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

NCT07254221 | Not Yet Recruiting Phase 4 DMC

• 2 other identifiers: IR.SUMS.MED.REC.1404.351IRCT20191002044961N2
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 7

Brief 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

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

Keywords

Breast cancer; rosuvastatin; statin therapy,; cancer-related treatment cardiac dysfunction; anthracycline induced cardiomyopathy; cardiac dysfunction; cardiotoxicity; chemotherapy; anthracycline

Outcome Measures

Primary Outcomes (1)

• CTRCD (cancer treatment-related cardiac dysfunction)

  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 Outcomes (5)

• changes in LVEF

  3, 6, and 12 months after randomization

• changes in Global Longitudinal Strain (GLS)

  3, 6, and 12 months after randomization

• changes in Troponin level

  3, 6, and 12 months after randomization

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

  3, 6, and 12 months after randomization

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

  3, 6, and 12 months after randomization

Other Outcomes (1)

• major adverse cardiovascular events (MACE)

  12 months after randomization

Study Arms (2)

Intervention

ACTIVE COMPARATOR

Consumption of 20 milligrams rosuvastatin daily

Drug: Rosuvastatin 20 mg/day

Placebo

PLACEBO COMPARATOR

Placebo (placebo tablets similar to rosuvastatin)

Drug: Placebo tablets similar to rosuvastatin 20mg tablets

Interventions

Rosuvastatin 20 mg/day DRUG

Consumption of rosuvastatin 20mg tablets every day

Intervention

Placebo tablets similar to rosuvastatin 20mg tablets DRUG

consumption of placebo tablets similar to rosuvastatin 20mg

Placebo

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shiraz University of Medical Sciences: lead

Study Sites (7)

Motahari Breast Cancer Clinic

Shiraz, Fars, 71344-1864, Iran

Location

Kowsar Hospital, Fars Heart Foundation

Shiraz, Fars, Iran

Location

Toba Oncology Department, Mazandaran University of Medical Sciences

Sari, Mazandaran, Iran

Location

Modarres Hospital, Shahid Beheshti University of Medical Sciences

Tehran, Tehran Province, Iran

Location

Rajaee Hospital, Iran University of Medical Sciences

Tehran, Tehran Province, Iran

Location

Sina Hospital, Tehran University of Medical Sciences

Tehran, Tehran Province, Iran

Location

Taleghani Hospital, Shahid Beheshti University of Medical Sciences

Tehran, Tehran Province, Iran

Location

MeSH Terms

Conditions

Breast Neoplasms; Cardiotoxicity

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Armin Attar

Model Details: multicenter, two-arm, double-blinded, superiority, parallel-group, randomized, placebo-controlled clinical trial

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: November 28, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): April 21, 2028
• Study Completion (Estimated): April 21, 2028
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: The IPD can be shared after the release of CSR.
• 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.

Locations

IR (7)