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

Inclusion Criteria4

Chemotherapy-naive patients, scheduled for antracycline +/- trastuzumab treatment in the (neo-)adjuvant setting for stage I-III breast cancer.
Adult women between 18 and 70 years of age
eGFR\>25 ml/min/1.7 mq
ECOG score 0-2Consent form signed. Female patients of childbearing potential (not surgically sterilized and between menarche and 1 year post menopause) must have a negative result from a serum pregnancy test performed within 7 days of randomization and on the day of first study treatment prior to the initiation of study treatment. Women of childbearing potential must agree to use highly effective contraceptive measures from the time of informed consent through 7 months after last dose of study drug. Women of childbearing potential willing to use highly effective contraceptive measures from the time of informed consent through 7 months after last dose of study drug .

Exclusion Criteria9

Left ventricular ejection fraction (LVEF) \<53%\*
Valvular heart disease.
Previous malignancy requiring treatment with anthracyclines or chest radiotherapy.
A life expectancy of ≤12 weeks.
Currently pregnant (confirmed with positive pregnancy test performed from -7 to -1 days prior to start study drug) or unwilling to adopt highly effective contraceptive method.
Currently breast-feeding women
History of hypersensitivity to dapagliflozin or any of the excipients of the product.
History of Diabetic Ketoacidosis (DKA) requiring medical intervention (e.g. emergency room visit and/or hospitalization) within 1 month prior to enrolment visit.
Type 1 diabetes mellitus