RecruitingPhase 2NCT06341842

Potential Protective Role of SGLT-2 Inhibitors for Chemotherapy-induced Cardiotoxicity

Study Phase II "Proof of Concept", National Multi-centered. Randomised 1:1, Evaluate Whether Dapagliflozin Reduces Chemotherapy Induced Cardiotoxicity in Participants With Breast Cancer Treated With (Neo-) Adjuvant Anthracycline-based Chemotherapy +/- Trastuzumab

Sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Enrollment

316 participants

Start Date

Oct 19, 2023

Study Type

INTERVENTIONAL

Conditions

Breast Cancer

Summary

The purpose of this study is to evaluate whether dapagliflozin reduces chemotherapy-induced cardiotoxicity in participants with breast cancer treated with (neo-)adjuvant Anthracycline-based chemotherapy +/- trastuzumab. The study aims to describe the efficacy for dapagliflozin as compared to standard of care. Participants will be recruited in participating centers, where they are planning on starting (neo-) adjuvant ACT-based chemotherapy and/or trastuzumab for stage I-III breast cancer.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study investigates whether a diabetes medication called an SGLT-2 inhibitor (dapagliflozin) can protect the heart from damage caused by chemotherapy in women being treated for early-stage breast cancer with anthracycline-based drugs (and possibly trastuzumab). **You may be eligible if...** - You are a woman between 18 and 70 years old - You have been diagnosed with stage I–III breast cancer - You are scheduled to receive anthracycline-based chemotherapy (with or without trastuzumab) - You have never received cancer chemotherapy before - Your kidney function is adequate (eGFR above 25) **You may NOT be eligible if...** - Your heart's pumping function is already reduced (LVEF below 53%) - You have significant heart valve disease - You have had prior anthracycline treatment or chest radiation - You are currently pregnant, breastfeeding, or unwilling to use contraception - You have had diabetic ketoacidosis in the past - You are allergic to dapagliflozin 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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