Actively Recruiting

Phase 4
Age: 18Years - 60Years
All Genders
NCT06491680

Cardiotoxicity in Breast Cancer Patients

Led by Helwan University · Updated on 2025-09-22

40

Participants Needed

1

Research Sites

89 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Cardiotoxicity in Breast Cancer Patients

Who Can Participate

Age: 18Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with pathologically confirmed invasive breast carcinoma
  • Patients scheduled for anthracycline-containing adjuvant chemotherapy or new anthracycline adjuvant therapy
  • Kidney function with estimated glomerular filtration rate (eGFR) greater than 30 mL/minute per 1.73 m2
  • Left ventricular ejection fraction (LVEF) greater than 50%
  • Age between 18 and 60 years old
Not Eligible

You will not qualify if you...

  • Any heart condition that prevents the use of anthracyclines, such as heart failure, arrhythmia, stroke, or heart attack
  • Prior treatment with anthracycline chemotherapy or other cardiotoxic chemotherapy regimens
  • Pregnancy or breastfeeding
  • Use of other cardiotoxic medications
  • Having diabetic ketoacidosis or type 1 diabetes mellitus
  • Radiation therapy to the chest area including the heart
  • Refusal to provide written informed consent

AI-Screening

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Trial Site Locations

Total: 1 location

1

Al demerdash hospital at oncology departement

Cairo, Cairo Governorate, Egypt, 202

Actively Recruiting

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Research Team

S

Shimaa Nabil Abd elaziz Hassanein, bachelor

CONTACT

S

Sara Mohamed Mohamed, Lecturer

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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