NCT00210236终止3 期
Surgical Resection With or Without Axillary Lymph Node Excision in Treating Menopausal Women With Infiltrative Breast Cancer Smaller Than 10 mm
适应症
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 625
- 试验地点
- 28
- 主要终点
- Number of Deaths
研究概览
简要总结
This randomized phase III trial is studying surgery and axillary lymph node dissection to evaluate if systematic Axillary Lymph Node Excision can be avoided in locoregional treatment for operable breast cancer smaller than 10 mm among menopausal women older than 50
详细描述
Phase III randomized multicenter equivalence trial evaluating the role of Axillary Lymph Node Excision.
Primary aim is to assess if it is possible to avoid routine Axillary Lymph Node Excision during the initial treatment of breast cancers smaller than 11 mm in women aged 50 and older without compromising survival? The primary endpoint is overall survival: the event considered will be death from any cause.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 100 Years（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
结局指标
主要结局
Number of Deaths
时间窗: Five years after surgery
次要结局
- Rate of Axillary Recurrence(Five years after surgery)
研究者
研究点 (28)
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