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

NCT ID: NCT07254221

Last Updated: 2025-12-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-01
• Study Completion Date: 2028-04-21

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.

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Intervention

Consumption of 20 milligrams rosuvastatin daily

Group Type: ACTIVE_COMPARATOR

Rosuvastatin 20 mg/day

Intervention Type: DRUG

Consumption of rosuvastatin 20mg tablets every day

Placebo

Placebo (placebo tablets similar to rosuvastatin)

Group Type: PLACEBO_COMPARATOR

Placebo tablets similar to rosuvastatin 20mg tablets

Intervention Type: DRUG

consumption of placebo tablets similar to rosuvastatin 20mg

Interventions

Rosuvastatin 20 mg/day

Consumption of rosuvastatin 20mg tablets every day

Intervention Type: DRUG

Placebo tablets similar to rosuvastatin 20mg tablets

consumption of placebo tablets similar to rosuvastatin 20mg

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Shiraz University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Armin Attar

Prof. Armin Attar

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Motahari Breast Cancer Clinic

Shiraz, Fars, Iran

Kowsar Hospital, Fars Heart Foundation

Shiraz, Fars, Iran

Toba Oncology Department, Mazandaran University of Medical Sciences

Sari, Mazandaran, Iran

Modarres Hospital, Shahid Beheshti University of Medical Sciences

Tehran, Tehran Province, Iran

Rajaee Hospital, Iran University of Medical Sciences

Tehran, Tehran Province, Iran

Sina Hospital, Tehran University of Medical Sciences

Tehran, Tehran Province, Iran

Taleghani Hospital, Shahid Beheshti University of Medical Sciences

Tehran, Tehran Province, Iran

Countries

Iran

Facility Contacts

Armin Attar, Associate Professor

Role: primary

attar_armin@yahoo.com

Masoud Sayad

Role: primary

masoud.sayad@yahoo.com

+98 71 3614 1000

Maryam Nabati

Role: primary

dr.mr.nabati@gmail.com

+98 11 3304 4000

Shabnam Kazemloo

Role: primary

kazemloo.shabnam@sbmu.ac.ir

+98 21 23515

Azin Alizadehasl

Role: primary

alizadeasl@gmail.com

+98 21 3455 2001

Zahra Shajari

Role: primary

adz.shajari@gmail.com

+98 21 6634 8587

Alireza Farzaei

Role: primary

alirezafarzaei@gmail.com

+98 21 2243 2566

Other Identifiers

IRCT20191002044961N2

Identifier Type: OTHER

Identifier Source: secondary_id

IR.SUMS.MED.REC.1404.351

Identifier Type: -

Identifier Source: org_study_id