RecruitingPhase 2NCT07245069

Use of Dapagliflozin in Primary Prevention of Cardiotoxicity of Anthracycline Chemotherapy in Breast Cancer Patients


Sponsor

University Medical Centre Ljubljana

Enrollment

100 participants

Start Date

Feb 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this randomized, double-blind, placebo-controlled clinical trial is to determine whether dapagliflozin, a sodium-glucose cotransporter-2 (SGLT-2) inhibitor, can help prevent anthracycline-induced cardiotoxicity caused by anthracycline chemotherapy in adult women with breast cancer receiving (neo)adjuvant treatment. The main questions the study aims to answer are: i) Does dapagliflozin reduce the decline in left ventricular function (measured by LVEF, GLS, and myocardial work) during and after anthracycline therapy? ii) Does dapagliflozin lessen the deteriorating effect of chemotherapy on endothelial function and arterial stiffness? iii) Does dapagliflozin effect levels of cardiac injury and inflammation biomarkers (e.g., hs-troponin T, NT-proBNP, ST-2, GDF-15, galectin-3, IL-6, MPO)? Researchers will compare dapagliflozin 10 mg daily with placebo to see whether those receiving dapagliflozin experience less heart and vascular impairment during treatment. Participants will: * Take either dapagliflozin or placebo once daily during anthracycline chemotherapy. * Undergo heart and vascular ultrasound, and a 6-minute walk test before chemotherapy and again at 24 and 52 weeks. * Provide blood samples before, during and after chemotherapy to measure cardiac biomarkers. * Complete multiple questionnaires on quality of life.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests whether the diabetes drug dapagliflozin (an SGLT-2 inhibitor) can protect the heart from damage caused by anthracycline chemotherapy (a powerful but potentially heart-damaging type of chemo) in breast cancer patients. Heart damage is a known risk with anthracycline treatment, and this study explores if dapagliflozin can reduce that risk. **You may be eligible if...** - You are 18 or older with confirmed breast cancer - You are scheduled to receive anthracycline-based chemotherapy (such as epirubicin or doxorubicin with cyclophosphamide) - You have normal heart function before starting chemotherapy - You do not currently have diabetes **You may NOT be eligible if...** - You already have significant heart disease or reduced heart function - You already take SGLT-2 inhibitor medications - You have significant kidney problems - 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.

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Interventions

DRUGDapagliflozin 10 mg

Forgixa® 10 mg daily

DRUGPlacebo

Lactose tablet daily


Locations(1)

University Medical Centre Ljubljana

Ljubljana, Slovenia

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NCT07245069


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