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).
Study Type
OBSERVATIONAL
Enrollment
389
Mayo Clinic
Phoenix, Arizona, United States
Real-world Objective Response Rate (rwORR) per modified response evaluation criteria in solid tumors version 1.1 (RECIST v1.1)
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.
Time frame: Up to 5 years
Percentages of IHC0, 1+, 2+, and 3+ participants
Time frame: Up to 5 years
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
Characteristics of LA/mUC participants
Time frame: Up to 5 years
Real-world Overall Survival (rwOS)
Time from the index date to date of death from any cause.
Time frame: Up to 5 years
Characteristics of treatment patterns in LA/mUC participants
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
Time frame: Up to 5 years
rwORR for each subsequent LOT following the index LOT
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University of California Irvine
Orange, California, United States
Stanford Cancer Institute - School of Medicine
Palo Alto, California, United States
University of California San Francisco
San Francisco, California, United States
University of California Los Angeles
Santa Monica, California, United States
University of Colorado Hospital
Aurora, Colorado, United States
ICAHN School of Medicine at Mount Sinai,
New York, New York, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
Duke Cancer Institute - School of Medicine
Durham, North Carolina, United States
Avera Cancer Institute Center
Sioux Falls, South Dakota, United States
...and 13 more locations
Time frame: Up to 5 years
Real-world Time on Treatment (rwTOT)
Time from the start date of the LOT to the end date of the same LOT for any reason.
Time frame: Up to 5 years
Real-world Time to Next Treatment (rwTTNT)
The time from the start date of each LOT to the initiation of the next LOT for any reason.
Time frame: Up to 5 years
Real-world Progression Free Survival (rwPFS)
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.
Time frame: Up to 5 years
Real-world Duration of Response (rwDOR)
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.
Time frame: Up to 5 years