STOP Heart Disease in Breast Cancer Survivors Trial
Condition: Breast Cancer; Heart Disease; Cardiotoxicity; Myocardial Dysfunction
MeSH terms: Breast Neoplasms; Heart Diseases; Cardiotoxicity
Intervention: Atorvastatin; Placebo
Intervention description: Atorvastatin calcium, a synthetic lipid-lowering agent, is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis.; A substance that has no therapeutic effect, and will be used as a control in testing the study agent.
Intervention MeSH terms: Atorvastatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 2.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Statin therapy; trastuzumab

Summary:

      The purpose of this study is to to examine the effects of atorvastatin, a type of statin, on
      changes to the heart among women undergoing breast cancer treatment. Atorvastatin may reduce
      or eliminate the harmful effects of chemotherapy treatment to the heart tissue of breast
      cancer patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female patients with newly diagnosed stage 1-3 breast cancer

          -  Histologically confirmed HER2, ER, and PR status

          -  Recommended to undergo trastuzumab treatment, with or without anthracycline. Patients
             will be eligible for up to 3 weeks after starting treatment.

          -  Age minimum 18 years

          -  Able and willing to read, understand, and sign an informed consent form (ICF) and
             medical release form

          -  Willing and able to comply with trial protocol and follow-up

          -  ECOG performance status 0-1 (Karnofsky ≥ 70%)

        Exclusion Criteria:

          -  Prior use of statin medication within the past year

          -  Not using statin medication but is eligible for statin therapy based on the 2013
             ACC/AHA guidelines (LDL cholesterol >190, or LDL <190 and ASCVD risk >7.5%;
             http://tools.acc.org/ASCVD-Risk-Estimator/) and is > 50 years old; or is eligible for
             statin therapy based on the 2013 ACC/AHA guidelines and is 40-50 years old and wishes
             to be placed on statin therapy

          -  History of adverse effects, intolerance, or allergic reactions attributed to statin
             medication

          -  Current use of gemfibrozil, cyclosporine, clarithromycin, itraconazole, erythromycin,
             the hepatitis C protease inhibitor telaprevir, HIV protease inhibitors, colchicine, or
             red yeast rice

          -  Current use of any other investigational agent

          -  Pregnant or intention to get pregnant during the next 18 months. Pregnant women are
             excluded from this study because atorvastatin is a lipid-lowering agent with the
             potential for teratogenic or abortifacient effects, and MRI is contraindicated in
             pregnant women.

          -  History of diabetes, severe lung disease, renal disease (creatinine > 1.8 mg/dL or
             CrCl ≤ 50 mL/min), or hepatic disease (AST and ALT > 3 times upper normal limits)

          -  Abnormal baseline echocardiogram or cardiac MRI (detection of congenital heart
             disease; ischemic heart disease; moderate or severe valvular heart disease;
             cardiomyopathy; EF < 55%)

          -  Previously known or diagnosed heart disease (e.g. congenital; valvular; coronary
             artery disease; history of myocardial infarction or acute coronary syndrome;
             cardiomyopathy, including infiltrative, hypertensive, hypertrophic, dilated,
             constrictive pericarditis, or other cardiomyopathy)

          -  Left ventricular dysfunction (EF < 55%)

          -  Prior non-cardiac illness with an estimated life expectancy < 4 years

          -  Known active infection with HIV

          -  Allergy or contraindication to MRI testing, including claustrophobia, metallic parts
             in body the prohibiting MRI, prior gadolinium contrast reaction, or uncontrolled
             moderate hypertension (sitting blood pressure >160/95 mm Hg with measurements recorded
             on at least 2 occasions).

          -  Has metallic breast expanders in place at the time of screening

          -  Concurrent illness which in the opinion of the investigators would compromise either
             the patient or the integrity of the data