Raloxifene in Preventing Breast Cancer in Premenopausal Women

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