OncRef

Clinical Trial: NCT06279364

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

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 3

Lead Sponsor:Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Information Provided By:Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Last Update Posted:2026-10-21

Study Overview

Brief 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

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

Conditions

Triple Negative Breast Cancer

Intervention / Treatment

  • Drug: SKB264
  • Drug: Paclitaxel
  • Drug: Nab-paclitaxel
  • Drug: Capecitabine
  • Drug: Eribulin
  • Drug: Carboplatin

Other Study ID Numbers

  • SKB264-Ⅲ-11

Start Date (Actual)

2024-02-28

Primary Completion Date (Estimated)

2027-04

Study Completion Date (Estimated)

2028-12

Enrollment (Actual)

537

Study Type

Interventional

Phase

Phase 3