This multicenter observational real-world study is planned to enroll 100 patients, divided into two cohorts: the triple-negative breast cancer (TNBC) cohort and the hormone receptor-positive/human epidermal growth factor receptor 2-negative breast cancer (HR+/HER2- BC) cohort. The study aims to evaluate the efficacy and safety of sacituzumab govetican (SG) monotherapy or combination regimens in patients with unresectable locally advanced, recurrent, or metastatic HER2-negative breast cancer within a real-world context.
Study Type
OBSERVATIONAL
Enrollment
70
The interventions in this study comprised either Sacituzumab Govitecan monotherapy or combination therapy. The specific combination regimens were determined based on real - world clinical practice patterns.
Peking University Cancer Hospital & Institute
Beijing, Beijing Municipality, China
Real world progression free survival (rwPFS)
The time interval from the date of Sacituzumab Govitecan initiation until date of progressive disease (PD) or death from any causes, whichever occurred first.
Time frame: 12 months after the last patient was enrolled
Real world objective response rate (rwORR)
The percentage of participants with the best overall response of complete response (CR) or partial response (PR) according to RECIST 1.1. CR = Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR = At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
Time frame: approximately up to 24 weeks from the initiation of the study treatment.
Real world overall survival (rwOS)
Time from initiation of SG monotherapy or combination therapy to death from any cause
Time frame: up to 48 months from the initiation of the study treatment.
Number of patients with adverse events
Adverse events were assessed during study treatment and at follow-up visits
Time frame: approximately up to 68 weeks from the initiation of the treatment.
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