RecruitingPhase 2NCT05559164

Statins for Reduction of Cardiac Toxicity in Patients Receiving HER2 Targeted

STACIE: Statins for Reduction of Cardiac Toxicity in Patients Receiving HER2 Targeted Therapy


Sponsor

Rutgers, The State University of New Jersey

Enrollment

60 participants

Start Date

Sep 19, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This study proposes that the addition of statins reduces the treatment delays or early discontinuations secondary to cardiotoxicity in patients with Stage I-III HER2 positive breast being treated with anti-HER2 therapy.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether statin medications (commonly used for cholesterol) can protect the heart from damage caused by HER2-targeted therapy (a type of breast cancer treatment that can sometimes weaken the heart). Researchers want to see if statins reduce the risk of heart problems during breast cancer treatment. **You may be eligible if:** - You are a woman 18 or older diagnosed with Stage I–III breast cancer - Your cancer is HER2-positive and you are scheduled to receive HER2-targeted therapy - Your heart function is normal (ejection fraction of at least 50%) - You have not previously received HER2-targeted therapy or anthracycline chemotherapy - Your blood counts, liver, and kidney function are adequate **You may NOT be eligible if:** - You have Stage IV (metastatic) breast cancer - You are currently taking statin medications - You have uncontrolled high blood pressure - You have active liver disease - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLipitor 40mg Tablet

LIPITOR® (atorvastatin calcium) tablets will be administered orally as a single dose of 40 mg once daily, with or without food


Locations(10)

Trinitas Hospital and Comprehensive Cancer Center

Elizabeth, New Jersey, United States

RWJBarnabas Health - Robert Wood Johnson University Hospital, Hamilton

Hamilton, New Jersey, United States

RWJBarnabas Health - - Jersey City Medical Medical

Jersey City, New Jersey, United States

Monmouth Medical Center Southern Campus

Lakewood, New Jersey, United States

RWJBarnabas Health - Monmouth Medical Center

Long Branch, New Jersey, United States

Monmouth Community Medical

Long Branch, New Jersey, United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

RWJBarnabas Health - Robert Wood Johnson University Hospital

New Brunswick, New Jersey, United States

RWJBarnabas Health - Newark Beth Israel Medical Center

Newark, New Jersey, United States

RWJBarnabas Health - Robert Wood Johnson University Hospital

Somerset, New Jersey, United States

View Full Details on ClinicalTrials.gov

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NCT05559164


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