Clinical trial NCT05902494: HER2 and LA/mUC: A Multi-country Chart Review Cohort Study
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Urothelial Carcinoma
Keywords: Urothelial Cancer
Bladder Cancer
HER2 Mutations
HER2 Overexpression
HER2 Amplification
Seattle Genetics
Lead sponsor: Seagen Inc.
Sponsor class: INDUSTRY
First posted: 2023-06-15
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
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.

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).


Eligibility criteria: 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

Primary outcomes:
measure: Real-world Objective Response Rate (rwORR) per modified response evaluation criteria in solid tumors version 1.1 (RECIST v1.1)
timeFrame: Up to 5 years
Secondary outcomes:
measure: Percentages of IHC0, 1+, 2+, and 3+ participants
timeFrame: Up to 5 years
measure: Percentages of HER2+ (IHC3+, IHC2+/ISH+), HER2-low (IHC1+, IHC2+/ISH-), HER2-expressing (IHC1+, IHC2+, and IHC3+), and HER2-zero (IHC0) participants
timeFrame: Up to 5 years
measure: Characteristics of LA/mUC participants
timeFrame: Up to 5 years
measure: Real-world Overall Survival (rwOS)
timeFrame: Up to 5 years
measure: Characteristics of treatment patterns in LA/mUC participants
timeFrame: Up to 5 years
measure: rwORR for each subsequent LOT following the index LOT
timeFrame: Up to 5 years
measure: Real-world Time on Treatment (rwTOT)
timeFrame: Up to 5 years
measure: Real-world Time to Next Treatment (rwTTNT)
timeFrame: Up to 5 years
measure: Real-world Progression Free Survival (rwPFS)
timeFrame: Up to 5 years
measure: Real-world Duration of Response (rwDOR)
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic
state: Arizona
city: Orange
country: United States
facility: University of California Irvine
state: California
city: Palo Alto
country: United States
facility: Stanford Cancer Institute - School of Medicine
state: California
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Santa Monica
country: United States
facility: University of California Los Angeles
state: California
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
city: New York
country: United States
facility: ICAHN School of Medicine at Mount Sinai,
state: New York
city: Charlotte
country: United States
facility: Levine Cancer Institute
state: North Carolina
city: Durham
country: United States
facility: Duke Cancer Institute - School of Medicine
state: North Carolina
city: Sioux Falls
country: United States
facility: Avera Cancer Institute Center
state: South Dakota
city: Nashville
country: United States
facility: Vanderbilt - Ingram Cancer Center
state: Tennessee
city: Wien
country: Austria
facility: AKH Wien
city: Lyon
country: France
facility: Centre Léon Bérard
city: Paris
country: France
facility: Institut Mutualiste Montsouris
city: Rouen
country: France
facility: CHU de Rouen.
city: Suresnes
country: France
facility: Foch Hospital
city: Krefeld
country: Germany
facility: Alexianer Krefeld GmbH
state: Nordrhein-westfalen
city: Lübeck
country: Germany
facility: University Hospital Lübeck
state: Schleswig-holstein
city: Stuttgart
country: Germany
facility: Stuttgart Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: