NCT02595762已完成不适用
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
- 已完成
- 入组人数
- 110
- 试验地点
- 12
- 主要终点
- Percentage of Participants Receiving Each Unique Treatment Regimen as First-Line Versus Subsequent-Line Therapy
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 locally advanced breast cancer (LABC) or metastatic breast cancer (MBC).
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
- •Diagnosis of HER2-positive unresectable LABC or MBC within 6 months prior to enrollment
排除标准
- •None specified
结局指标
主要结局
Percentage of Participants Receiving Each Unique Treatment Regimen as First-Line Versus Subsequent-Line Therapy
时间窗: Baseline up to approximately 8 years
Percentage of Participants Receiving Each Unique Treatment Regimen Overall
时间窗: Baseline up to approximately 8 years
Percentage of Participants Receiving Each Unique Treatment Regimen Sequence
时间窗: Baseline up to approximately 8 years
Progression-Free Survival (PFS)
时间窗: From start date of anti-cancer treatment regimen to the date of either disease progression or death (up to approximately 8 years)
Tumor response will be evaluated by the Investigator according to site-/country-specific medical practice. Study protocol does not specify any particular method of assessment.
次要结局
- Number of Treatment Regimens Received(Baseline up to approximately 8 years)
- Percentage of Participants Receiving Each Treatment Regimen, by Country/Region(Baseline up to approximately 8 years)
- Overall Survival (OS)(From the date of initiation of treatment to the date of death from any cause (up to approximately 8 years))
- Percentage of Participants by Reasons for Treatment Modification(Baseline up to approximately 8 years)
- Functional Assessment of Cancer Therapy-Breast (FACT-B) Questionnaire Score(Baseline up to approximately 8 years)
- Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs)(Baseline up to approximately 8 years)
- Percentage of Participants Receiving Each Treatment Regimen, by Participant Characteristics(Baseline up to approximately 8 years)
- Percentage of Participants With Complete Response (CR) or Partial Response (PR) - Objective Response Rate (ORR)(From the date of initiation of treatment to the date of disease progression or death from any cause (up to approximately 8 years))
- Duration of Response (DOR)(From date of first response (CR or PR) to the date of disease progression (up to approximately 8 years))
- EuroQoL 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Score(Baseline up to approximately 8 years)
- Percentage of Participants With HER2 Retesting(Baseline up to approximately 8 years)
- Healthcare Resource Utilization - Total Healthcare Cost(Baseline up to approximately 8 years)
- Healthcare Resource Utilization - Length of Hospitalization(Baseline up to approximately 8 years)
- Healthcare Resource Utilization - Percentage of Participants With Emergency Room Visit(Baseline up to approximately 8 years)
- Healthcare Resource Utilization - Percentage of Participants With Outpatient Visit(Baseline up to approximately 8 years)
- Healthcare Resource Utilization - Number of Working Hours Missed Among Informal Caregivers due to Disease-Related Caregiving Responsibilities(Baseline up to approximately 8 years)
- Healthcare Resource Utilization - Percentage of Participants Receiving Monetary Social Benefits(Baseline up to approximately 8 years)
- Work Productivity and Activity Impairment-General Health (WPAI-GH) Questionnaire Score(Baseline up to approximately 8 years)
- Percentage of Participants With HER2 Overexpression, as Assessed Using In Situ Hybridization or Immunohistochemistry(Baseline up to approximately 8 years)
- Healthcare Resource Utilization - Percentage of Participants Who Are Hospitalized(Baseline up to approximately 8 years)
- Healthcare Resource Utilization - Cost of Disease Related Out-of-Pocket Healthcare Expenditures(Baseline up to approximately 8 years)
- Healthcare Resource Utilization - Indirect Disease Related Cost(Baseline up to approximately 8 years)
研究者
研究点 (12)
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