NCT04158505Unknown不适用
Real World Study on the Efficacy and Safety of Pyrotinib in the Treatment of HER2 Positive Breast Cancer: An Observational,Multi-center,Prospective Study (Real Pretty Study)
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Pathological Complete Response（pCR）Rate
研究概览
简要总结
This Non-Interventional Study will describe and analyze the clinical use of pyrotinib in clinical practice in the treatment of HER2 positive breast cancer in the real world.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years old with histologically confirmed HER2 positive breast cancer.
- •Documented HER2 overexpression by local laboratory ,defined as immunohistochemistry (IHC) 3+ or fluorescence in situ hybridization (FISH) positive.
- •Physician has determined that treatment with pyrotinib is indicated.
- •Traceable medical record available.
排除标准
- •Patients who are unable to understand the nature of the study and are unwilling to sign an informed consent .
- •Pregnant or breast feeding patients
- •Patients participating in any interventional clinical trial that includes investigational or marketed products at the time of enrollment.
- •Patients not suitable for this study under investigators' consideration.
结局指标
主要结局
Pathological Complete Response（pCR）Rate
时间窗: through study completion, an average of 1 year
Percentage of Participants With Pathological Complete Response
Incidences of adverse events and toxicities
时间窗: through study completion, an average of 1 year
Incidences of adverse events and toxicities
Progression Free Survival(PFS)
时间窗: 12 months
Progression Free Survival(PFS)
次要结局
未报告次要终点
研究者
Binghe Xu
chief physician
Chinese Academy of Medical Sciences
研究点 (1)
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