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OncoMatch/Clinical Trials/NCT07245069

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

Is NCT07245069 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Dapagliflozin 10 mg for heart failure.

Phase 2RecruitingUniversity Medical Centre LjubljanaNCT07245069Data as of May 2026

Treatment: Dapagliflozin 10 mgThe 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.

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Extracted eligibility criteria

Cancer type

Breast Carcinoma

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: chemotherapy

Prior exposure to chemotherapy

Cannot have received: radiation therapy

Exception: to the left chest

Prior exposure to radiotherapy to the left chest

Cannot have received: SGLT-2 inhibitor

Any use of SGLT-2 inhibitor therapy within 3 months prior to enrollment

Lab requirements

Kidney function

Severe renal impairment (eGFR <20 mL/min/1.73 m²) [excluded]

Liver function

Severe hepatic impairment (ALT, AST, ALP >3× upper limit of normal) [excluded]

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

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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