Study of Tamoxifen and Raloxifene (STAR) for the Prevention of Breast Cancer in Postmenopausal Women

DISEASE CHARACTERISTICS:

Postmenopausal women at increased risk for developing invasive breast cancer, who meet one of the following criteria:

At least 12 months since spontaneous menstrual bleeding
Prior documented hysterectomy and bilateral salpingo-oophorectomy
At least 55 years of age with prior hysterectomy with or without oophorectomy
Age 35 to 54 with a prior hysterectomy without oophorectomy OR with a status of ovaries unknown with documented follicle-stimulating hormone level demonstrating elevation in postmenopausal range
Histologically confirmed lobular carcinoma in situ treated by local excision only OR a minimum projected 5 year probability of invasive breast cancer of at least 1.66%, using Breast Cancer Risk Assessment Profile
No clinical evidence of malignancy on physical exam within the past 180 days
No evidence of suspicious or malignant disease on bilateral mammogram within the past year
No bilateral or unilateral prophylactic mastectomy
No prior invasive breast cancer or intraductal carcinoma in situ

Hormone receptor status:

Not specified

PATIENT CHARACTERISTICS:

Age:

35 and over

Sex:

Female

Menopausal status:

See Disease Characteristics

Performance status:

No restricted normal activity for a significant portion of each day

Life expectancy:

At least 10 years

Hematopoietic:

Granulocyte count at least 1,500/mm^3
Complete blood count and differential normal
Platelet count normal

Hepatic:

SGOT or SGPT normal
Bilirubin normal
Alkaline phosphatase normal

Renal:

Creatinine normal

Cardiovascular:

No cerebral vascular accident, transient ischemic attack, atrial fibrillation, or uncontrolled hypertension
No deep vein thrombosis

Pulmonary:

No pulmonary embolus

Other:

No other prior malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
No concurrent nonmalignant disease that would preclude administration of tamoxifen or raloxifene
No clinical depression, psychiatric condition, or addictive disorder
No uncontrolled diabetes

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Not specified

Chemotherapy:

Not specified

Endocrine therapy:

At least 3 months since prior estrogen or progesterone replacement therapy, oral contraceptives, androgens, luteinizing hormone-releasing hormone analogs, prolactin inhibitors, or antiandrogens
At least 3 months since prior tamoxifen, raloxifene, or other selective estrogen-receptor modulators of less than 3 months duration
Concurrent Estring allowed

Radiotherapy:

No prior breast radiotherapy

Surgery:

See Disease Characteristics

Other:

No prior systemic adjuvant therapy for breast cancer

No other participation in a cancer prevention or osteoporosis prevention study involving pharmacologic intervention(s)

NSABP-P-1 patients who received placebo are eligible
No concurrent warfarin or cholestyramine
Concurrent calcitonin or nonhormonal medication (e.g., cholecalciferol, fluoride, or bisphosphonates) allowed