NCT06993506

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

Sacituzumab Tirumotecan Monotherapy or Combination Therapy in Patients With Unresectable Locally Advanced, Recurrent or Metastatic HER2-Negative Breast Cancer: A Real-World Study

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2025-08-01
• Primary completion: 2027-08-01
• Completion: 2027-10-31
• First posted: 2025-05-29
• Last updated: 2025-05-29

Locations

1 site across 1 country: China