A Statin (Atorvastatin Calcium) for the Reduction of Cardiac Toxicity in Patients with Stage I-III Breast Cancer Receiving HER2 Targeted Therapy, STACIE Study

Inclusion Criteria

• Histologically and/or cytologically confirmed diagnosis of Stage I-III breast cancer (including inflammatory breast cancer)
• Scheduled to receive neoadjuvant/adjuvant HER2 targeted therapy
• >= 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 left ventricular ejection fraction (LVEF) >= 50%
• Patients with a history of any other cancer (except non-melanoma skin cancer, stage I uterine cancer, or carcinoma in situ of the cervix or other in-situ cancer), unless in complete remission with no therapy for a minimum of 3 years from the date of trial consent. Other non-active cancers after review by principal investigator (PI) may be included
• Eastern Cooperative Oncology Group (ECOG) 0-2
• No prior history of treatment with HER2 targeted therapy or anthracyclines based chemotherapy
• Absolute neutrophil count (ANC) >= 1000/uL
• Platelet count >= 100,000/uL
• Hemoglobin >= 9.0 g/dL
• Total bilirubin =< 1.5 X upper limit of normal (ULN)
• Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) =< 5 X ULN
• Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 5 X ULN
• 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

• Patients with stage IV breast cancer
• Patients currently taking statins-Current treatment with Lipitor/statin is allowed if duration has been less than 3 months prior to study enrollment. Patients on another statin will be switched to Lipitor (study drug)
• Uncontrolled hypertension (systolic blood pressure >190 mm Hg or diastolic blood pressure >100 mm Hg)
• 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 1
• Has significant cardiovascular disease, such as: * LVEF < 50% at baseline as assessed by echocardiogram (ECHO) (preferred) * Class III or Class IV myocardial disease as described by the New York Heart Association. * Recent history (within 6 months prior to enrollment) of myocardial infarction; or * Symptomatic arrhythmia at the time of randomization
• Major surgery without complete recovery in the past 4 weeks prior to screening
• Concurrent active infection
• Patient with uncontrolled and/ or active infection with human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C
• Patient who has a history of allergy or hypersensitivity to any of the study drugs
• Patients 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