Review of HER2 in advanced urothelial cancer
A Retrospective Chart Review of Real-world Treatment Outcomes in Patients With Locally Advanced Unresectable or Metastatic Urothelial Cancer Based on HER2 Expression
This study looks at how the HER2 status in patients with advanced bladder cancer affects their treatment choices and outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 350 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Seagen Inc. Industry-sponsored |
| Drugs / interventions | avelumab, chemotherapy |
| Locations | 19 sites (Phoenix, Arizona and 18 other locations) |
| Trial ID | NCT05902494 on ClinicalTrials.gov |
What this trial studies
This observational study aims to gather data on patients with urothelial carcinoma that expresses HER2 to understand how this affects treatment decisions. It involves reviewing medical and health records of participants who have locally advanced unresectable or metastatic urothelial cancer. The study will focus on patients who have undergone at least one line of systemic therapy and have measurable disease progression. By analyzing this data, researchers hope to gain insights into the implications of HER2 status on treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates are individuals with locally advanced unresectable or metastatic urothelial carcinoma who have received prior systemic therapy.
Not a fit: Patients with concurrent malignant neoplasms requiring systemic therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for patients with HER2-positive urothelial cancer.
How similar studies have performed: Other studies have explored HER2 in various cancers, showing promising results, but this specific approach in urothelial carcinoma is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Phoenix, Arizona and 18 other locations
- Mayo Clinic — Phoenix, Arizona, United States (Recruiting)
- University of California Irvine — Orange, California, United States (Recruiting)
- Stanford Cancer Institute - School of Medicine — Palo Alto, California, United States (Recruiting)
- University of California San Francisco — San Francisco, California, United States (Recruiting)
- University of California Los Angeles — Santa Monica, California, United States (Recruiting)
- University of Colorado Hospital — Aurora, Colorado, United States (Recruiting)
- ICAHN School of Medicine at Mount Sinai, — New York, New York, United States (Recruiting)
- Levine Cancer Institute — Charlotte, North Carolina, United States (Recruiting)
- Duke Cancer Institute - School of Medicine — Durham, North Carolina, United States (Recruiting)
- Avera Cancer Institute Center — Sioux Falls, South Dakota, United States (Recruiting)
- Vanderbilt - Ingram Cancer Center — Nashville, Tennessee, United States (Recruiting)
- AKH Wien — Wien, Austria (Recruiting)
- Centre Léon Bérard — Lyon, France (Recruiting)
- Institut Mutualiste Montsouris — Paris, France (Recruiting)
- CHU de Rouen. — Rouen, France (Recruiting)
- Foch Hospital — Suresnes, France (Recruiting)
- Alexianer Krefeld GmbH — Krefeld, Nordrhein-westfalen, Germany (Recruiting)
- University Hospital Lübeck — Lübeck, Schleswig-holstein, Germany (Recruiting)
- Stuttgart Hospital — Stuttgart, Germany (Recruiting)
Study contacts
- Study coordinator: Seagen Pfizer CT.gov Call Center
- Email: ClinicalTrials.gov_Inquiries@pfizer.com
- Phone: 1-800-718-1021
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.