About this trial
This study, called "ROSUBREAST", is a multicenter, double-blind, randomized clinical trial evaluating whether rosuvastatin (20 mg daily) can protect the heart in women with breast cancer receiving anthracycline-based chemotherapy. A total of 400 participants will be randomly assigned to receive either rosuvastatin or placebo for 12 months. The main goal is to determine whether rosuvastatin can prevent cancer treatment-related cardiac dysfunction (CTRCD), defined as a significant drop in heart pumping function. The study will also assess changes in cardiac strain, blood biomarkers, symptoms of heart failure, quality of life, and possible side effects.
Eligibility criteria
Qualifiers
Female individuals with ≥18 years of age
Documented breast cancer diagnosis based on imaging and pathology findings
Scheduled to receive the first time anthracycline-based chemotherapy
Disqualifiers
Baseline LVEF < 50%
Prior Statin use or Statin use is indicated based on guidelines
history of congestive heart failure (CHF) or cardiomyopathy
Pregnancy or breastfeeding
Trial design
Treatments tested in this trial
- Rosuvastatin 20 mg/day
- Placebo tablets similar to rosuvastatin 20mg tablets
Treatment groups
Locations
7Sponsors and collaborators
Shiraz University of Medical Sciences
Lead sponsor