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

CompletedN/A

Sponsor: Seagen, a wholly owned subsidiary of Pfizer

Conditions: Urothelial Carcinoma

Countries: United States, Austria, France, Germany

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).

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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

Locations (23)

Phoenix, Arizona, United States
Orange, California, United States
Palo Alto, California, United States
San Francisco, California, United States
Santa Monica, California, United States
Aurora, Colorado, United States
New York, New York, United States
Charlotte, North Carolina, United States
Durham, North Carolina, United States
Sioux Falls, South Dakota, United States
Nashville, Tennessee, United States
Vienna, Austria
Bordeaux, France
La Roche-sur-Yon, France
Lyon, France
Nice, France
Paris, France
Pierre-Bénite, France
Rouen, France
Suresnes, France
Krefeld, North Rhine-Westphalia, Germany
Lübeck, Schleswig-Holstein, Germany
Stuttgart, Germany