Clinical Trial

Real-world Study of SKB264 Monotherapy or Combination Therapy in Recurrent or Metastatic HER2-negative Breast Cancer

Not Yet Recruiting
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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.
Trial Details
NCT Number NCT06993506
Lead Sponsor Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Conditions HER2-negative Breast Cancer, Recurrence, Metastasis
Enrollment 500 participants
Start Date 2025-08-01
Primary Completion 2027-08-01 (estimated)
Study Completion 2027-10-31 (estimated)
Updated on ClinicalTrials.gov 2025-05-29