A Randomized Trial Of Axillary Dissection Versus No Axillary Dissection For Patients With Clinically Node Negative Breast Cancer And Micrometastases In The Sentinel Node
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 931
- 试验地点
- 61
- 主要终点
- 5-year Disease-Free Survival
研究概览
简要总结
RATIONALE: Surgery to remove lymph nodes in the armpit in patients with sentinel lymph node micrometastases may remove cancer cells that have spread from tumors in the breast. It is not yet known whether surgery to remove the primary tumor is more effective with or without axillary lymph node dissection.
PURPOSE: This randomized phase III trial is studying surgery and axillary lymph node dissection to see how well they work compared to surgery alone in treating women with node-negative breast cancer and sentinel lymph node micrometastases.
详细描述
OBJECTIVES:
- Compare disease-free survival of women with clinically node-negative breast cancer with sentinel lymph node micrometastases treated with surgical resection with or without axillary dissection.
- Compare overall survival of patients treated with these regimens.
- Assess sites of recurrence, particularly reappearance of disease in the undissected axilla.
- Assess long-term surgical complications in patients treated with these regimens.
OUTLINE: This is a multicenter study. Patients are stratified according to participating center, menopausal status (pre- vs postmenopausal), and preoperative sentinel node biopsy (yes vs no). Patients are followed every 4 months for 1 year, every 6 months for 4 years, and then annually thereafter.
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
- 18 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
Axillary Dissection
Patients undergo surgical resection of the primary tumor with axillary lymph node dissection following sentinel lymph node assessment.
干预措施: Axillary lymph node dissection (Procedure)
No Axillary Dissection
Patients undergo surgical resection of the primary tumor with no axillary lymph node dissection following sentinel lymph node assessment.
干预措施: No axillary lymph node dissection (Procedure)
结局指标
主要结局
5-year Disease-Free Survival
时间窗: 5-year estimate reported after a median follow-up of 60 months
Estimated percentage of patients alive and disease-free at 5 years from randomization, where disease-free survival is defined as the time from randomization to first evidence of invasive relapse at any site, second primary tumor (contralateral or non-breast) or death.
次要结局
- Site of Recurrence(Reported after a median follow-up of 60 months)
- 5-year Overall Survival(5-year estimate reported after a median follow-up of 60 months)