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

December 3, 2025 updated by: Armin Attar, Shiraz University of Medical Sciences

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iran
    • Fars
      • Shiraz, Fars, Iran, 71344-1864
      • Shiraz, Fars, Iran
        • Kowsar Hospital, Fars Heart Foundation
        • Contact:
    • Mazandaran
      • Sari, Mazandaran, Iran
        • Toba Oncology Department, Mazandaran University of Medical Sciences
        • Contact:
    • Tehran Province
      • Tehran, Tehran Province, Iran
        • Modarres Hospital, Shahid Beheshti University of Medical Sciences
        • Contact:
      • Tehran, Tehran Province, Iran
        • Rajaee Hospital, Iran University of Medical Sciences
        • Contact:
      • Tehran, Tehran Province, Iran
        • Sina Hospital, Tehran University of Medical Sciences
        • Contact:
      • Tehran, Tehran Province, Iran
        • Taleghani Hospital, Shahid Beheshti University of Medical Sciences
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intervention
Consumption of 20 milligrams rosuvastatin daily
Drug: Rosuvastatin 20 mg/day
Consumption of rosuvastatin 20mg tablets every day
Placebo Comparator: Placebo
Placebo (placebo tablets similar to rosuvastatin)
Drug: Placebo tablets similar to rosuvastatin 20mg tablets
consumption of placebo tablets similar to rosuvastatin 20mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months after randomization

Secondary Outcome Measures

Outcome Measure
Time Frame
changes in LVEF
Time Frame: 3, 6, and 12 months after randomization
3, 6, and 12 months after randomization
changes in Global Longitudinal Strain (GLS)
Time Frame: 3, 6, and 12 months after randomization
3, 6, and 12 months after randomization
changes in Troponin level
Time Frame: 3, 6, and 12 months after randomization
3, 6, and 12 months after randomization
changes in N-terminal pro b-type Natriuretic Peptide (NT-proBNP) level
Time Frame: 3, 6, and 12 months after randomization
3, 6, and 12 months after randomization
changes in High-sensitivity C-reactive Protein (hsCRP) level
Time Frame: 3, 6, and 12 months after randomization
3, 6, and 12 months after randomization

Other Outcome Measures

Outcome Measure
Time Frame
major adverse cardiovascular events (MACE)
Time Frame: 12 months after randomization
12 months after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shiraz University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

April 21, 2028

Study Completion (Estimated)

April 21, 2028

Study Registration Dates

First Submitted

November 19, 2025

First Submitted That Met QC Criteria

November 19, 2025

First Posted (Estimated)

November 28, 2025

Study Record Updates

Last Update Posted (Actual)

December 10, 2025

Last Update Submitted That Met QC Criteria

December 3, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IR.SUMS.MED.REC.1404.351
  • IRCT20191002044961N2 (Other Identifier: Iranian Registry of Clinical Trials (IRCT))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The IPD used in the main analyses of CSR will be shared upon reasonable request from the principal investigator and confirmation by trial management committee (TMC).

IPD Sharing Time Frame

The IPD can be shared after the release of CSR.

IPD Sharing Access Criteria

Reseaonable request for IPD sharing from the principal investigator will be assessed in TMC. If the commiittee agreed and confirmed the IPD sharing, the IPD will be shared through a suitable platform.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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