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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Slovenia
University Medical Centre Ljubljana
RECRUITING
Ljubljana
Contact Information
Primary
Jure Tršan
jure.trsan@gmail.com
Slovenia
Time Frame
Start Date: 2025-02-01
Estimated Completion Date: 2029-02
Participants
Target number of participants: 100
Treatments
Experimental: Dapagliflozin 10 mg Daily
Participants randomized to this arm will receive dapagliflozin 10 mg orally once daily for a total duration of 52 weeks (1 year). Study medication will begin before or at the start of anthracycline chemotherapy and will continue throughout chemotherapy and the post-treatment follow-up period, according to protocol.
Placebo_comparator: Placebo
Participants randomized to this arm will receive a matching placebo orally once daily for a total duration of 52 weeks (1 year). Placebo will be initiated before or at the start of anthracycline chemotherapy and continued throughout chemotherapy and the 1-year protocol-defined follow-up period.
Related Therapeutic Areas
Sponsors
Leads: University Medical Centre Ljubljana

This content was sourced from clinicaltrials.gov

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