Real-world Study of SKB264 Monotherapy or Combination Therapy in Recurrent or Metastatic HER2-negative Breast Cancer
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…
Conditions studied
HER2-negative Breast Cancer, Recurrence, Metastasis
About this study
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.
Interventions
- Drug: SKB264 Monotherapy or Combination Therapy — 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.
Primary outcomes
- 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 from initiation of SKB264 monotherapy or combination therapy to start of next treatment, assessed up to 24 weeks.)
Eligibility information
Study locations
- The Second Affiliated Hospital of Anhui Medical University, Hefei, Anhui 230601 China
- Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, Beijing Municipality 100021 China
- Peking University First Hospital, Beijing, Beijing Municipality 100034 China
- Chinese PLA General Hospital, Beijing, Beijing Municipality 100853 China
- Fujian Cancer Hospital, Fuzhou, Fujian 350000 China
- The First Affiliated Hospital of Xiamen University, Xiamen, Fujian China
- The Fourth Hospital of Hebei Medical University, Shijiazhuang, Hebei China
- The Third People's Hospital of Zhengzhou, Zhengzhou, Henan 450000 China
- The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan China
- Taihe Hospital, Shiyan, Hubei 442099 China
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Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.