Evaluation of the Possible Safety and Efficacy of Dapagliflozin in the Prophylaxis of Doxorubicin-Induced Cardiotoxicity

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.