The Effect of Simvastatin on Breast Cancer Cell Growth in Women With Stage I-II Breast Cancer
Condition: Invasive Breast Carcinoma; Stage I Breast Cancer AJCC v7; Stage IA Breast Cancer AJCC v7; Stage IB Breast Cancer AJCC v7; Stage II Breast Cancer AJCC v6 and v7; Stage IIA Breast Cancer AJCC v6 and v7; Stage IIB Breast Cancer AJCC v6 and v7
MeSH terms: Breast Neoplasms
Intervention: Laboratory Biomarker Analysis; Simvastatin
Intervention description: Correlative studies; Given PO
Intervention MeSH terms: Simvastatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: Female
Minimum age: 19 Years
Healthy volunteers: No

Summary:

      The purpose of this pilot phase II trial is to identify the molecular and genetic mechanisms
      by which statins influence breast cancer cell proliferation. Simvastatin may stop the growth
      of tumor cells by blocking some of the enzymes needed for cell growth and reduce the
      aggressiveness of breast cancer cells.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provision of informed consent prior to any study specific procedures

          -  Histologic confirmation of invasive breast cancer with any measures of ER, PR and
             HER2neu

          -  Clinical stage I or II breast cancer for which there will be at least a 2 week period
             of time between diagnosis and definitive surgery

          -  Performance status (Eastern Cooperative Oncology Group [ECOG] 0-1)

          -  Not currently pregnant during the study; participants will be informed that the use of
             contraceptive pills is contraindicated because it may interfere with the study drug
             and it may be harmful to the woman who has been diagnosed with breast cancer

        Exclusion Criteria:

          -  Plans for administration of neoadjuvant chemotherapy or hormonal therapy

          -  Insufficient tissue on diagnostic core breast biopsy for analysis

          -  Previous or concurrent malignancy (with the exception of non-melanomatous skin cancer)

          -  Severe gastrointestinal disorder

          -  Current use of statins or fibrates for any time during the 3 months prior to the study

          -  Proven hypersensitivity to statins

          -  White blood cell (WBC) < 3,500/mm^3

          -  Platelet (Plt) < 120,000/mm^3

          -  Hemoglobin (HgB) < 10 g/dL

          -  Aspartate aminotransferase (AST) > 45 U/L

          -  Alanine aminotransferase (ALT) > 45 U/L

          -  Creatinine > 1.5 mg/dL

          -  Bilirubin > 1.15 mg/dL

          -  Creatine kinase measurement (CPK) > or = 250 mg/dL

          -  Central nervous system (CNS) diseases and major psychiatric diseases or inability to
             comply to the protocol procedures

          -  Active infections

          -  Cardiac failure, class I-IV

          -  Current anticoagulant or antiplatelet aggregation therapy

          -  Mitral and/or tricuspid valvopathy or valvular prosthesis; angina; severe arterial
             hypertension; chronic and/or paroxysmal atrial fibrillation; previous myocardial
             infarction

          -  Current lactation