STOP Heart Disease in Breast Cancer Survivors Trial (STOP)

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