Effect of DAPAglifozin on MYOcardial Remodeling of Breast CANCER Patients Treated with Anthracycline Based Chemotherapy
NCT ID: NCT06711185
Last Updated: 2024-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
80 participants
INTERVENTIONAL
2024-01-30
2026-08-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Consistent data have established that sodium-glucose transport protein 2 (SGLT2) inhibitors reduce incident heart failure in patients without cancer. There is biological plausibility and animal data to support the hypothesis central to this proposal that SGLT2 will reduce anthracycline-induced cardiotoxicity (AIC). Anthracyclines increase inflammatory cytokines, increase cell death, increase myocardial fibrosis leading to a decrease in the LVEF. In animal and cellular models, SGLT2 inhibitors reduce inflammatory cytokines, increase cell viability, reduce myocardial fibrosis and prevent the decline in LVEF with anthracyclines. There are no preliminary clinical data testing whether SGLT2 inhibitors are cardioprotective during treatment with anthracyclines among patients with breast cancer.
We propose a single-center randomized double-blind placebo-controlled trial, in 80 patients, who will be randomized 1:1 to dapagliflozin 10mg/daily or placebo to determine whether dapagliflozin started prior to anthracyclines reduces AIC in patients breast cancer. The endpoint AIC will be defined as a 6% difference in the change in LVEF between groups within the first 9 months after the start of therapy. LVEF will be measured using the gold-standard, cardiac magnetic resonance (CMR), performed in an established core clinical trials laboratory by expert researchers.
Participants will be recruited over 2 years from a large volume academic oncology network. Myocardial fibrosis is a key intermediary that occurs prior to the development of LV dysfunction. CMR is the gold-standard imaging technique for fibrosis; therefore, to test whether the sub-acute development of myocardial fibrosis can predict the late occurrence of AIC and whether dapagliflozin reduces myocardial fibrosis, we also propose measuring the extent of fibrosis at baseline and 9 months.
We hypothesize that dapagliflozin will attenuate the anthracycline-induced increase in myocardial fibrosis. Secondary and exploratory outcomes will include significant changes in myocardial perfusion assessed by stress CMR, flow-mediated vasodilatation assessed by ultrasound, exercise capacity assessed by cardiopulmonary exercise test, and biomarkers.
If successful, this study will show that dapagliflozin started prior to anthracyclines will preserve the LVEF and will attenuate the anthracycline-induced cardiovascular toxicity.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Dapagliflozin
Standard chemotherapy treatment + Dapagliflozin 10mg/day.
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 Group
Standard chemotherapy treatment + Placebo.
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Over 18 years old
* Breast cancer
* Chemotherapy as treatment planning and programmed cumulative dose equivalent to 240 mg/m2 of doxorubicin.
Exclusion Criteria
* 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.
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Campinas, Brazil
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Otavio Rizzi Coelho Filho
Professor (Assistant) at Unicamp
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Otavio Rizzi Coelho-Filho, MD, MPH, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Campinas, Brazil
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hospital de Clinicas da Unicamp
Campinas, São Paulo, Brazil
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Joaquim Barreto Oliveira, MD
Role: backup
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
57488122.1.0000.5404
Identifier Type: -
Identifier Source: org_study_id