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

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

Trial statusNot yet recruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexFemale

Age18+

SponsorShiraz University of Medical Sciences

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Rosuvastatin 20 mg/day
Drug
Consumption of rosuvastatin 20mg tablets every day
Placebo tablets similar to rosuvastatin 20mg tablets
Drug
consumption of placebo tablets similar to rosuvastatin 20mg

Treatment groups

400 Participants

are divided into 2 treatment groups

Group A: InterventionActive comparator 1 intervention

Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

12 months after randomization

Secondary outcomes

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

Other outcomes

major adverse cardiovascular events (MACE)

Time frame

12 months after randomization

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shiraz University of Medical Sciences

Lead sponsor

Source ClinicalTrials.gov

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