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

NCT07254221 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2025-12-10

No results posted yet for this study

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.

Conditions

  • Anthracycline-induced Cardiac Toxicity
  • Breast Cancer
  • Anthracycline Related Cardiotoxicity in Breast Cancer
  • Anthracycline-induced Cardiotoxicity

Interventions

DRUG

Rosuvastatin 20 mg/day

Consumption of rosuvastatin 20mg tablets every day

DRUG

Placebo tablets similar to rosuvastatin 20mg tablets

consumption of placebo tablets similar to rosuvastatin 20mg

Sponsors & Collaborators

  • Shiraz University of Medical Sciences

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-01
Primary Completion
2028-04-21
Completion
2028-04-21

Countries

  • Iran

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07254221 on ClinicalTrials.gov