Simvastatin in Preventing a New Breast Cancer in Women at High Risk for a New Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: simvastatin
Intervention description: 24-28 weeks of simvastatin
Intervention MeSH terms: Simvastatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: breast cancer; ductal breast carcinoma in situ; breast cancer in situ; stage I breast cancer; stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer

Summary:

      RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing,
      or coming back. The use of simvastatin may keep cancer from coming back in women who are at
      high risk for a new breast cancer after undergoing surgery for ductal carcinoma in situ or
      stage I, stage II, or stage III breast cancer.

      PURPOSE: This phase II trial is studying how well simvastatin works in preventing a new
      breast cancer in women at high risk for a new breast cancer after undergoing surgery for
      ductal carcinoma in situ or stage I, stage II, or stage III breast cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  History of histologically confirmed breast cancer, meeting 1 of the following staging
             criteria:

               -  Ductal carcinoma in situ

               -  Stage I-III invasive breast cancer

          -  At least 3 months since completion of all intended local and systemic therapy,
             including mastectomy or lumpectomy with or without radiotherapy, adjuvant
             chemotherapy, and/or endocrine therapy

               -  May have declined recommended treatment provided all treatment intended/agreed
                  upon by the patient and treating physician was completed ≥ 3 months ago

          -  At least 1 healthy intact breast

               -  No prior radiotherapy or mastectomy

               -  Prior biopsies allowed

          -  Any hormone-receptor status

        PATIENT CHARACTERISTICS:

          -  Female

          -  Pre- or post-menopausal

          -  ECOG performance status 0-2

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective nonhormonal contraception

          -  No active liver disease

          -  AST and ALT ≤ 3 times upper limit of normal

          -  Creatinine clearance ≥ 30 mL/min

          -  No prior hypersensitivity to any 3-hydroxyl-3-methylglutaryl-Coenzyme A (HMG-CoA)
             reductase inhibitor or any of its components

          -  No other concurrent infectious, inflammatory, or autoimmune diseases (at the
             discretion of principal investigator)

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  No daily alcohol use > 3 standard drinks per day

               -  Standard drink defined as 10 grams of alcohol, which is equivalent to 285 mL of
                  beer, 530 mL of light beer, 100 mL of wine, or 30 mL of liquor

          -  No selective estrogen receptor modulator or aromatase inhibitor within the past 3
             months

          -  No hormone replacement therapy (HRT) within the past 3 months

          -  No prior estrogen and/or progesterone HRT ≥ 5 years in duration

               -  Vaginal estrogen preparations allowed

          -  No concurrent HRT

          -  No other cholesterol-lowering drug, including a statin, within the past 3 months

          -  No concurrent itraconazole, ketoconazole, nefazodone, cyclosporine, HIV protease
             inhibitors, clarithromycin, erythromycin, mibefradil, carbamazepine, bosentan,
             chaparral, amiodarone, or verapamil

          -  No concurrent daily grapefruit juice consumption > 8 ounces per day

          -  No other concurrent agents or therapies intended to treat or prevent in situ or
             invasive breast cancer