NCT07245069RecruitingPhase 2

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

Source: ClinicalTrials.gov · Last updated 24 Nov 2025

Brief summary (registry, in English)

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.

Status (registry): Recruiting
Phase (registry): Phase 2
Study type: Interventional
Enrollment: 100 (estimated)
First submitted: 17 Nov 2025
Start date: 1 Feb 2025
Primary completion date: Nov 2028
Lead sponsor: University Medical Centre Ljubljana
Diseases: Heart failure
NCT number: NCT07245069

What you commit to

Study type: Interventional · Phase 2
Planned participants: 100
From 1 Feb 2025 to the primary completion date, Nov 2028
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

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.

Other illness

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.

Lab values

Severe hepatic impairment (ALT, AST, ALP \>3× upper limit of normal).
Severe renal impairment (eGFR \<20 mL/min/1.73 m²).

Other

Symptomatic hypotension.
Pregnancy or breastfeeding.

Who the study is looking for

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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
University Medical Centre Ljubljana Coordinator of this site? Confirm its status	Ljubljana	Slovenia	Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.