Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07254221

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Anthracycline-induced Cardiac Toxicity Anthracycline Related Cardiotoxicity in Breast Cancer Anthracycline-induced Cardiotoxicity Breast Cancer Breast Diseases Breast Neoplasms Cardiotoxicity Cardiovascular Diseases Chemically-Induced Disorders Drug-Related Side Effects and Adverse Reactions Heart Diseases Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Radiation Injuries Skin Diseases Skin and Connective Tissue Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Kowsar Hospital, Fars Heart Foundation, Shiraz, Fars, Iran

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rosuvastatin 20 mg/day

Drug

Consumption of rosuvastatin 20mg tablets every day

Placebo tablets similar to rosuvastatin 20mg tablets

Drug

consumption of placebo tablets similar to rosuvastatin 20mg

Primary outcomes

  1. CTRCD (cancer treatment-related cardiac dysfunction)

    Time frame: 12 months after randomization

    CTRCD is defined as a reduction of ≥10 percentage points in LVEF by echocardiography to <53% or a >15% relative decline in global longitudinal strain (GLS) compared with baseline strain.

Secondary outcomes

  1. changes in LVEF

    Time frame: 3, 6, and 12 months after randomization

  2. changes in Global Longitudinal Strain (GLS)

    Time frame: 3, 6, and 12 months after randomization

  3. changes in Troponin level

    Time frame: 3, 6, and 12 months after randomization

  4. changes in N-terminal pro b-type Natriuretic Peptide (NT-proBNP) level

    Time frame: 3, 6, and 12 months after randomization

  5. changes in High-sensitivity C-reactive Protein (hsCRP) level

    Time frame: 3, 6, and 12 months after randomization

Other outcomes

  1. major adverse cardiovascular events (MACE)

    Time frame: 12 months after randomization

Sponsors and collaborators

Lead sponsor

Shiraz University of Medical Sciences

Other

Registry information

Official study title

Evaluation of Rosuvastatin Efficacy in Prevention of Anthracycline-induced Cardiac Dysfunction in Breast Cancer Patients After Chemotherapy

Acronym: ROSUBREAST

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Nov 28, 2025
Registry last updated
Dec 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.