This study is a multi-center observational real-world study, with a total of 500 patients planned to be enrolled. This study is 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 aim of this study is to assess the efficacy and safety of Sacituzumab Tirumotecan (SKB264) monotherapy or combination therapy in patients with unresectable locally advanced, recurrent or metastatic HER2-negative breast cancer in the real-world setting.
Study Type
OBSERVATIONAL
Enrollment
500
The interventions in this study comprised SKB264 monotherapy or combination therapy involving SKB264. The specific combination regimens were determined based on real-world clinical practice.
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Time to next treatment (TTNT) of SKB264 monotherapy or combination therapy in patients with unresectable locally advanced, recurrent or metastatic HER2-negative breast cancer
Time frame: Time from initiation of SKB264 monotherapy or combination therapy to start of next treatment, assessed up to 24 weeks.
Real world progression free survival (rwPFS) of SKB264 monotherapy or combination therapy
Time frame: Time from initiation of SKB264 monotherapy or combination therapy to the first documented evidence of progression or death, whichever came first, assessed up to 24 weeks.
Duration of treatment (DOT) of SKB264 monotherapy or combination therapy
Time frame: Time from initiation of SKB264 monotherapy or combination therapy to its discontinuation, assessed up to 24 weeks.
Real world objective response rate (rwORR) of SKB264 monotherapy or combination therapy
Time frame: The proportion of patients who had a complete or partial response documented by imaging reports or by assessment of treating physician during the study treatment, which is approximately up to 24 weeks from the initiation of the study treatment.
Real world overall survival (rwOS) of SKB264 monotherapy or combination therapy
Time frame: Time from initiation of SKB264 monotherapy or combination therapy to death from any cause, assessed up to 48 weeks.
Number of patients with adverse events of SKB264 monotherapy or combination therapy in the real-world setting, graded and recorded according to NCI CTCAE v5.0.
Time frame: Adverse events were assessed during study treatment and at follow-up visits, which is approximately up to 30 weeks from the initiation of the study treatment.
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