Study of Tamoxifen and Raloxifene (STAR) for the Prevention of Breast Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 19,747
- 试验地点
- 516
- 主要终点
- Incidence of invasive breast cancer; superiority of one of the therapies.
研究概览
简要总结
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.
详细描述
OBJECTIVES:
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Group 2
Raloxifene and Placebo
干预措施: Raloxifene (Drug)
Group 1
Tamoxifen and placebo
干预措施: Tamoxifen (Drug)
结局指标
主要结局
Incidence of invasive breast cancer; superiority of one of the therapies.
时间窗: Time from randomization to the occurance of invasive breast cancer.
Determine which of the following is true: 1. compared to tamoxifen, raloxifene significantly reduces the incidence rate of invasive breast cancer; 2. compared to raloxifene, tamoxifen significantly reduces the incidence rate of invasive breast cancer; or 3. the statistical superiority of one of the treatments cannot be demonstrated and the choice of therapy should be based on benefit/risk considerations.
次要结局
- Effect of the study therapies on the incidence of intraductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS).(Time from randomization to the occurance of DCIS or LCIS.)
- Effect of the study therapies on the incidence of endometrial cancer.(Time from randomization to the occurance of endometrial cancer.)
- Effect of the study therapies on the incidence of fractures of the hip, spine, or Colles' fractures of the wrist.(Time from randomization to the occurance of fractures of the hip, spine, or Colles' fractures of the wrist.)
- Effect of the study therapies on the incidence of ischemic heart disease.(Time from randomization to the occurance of ischimic heart disease.)
- Effect of the study therapies on the toxicity and side effects of each therapy.(Incidences of protocol defined toxicities and side effects.)
- Effect of the study therapies on participants' quality of life.(pre-entry, every 6 months for 5 years, and then annual after 5 years following randomization.)