Clinical Study to Evaluate the Possible Safety and Efficacy of Dapagliflozin in the Prophylaxis of Doxorubicin-Induced Cardiotoxicity in Breast Cancer Patients

Dapagliflozin in breast cancer

This is a randomized controlled clinical trial that aims to evaluate the safety and efficacy of Dapagliflozin as a cardioprotective in doxorubicin-induced cardiotoxicity in breast cancer patients.

2024-06-01

2025-06-01

2025-08-01

Not yet recruiting

Early phase I

46

Inclusion Criteria: * Age ≥18 years old. * Chemo-naïve patients with biopsy confirmed diagnosis of breast cancer and with stage I-III breast cancer according to the American Joint Committee on Cancer (TNM staging system of breast cancer). * Patients intended to receive at least 4 cycles of doxorubicin or more. * Patients with performance status \<2 according to Eastern Cooperative Oncology Group (ECOG) score. * Echocardiographic LVEF ≥55%. * Adequate baseline hematologic values (absolute neutrophilic count ≥ 1.5 ×109/L, platelet count ≥ 90 × 109/L and hemoglobin level ≥ 10 g/dl). * Patients with adequate liver function and adequate renal function. * Signed informed consent to participate in the study. Exclusion Criteria: * Age \<18 years old and \>65 years old. * Patients with prior exposure to anthracyclines within the last 6 months. * Patients with evidence of metastasis at initial assessment. * Treatment with any SGLT-2 inhibitors for 6 months prior to the screening. * Patients taking any other cardioprotective medications. * Pregnancy and breast feeding. * Alcohol abuse. * History of heart failure or LVEF \<50%. * Presence of any cardiac-related conditions such as angina pectoris, valvular disease, uncontrolled systemic hypertension, coronary heart disease, and cardiac surgery within the last 3 months. * Patients with type 1 diabetes mellitus or diabetic ketoacidosis, history of stroke, and patients with severe renal impairment with GFR \<25ml/min/1.73m2 . - Patients taking gatifloxacin as it causes major drug interaction with dapagliflozin.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 46, 'type': 'ESTIMATED'}}

2024-05-23