Clinical trial · Interventional
Rosuvastatin for Prevention of Anthracycline-induced Cardiac Dysfunction in Breast Cancer Patients
Evaluation of Rosuvastatin Efficacy in Prevention of Anthracycline-induced Cardiac Dysfunction in Breast Cancer Patients After Chemotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anthracycline-induced Cardiac Toxicity | — | UNRESOLVED | — |
| Anthracycline-induced Cardiotoxicity | — | UNRESOLVED | — |
| Anthracycline Related Cardiotoxicity in Breast Cancer | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo tablets similar to rosuvastatin 20mg tablets | Drug | — | UNRESOLVED |
| Rosuvastatin 20 mg/day | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Intervention
- description
- Consumption of 20 milligrams rosuvastatin daily
- interventionNames
- Drug: Rosuvastatin 20 mg/day
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Placebo (placebo tablets similar to rosuvastatin)
- interventionNames
- Drug: Placebo tablets similar to rosuvastatin 20mg tablets
Primary outcomes (1)
- measure
- CTRCD (cancer treatment-related cardiac dysfunction)
- timeFrame
- 12 months after randomization
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available