NCT06383767

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

A Open-label, Randomized, Multicenter Phase III Study of ESG401 Versus Investigator's Choice Chemotherapy in Patients With Locally Advanced or Metastatic HR+/HER2- Breast Cancer Who Had Failed at Least One Line of Chemotherapy

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 378 (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 in patients with unresectable locally advanced or metastatic HR+/HER2- breast cancer.

Detailed description

This is a open-label, randomized, multicenter Phase 3 study to evaluate ESG401 versus Treatment of Physician's Choice (TPC) in subjects with unresectable locally advanced or metastatic HR+/HER2- breast cancer who had failed at least one line of systemic chemotherapy.

Conditions

• Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	ESG401	IV infusion on day 1,8, and 15 of each 28 day cycle
DRUG	Eribulin, capecitabine, gemcitabine or vinorelbine (Treatment of Physician's Choice)	Eribulin, capecitabine, gemcitabine or vinorelbine

Timeline

• Start date: 2024-07-11
• Primary completion: 2027-06-30
• Completion: 2028-07-31
• First posted: 2024-04-25
• Last updated: 2025-06-19

Locations

1 site across 1 country: China