NCT06711185 Effect of DAPAglifozin on MYOcardial Remodeling of Breast CANCER Patients Treated with Anthracycline Based Chemotherapy
| NCT ID | NCT06711185 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University of Campinas, Brazil |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2024-01-30 |
| Primary Completion | 2026-01-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 80 participants in total. It began in 2024-01-30 with a primary completion date of 2026-01-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Otavio Rizzi Coelho-Filho, MD, MPH, PhD
PRINCIPAL INVESTIGATOR
University of Campinas, Brazil
Frequently Asked Questions
Who can join the NCT06711185 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06711185 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 80 participants.
Is NCT06711185 currently recruiting?
Yes, NCT06711185 is actively recruiting participants. Contact the research team at tavicocoelho@gmail.com for enrollment information.
Where is the NCT06711185 trial being conducted?
This trial is being conducted at Campinas, Brazil.
Who is sponsoring the NCT06711185 clinical trial?
NCT06711185 is sponsored by University of Campinas, Brazil. The principal investigator is Otavio Rizzi Coelho-Filho, MD, MPH, PhD at University of Campinas, Brazil. The trial plans to enroll 80 participants.
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