NCT02611310终止不适用
Saudi Arabia - A 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
- 终止
- 入组人数
- 15
- 试验地点
- 3
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
This is a prospective, national, multicenter, non-interventional study designed to enroll participants who have an initial diagnosis of unresectable LA/mBC made up to 6 months prior to registry enrollment. These participants will be prospectively followed for at least 5 years after study enrollment to evaluate their anti-cancer treatments. Data on participants' previous anti-cancer treatments for breast cancer will be collected retrospectively at study entry.
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
- •Able to comply with the study protocol
排除标准
- 未提供
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: Up to 5 years
次要结局
- Quality of Life, as Assessed by the EuroQol 5-Dimensions Questionnaire (EQ-5D)(Up to 5 years)
- Overall Survival (OS)(Up to 5 years)
- Objective Response Rate (ORR) Per Anti-Cancer Treatment Regimen(Up to 5 years)
- Number of Participants With Adverse Events(Up to 5 years)
- Duration of Response (DoR) Per Anti-Cancer Treatment Regimen(Up to 5 years)
- Overall Health Status, as Assessed by the Functional Assessment of Cancer Therapy-Breast (FACT-B)(Up to 5 years)
研究者
研究点 (3)
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