NCT06732323

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

A Randomized, Open-label, Phase III Study of ESG401 Versus Investigator's Choice Chemotherapy as First-line Treatment in Patients With Unresectable Recurrent or Metastatic Triple-Negative Breast Cancer

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 504 (estimated)
• Sponsor: Qilu Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a randomized, open-label, multicenter Phase 3 study to evaluate ESG401 versus Investigator's Choice Chemotherapy (ICC) as first-line treatment in subjects with unresectable recurrent or metastatic triple-negative breast cancer.

Conditions

• Triple-Negative Breast Cancer (TNBC)

Interventions

Type	Name	Description
DRUG	ESG401	IV infusion on day 1,8, and 15 of each 28 day cycle
DRUG	Investigator's Choice Chemotherapy	Paclitaxel, Nab-paclitaxel, Capecitabine, Eribulin, or Carboplatin

Timeline

• Start date: 2025-09-04
• Primary completion: 2027-06-01
• Completion: 2028-07-01
• First posted: 2024-12-13
• Last updated: 2025-09-23

Locations

1 site across 1 country: China