HER2 and LA/mUC: A Multi-country Chart Review Cohort Study
- Conditions
- Urothelial Carcinoma
- Registration Number
- NCT05902494
- Lead Sponsor
- Seagen, a wholly owned subsidiary of Pfizer
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 350
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Real-world Objective Response Rate (rwORR) per modified response evaluation criteria in solid tumors version 1.1 (RECIST v1.1) 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 Outcome Measures
Name Time Method Characteristics of treatment patterns in LA/mUC participants 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
Real-world Time on Treatment (rwTOT) Up to 5 years Time from the start date of the LOT to the end date of the same LOT for any reason.
rwORR for each subsequent LOT following the index LOT 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.
Percentages of IHC0, 1+, 2+, and 3+ participants Up to 5 years Characteristics of LA/mUC participants Up to 5 years Real-world Time to Next Treatment (rwTTNT) Up to 5 years The time from the start date of each LOT to the initiation of the next LOT for any reason.
Real-world Progression Free Survival (rwPFS) 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.
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 Real-world Overall Survival (rwOS) Up to 5 years Time from the index date to date of death from any cause.
Real-world Duration of Response (rwDOR) 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.
Trial Locations
- Locations (19)
Mayo Clinic
๐บ๐ธPhoenix, Arizona, United States
University of California Irvine
๐บ๐ธOrange, California, United States
Stanford Cancer Institute - School of Medicine
๐บ๐ธPalo Alto, California, United States
University of California San Francisco
๐บ๐ธSan Francisco, California, United States
University of California Los Angeles
๐บ๐ธSanta Monica, California, United States
University of Colorado Hospital
๐บ๐ธAurora, Colorado, United States
ICAHN School of Medicine at Mount Sinai,
๐บ๐ธNew York, New York, United States
Levine Cancer Institute
๐บ๐ธCharlotte, North Carolina, United States
Duke Cancer Institute - School of Medicine
๐บ๐ธDurham, North Carolina, United States
Avera Cancer Institute Center
๐บ๐ธSioux Falls, South Dakota, United States
Vanderbilt - Ingram Cancer Center
๐บ๐ธNashville, Tennessee, United States
AKH Wien
๐ฆ๐นWien, Austria
Centre Lรฉon Bรฉrard
๐ซ๐ทLyon, France
Institut Mutualiste Montsouris
๐ซ๐ทParis, France
CHU de Rouen.
๐ซ๐ทRouen, France
Foch Hospital
๐ซ๐ทSuresnes, France
Alexianer Krefeld GmbH
๐ฉ๐ชKrefeld, Nordrhein-westfalen, Germany
University Hospital Lรผbeck
๐ฉ๐ชLรผbeck, Schleswig-holstein, Germany
Stuttgart Hospital
๐ฉ๐ชStuttgart, Germany