Not Yet RecruitingPhase 4

Rosuvastatin for Prevention of Anthracycline-induced Cardiac Dysfunction in Breast Cancer Patients

Iran400 participantsStarted 2026-02-01

Plain-language summary

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.

Who can participate

Age range18 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Unable to provide informed consent * Unexplained persistent elevation of transaminases (\>3 times upper limits of normal) * Concomitant use of oral cyclosporine * Metastatic invasion of cancer to other organs * Previous cycles of chemotherapy * Any contraindication for statin use

What they're measuring

CTRCD (cancer treatment-related cardiac dysfunction)

Timeframe: 12 months after randomization

Trial details

NCT IDNCT07254221

SponsorShiraz University of Medical Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-04-21