A Randomized Phase II Trial of Two Doses of Raloxifene in Pre-Menopausal Women at High Risk For Developing Invasive Breast Cancer

Inclusion Criteria

DISEASE CHARACTERISTICS:

- At risk for developing invasive breast cancer by virtue of 1 of the following
criteria:

- Gail model risk equal to that of an average 60 year old woman as determined
using the Gail risk assessment model

- Lobular neoplasia

- Atypical ductal hyperplasia with a positive family history of breast cancer

- Ductal carcinoma in situ previously treated with mastectomy or lumpectomy and
radiation

- BRCA1 or BRCA2 mutation-positive genotyping

- Family history consistent with hereditary cancer syndrome of increased breast
cancer risk defined as 1 of the following:

- Family with more than 2 breast cancer cases and one or more cases of
ovarian cancer diagnosed at any age

- Family with more than 3 breast cancer cases diagnosed before age 50

- Sister pairs with 2 breast cancers, 2 ovarian cancers, or 1 breast and 1
ovarian cancer diagnosed before age 50

- Premenopausal

- Menstrual cycle of 26-35 days

- No change in menstrual pattern within the past 6 months (no irregularities)

- FSH level less than 20 mIU/mL

- Hormone receptor status:

- Not specified

PATIENT CHARACTERISTICS:

Age

- 23 to 47

Sex

- Female

Menopausal status

- Premenopausal

Performance status

- Not specified

Life expectancy

- Not specified

Hematopoietic

- No history of bleeding disorder

Hepatic

- No history of cirrhosis of the liver

- SGOT/SGPT no greater than 3 times upper limit of normal (ULN)

Renal

- Creatinine no greater than 1.7 mg/dL

Cardiovascular

- No history of pulmonary embolism or deep venous thrombosis

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile participants must use effective non-hormonal contraception (e.g. barrier
methods, spermicides, or surgical methods) during and for 3 months after study

- No history of infertility with a suspected ovarian etiology or recurrent ovarian
cysts

- No allergy to raloxifene

- No dysfunctional uterine bleeding

- No menorrhagia

- No cervical dysplasia or significant uterine pathology requiring concurrent surgery

- No medical or psychiatric disorder that would preclude study participation

- Normal CA 125 levels

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- Not specified

Endocrine therapy

- At least 6 months since prior steroid therapy (e.g., tamoxifen, estrogen, DHEA,
anabolic steroids, or oral contraceptives)

Radiotherapy

- See Disease Characteristics

Surgery

- See Disease Characteristics

- No prior hysterectomy