Recruiting

Cardiotoxicity in Breast Cancer Patients

ClinicalTrials.gov IDNCT06491680

PhasePHASE4

Enrollment40

SponsorHelwan University

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Breast Cancer

About this study

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.

Interventions

Drug: Dapagliflozin 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.

Primary outcomes

N-terminal pro-B-type natriuretic peptide (NT-pro BNP) testing (Baseline and after the last cycle of anthracyclines ( 0 and 2 to 3 months from baseline))

Eligibility information

Inclusion Criteria: 1. patients with pathologically proved invasive breast carcinoma. 2. Patients were indicated for anthracyclines containing adjuvant chemotherapy or new adjuvant anthracyclines. 3. Renal function (eGFR \> 30 mL/minute per 1.73 m2 ) 4. LVEF is more than 50 % 5. Age ≥ 18 and ≤ 60 years old Exclusion Criteria: 1. patients with any cardiac condition that contraindicate the use of anthracyclines, like heart failure, arrythmia, stroke and myocardial infarction. 2. Previous anthracycline-containing regimens and any cardiotoxic chemotherapy regimens 3. pregnant or breastfeeding patients 4. patients receiving any other cardiotoxic agents. 5. Patients with diabetic ketoacidosis or patients with type 1 diabetes mellitus. 6. Mediastinal irradiation including heart. 7. Refusal to sign the written informed consent.

Study locations

Al demerdash hospital at oncology departement, Cairo, Cairo Governorate 202 Egypt

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.