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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
LIPITOR® (atorvastatin calcium) tablets will be administered orally as a single dose of 40 mg once daily, with or without food
Trinitas Hospital and Comprehensive Cancer Center
Elizabeth, New Jersey, United States
RECRUITINGRWJBarnabas Health - Robert Wood Johnson University Hospital, Hamilton
Hamilton, New Jersey, United States
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
Patient reported outcome (PRO) for pain measured by the quality of Life questionnaire using PROMIS to measure pain
Quality of Life questionnaire using PROMIS will be administered at baseline, six, twelve and fifteen months
Time frame: Baseline, six, twelve and fifteen months
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RWJBarnabas Health - - Jersey City Medical Medical
Jersey City, New Jersey, United States
RECRUITINGMonmouth Medical Center Southern Campus
Lakewood, New Jersey, United States
RECRUITINGRWJBarnabas Health - Monmouth Medical Center
Long Branch, New Jersey, United States
RECRUITINGMonmouth Community Medical
Long Branch, New Jersey, United States
RECRUITINGRutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
RECRUITINGRWJBarnabas Health - Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States
NOT_YET_RECRUITINGRWJBarnabas Health - Newark Beth Israel Medical Center
Newark, New Jersey, United States
RECRUITINGRWJBarnabas Health - Robert Wood Johnson University Hospital
Somerset, New Jersey, United States
RECRUITING