Palbociclib, Trastuzumab, Pyrotinib and Fulvestrant Treatment in Patients With Brain Metastasis From ER/PR Positive, HER-2 Positive Breast Cancer: A Multi-center, Prospective Study in China
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Objective response rate in the CNS
研究概览
简要总结
The objective of this study is to evaluate the efficacy of combination of palbociclib, trastuzumab and pyrotinib with fulvestrant in ER/PR positive and HER2-positive breast cancer patients with brain metastasis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Treatment group
干预措施: Palbociclib, Trastuzumab, Pyrotinib and Fulvestrant (Drug)
结局指标
主要结局
Objective response rate in the CNS
时间窗: Up to 3 years
Assess the response rate in the CNS by MRI according to modified Response Assessment in modified RECIST 1.1 criteria. Objective CNS response is defined as at least 30% decrease in the sum of diameters of CNS target lesions in the absence of new lesions (defined as ≥ 6 mm), increased steroid use, progressive neurological symptoms, and progressive extra-CNS disease as assessed by RECIST 1.1. Confirmatory scans are not required.
次要结局
- Overall Response Rate(Up to 3 years)
- Time to CNS progression(Up to 3 years)
- Overall Survival(Up to 3 years)
- Progression Free Survival(Up to 3 years)
- Time to radiotherapy(Up to 3 years)
研究者
wang shusen
Chief Physician
Sun Yat-sen University