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

400 Participants
are divided into 2 treatment groups

Locations

7
Kowsar Hospital, Fars Heart Foundation ShirazFars, Iran
Motahari Breast Cancer Clinic71344-1864, ShirazFars, Iran
Toba Oncology Department, Mazandaran University of Medical Sciences SariMazandaran, Iran
Modarres Hospital, Shahid Beheshti University of Medical Sciences TehranTehran Province, Iran

Sponsors and collaborators

Shiraz University of Medical Sciences

Lead sponsor