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

Shiraz University of Medical Sciences

Status and phase

Not yet enrolling

Phase 4

Conditions

Breast Cancer

Anthracycline Related Cardiotoxicity in Breast Cancer

Anthracycline-induced Cardiotoxicity

Anthracycline-induced Cardiac Toxicity

Treatments

Drug: Placebo tablets similar to rosuvastatin 20mg tablets

Drug: Rosuvastatin 20 mg/day

Study type

Interventional

Funder types

Other

Identifiers

NCT07254221

IR.SUMS.MED.REC.1404.351

IRCT20191002044961N2 (Other Identifier)

Details and patient eligibility

About

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.

Full description

Introduction: Anthracycline-induced cardiotoxicity significantly threatens the long-term cardiac health of breast cancer patients undergoing chemotherapy. Statins have shown potential cardioprotective effects without compromising cancer treatment efficacy. The ROSUBREAST study aims to evaluate the efficacy of rosuvastatin in preventing CTRCD in breast cancer patients receiving anthracycline-based chemotherapy. Methods: This multicenter, two-arm, double-blinded, superiority, parallel-group, randomized, placebo controlled clinical trial will be conducted across seven oncocardiology centers in Iran. A total of 400 participants will be enrolled and will be randomly assigned in a 1:1 ratio to receive either rosuvastatin (20 mg daily) or no intervention for 12 months. The primary endpoint is the incidence of CTRCD, defined as a ≥10% reduction in left ventricular ejection fraction (LVEF) to below the lower normal limit (53%). Secondary endpoints include changes in Global Longitudinal Strain (GLS), biomarkers (Troponin, NT-proBNP, hsCRP), and development of heart failure (HF). Ancillary endpoints are quality-of-life assessments and adverse effects of treatment. Conclusion: The ROSUBREAST study seeks to provide evidence on the cardioprotective role of rosuvastatin in breast cancer patients undergoing anthracycline-based chemotherapy, potentially informing clinical guidelines and improving patient outcomes.

Enrollment

400 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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