STACIE: Statins for Reduction of Cardiac Toxicity in Patients Receiving HER2 Targeted Therapy
Rutgers, The State University of New Jersey
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.
Description
A single arm open-label phase 2 study to evaluate the cardioprotective effects of statins in patients with Stage I-III HER2 positive breast cancer receiving HER2 targeted therapy. This study will evaluate the hypothesis that addition of statins will reduce treatment delays/discontinuations related to symptomatic/asymptomatic cardiac dysfunction in patients being treated with anti-HER2 therapy. The long-term goal of this study is to improve disease related outcomes and quality of life measures in patients being treated with anti-HER2 therapy.
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * Histologically and/or cytologically confirmed diagnosis of Stage I-III female breast cancer (including inflammatory breast cancer) * Scheduled to receive neoadjuvant/adjuvant HER2 targeted therapy * Between ≥18 years of age * Female patients of childbearing potential must have a negative pregnancy test (serum or urine) prior to enrollment. Female patients must agree to use effective barrier contraception during the period of therapy * Baseline LVEF ≥ 50% * Prior cancers allowed if no evidence of disease in last 5 years * ECOG 0-2 * No prior history of treatment with HER2…
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 CenterElizabeth, New Jersey
- RWJBarnabas Health - Robert Wood Johnson University Hospital, HamiltonHamilton, New Jersey
- RWJBarnabas Health - - Jersey City Medical MedicalJersey City, New Jersey
- Monmouth Medical Center Southern CampusLakewood, New Jersey
- RWJBarnabas Health - Monmouth Medical CenterLong Branch, New Jersey
- Monmouth Community MedicalLong Branch, New Jersey