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.
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.
Check if I qualifyExtracted 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
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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