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

NCT06711185 | Recruiting Phase 3

• 1 other identifier: 57488122.1.0000.5404
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Dapagliflozin; Anthracyclines; chemotherapy induced cardiomyopathy

Outcome Measures

Primary Outcomes (1)

• Change in left ventricle ejection fraction

  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

  36 weeks

Study Arms (2)

Dapagliflozin

EXPERIMENTAL

Standard chemotherapy treatment + Dapagliflozin 10mg/day.

Drug: Dapagliflozin 10 mg

Placebo Group

PLACEBO COMPARATOR

Standard chemotherapy treatment + Placebo.

Other: Placebo

Interventions

Dapagliflozin 10 mg DRUG

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

Dapagliflozin

Placebo OTHER

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

Placebo Group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only female individuals (biological sex) with breast cancer.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female
• Over 18 years old
• Breast cancer
• Chemotherapy as treatment planning and programmed cumulative dose equivalent to 240 mg/m2 of doxorubicin.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Campinas, Brazil: lead

Study Sites (1)

Hospital de Clinicas da Unicamp

Campinas, São Paulo, 13083-888, Brazil

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Otavio Rizzi Coelho-Filho, MD, MPH, PhD

  University of Campinas, Brazil

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Otavio Rizzi Coelho-Filho, MD, MPH, PhD

CONTACT

+55 19 3521-7755; tavicocoelho@gmail.com

Joaquim Barreto Oliveira, MD

CONTACT

+55 19 3521 7959; jba.clinicamedica@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor (Assistant) at Unicamp

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: December 2, 2024
• Study Start: January 30, 2024
• Primary Completion: January 30, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: December 2, 2024

Record last verified: 2024-11

Locations

BR (1)