Statins for Reduction of Cardiac Toxicity in Patients Receiving HER2 Targeted Therapy.

Inclusion Criteria

- Histologically and/or cytologically confirmed diagnosis of Stage I-III female breast

cancer (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 (serum

or urine) prior to enrollment. Female patients must agree to use effective barrier

contraception 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 based

chemotherapy

- 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 creatinine

clearance ≥ 50 mL/min as estimated using the Cockcroft-Gault formula

- Ability to understand the nature of this study protocol and give written informed

consent

- Willingness and ability to comply with scheduled visits, treatment plans, laboratory

tests, 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 blood

pressure >100 mm Hg)

- No active liver disease

- Current use of CYP 3A4 inhibitors

- Any condition including the presence of laboratory abnormalities, which, in the

opinion of the investigator places the subject at unacceptable risk if he/she were to

participate 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 myocardial

disease as described by the New York Heart Association ii) Recent history (within 6 months

prior to enrollment) of myocardial infarction; or iii) Symptomatic arrhythmia at the time

of 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 or

Hepatitis 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 progressive

dyspnea and unproductive cough, sarcoidosis, silicosis, interstitial pulmonary

fibrosis, pulmonary hypersensitivity pneumonitis

- Any significant medical condition, laboratory abnormality, or psychiatric illness that

would prevent the subject from participating in the study