Recruiting

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

ClinicalTrials.gov IDNCT07245069

PhasePHASE2

Enrollment100

SponsorUniversity Medical Centre Ljubljana

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Heart Failure, Anthracycline-induced Cardiac Toxicity, Endothelial Function (FMD), Arterial Stiffness, Breast Cancer

About this study

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.

Interventions

Drug: Dapagliflozin 10 mg — Forgixa® 10 mg daily
Drug: Placebo — Lactose tablet daily

Primary outcomes

Change in Global Longitudinal Strain (GLS) (52 weeks)
Change in Flow-Mediated Dilation (FMD) of the Brachial Artery (52 weeks)

Eligibility information

Inclusion Criteria: * Adults ≥18 years. * Histologically confirmed breast cancer with planned (neo)adjuvant anthracycline-based chemotherapy (4 cycles of epirubicin + cyclophosphamide or doxorubicin + cyclophosphamide). * Eligible to start dapagliflozin or placebo prior to or at initiation of chemotherapy. * Able to perform baseline echocardiography, vascular ultrasound (FMD and carotid stiffness), 6-minute walk test, and biomarker sampling. * Willing and able to provide written informed consent. Exclusion Criteria: * Known heart failure (any prior diagnosis of HF). * Clinically significant valvular heart disease. * Prior exposure to chemotherapy or radiotherapy to the left chest. * Type 1 diabetes mellitus. * Symptomatic hypotension. * History of recurrent urinary tract infections. * History of diabetic ketoacidosis or ketonemia. * Severe hepatic impairment (ALT, AST, ALP \>3× upper limit of normal). * Severe renal impairment (eGFR \<20 mL/min/1.73 m²). * Known allergy or intolerance to SGLT-2 inhibitors. * Any use of SGLT-2 inhibitor therapy within 3 months prior to enrollment. * Pregnancy or breastfeeding. * Any condition that, in the investigator's judgment, could interfere with study participation, safety, or completion.

Study locations

University Medical Centre Ljubljana, Ljubljana, 1000 Slovenia

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.