Clinical trial NCT02674204 (phase 2, status: terminated)
Conditions: breast cancer, heart disease, cardiotoxicity, myocardial dysfunction
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60, I11.0, I11.9, I27.1, I51.9, I09.9, I27.9, I01.8, Q93.81, B33.4, A36.81, A50.54, A52.00, A52.09, B33.24, E28.8, E28.9, E29.8, E29.9, E31.8, E31.9, H83.2X3
Drugs: atorvastatin, placebo
SMILES: CC(C)C1=C(C(=O)NC2=CC=CC=C2)C(=C(N1CC[C@@H](O)C[C@@H](O)CC(O)=O)C1=CC=C(F)C=C1)C1=CC=CC=C1, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Reason stopped: 
    closed due to low accrual
  
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