NCT01615068已完成不适用
An Observational Cohort Study of Treatment Patterns and Outcomes in Patients With HER2 Positive (HER2+) Metastatic Breast Cancer (SystHERs Registry (Systemic Therapies for HER2+ Metastatic Breast Cancer Study)).
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,007
- 试验地点
- 142
- 主要终点
- Distribution of patients receiving unique treatment regimen/sequence of treatment regimens
研究概览
简要总结
This multi-center, prospective observational study will evaluate the treatment patterns, and the safety in patients with HER2-positive (HER2+) metastatic breast cancer (MBC). Eligible patients will have an initial metastatic breast cancer diagnosis that has not been previously treated with systemic therapy; patients may be enrolled up to 6 months after the diagnosis. Data will be collected for up to 8 years.
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
- •Adult patients, >/=18 years of age
- •Initial diagnosis of HER2+ MBC, as diagnosed by the treating physician, no more than 6 months prior to study enrollment
- •Availability of cancer-specific historical data points in the patient's medical records
排除标准
- •Any inability to provide informed consent
结局指标
主要结局
Distribution of patients receiving unique treatment regimen/sequence of treatment regimens
时间窗: Up to 8 years
次要结局
- Progression-free survival (PFS)(Up to 8 years)
- Time-to-treatment failure (TTF)(Up to 8 years)
- Post-progression survival (PPS)(Up to 8 years)
- Patient-reported outcome assessment (PRO)(Up to 8 years)
- Overall survival (OS)(Up to 8 years)
- Response rate (RR)(Up to 8 years)
- Safety: Incidence of adverse events(Up to 8 years)
研究者
研究点 (142)
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