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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


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

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