HER2 and LA/mUC: A Multi-country Chart Review Cohort Study
Completed
Conditions studied: Urothelial Carcinoma
In brief
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).
Key facts
- Study ID
- NCT05902494
- Run by
- Seagen, a wholly owned subsidiary of Pfizer
- People needed
- 389
- Starts
- 2023-06-29
- Expected to finish
- 2025-06-18
- Last updated by the study team
- 2025-07-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Mayo Clinic — Phoenix, Arizona, United States
- University of California Irvine — Orange, California, United States
- Stanford Cancer Institute - School of Medicine — Palo Alto, California, United States
- University of California San Francisco — San Francisco, California, United States
- University of California Los Angeles — Santa Monica, California, United States
- University of Colorado Hospital — Aurora, Colorado, United States
- ICAHN School of Medicine at Mount Sinai, — New York, New York, United States
- Levine Cancer Institute — Charlotte, North Carolina, United States
- Duke Cancer Institute - School of Medicine — Durham, North Carolina, United States
- Avera Cancer Institute Center — Sioux Falls, South Dakota, United States
- Vanderbilt - Ingram Cancer Center — Nashville, Tennessee, United States
- AKH Wien — Vienna, Austria
- Chu Bordeaux Hopital Saint Andre — Bordeaux, France
- Centre Hospitalier Départemental Les Oudairies — La Roche-sur-Yon, France
- Centre Léon Bérard — Lyon, France
- Centre Antoine Lacassagne — Nice, France
- Institut Mutualiste Montsouris — Paris, France
- CHU LYON — Pierre-Bénite, France
- CHU de Rouen. — Rouen, France
- Foch Hospital — Suresnes, France
- Alexianer Krefeld GmbH — Krefeld, North Rhine-Westphalia, Germany
- University Hospital Lübeck — Lübeck, Schleswig-Holstein, Germany
- Stuttgart Hospital — Stuttgart, Germany
Full record on ClinicalTrials.gov
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