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

Description

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).

Conditions

Urothelial Carcinoma

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Study Overview

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Study Details

Study overview

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).

A Retrospective Chart Review of Real-world Treatment Outcomes in Patients With Locally Advanced Unresectable or Metastatic Urothelial Cancer Based on HER2 Expression

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

Condition
Urothelial Carcinoma
Intervention / Treatment

-

Contacts and Locations

Orange

University of California Irvine, Orange, California, United States, 92868

San Francisco

University of California San Francisco, San Francisco, California, United States, 94158

Aurora

University of Colorado, Aurora, Colorado, United States, 80045

Sioux Falls

Avera, Sioux Falls, South Dakota, United States, 57105

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Seagen Inc.,

Medical Monitor, STUDY_DIRECTOR, Seagen Inc.

Study Record Dates

2025-09-30