The Effect of Primary Surgery in Patients With Stage IV Breast Cancer With Bone Metastasis Only
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 460
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
A registry trial evaluating resection of the primary breast tumor in women presenting with de novo stage IV breast cancer with bone metastasis only. Previous reports of carefully selected patients presenting with stage IV breast cancer suggest that surgery on the primary tumor may result in improved survival, but this remains unproven. The early results of our ongoing trial MF07-01 trial (a phase III randomized controlled trial of breast cancer women with distant metastases at presentation who receive loco-regional treatment for intact primary tumor compared with those who do not receive such treatment) showed that patients with bone metastasis only have a trend toward improved survival with initial surgery.
详细描述
This registry trial evaluating resection of the primary breast tumor in women presenting with de novo stage IV breast cancer with bone metastasis only. Previous reports of carefully selected patients presenting with stage IV breast cancer suggest that surgery on the primary tumor may result in improved survival, but this remains unproven. The early results of our ongoing trial MF07-01 trial (a phase III randomized controlled trial of breast cancer women with distant metastases at presentation who receive loco-regional treatment for intact primary tumor compared with those who do not receive such treatment) showed that patients with bone metastasis only have a trend toward improved survival with initial surgery. Our goal is to test if primary surgery improves overall survival in bone only metastasis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Primary breast tumor amenable for complete surgical resection
- •Patients in good physical condition for receiving protocol driven locoregional and systemic treatment
- •Patients eligible for sentinel lymph node (SLN) biopsy and receiving radiotherapy.
排除标准
- •Primary tumor not amenable for complete resection (such as tumor extending to neighboring tissues; T4a,c or inflammatory breast cancer; T4d)
- •Primary tumor with extended infection, bleeding, or necrosis
- •Patients with poor physical condition which prevents the patient from receiving protocol driven locoregional and systemic treatment
- •Synchronous primary cancer at the contralateral breast
- •Previous diagnosis of other cancers (excluding basal cell skin cancer
- •Squamous cell skin cancer
- •Cervical intraepithelial neoplasia)
- •Clinically involved contralateral axillary nodes
- •Patients not suitable for adequate follow-up
- •Failure to give informed consent
研究组 & 干预措施
Neoadjuvant chemotherapy
Standart chemotherapy followed by surgery
干预措施: Surgery (Procedure)
Neoadjuvant chemotherapy
Standart chemotherapy followed by surgery
干预措施: Systemic therapy (Drug)
Systemic therapy
Standart chemotherapy
干预措施: Systemic therapy (Drug)
Primary surgery
Standart surgery
干预措施: Surgery (Procedure)
结局指标
主要结局
Overall survival
时间窗: 5 years
Years
次要结局
- Locoregional progression(5 years)