NCT02913456已完成不适用
A European Disease Registry Study to Prospectively Observe Treatment Patterns and Outcomes in Patients With HER2-Positive Unresectable Locally Advanced or Metastatic Breast Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 629
- 试验地点
- 54
- 主要终点
- Percentage of Participants by Different Anti-cancer Treatment Regimens and Treatment Sequences
研究概览
简要总结
This disease registry is a prospective, multicenter non-interventional study designed to observe anti-cancer treatment regimens and clinical outcomes in participants with HER2-positive unresectable LA/mBC. Diagnosis of unresectable LA or mBC can be up to 6 months old prior to registry enrollment.
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
- •Initially diagnosed with HER2-positive unresectable LA/mBC no more than 6 months prior to enrollment, although they can have received anti-cancer treatment during that time
排除标准
- •Not applicable
结局指标
主要结局
Percentage of Participants by Different Anti-cancer Treatment Regimens and Treatment Sequences
时间窗: Baseline up to 8 years
Progression-free Survival per Anti-cancer Treatment Regimens Assessed According to Site-/Country-Specific Medical Practice
时间窗: Baseline up to 8 years
次要结局
- Total Number of Treatment Regimens Received by Participants(Baseline up to 8 years)
- Percentage of Participants with Different Anti-Cancer Treatment Regimens by Country(Baseline up to 8 years)
- Percentage of Participants with History of Breast Cancer by Different Anti-Cancer Treatment Regimens(Baseline up to 8 years)
- Resource Utilization: Percentage of Participants with Emergency Room Attendances and Outpatient Visits(Baseline up to 8 years)
- Total Healthcare Cost(Baseline up to 8 years)
- Cost of Treating Associated AEs(Baseline up to 8 years)
- Overall Survival(Baseline up to 8 years)
- Percentage of Participants with Best Overall Response of Complete Response (CR) or Partial Response (PR) per Anti-cancer Treatment Regimens Assessed According to Site-/Country-Specific Medical Practice(Baseline up to 8 years)
- Resource Utilization: Percentage of Participants with Hospitalization(Baseline up to 8 years)
- Duration of Response per Anti-cancer Treatment Regimens Assessed According to Site-/Country-Specific Medical Practice(Baseline up to 8 years)
- Percentage of Participants by Type of HER2 Testing (Immunohistochemistry and/or Fluorescence In situ Hybridization [FISH])(Baseline up to 8 years)
- Resource Utilization: Percentage of Participants with Breast Cancer Associated Procedures(Baseline up to 8 years)
- Percentage of Participants with HER2 Re-testing of Metastases(Baseline up to 8 years)
- Percentage of Participants with Adverse Events (AEs), Serious AEs, and Protocol-defined AEs of Special Interest(Baseline up to 8 years)
- Percentage of Participants with Change in HER2 Status(Baseline up to 8 years)
- EuroQol 5-Dimensions Questionnaire (EQ-5D) Score(Baseline up to 8 years)
- Functional Assessment of Cancer Therapy-Breast (FACT-B) Questionnaire Score(Baseline up to 8 years)
研究者
研究点 (54)
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