A Retrospective Chart Review of Real-world Treatment Outcomes in Patients With Locally Advanced Unresectable or Metastatic Urothelial Cancer Based on HER2 Expression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 389
- 试验地点
- 23
- 主要终点
- Real-world Objective Response Rate (rwORR) per modified response evaluation criteria in solid tumors version 1.1 (RECIST v1.1)
研究概览
简要总结
This study is being done to learn about urothelial cancers that make HER2 and how that affects treatment choices for participants with urothelial cancer. During this study, the medical and health records of participants will be reviewed to learn more about their health.
Participants will have urothelial cancer that has grown in the body near where it started (locally advanced) and cannot be removed (unresectable) or has spread through the body (metastatic).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
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
- •Histologically confirmed UC originating from the renal pelvis, ureters, bladder, or urethra. Mixed-cell type tumors are eligible as long as urothelial cell carcinoma is the predominant cell type.
- •Locally advanced unresectable or metastatic stage disease
- •Formalin fixed paraffin embedded (FFPE) tumor tissue blocks (or freshly sectioned slides, see laboratory manual for details) available for HER2 testing.
- •At least 1 prior line of systemic therapy for locally advanced unresectable or metastatic urothelial carcinoma (LA/mUC), including 1 line of platinum-containing chemotherapy.
- •Initiation of anticancer therapy for UC after prior progression on platinum-based therapy with or without maintenance avelumab between 01 January 2019 and 12 months before the end of data collection
- •Radiographically documented and measurable disease progression immediately before index date
排除标准
- •Any concurrent malignant neoplasm requiring systemic therapy during the study window
- •Enrollment in a therapeutic clinical trial and received non-standard of care treatment during index line of therapy
结局指标
主要结局
Real-world Objective Response Rate (rwORR) per modified response evaluation criteria in solid tumors version 1.1 (RECIST v1.1)
时间窗: Up to 5 years
The proportion of participants who have a best overall response (BOR) based on complete response (CR) or partial response (PR). The BOR for each participant is the best response (radiographically documented and measurable disease or physician-assessed response) achieved after the start date of the lines of treatment (LOT) prior to the initiation of any subsequent LOT.
次要结局
- Characteristics of treatment patterns in LA/mUC participants(Up to 5 years)
- Real-world Time on Treatment (rwTOT)(Up to 5 years)
- rwORR for each subsequent LOT following the index LOT(Up to 5 years)
- Percentages of IHC0, 1+, 2+, and 3+ participants(Up to 5 years)
- Characteristics of LA/mUC participants(Up to 5 years)
- Real-world Time to Next Treatment (rwTTNT)(Up to 5 years)
- Real-world Progression Free Survival (rwPFS)(Up to 5 years)
- Percentages of HER2+ (IHC3+, IHC2+/ISH+), HER2-low (IHC1+, IHC2+/ISH-), HER2-expressing (IHC1+, IHC2+, and IHC3+), and HER2-zero (IHC0) participants(Up to 5 years)
- Real-world Overall Survival (rwOS)(Up to 5 years)
- Real-world Duration of Response (rwDOR)(Up to 5 years)