Skip to main content
OpenTrials
Completed

NCT Number: NCT05902494

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Urothelial Carcinoma Carcinoma Carcinoma, Transitional Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AKH Wien, Vienna, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Real-world Objective Response Rate (rwORR) per modified response evaluation criteria in solid tumors version 1.1 (RECIST v1.1)

    Time frame: Up to 5 years

    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.

Secondary outcomes

  1. Percentages of IHC0, 1+, 2+, and 3+ participants

    Time frame: Up to 5 years

  2. Percentages of HER2+ (IHC3+, IHC2+/ISH+), HER2-low (IHC1+, IHC2+/ISH-), HER2-expressing (IHC1+, IHC2+, and IHC3+), and HER2-zero (IHC0) participants

    Time frame: Up to 5 years

  3. Characteristics of LA/mUC participants

    Time frame: Up to 5 years

  4. Real-world Overall Survival (rwOS)

    Time frame: Up to 5 years

    Time from the index date to date of death from any cause.

  5. Characteristics of treatment patterns in LA/mUC participants

    Time frame: Up to 5 years

    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

  6. rwORR for each subsequent LOT following the index LOT

    Time frame: Up to 5 years

    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.

  7. Real-world Time on Treatment (rwTOT)

    Time frame: Up to 5 years

    Time from the start date of the LOT to the end date of the same LOT for any reason.

  8. Real-world Time to Next Treatment (rwTTNT)

    Time frame: Up to 5 years

    The time from the start date of each LOT to the initiation of the next LOT for any reason.

  9. Real-world Progression Free Survival (rwPFS)

    Time frame: Up to 5 years

    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.

  10. Real-world Duration of Response (rwDOR)

    Time frame: Up to 5 years

    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.

Sponsors and collaborators

Lead sponsor

Seagen, a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jun 15, 2023
Registry last updated
Jul 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.