drugset / Trial / NCT06279364

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

NCT06279364

Phase 3 Recruiting 524 enrolled Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
RandomizedParallel-groupOpen-labelTreatment

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

Timeline

Start
2024-02-28
Primary completion
2026-07
Completion
2026-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator Capecitabine Small molecule Oral
Comparator Carboplatin Small molecule Intravenous
Comparator Eribulin Small molecule Intravenous
Comparator Paclitaxel Small molecule Intravenous
Subject Sacituzumab Tirumotecan Other / unclassified Intravenous