LY353381 in Preventing Breast Cancer in Women With Hyperplasia

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