Study of Tamoxifen and Raloxifene (STAR) for the Prevention of Breast Cancer
Study of Tamoxifen and Raloxifene (STAR) for the Prevention of Breast Cancer
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using raloxifene and tamoxifen may fight breast cancer by blocking the uptake of estrogen by the tumor cells.
PURPOSE: Randomized double-blinded clinical trial to compare the effectiveness of raloxifene with that of tamoxifen in preventing breast cancer in postmenopausal women.
OBJECTIVES:
OUTLINE: This is a randomized, double-blind study. Participants are stratified by age (35 to 49 vs 50 to 59 vs over 59), race (black vs white vs other), history of lobular carcinoma in situ (yes vs no), prior hysterectomy (yes vs no), and estimated absolute risk of invasive breast cancer within 5 years (using the Gail model)(less than 2.0 vs 2.0-2.9 vs 3.0-4.9 vs 5.0 or greater). Participants are randomized to 1 of 2 arms.
Participants are followed annually after 5 years.
PROJECTED ACCRUAL: Approximately 19,000 participants will be accrued for this study within 5 years.
DISEASE CHARACTERISTICS:
Postmenopausal women at increased risk for developing invasive breast cancer, who meet one of the following criteria:
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:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
No prior systemic adjuvant therapy for breast cancer
No other participation in a cancer prevention or osteoporosis prevention study involving pharmacologic intervention(s)
No concurrent warfarin or cholestyramine
Concurrent calcitonin or nonhormonal medication (e.g., cholecalciferol, fluoride, or bisphosphonates) allowed
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Little Rock, Arkansas 72205, United States
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