A Prospective Cohort Study： the Establishment of a Survival Prediction Model for ER Positive / HER-2 Negative Advanced Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 288
- 试验地点
- 2
- 主要终点
- overall survival，OS
研究概览
简要总结
This project is a prospective, clinical cohort study initiated by researchers to study the high-risk factors affecting the overall survival of newly diagnosed ER + / HER2 - advanced breast cancer patients and to establish a prediction model of ER + / HER2 - advanced breast cancer patients affecting overall survival. This project is the first prospective prediction model for the survival of patients with advanced breast cancer, and it is also the first time to establish a survival prediction model for ER-positive / HER2 negative advanced breast cancer suitable for China's national conditions. According to the survival outcome predicted by the model, the newly diagnosed ER positive / HER2 negative advanced breast cancer was divided into three groups: low, medium, and high risk, which provided an important theoretical basis for further design of randomized controlled clinical research and guidance of individualized precise treatment scheme for different groups in the future.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •At the time of signing the informed consent form, 18 years old ≤ 70 years old, female
- •ER positive breast cancer confirmed by pathology: ER positive (≥ 1%) by immunohistochemistry
- •Newly diagnosed advanced patients, including patients with early breast cancer who have evidence of recurrence and metastasis after adjuvant therapy and patients with stage IV breast cancer at the first visit
- •Patients who are willing to receive follow-up treatment in the research center.
排除标准
- •ErbB-2 gene amplification was recorded by fish (defined as HER2 / CEP17 ratio ≥ 2) or chromogenic in situ hybridization (CISH) or IHC (defined as ihc3 +, or ihc2 + confirmed by fish or CISH) was used to record HER2 positive tumors.
- •Any form of anti-cancer treatment has been carried out for recurrent or metastatic lesions
- •Combined with other malignant tumors or had other malignant tumors in recent 5 years
- •Patients with nervous system disorders caused by diseases or obvious mental disorders will affect patients' right to know, compliance or make them in a dangerous state
- •Patients with life expectancy less than 3 months
结局指标
主要结局
overall survival，OS
时间窗: 5 years
The time from the beginning of treatment to the death of the patient
Tumor specific survival time, CSS
时间窗: 5 years
The follow-up started from the first day of confirmed recurrence and metastasis. The end point of follow-up was the death caused by tumor related causes.
次要结局
- Progression Free Survival，PFS(2 years)
- 5-year survival rate(5 years)
研究者
Ying Wang
Professor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University