TPS 31 Real-World Sacituzumab Govitecan Treatment Patterns and Outcomes in Second-Line or Later Metastatic Triple-Negative Breast Cancer: Leveraging Electronic Health Records and Manual Curation of a US Database
Triple-negative breast cancer (TNBC) is an aggressive type of breast cancer that grows and spreads quickly, has limited treatment options, and tends to have a poor prognosis. The 5-year relative survival rate for metastatic TNBC is 14.3%, consistently lower than other breast cancer subtypes. Sacituzumab govitecan-hziy is FDA approved for patients with metastatic TNBC who have received 2 or more prior therapies, with 1 or more in the metastatic setting. Here, we aim to describe real-world demographics, clinical characteristics, treatment patterns, and outcomes for patients with metastatic TNBC treated with sacituzumab govitecan in the second-line setting or later. The present study builds on findings of 2 recent observational studies in the ConcertAI Patient360 database and Flatiron Health electronic health record (EHR)–derived deidentified database and is designed to include a larger sample size and longer follow-up to further characterize early adoption and more recent real-world utilization patterns of SG for treatment of metastatic TNBC.
The Integra Connect-PrecisionQ de-identified database harmonizes real-world EHR data of more than 3.2 million lives and more than 5000 providers across community oncology clinics in the US. The database contains structured patient-level data enhanced by manual curation, including diagnosis codes, laboratory values, comorbidities, treatments (dose, duration), unstructured fields comprising physician notes, biomarker testing details, reasons for treatment discontinuation, medical events, response, disease progression, etc. Adult patients diagnosed with metastatic TNBC treated in US community oncology practices receiving second-line sacituzumab govitecan from April 1, 2020, through December 31, 2023, will be included. Patients with any other primary cancer diagnosed or who participated in a clinical trial during the study observation period will be excluded.
Data from up to 500 patients with metastatic TNBC treated with sacituzumab govitecan will be curated, with follow-up data through October 31, 2024. The planned analyses include descriptions of baseline demographic and clinical characteristics, treatment patterns, and clinical outcomes. Key clinical end points of interest are time to treatment discontinuation or death, time to next treatment or death, overall response rate, real-world progression-free survival, and real-world overall survival.