Simvastatin and Anastrozole in Treating Postmenopausal Women With Ductal Carcinoma In Situ or Invasive Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms; Carcinoma in Situ
Intervention: anastrozole; simvastatin; pharmacological study; adjuvant therapy
Intervention description: 1 milligram tablet PO QD for 14 days; 40 milligram tablet PO QD for 14 days; laboratory analysis; laboratory analysis
Intervention MeSH terms: Anastrozole; Simvastatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: breast cancer; breast cancer in situ; ductal breast carcinoma 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 and anastrozole may stop cancer from forming, growing,
      or coming back in patients with invasive breast cancer, ductal carcinoma in situ, or a high
      risk of breast cancer.

      PURPOSE: This phase II trial is studying how well giving simvastatin together with
      anastrozole works in treating postmenopausal women with invasive breast cancer, ductal
      carcinoma in situ, or a high risk of breast cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Meets any of the following criteria:

               -  History of invasive breast cancer

               -  History of ductal carcinoma in situ

               -  At high risk for breast cancer, defined as being on anastrozole for
                  chemoprevention of breast cancer

          -  Receiving anastrozole for ≥ 30 days as adjuvant breast cancer treatment or for
             prevention of breast cancer

          -  No active breast cancer with known metastatic involvement

          -  Hormone receptor status not specified

        PATIENT CHARACTERISTICS:

          -  Female

          -  Postmenopausal

          -  ECOG performance status 0-2

          -  AST and ALT ≤ 3 times upper limit of normal

          -  Creatinine clearance ≥ 30 mL/min

          -  No active liver disease

          -  No prior hypersensitivity to any HMG-CoA reductase inhibitor or any of its components

          -  No daily alcohol use of > 3 standard drinks/day

               -  A standard drink is defined as 10 g of alcohol, which is equivalent to 285 mL of
                  beer, 530 mL of light beer, 100 mL of wine, or 30 mL of liquor

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  No cholesterol-lowering drug, including a statin, within the past 3 months

          -  No selective estrogen receptor modulator (SERM) within the past 3 months

          -  No other hormone therapy within the past 3 months

          -  No prior estrogen and/or progesterone hormone replacement therapy that lasted for ≥ 5
             years

               -  Vaginal estrogen preparations allowed

          -  No other concurrent statin or cholesterol-lowering drug

          -  No other concurrent SERM

          -  No other concurrent hormone therapy

          -  No other concurrent investigational drugs

          -  No concurrent CYP3A4 inhibitors, including itraconazole, ketoconazole, erythromycin,
             clarithromycin, telithromycin, HIV protease inhibitors, nefazodone, or cyclosporine

          -  No concurrent chemotherapy or biological agents

          -  No concurrent daily grapefruit juice > 8 oz/day

          -  No other concurrent anticancer agents or therapies