RecruitingPhase 4NCT06491680

Cardiotoxicity in Breast Cancer Patients

Evaluation of the Cardioprotective Effect of Dapagliflozin on Anthracyclines-Induced Cardiotoxicity in Breast Cancer Patients

Sponsor

Helwan University

Enrollment

40 participants

Start Date

Sep 10, 2024

Study Type

INTERVENTIONAL

Conditions

Breast Cancer

Summary

The goal of this clinical trial is to learn if dapagliflozin drug has a cardioprotective effect against anthracyclines-induced cardiotoxicity. It will also learn about the safety of dapagliflozin drug. Aim of the study: Evaluate cardioprotective effect and safety of dapagliflozin against anthracyclines-induced cardiotoxicity. The main questions it aims to answer are: 1. Does the drug lower the cardiotoxicity which induced by anthracyclines? 2. What medical problems do participants have when taking dapagliflozin drug? Treatment 1. Anthracyclines by 4 cycles included doxorubicin 50-60 mg/m2 with cyclophosphamide 600 mg as a combination or epirubicin 90-100 mg/m2 with cyclophosphamide 600 mg as a combination. 2. Dapagliflozin 10 mg tablet orally, once daily. Started 7 days before the first cycle of anthracyclines till the end of last anthracyclines dose.

Eligibility

Min Age: 18 YearsMax Age: 60 Years

Inclusion Criteria5

patients with pathologically proved invasive breast carcinoma.
Patients were indicated for anthracyclines containing adjuvant chemotherapy or new adjuvant anthracyclines.
Renal function (eGFR \> 30 mL/minute per 1.73 m2 )
LVEF is more than 50 %
Age ≥ 18 and ≤ 60 years old

Exclusion Criteria7

patients with any cardiac condition that contraindicate the use of anthracyclines, like heart failure, arrythmia, stroke and myocardial infarction.
Previous anthracycline-containing regimens and any cardiotoxic chemotherapy regimens
pregnant or breastfeeding patients
patients receiving any other cardiotoxic agents.
Patients with diabetic ketoacidosis or patients with type 1 diabetes mellitus.
Mediastinal irradiation including heart.
Refusal to sign the written informed consent.

Interventions

DRUGDapagliflozin 10mg Tab

Dapagliflozin 10 mg tablet orally, once daily. Started 7 days before the first cycle of anthracyclines till the end of last anthracyclines dose. taken orally, once daily. Started from 5 to 7 days before the first cycle of anthracyclines till the end of last anthracycline dose.