Clinical Trial

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

Recruiting Phase 3
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Summary
The 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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2024-12-10; most recent amendment 2025-09-18.
Status change: Not Yet Recruiting → Recruiting 2025-09-18
Trial Details
NCT Number NCT06732323
Lead Sponsor Qilu Pharmaceutical Co., Ltd.
Conditions Triple-Negative Breast Cancer (TNBC)
Enrollment 504 participants
Start Date 2025-09-04
Primary Completion 2027-06 (estimated)
Study Completion 2028-07 (estimated)
Updated on ClinicalTrials.gov 2025-09-23