OncoMatch/Clinical Trials/NCT06279364
A Study of SKB264 Versus Investigator's Choice Chemotherapy in Patients With Unresectable Recurrent or Metastatic Triple-Negative Breast Cancer
Is NCT06279364 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments for triple negative breast cancer.
Treatment: SKB264 · Paclitaxel · Nab-paclitaxel · Capecitabine · Eribulin · Carboplatin — 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
Check if I qualifyExtracted eligibility criteria
Cancer type
Triple-Negative Breast Cancer
Breast Carcinoma
Biomarker criteria
Allowed: PD-L1 (CD274) negative
Participants whose tumours are PD-L1-negative
Allowed: PD-L1 (CD274) positive, relapsed after prior anti-PD-1/PD-L1 inhibitor for early-stage disease
participants whose tumors are PD-L1 positive and have relapsed after prior anti-PD-1/PD-L1 inhibitor for early-stage disease
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: TROP2-targeted therapy
Previously received TROP2-targeted therapy
Cannot have received: topoisomerase 1 inhibitor
Previously received...topoisomerase 1 inhibitors
Cannot have received: investigator's choice chemotherapy (except taxane) (paclitaxel, nab-paclitaxel, capecitabine, eribulin, carboplatin)
Exception: except taxane
Prior treatment with the same investigator's choice chemotherapy (except taxane)
Lab requirements
Blood counts
adequate organ and bone marrow function
Kidney function
adequate organ and bone marrow function
Liver function
adequate organ and bone marrow function
Adequate organ and bone marrow function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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