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A Study of SKB264 Versus Investigator's Choice Chemotherapy in Patients With Unresectable Recurrent or Metastatic Triple-Negative Breast Cancer

Triple Negative Breast Cancer Clinical Trial

Official title:
A Randomized, Open-Label, Multicenter Phase 3 Study of SKB264 Versus Investigator's Choice Chemotherapy as First-Line Treatment in Patients With Unresectable Recurrent or Metastatic Triple-Negative Breast Cancer

Clinical Trial Summary

The aim of the study is to evaluate the efficacy and safety of SKB264 as first-line treatment for patients with unresectable recurrent or metastatic triple-negative breast cancer (TNBC) whose tumors do not express programmed cell death ligand 1 (PD-L1) or in patients with PD-L1 positive tumors who received prior anti-programmed cell death 1 (PD-1)/PD-L1 inhibitor in early setting

Clinical Trial Description

This is a randomized, open-label, multicenter, Phase 3 study to evaluate the efficacy and safety of SKB264 versus investigator's choice chemotherapy as first-line treatment for patients with unresectable recurrent or metastatic TNBC whose tumors do not express PD-L1 or in patients with PD-L1 positive tumors who received prior anti-PD-1/PD-L1 inhibitor in early setting. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06279364
Study type Interventional
Source Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.
Contact Xiaoping Jin, PhD
Phone 86-028-67255165
Email jinxp@kelun.com
Status Not yet recruiting
Phase Phase 3
Start date February 2024
Completion date July 2026
View Details
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