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

Launched by TANTA UNIVERSITY · May 18, 2024

Keywords

ClinConnect Summary

Breast cancer is the most common type of cancer in women and the first cause of cancer death among them. In Egypt, it represents 33%of female cancer cases and more than 22,000 new cases are diagnosed each year. This is expected to rise exponentially over the next years given the enlarging population and changes in the population pyramid.

The Early Breast Cancer "Trialists" Collaborative Group (EBCTCG) reported that the inclusion of anthracyclines as doxorubicin in the management of breast cancer improved absolute survival by approximately 3% at 5 years and 4% at 10 years. Therefore, anthra...

Gender

FEMALE

Eligibility criteria

• 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.

Trial Officials