Dapagliflozin's effect on heart health in breast cancer patients receiving chemotherapy
Official title: Effect of DAPAglifozin on MYOcardial Remodeling of Breast CANCER Patients Treated with Anthracycline Based Chemotherapy
Run by University of Campinas, Brazil · NCT06711185 · Data updated 2026-11-12
This study is testing if the drug dapagliflozin can help protect the hearts of women with breast cancer who are receiving chemotherapy.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 80 (estimated) |
| Sponsor | University of Campinas, Brazil Academic / other |
| Drugs / interventions | Chemotherapy, doxorubicin |
| Locations | 1 site (Campinas, São Paulo) |
| Status | Recruiting |
| Started | January 30, 2024 |
| Main results expected | January 30, 2026 |
| Study ends | August 30, 2026 |
| Registry record updated | December 2, 2024 |
| Trial ID | NCT06711185 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are female patients over 18 years old diagnosed with breast cancer who are scheduled to receive anthracycline chemotherapy.
✕Probably not a fit
Patients with contraindications for cardiac MRI, severe renal failure, or a history of significant heart disease may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial is a prospective, randomized, double-blind, controlled study designed to evaluate the impact of dapagliflozin on cardiotoxicity in breast cancer patients undergoing anthracycline-based chemotherapy. It aims to enroll 80 female participants who will be randomly assigned to receive either dapagliflozin or a placebo for nine months. The study will assess changes in left ventricular ejection fraction (LVEF) and other cardiac parameters to determine if dapagliflozin can mitigate the heart damage often caused by chemotherapy. The trial is significant as it explores a novel use of SGLT2 inhibitors in a cancer treatment context.
Why it matters
Potential benefit: If successful, this study could provide a new therapeutic option to protect heart health in breast cancer patients undergoing chemotherapy.
How similar studies have gone: While there is no prior clinical data specifically testing SGLT2 inhibitors in this context, similar studies have shown promise in reducing heart failure in non-cancer patients.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Hospital de Clinicas da Unicamp
Campinas, São Paulo, Brazil Recruiting
Study contacts
- Principal investigator: Otavio Rizzi Coelho-Filho, MD, MPH, PhD — University of Campinas, Brazil
- Study coordinator: Otavio Rizzi Coelho-Filho, MD, MPH, PhD
- Email: tavicocoelho@gmail.com
- Phone: +55 19 3521-7755
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.