Effect of DAPAglifozin on MYOcardial Remodeling of Breast CANCER Patients Treated with Anthracycline Based Chemotherapy

NCT06711185 · tracked via the Priya Life Science Brazil tracker

Sponsor

University of Campinas, Brazil

Phase

Phase 3

Started

2024-01-30

Last updated

2024-12-02

Condition(s) studied

Breast Cancer

Investigational drug(s) / intervention(s)

Dapagliflozin 10 mg →Placebo

Dapagliflozin 10 mg: Patients in this group will receive 1 tablet of 10mg dapagliflozin daily for 9 months, starting 7-10 days before chemotherapy treatment.

Placebo: Patients in this group will receive 1 placebo tablet per day, with identical characteristics to the group receiving dapagliflozin, for 9 months, starting 7-10 days before the start of chemotherapy treatment

Study summary

Prospective, randomized, double-blind, controlled clinical trial to compare the effect of 9 months of treatment with dapagliflozin vs. placebo on anthracycline-induced cardiotoxicity in patients with breast cancer.

Eligibility

Sex

FEMALE

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Female * Over 18 years old * Breast cancer * Chemotherapy as treatment planning and programmed cumulative dose equivalent to 240 mg/m2 of doxorubicin. Exclusion Criteria: * Contraindications for performing CMR exams, such as patients with pacemakers or cardiac defibrillators of any type, metal clips for cerebral aneurysms, cochlear implants, and ventriculoperitoneal bypass valves. * Inability to perform CMR due to claustrophobia. * Renal failure with a glomerular filtration rate \< 30 ml/min/1.73 m2. * Previous history of myocardial infarction, congestive heart failure, or myocardial revascularization, whether percutaneous or surgical. * Previous history of significant valvular heart disease. * Previous history of cardiomyopathies.

Primary outcome measure(s)

Change in left ventricle ejection fraction — 36 weeks
The primary outcome will be the 6% difference in the mean of left ventricle ejection fraction change, as assessed by CMR, between the placebo group and the dapagliflozin group

Trial sites (1)

Facility	City	Region	Status
Hospital de Clinicas da Unicamp	Campinas	São Paulo	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06711185 on ClinicalTrials.gov ↗ ← All trials in Brazil