Breast Cancer Liver Metastases-2 - A Multicentre Randomized Clinical Trial Investigating Local Treatment for Breast Cancer Liver Metastases
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Survival
研究概览
简要总结
Breast cancer is the second most common cancer in Sweden with an incidence of 8000 per year. The role of surgery for distant breast cancer metastasis beyond local lymph nodes remains controversial even though some reports suggest there might be a survival benefit from resection of oligometastases in the liver.
The purpose of this multicentre randomized clinical trial is to evaluate local treatment for breast cancer liver metastases, compared to systemic oncological treatment only. The primary endpoint is time to death from any cause, which will be compared using cox proportional hazard regression. The secondary endpoints are three years survival, progression-free survival, median overall survival and quality of life. The aim is also to evaluate overall safety and predictive factors for survival during oncological and surgical treatment. The overall purpose is to ameliorate treatment for advanced breast cancer.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •>18 years old
- •Breast cancer history
- •Breast cancer liver metastasis verified by biopsy
- •Patient amendable for liver surgery and pre- and postoperative oncological treatment
- •1-4 liver metastasis amendable to surgery with functional liver remnant volume >30%
- •Liver metastasis (and skeletal metastasis) stable or responding to preoperative oncological treatment
排除标准
- •Non-skeletal extrahepatic disease
- •Non-resected primary tumour
- •Pregnancy
- •Progression of disease upon oncological treatment
研究组 & 干预措施
Surgical intervention
Surgical and oncological treatment
干预措施: Surgical intervention (Procedure)
Control
Oncological treatment
干预措施: Control (Drug)
结局指标
主要结局
Survival
时间窗: Three years after randomization
Time to death from any cause
次要结局
未报告次要终点