500mg Fulvestrant Versus Everolimus Plus Exemestane in MBC Patients Refractory to Previous AI
赞助:
Fudan University
合作者:
信息的提供 (责任方):
Biyun Wang, MD，Fudan University
| 追踪信息 | |||
|---|---|---|---|
| 首次提交日期 ICMJE | October 2, 2018 | ||
| 首次发布日期e ICMJE | October 4, 2018 | ||
| 最后更新发布日期 | October 4, 2018 | ||
| 预计研究开始日期 ICMJE | May 14, 2018 | ||
| 预计主要完成日期 | March 10, 2019 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
PFS[ Time Frame: 6 weeks ] Progression free survival |
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| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
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| 描述性信息 | |||
| 简略标题 ICMJE | 500mg Fulvestrant Versus Everolimus Plus Exemestane in MBC Patients Refractory to Previous AI | ||
| 正式标题 ICMJE | Fulvestrant Versus Everolimus Plus Exemestane for Patients With Metastatic Breast Cancer Resistant to Aromatase Inhibitors: the Clinical Experience From Real -World | ||
| 简要概况 | 500mg Fulvestrant versus Everolimus plus Exemestane in MBC patients refractory to previous AI |
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| 详细说明 | Fulvestrant versus Everolimus plus Exemestane for patients with Metastatic Breast Cancer resistant to Aromatase Inhibitors: the clinical experience from real -world | ||
| 研究类型 ICMJE | Observational | ||
| 研究阶段 | |||
| 研究设计 ICMJE | 分配: 干预模型: 干预模型描述: 盲法: Observational 盲法描述: 主要目的: |
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| 适用条件 ICMJE | |||
| 干预项目 ICMJE |
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| 研究工具 |
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| 招募信息 | |||
| 招募状态 ICMJE | Active, not recruiting | ||
| 预计入组 ICMJE |
150 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | May 15, 2019 | ||
| 预计主要完成日期 | March 10, 2019 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: 1. Patients diagnosed with ER/PR+，HER2- Metastatic Breast Cancer 2. Patients who were refractory to previous Aromatase Inhibitors 3. Patients treated with Fulvestrant or Everolimus plus Exemestane in any line in metastatic setting in Fudan University Shanghai Cancer Center，starting from 2013.06.01-2016.06.01 4. Available medical history Exclusion Criteria: 1.Incomplete medical history | ||
| 性别 |
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| 年龄 | 最小年龄：18 Years ，最大年龄：N/A | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | China | ||
| 管理信息 | 数据检测委员会 | No | |
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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| IPD 共享声明 |
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| 责任方 | Biyun Wang, MD，Fudan University | ||
| 研究赞助商 ICMJE | Fudan University | ||
| 合作者 ICMJE | |||
| 研究员 ICMJE |
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| PRS 账户 | Fudan University | ||
| 验证日期 | October 2018 | ||
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ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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