This study aims to address the following key objectives in patients with HER2-altered mBC: Primary objectives * Estimate the prevalence of human epidermal growth factor receptor 2 positive (HER2+), human epidermal growth factor receptor 2 (HER2) mutation, cooccurrence of HER2+ and HER2 mutation among adult patients with metastatic breast cancer (mBC) * Among mBC patients with HER2+ and HER2 mutation, describe the following: * Baseline demographic and clinical characteristics * Treatment patterns during follow-up including 1L through fifth-line (5L) settings * Real-world overall survival (rwOS) for 1L through 5L Secondary objectives \- Among mBC patients with HER2+ and HER2 mutation, examine the following (as permissible in the study data): * Real-world progression-free survival (rwPFS) * Real-world time to discontinuation (rwTTD) * Real-world time to next treatment (rwTTNT) * Real-world overall response rate (rwORR)
Study Type
OBSERVATIONAL
Enrollment
7,933
Ridgefield
Ridgefield, Connecticut, United States
Real-world overall survival (rwOS)
OS as an event for each patient will be defined as the date of death minus the index date + 1. For patients with no record of death, OS will be censored at the last visit date, defined as the date of the last visit of any type prior to data cutoff. Month and year of death are noted in the Flatiron Discovery Clinico-Genomic Database (CGDB); the day of death will be imputed as the midpoint (15 th) of the month of death. Endpoint will be assessed separately from the study index date (mBC diagnosis) and each of the line of therapy (LOT) index dates.
Time frame: Up to 15 years
Real-world time to treatment discontinuation (rwTTD)
rwTTD is defined as the time from the LOT start date to the end of the LOT + 1 (inclusive of maintenance therapies associated with the main therapeutic regimen). End of LOT will be defined as a composite of discontinuation (with or without subsequent LOT) or death. Patients on treatment at the end of the study period will be censored at that date.
Time frame: Up to 15 years
Real-world time to next treatment (rwTTNT)
rwTTNT is defined as the difference between subsequent LOT index dates (e.g., time from the 1L start date to the 2L start date, time from 2L start date to the 3L start date). Patients not receiving a subsequent treatment line will be censored at the last visit date.
Time frame: Up to 15 years
Real-world overall response rate (rwORR)
rwORR will be computed as the proportion of patients who achieved either a complete response or a partial response at any time during the therapy line. Distribution of best responses will be reported only for patients with known clinical responses (excluding unknown and missing/not available) for each treatment line. Endpoint will be assessed separately for each LOT.
Time frame: Up to 15 years
Real-world progression-free survival (rwPFS)
rwPFS will be defined as the difference between the index date and first record of disease progression or death after the index date + 1. For patients with no record of disease progression, rwPFS will be censored at the start of a subsequent LOT or the date of the last clinical note before the end of the study period, whichever is earlier. Endpoint will be assessed separately from each of the LOT index dates.
Time frame: Up to 15 years
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