Dapagliflozin to protect the heart during anthracycline chemotherapy for breast cancer
Tests dapagliflozin against placebo for heart protection in women having breast cancer chemotherapy.
Plain-language title generated from the registry record
Registry title: Use of Dapagliflozin in Primary Prevention of Cardiotoxicity of Anthracycline Chemotherapy in Breast Cancer Patients
Key facts
- Where
- Ljubljana, SloveniaSee the site
- Phase
- Phase 2
Where in Slovenia
- University Medical Centre LjubljanaLjubljana, SloveniaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Medical Centre Ljubljana
- Trial code
- NCT07245069
- Record updated
- 24 November 2025
- Original description
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.Read full original descriptionShow less
Use of Dapagliflozin in Primary Prevention of Cardiotoxicity of Anthracycline Chemotherapy in Breast Cancer Patients
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.
Inclusion: 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: Known heart failure (any prior diagnosis of HF); Prior exposure to chemotherapy or radiotherapy to the left chest; Any use of SGLT-2 inhibitor therapy within 3 months prior to enrollment; Clinically significant valvular heart disease; Type 1 diabetes mellitus; History of recurrent urinary tract infections; History of diabetic ketoacidosis or ketonemia; Known allergy or intolerance to SGLT-2 inhibitors; Any condition that, in the investigator's judgment, could interfere with study participation, safety, or completion; Severe hepatic impairment (ALT, AST, ALP >3× upper limit of normal); Severe renal impairment (eGFR <20 mL/min/1.73 m²); Symptomatic hypotension; Pregnancy or breastfeeding.