Statins for Reduction of Cardiac Toxicity in Patients Receiving HER2 Targeted

Inclusion Criteria:

• Histologically and/or cytologically confirmed diagnosis of Stage I-III female breastcancer (including inflammatory breast cancer)
• Scheduled to receive neoadjuvant/adjuvant HER2 targeted therapy
• Between ≥18 years of age
• Female patients of childbearing potential must have a negative pregnancy test (serumor urine) prior to enrollment. Female patients must agree to use effective barriercontraception during the period of therapy
• Baseline LVEF ≥ 50%
• Prior cancers allowed if no evidence of disease in last 5 years
• ECOG 0-2
• No prior history of treatment with HER2 targeted therapy or anthracyclines basedchemotherapy
• Adequate bone marrow function: I. ANC ≥ 1000/uL II. platelet count ≥ 100,000/uL III. hemoglobin ≥ 9.0 g/dL

• Adequate hepatic function: I. Total bilirubin ≤ 1.5 X ULN II. AST (SGOT) ≤ 5 X ULN III.ALT (SGPT) ≤ 5 X ULN

• Adequate renal function, Creatinine < 1.5x institutional ULN or calculated creatinineclearance ≥ 50 mL/min as estimated using the Cockcroft-Gault formula
• Ability to understand the nature of this study protocol and give written informedconsent
• Willingness and ability to comply with scheduled visits, treatment plans, laboratorytests, and other study procedures

Exclusion Criteria:

• Participants with stage IV breast cancer
• Participants currently taking statins
• Uncontrolled hypertension (systolic blood pressure >190 mm Hg or diastolic bloodpressure >100 mm Hg)
• No active liver disease
• Current use of CYP 3A4 inhibitors
• Any condition including the presence of laboratory abnormalities, which, in theopinion of the investigator places the subject at unacceptable risk if he/she were toparticipate in the study
• Life expectancy < 12 weeks
• Pregnancy (positive pregnancy test) or lactation
• Pre-existing sensory neuropathy > grade one
• Has significant cardiovascular disease, such as: LVEF < 50% at baseline as assessed by ECHO (preferred) i) Class III or Class IV myocardialdisease as described by the New York Heart Association ii) Recent history (within 6 monthsprior to enrollment) of myocardial infarction; or iii) Symptomatic arrhythmia at the timeof randomization
• Major surgery without complete recovery in the past four weeks prior to screening
• Concurrent active infection
• Participant with uncontrolled and/ or active infection with HIV, Hepatitis B orHepatitis C
• Participant who has a history of allergy or hypersensitivity to any of the study drugs
• Participant with a history of interstitial lung disease, history of slowly progressivedyspnea and unproductive cough, sarcoidosis, silicosis, interstitial pulmonaryfibrosis, pulmonary hypersensitivity pneumonitis
• Any significant medical condition, laboratory abnormality, or psychiatric illness thatwould prevent the subject from participating in the study