Anthracycline-induced Cardiac Toxicity, Breast Cancer, Anthracycline Related Cardiotoxicity in Breast Cancer, Anthracycline-induced Cardiotoxicity
Conditions
Keywords
Breast cancer, rosuvastatin, statin therapy,, cancer-related treatment cardiac dysfunction, anthracycline induced cardiomyopathy, cardiac dysfunction, cardiotoxicity, chemotherapy, anthracycline
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.
Interventions
Consumption of rosuvastatin 20mg tablets every day
DRUGPlacebo tablets similar to rosuvastatin 20mg tablets
consumption of placebo tablets similar to rosuvastatin 20mg
Sponsors
Shiraz University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
multicenter, two-arm, double-blinded, superiority, parallel-group, randomized, placebo-controlled clinical trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CTRCD (cancer treatment-related cardiac dysfunction) | 12 months after randomization | 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. |
Secondary
| Measure | Time frame |
|---|---|
| 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 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 |
| changes in Troponin level | 3, 6, and 12 months after randomization |
Other
| Measure | Time frame |
|---|---|
| major adverse cardiovascular events (MACE) | 12 months after randomization |
Countries
Iran
Outcome results
None listed