NCT00078832已完成3 期
International Breast Cancer Intervention Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 3,864
- 试验地点
- 73
- 主要终点
- Development of histologically confirmed breast cancer, both invasive and non-invasive with median follow-up at 5 years
研究概览
简要总结
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. Anastrozole may be effective in preventing breast cancer.
PURPOSE: This randomized clinical trial is studying how well anastrozole works in preventing breast cancer in postmenopausal women who are at increased risk for the disease.
详细描述
OBJECTIVES:
Primary
- Determine the effectiveness of anastrozole in preventing breast cancer in postmenopausal women at increased risk for the disease.
Secondary
- Determine the role of this drug in preventing estrogen receptor-positive breast cancer in these participants.
- Determine the effect of this drug on breast cancer mortality in these participants.
- Determine the effect of this drug on other cancers, cardiovascular disease, fracture rates, and non-breast cancer deaths in these participants.
- Determine the tolerability and acceptability of side effects of this drug in these participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
anastrozole
Experimental
anastrozole 1mg
干预措施: anastrozole (Drug)
placebo
Placebo Comparator
anastrozole 1mg PLACEBO
干预措施: placebo (Drug)
结局指标
主要结局
Development of histologically confirmed breast cancer, both invasive and non-invasive with median follow-up at 5 years
时间窗: Dec 2013
次要结局
- Breast cancer mortality with median follow-up at 10 years(Dec 2018)
研究者
研究点 (73)
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