The Effect of Primary Surgical Treatment on Survival in Patients With Metastatic Breast Cancer at Diagnosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 281
- 试验地点
- 8
- 主要终点
- Measure: all cause mortality
研究概览
简要总结
Primary treatments for metastatic breast cancer are chemotherapy and radiation therapy, and surgery is reserved for tumor related complications such as bleeding. Retrospective studies showed that surgical removal of the primary tumor improves survival of patients with metastatic breast cancer at diagnosis. We hypothesis and testing that surgical removal of the primary tumor will lead to an improvement of overall survival
详细描述
This is a randomised, controled clinical trial. Our aim is to observe whether primary surgery improves survival in metastatic breast cancer. Women who have metastatic breast cancer at the initial diagnosis will be included in the study. There will be two study arms: primary surgery and systemic chemotherapy groups.
In the primary surgery group patients will have adjuvant therapies after they had the proper surgery. In the systemic chemotherapy group patients will be followed after their initial therapy and will have surgery only if they have locoregional problems (such as wide necrosis or bleeding, etc). During the follow-up period, patients will be seen in every 6 months.
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
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with metastatic breast cancer at the initial diagnosis
排除标准
- •Women needs breast surgery at the time of initial diagnosis (such as bleeding, necrosis, etc)
- •who have systemic morbidity that do not allows her to be in the trial,
- •who have synchronous breast cancer at the contralateral breast,
- •who have a previous cancer history or another primary cancer history and metastasis at the past,
- •who have palpable lymph node/nodes at the contralateral axilla,
- •who do not agree to participate the trial
结局指标
主要结局
Measure: all cause mortality
时间窗: 5 years
次要结局
- Quality of life(5 year)
- mordities(5 years)