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Study of Tamoxifen and Raloxifene (STAR) for the Prevention of Breast Cancer (NCT00003906)

Eli Lilly and Company
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.
  • Drug: Raloxifene
    60 mg/day plus placebo for 5 years
    • Drug: Tamoxifen
      20 mg/day plus placebo for 5 years
      Ages eligible for Study
      35 Years and older
      Genders eligible for Study
      Accepts Healthy Volunteers

      - Determine whether raloxifene is more or less effective than tamoxifen in significantly reducing the incidence rate of invasive breast cancer in postmenopausal women.

      - Evaluate the effects of tamoxifen and raloxifene on the incidence of intraductal carcinoma in situ, lobular carcinoma in situ, endometrial cancer, ischemic heart disease, fractures of the hip and spine, or Colles' fractures of the wrist in these participants.

      - Evaluate the toxic effects of these regimens in these participants.

      - Determine the effect of these regimens on the quality of life of these participants (at selected centers). (Quality of life evaluation closed to accrual effective 5/31/01.)

      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.

      - Arm I: Participants receive oral tamoxifen plus placebo daily for 5 years.

      - Arm II: Participants receive oral raloxifene plus placebo daily for 5 years. Quality of life is assessed (at selected centers) at baseline and at 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, and 72 months. (Quality of life evaluation closed to accrual effective 5/31/01.)

      Participants are followed annually after 5 years.

      PROJECTED ACCRUAL: Approximately 19,000 participants will be accrued for this study within 5 years.

      516 locations

      30 April, 1999
      04 October, 2015
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