Rosuvastatin for Prevention of Anthracycline-induced Cardiac Dysfunction in Breast Cancer Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Rosuvastatin 20 mg/day, Placebo tablets similar to rosuvastatin 20mg tablets.
- Who it may be relevant to
- Registry conditions: Anthracycline-induced Cardiac Toxicity, Breast Cancer, Anthracycline Related Cardiotoxicity in Breast Cancer, Anthracycline-induced Cardiotoxicity. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Iran
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of Rosuvastatin Efficacy in Prevention of Anthracycline-induced Cardiac Dysfunction in Breast Cancer Patients After Chemotherapy
Overview
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.
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
Primary outcome measures
- CTRCD (cancer treatment-related cardiac dysfunction) [Time frame: 12 months after randomization]
Secondary outcome measures (5)
- changes in LVEF [Time frame: 3, 6, and 12 months after randomization]
- changes in Global Longitudinal Strain (GLS) [Time frame: 3, 6, and 12 months after randomization]
- changes in Troponin level [Time frame: 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]
- changes in High-sensitivity C-reactive Protein (hsCRP) level [Time frame: 3, 6, and 12 months after randomization]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
Iran · 7 centers
- Motahari Breast Cancer Clinic — Shiraz
- Kowsar Hospital, Fars Heart Foundation — Shiraz
- Toba Oncology Department, Mazandaran University of Medical Sciences — Sari
- Modarres Hospital, Shahid Beheshti University of Medical Sciences — Tehran
- Rajaee Hospital, Iran University of Medical Sciences — Tehran
- Sina Hospital, Tehran University of Medical Sciences — Tehran
- Taleghani Hospital, Shahid Beheshti University of Medical Sciences — Tehran
Identifiers
NCT: NCT07254221 · IR.SUMS.MED.REC.1404.351 · IRCT20191002044961N2