NCT04456855Unknown不适用
Locoregional Surgery of the Primary Tumor in de Novo Stage IV Breast Cancer Patients
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University3 个研究点 分布在 1 个国家目标入组 358 人开始时间: 2019年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 358
- 试验地点
- 3
- 主要终点
- Overall survival
研究概览
简要总结
Current guidelines lack definitive evidences about the relative benefits of locoregional surgery for the primary tumor in de novo stage IV breast cancer. The aim of this study (SYSBTC-001) was to investigate the role of locoregional surgery for primary tumor in de novo stage IV breast cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Operable stage IV breast cancer patients,whose primary lesion is invasive breast cancer confirmed by pathology, and metastases can be confirmed by pathology or imageology examination.
- •ECOG-PS 0-
- •Bone marrow, liver and kidney should be fully functional.
- •Patients received the locoregional surgery of the primary tumor in de novo in our center, or didn't received the locoregional surgery of the primary tumor in de novo.
- •For the patient who accepted systematic treatment before operation, the systematic treatment must be administered within a year since diagnosed.
排除标准
- •Accompanied with other primary malignant tumors.
- •Patients who can't plan for follow-up effectively and regularly.
- •Multiple liver metastasis and ALT/AST four times higher than normal at patients' first diagnosis.
结局指标
主要结局
Overall survival
时间窗: 5 years
The association between locoregional surgery and overall survival (OS), which defined as the time from the beginning of diagnosis of breast cancer to the death with any causes.
次要结局
- Locoregional progression free survival(5 years)
- Distant progression free survival(5 years)
研究者
Herui Yao
Principal Investigator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
研究点 (3)
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