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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.

Phase 3RecruitingSichuan Kelun-Biotech Biopharmaceutical Co., Ltd.NCT06279364Data as of May 2026

Treatment: SKB264 · Paclitaxel · Nab-paclitaxel · Capecitabine · Eribulin · CarboplatinThe 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

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Extracted 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

No prior treatment (treatment-naive required)
Max 0 prior lines

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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