NCT07018427

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

Efficacy and Safety of Sacituzumab Govitecan in Heavily Pretreated Unresectable Locally Advanced, Recurrent, or Metastatic HER2-Negative Breast Cancer: A Multicenter Real-World Study

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 70 (actual)
• Sponsor: Peking University Cancer Hospital & Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This multicenter observational real-world study is planned to enroll 100 patients, 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 study aims to evaluate the efficacy and safety of sacituzumab govetican (SG) monotherapy or combination regimens in patients with unresectable locally advanced, recurrent, or metastatic HER2-negative breast cancer within a real-world context.

Conditions

• Breast Neoplasms
• Triple Negative Breast Cancer
• HR+, HER2-, Advanced Breast Cancer
• Breast Cancer

Interventions

Type	Name	Description
DRUG	Sacituzumab Govitecan Monotherapy or Combination Therapy	The interventions in this study comprised either Sacituzumab Govitecan monotherapy or combination therapy. The specific combination regimens were determined based on real - world clinical practice patterns.

Timeline

• Start date: 2023-05-01
• Primary completion: 2025-05-01
• Completion: 2025-09-01
• First posted: 2025-06-12
• Last updated: 2025-06-12

Locations

1 site across 1 country: China