart failure, coronary artery disease, or LVEF $\\\u003C 55\\\\%$.\n3. Uncontrolled Type 2 Diabetes Mellitus (HbA1c $\\> 8.5\\\\%$) or Type 1 Diabetes Mellitus.\n4. Severe renal impairmet (eGFR \\\u003C 45 mL\u002Fmin\u002F1.73 m2) or hepatic dysfunction.\n5. History of recurrent Urinary Tract Infections (UTIs), genital mycotic infections, or ketoacidosis (for Empagliflozin safety).\n6. Hypersensitivity to Empagliflozin or Metformin.","FEMALE","18 Years",{"count":19,"type":20},150,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","Background: Doxorubicin (DOX) remains a cornerstone in adjuvant and neoadjuvant therapy for breast cancer, but its utility is hindered by dose-dependent cardiotoxicity. Both SGLT2 inhibitors (Empagliflozin) and Biguanides (Metformin) have demonstrated off-target cardioprotective and metabolic properties in preclinical and clinical settings.\n\nObjective: To compare the cardioprotective efficacy, safety, and metabolic\u002Foncologic outcomes of Empagliflozin versus Metformin in non-diabetic or controlled-diabetic women with breast cancer undergoing doxorubicin-based chemotherapy.\n\nDesign: Prospective, 3-arm, open-label (or double-blind), randomized controlled clinical trial (RCT).\n\nDuration: 18 months",[26],"Empgliflozin Cardioprotective Effect",[28,29,30],"Empagliflozin","Cardioprotection","Dox Cardiotoxicity","NOT_YET_RECRUITING","2026-09-07",{"date":34,"type":35},"2026-09-11","ACTUAL",{"date":37,"type":20},"2026-10-01",{"date":39,"type":20},"2028-12-31",{"name":41,"class":42},"Tanta University","OTHER"]