NCT02954471已完成不适用
A Retrospective, Observational Molecular Epidemiology Study of HER2 Expression in Patients With Early / Metastatic Breast Cancer in Saudi Arabia
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 351
- 试验地点
- 3
- 主要终点
- Percentage of Participants With Positive HER2 Test Result
研究概览
简要总结
This is a retrospective, multicenter study, consisting of chart review of Saudi Arabian participants diagnosed with breast cancer between 2007 and 2013 and with available human epidermal growth factor receptor 2 (HER2) testing. Data on survival will be collected through 2015.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Initially diagnosed with breast cancer
- •Has a proven result of HER2 testing by immunohistochemistry (IHC), fluorescent in situ hybridization (FISH) or any other in situ hybridization (ISH) method
- •Alive or not alive
排除标准
- •Inconclusive, equivocal or unavailable result of HER2/neu overexpression by IHC and FISH
结局指标
主要结局
Percentage of Participants With Positive HER2 Test Result
时间窗: From January 2007 to December 2013 (Up to 7 years; assessed retrospectively)
次要结局
- Kaplan-Meier Estimate of Overall Survival (OS)(From January 2007 to December 2015 (Up to 9 years; assessed retrospectively))
- Percentage of Participants with Stable Disease as Assessed Using RECIST(From January 2007 to December 2013 (Up to 7 years; assessed retrospectively))
- Percentage of Participants With Adverse Events(From January 2007 to December 2013 (Up to 7 years; assessed retrospectively))
- Percentage of Participants With Estrogen Receptor/Progesterone Receptor Positive Breast Cancer(From January 2007 to December 2013 (Up to 7 years; assessed retrospectively))
- Percentage of Participants With Progressive Disease as Assessed Using RECIST(From January 2007 to December 2013 (Up to 7 years; assessed retrospectively))
- Kaplan-Meier Estimates of Progression-free Survival (PFS) as Assessed Using Response Evaluation Criteria in Solid Tumors (RECIST)(From January 2007 to December 2013 (Up to 7 years; assessed retrospectively))
- Percentage of Participants With Complete Response as Assessed Using RECIST(From January 2007 to December 2013 (Up to 7 years; assessed retrospectively))
- Percentage of Participants by Type of First-line and Subsequent Treatment Regimens Used(From January 2007 to December 2013 (Up to 7 years; assessed retrospectively))
- Percentage of Participants With Partial Response as Assessed Using RECIST(From January 2007 to December 2013 (Up to 7 years; assessed retrospectively))
研究者
研究点 (3)
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