RecruitingPhase 3NCT06304857

CardioPROTECTion with Dapagliflozin in Breast Cancer Patients Treated with AnthrAcycline - PROTECTAA TRIAL

A Multicentre, Randomised, Double-blind, Placebo-controlled Phase III Study, Evaluating the Effect of Dapagliflozin on Prevention of Cardiotoxicity in Breast Cancer Patients Undergoing Anthracycline-based Chemotherapy


Sponsor

4th Military Clinical Hospital with Polyclinic, Poland

Enrollment

188 participants

Start Date

Apr 15, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to evaluate the effect of dapagliflozin on the incidence of cancer therapeutics-related cardiac dysfunction in patients with breast cancer receiving anthracycline treatment.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether dapagliflozin — a medication commonly used for diabetes and heart failure — can protect the heart in breast cancer patients who are receiving anthracycline chemotherapy, which is known to sometimes cause heart damage. **You may be eligible if...** - You are between 18 and 80 years old - You have been diagnosed with invasive breast cancer (stage I–III) - You are scheduled to start anthracycline-based chemotherapy within 60 days **You may NOT be eligible if...** - You have a urinary tract infection requiring antibiotics within 48 hours of starting chemotherapy - You have known heart failure or heart failure symptoms - Your heart pumping function (ejection fraction) is below 50% - You have severe heart valve disease, a history of significant irregular heartbeat, or a history of stroke - You have a pre-existing cardiomyopathy - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGDapagliflozin

10 mg tablet q.d

DRUGPlacebo

tablet matching dapagliflozin 10 mg q.d


Locations(3)

4th Military Clinical Hospital with Polyclinic

Wroclaw, Lower Silesian Voivodeship, Poland

Lower Silesian Centre for Oncology, Lung Diseases and Hematology

Wroclaw, Lower Silesian Voivodeship, Poland

Military Medical Institute

Warsaw, Masovian Voivodeship, Poland

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06304857


Related Trials