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OncoMatch/Clinical Trials/NCT06732323

A Phase III Study of ESG401 for Unresectable Recurrent or Metastatic Triple-Negative Breast Cancer

Is NCT06732323 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including ESG401 and Investigator's Choice Chemotherapy for triple-negative breast cancer (tnbc).

Phase 3RecruitingQilu Pharmaceutical Co., Ltd.NCT06732323Data as of May 2026

Treatment: ESG401 · Investigator's Choice ChemotherapyThe aim of this study is to evaluate the efficacy and safety of ESG401 as first-line treatment in patients with unresectable recurrent or metastatic triple-negative breast cancer.

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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

Participants whose tumours are PD-L1-positive and have relapsed after prior PD-1/PD-L1 inhibitor therapy for early-stage breast cancer, or comorbidities precluding PD-1/PD-L1 inhibitor therapy

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: systemic anti-cancer therapy

Exception: for unresectable recurrent or metastatic disease

No prior systemic anti-cancer therapy for unresectable recurrent or metastatic disease

Cannot have received: topoisomerase I inhibitor

Prior topoisomerase I inhibitor therapy, including antibody-drug conjugate(ADC) therapy

Cannot have received: antibody-drug conjugate

Prior topoisomerase I inhibitor therapy, including antibody-drug conjugate(ADC) therapy

Cannot have received: TROP2 targeted therapy

prior TROP2 targeted therapy

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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