STACIE: Statins for Reduction of Cardiac Toxicity in Patients Receiving HER2 Targeted Therapy
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.
Detailed 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.
Arms & 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
Outcome measures
Primary
Number of Participants With at Least One Adverse Event will be measured using Common Terminology Criteria for Adverse Events (CTCAE) v5.0 for five years
Adverse events (AEs) will be measured using Common Terminology Criteria for Adverse Events (CTCAE) v5.0 for five years
Time frame: Five years
Secondary
Patient reported outcome (PRO) for pain measured by the quality of Life questionnaire using PROMIS to measure pain
Time frame: Baseline, six, twelve and fifteen months
Eligibility criteria
Study locations (10)
Trinitas Hospital and Comprehensive Cancer Center
Elizabeth, New Jersey, 07202
RWJBarnabas Health - Robert Wood Johnson University Hospital, Hamilton
Hamilton, New Jersey, 08690
RWJBarnabas Health - - Jersey City Medical Medical
Jersey City, New Jersey, 07097
Monmouth Medical Center Southern Campus
Lakewood, New Jersey, 08701
RWJBarnabas Health - Monmouth Medical Center
Long Branch, New Jersey, 07740
Monmouth Community Medical
Long Branch, New Jersey, 07764
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
RWJBarnabas Health - Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08903
RWJBarnabas Health - Newark Beth Israel Medical Center
Newark, New Jersey, 07112
RWJBarnabas Health - Robert Wood Johnson University Hospital
Somerset, New Jersey, 08873