HER2 and LA/mUC: A Multi-country Chart Review Cohort Study
A Retrospective Chart Review of Real-world Treatment Outcomes in Patients With Locally Advanced Unresectable or Metastatic Urothelial Cancer Based on HER2 Expression
2 other identifiers
observational
389
4 countries
23
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2023
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 5, 2023
CompletedFirst Posted
Study publicly available on registry
June 15, 2023
CompletedStudy Start
First participant enrolled
June 29, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 18, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 18, 2025
CompletedJuly 20, 2025
July 1, 2025
2 years
June 5, 2023
July 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Real-world Objective Response Rate (rwORR) per modified response evaluation criteria in solid tumors version 1.1 (RECIST v1.1)
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.
Up to 5 years
Secondary Outcomes (10)
Percentages of IHC0, 1+, 2+, and 3+ participants
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
Characteristics of LA/mUC participants
Up to 5 years
Real-world Overall Survival (rwOS)
Up to 5 years
Characteristics of treatment patterns in LA/mUC participants
Up to 5 years
- +5 more secondary outcomes
Eligibility Criteria
Adults from US and European participating hospitals and physicians' practices with histologically confirmed LA/mUC who initiated therapy after prior progression on platinum-based therapy with or without maintenance avelumab.
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
Mayo Clinic
Phoenix, Arizona, 85054, United States
University of California Irvine
Orange, California, 92868, United States
Stanford Cancer Institute - School of Medicine
Palo Alto, California, 94394, United States
University of California San Francisco
San Francisco, California, 94143, United States
University of California Los Angeles
Santa Monica, California, 90404, United States
University of Colorado Hospital
Aurora, Colorado, 80045, United States
ICAHN School of Medicine at Mount Sinai,
New York, New York, 10029, United States
Levine Cancer Institute
Charlotte, North Carolina, 28204, United States
Duke Cancer Institute - School of Medicine
Durham, North Carolina, 27710, United States
Avera Cancer Institute Center
Sioux Falls, South Dakota, 57104, United States
Vanderbilt - Ingram Cancer Center
Nashville, Tennessee, 37232, United States
AKH Wien
Vienna, 1090, Austria
Chu Bordeaux Hopital Saint Andre
Bordeaux, 33075, France
Centre Hospitalier Départemental Les Oudairies
La Roche-sur-Yon, 85925, France
Centre Léon Bérard
Lyon, 69373, France
Centre Antoine Lacassagne
Nice, 06189 Cedex 2, France
Institut Mutualiste Montsouris
Paris, 75674, France
CHU LYON
Pierre-Bénite, 69495, France
CHU de Rouen.
Rouen, 76000, France
Foch Hospital
Suresnes, 92150, France
Alexianer Krefeld GmbH
Krefeld, North Rhine-Westphalia, 47805, Germany
University Hospital Lübeck
Lübeck, Schleswig-Holstein, 23538, Germany
Stuttgart Hospital
Stuttgart, 70174, Germany
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 5, 2023
First Posted
June 15, 2023
Study Start
June 29, 2023
Primary Completion
June 18, 2025
Study Completion
June 18, 2025
Last Updated
July 20, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.