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OncoMatch/Clinical Trials/NCT06383767

A Phase III Study of ESG401 for Locally Advanced or Metastatic HR+/HER2- Breast Cancer

Is NCT06383767 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including ESG401 and Eribulin, capecitabine, gemcitabine or vinorelbine (Treatment of Physician's Choice) for metastatic breast cancer.

Phase 3RecruitingQilu Pharmaceutical Co., Ltd.NCT06383767Data as of May 2026

Treatment: ESG401 · Eribulin, capecitabine, gemcitabine or vinorelbine (Treatment of Physician's Choice)The aim of this study is to evaluate the efficacy and safety of ESG401 in patients with unresectable locally advanced or metastatic HR+/HER2- breast cancer.

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Extracted eligibility criteria

Cancer type

Breast Carcinoma

Biomarker criteria

Required: ESR1 hormone receptor positive

HR+

Required: HER2 (ERBB2) negative

HER2-

Disease stage

Metastatic disease required

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Min 1 prior line

Must have received: systemic chemotherapy — metastatic

had failed at least one line of systemic chemotherapy in metastatic settings

Cannot have received: topoisomerase I inhibitor (irinotecan, topotecan)

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

Cannot have received: TROP2 targeted therapy

prior TROP2 targeted therapy

Cannot have received: investigational anti-cancer drug

use of any investigational anti-cancer drug within 28 days or 5 half-lives before the first investigational product administration

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

Patients with adequate organ and bone marrow function

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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