HER2 and LA/mUC: A Multi-country Chart Review Cohort Study

Seagen, a wholly owned subsidiary of Pfizer

Status: Completed

Conditions: Urothelial Carcinoma

Study type: Observational

Funder types: Industry

Identifiers

NCT05902494

SGNDV-003

C5731003 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 389 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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