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

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).

Study Overview

• Status: Completed
• Conditions: Urothelial Carcinoma

• Study Type: Observational
• Enrollment (Actual): 389

Contacts and Locations

Study Locations

• Austria
  • Wien, Austria, 1090
    • AKH Wien
• France
  • BORDEAUX Cedex, France, 33075
    • CHU Bordeaux Hopital Saint André
  • La Roche Sur Yon Cedex 9, France, 85925
    • Centre Hospitalier Departemental Les Oudairies
  • Lyon, France, 69373
    • Centre Leon Berard
  • Nice, France, 06189 Cedex 2
    • Centre Antoine Lacassagne
  • Paris, France, 75674
    • Institut Mutualiste Montsouris
  • Pierre Benite, France, 69495
    • CHU Lyon
  • Rouen, France, 76000
    • CHU de Rouen.
  • Suresnes, France, 92150
    • Foch Hospital
• Germany
  • Stuttgart, Germany, 70174
    • Stuttgart Hospital
  • Nordrhein-westfalen
    • Krefeld, Nordrhein-westfalen, Germany, 47805
      • Alexianer Krefeld GmbH
  • Schleswig-holstein
    • Lübeck, Schleswig-holstein, Germany, 23538
      • University Hospital Lübeck
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Mayo Clinic
  • California
    • Orange, California, United States, 92868
      • University of California Irvine
    • Palo Alto, California, United States, 94394
      • Stanford Cancer Institute - School of Medicine
    • San Francisco, California, United States, 94143
      • University of California San Francisco
    • Santa Monica, California, United States, 90404
      • University of California Los Angeles
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Hospital
  • New York
    • New York, New York, United States, 10029
      • ICAHN School of Medicine at Mount Sinai,
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Levine Cancer Institute
    • Durham, North Carolina, United States, 27710
      • Duke Cancer Institute - School of Medicine
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57104
      • Avera Cancer Institute Center
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt - Ingram Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Time from the index date to date of death from any cause.	Up to 5 years
Characteristics of treatment patterns in LA/mUC participants	Agent, reason for change of LOT, surgery, radiotherapy, number of LOT, treatments in each LOT, mean number of LOT, median time to discontinuation of each LOT	Up to 5 years
Real-world Time on Treatment (rwTOT)	Time from the start date of the LOT to the end date of the same LOT for any reason.	Up to 5 years
Real-world Time to Next Treatment (rwTTNT)	The time from the start date of each LOT to the initiation of the next LOT for any reason.	Up to 5 years
Real-world Progression Free Survival (rwPFS)	Time from the index date to the first recorded disease progression (radiographically documented and measurable disease or physician assessed response) or death from any cause, before the start of next LOT whichever occurs first.	Up to 5 years
Real-world Duration of Response (rwDOR)	The duration of time from the first documented CR or PR in the LOT to the first recorded disease progression (radiographically documented and measurable disease or physician-assessed response) or death from any cause before the start of the next LOT, whichever occurs first.	Up to 5 years
rwORR for each subsequent LOT following the index LOT	The proportion of participants who had a real-world BOR based on CR or 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 LOT prior to the initiation of any subsequent LOT.	Up to 5 years

Collaborators and Investigators

• Sponsor: Seagen, a wholly owned subsidiary of Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2023
• Primary Completion (Actual): June 18, 2025
• Study Completion (Actual): June 18, 2025

Study Registration Dates

• First Submitted: June 5, 2023
• First Submitted That Met QC Criteria: June 5, 2023
• First Posted (Actual): June 15, 2023

Study Record Updates

• Last Update Posted (Actual): July 20, 2025
• Last Update Submitted That Met QC Criteria: July 17, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Seattle Genetics; Bladder Cancer; Urothelial Cancer; HER2 Mutations; HER2 Overexpression; HER2 Amplification
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Carcinoma; Carcinoma, Transitional Cell
• Other Study ID Numbers: SGNDV-003; C5731003 (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.