LY353381 in Preventing Breast Cancer in Women With Hyperplasia
Condition: Breast Cancer
MeSH terms: Breast Neoplasms; Hyperplasia
Intervention: arzoxifene; Placebo
Intervention description: one tablet daily; matched tablet dialy
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 199.0
Sex: Female
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: breast cancer

Summary:

      RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the
      development or recurrence of cancer. The use of LY353381 may be an effective way to prevent
      the development of breast cancer in women who have hyperplasia.

      PURPOSE: Randomized phase II trial to study the effectiveness of LY353381 in preventing
      breast cancer in women who have hyperplasia.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Current random fine needle breast aspiration (FNA) evidence of 1 of the following:

               -  Hyperplasia with atypia

               -  Hyperplasia without atypia but with a 10-year modified Gail risk of at least 4%

               -  Hyperplasia without atypia but with a BRCAPRO risk of at least 25%

               -  Hyperplasia without atypia but with a known mutation in BRCA1 or BRCA2

               -  Hyperplasia without atypia but with a history of contralateral ductal carcinoma
                  in situ or invasive breast cancer

          -  FNA must have been taken during days 1-14 of the menstrual cycle for premenopausal
             women

          -  Classified as ACR class I-III on mammogram with stepwedge within past 6 months If
             intact uterus and/or ovaries, must have color doppler transvaginal pelvic sonogram
             within past 6 months showing endometrial thickening no greater than 13 mm
             premenopausal or no greater than 8 mm postmenopausal

               -  No ovarian cysts felt to be possibly or probably non-physiologic that have not
                  resolved to gynecologist's satisfaction on repeat sonogram

          -  Must agree to have or have had genetic counseling and genetic testing performed for
             BRCA1 and BRCA2

          -  No active cancer (e.g., detectable disease)

          -  Hormone receptor status:

               -  Not specified

        PATIENT CHARACTERISTICS:

        Age:

          -  18 and over

        Sex:

          -  Female

        Menopausal status:

          -  Any

        Performance status:

          -  Not specified

        Life expectancy:

          -  At least 12 months

        Hematopoietic:

          -  Hemoglobin greater than 10 g/dL

          -  Granulocyte count greater than 1,000/mm^3

          -  No deficiencies in protein C, protein S, or antithrombin III

          -  No activated protein C resistance

        Hepatic:

          -  Albumin greater than 3.0 g/dL

          -  Bilirubin less than 1.5 mg/dL

          -  AST less than 100 U/L

          -  Alkaline phosphatase less than 200 U/L

        Renal:

          -  Creatinine less than 1.5 mg/dL

        Cardiovascular:

          -  No history of deep venous thrombosis not related to trauma or pregnancy

          -  No severe coronary artery disease

          -  No history of prior stroke

        Other:

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for 3 months after study

          -  No other active cancer

          -  No retinal vein thrombosis

          -  No concurrent severe poorly controlled migraine

          -  No factor V Leiden mutation carrier

        PRIOR CONCURRENT THERAPY:

        Biologic therapy:

          -  At least 12 months since prior immunotherapy

        Chemotherapy:

          -  At least 3 months between completion of prior KUMC phase II difluoromethylornithine
             (DFMO) study and baseline aspiration

          -  At least 12 months since prior chemotherapy

        Endocrine therapy:

          -  Must not have started or stopped hormone replacement therapy or oral contraceptives
             within 6 months of baseline aspiration

          -  Must continue all hormone replacement therapy and/or oral contraceptives that were
             being taken at time of baseline aspiration

          -  At least 12 months since prior tamoxifen, raloxifene, or other antihormonal therapy

        Radiotherapy:

          -  At least 3 months since prior radiotherapy

        Surgery:

          -  At least 6 months between prior oophorectomy and baseline aspiration

        Other:

          -  At least 2 weeks since the start of other new medication that would be ingested for 1
             or more months