Intervention: Arzoxifene
Trial phase: Phase 2
SMILES: COc1ccc(-c2sc3cc(O)ccc3c2Oc2ccc(OCCN3CCCCC3)cc2)cc1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 98
Group description: LY353381, 20 mg daily

arzoxifene: one tablet daily
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