A Multicenter, Open-label, Non-randomized Controlled Real World Study Comparing the Benefits of Continued Use of Ovarian Function Suppression After 5 Years
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,200
- 试验地点
- 1
- 主要终点
- invasive disease-free survival
研究概览
简要总结
To observe and evaluate the clinical efficacy and safety of continuous use of OFS for premenopausal patients with early breast cancer after 5 years use of OFS.
This study is a multicenter, prospective, observational, non randomized controlled, open-label real world study based on hospital medical record system data, aimed at evaluating the benefits of continuing to use OFS after 5 years of use. The retrospective analysis plan includes patient data from September 1, 2023 to September 1, 2026. Join two cohorts: the continued use group and the discontinued use group after 5 years of OFS, respectively.
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 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with early primary breast cancer
- •Female aged 18-60 years (including 18 year and 60 year)
- •Hormone receptor (HR) positive HER2 negative
- •Receive 5 years of OFS treatment
- •ECOG score 0-1
- •Voluntarily join this study and sign the informed consent form;
- •The researcher believes that it can benefit.
排除标准
- •The patient is receiving treatment that affects OFS at the same time The patient has received OFS treatment for less than 5 years
- •Central nervous system metastases with known obvious symptoms, such as headache, cerebral edema, blurred vision
- •Invasive metastases with known obvious symptoms
- •Invasive metastases with known obvious symptoms
- •Doctors think it is not suitable for inclusion
研究组 & 干预措施
OFS continues to use after 5 years
HR-positive premenopausal female patients whose doctors believe that they can benefit from continued use of OFS after 5 years should be included in the trial group.
干预措施: OFS continues to use group after 5 years use (Drug)
OFS continues to use after 5 years
HR-positive premenopausal female patients whose doctors believe that they can benefit from continued use of OFS after 5 years should be included in the trial group.
干预措施: Immunohistochemical detection of HR status (Diagnostic Test)
结局指标
主要结局
invasive disease-free survival
时间窗: 5 years
The main effect evaluation index was invasive disease-free survival (iDFS)
次要结局
- Overall survival(5 years)
研究者
Hongmei Zheng, PhD
vice director
Hubei Cancer Hospital