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Clinical Trials in Egypt / NCT06491680
Recruiting Phase 4

Cardiotoxicity in Breast Cancer Patients

NCT06491680 · tracked via the Priya Life Science Egypt tracker
Phase
Phase 4
Started
2024-09-10
Last updated
2025-09-22

Condition(s) studied

Breast Cancer

Investigational drug(s) / intervention(s)

Dapagliflozin 10mg Tab →

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.

Study 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

Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Al demerdash hospital at oncology departement Cairo Cairo Governorate Recruiting

More Helwan University trials in Egypt

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06491680 on ClinicalTrials.gov ↗ ← All trials in Egypt