NCT06279364

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

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 524 (estimated)
• Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Triple Negative Breast Cancer

Interventions

Type	Name	Description
DRUG	SKB264	IV Infusion
DRUG	Paclitaxel	IV Infusion.
DRUG	Nab-paclitaxel	IV infusion.
DRUG	Capecitabine	Tablet. Oral route of administration.
DRUG	Eribulin	IV infusion.
DRUG	Carboplatin	IV infusion.

Timeline

• Start date: 2024-02-28
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2024-02-28
• Last updated: 2026-01-27

Locations

1 site across 1 country: China