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

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Trial ID: NCT05902494

Purpose

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).

Official Title

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

Eligibility


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

Recruiting

I'm Interested

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Mohsin Rangwala
mrang@stanford.edu

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