LY353381 in Preventing Breast Cancer in Women With Hyperplasia

• Status: Completed
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Kansas Medical Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Estrogen Receptor Modulators; Selective Estrogen Receptor Modulators

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