Real-world Study of SKB264 Monotherapy or Combination Therapy in Recurrent or Metastatic HER2-negative Breast Cancer
NCT06993506 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 500
Last updated 2025-05-29
Summary
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.
Conditions
- HER2-negative Breast Cancer
- Recurrence
- Metastasis
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.
Sponsors & Collaborators
-
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
lead OTHER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-08-01
- Primary Completion
- 2027-08-01
- Completion
- 2027-10-31
Countries
- China
Study Locations
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