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NCT06383767Not yet recruiting

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 Treatment of Physician's Choice in Patients With Locally Advanced or Metastatic HR+/HER2- Breast Cancer Who Had Failed at Least One Line of Chemotherapy
Shanghai Escugen Biotechnology Co., LtdPhase 3ClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Metastatic Breast Cancer
Drug/Device/Intervention
ESG401
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Shanghai Escugen Biotechnology Co., Ltd
Location
Beijing, China
Timeline & enrollment
Phase
Phase 3
Start date
Jun 30, 2024
End date
Dec 31, 2026
Enrollment
378 participants
Primary outcome

Progression-free survival (PFS) assessed by IRC per RECIST 1.1

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.

ICD-10 classifications
Malignant neoplasm of breastMalignant neoplasm of breastMalignant neoplasm: Breast, unspecifiedMalignant neoplasm: Central portion of breastMalignant neoplasm: Overlapping lesion of breast
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06383767
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06383767 through Pure Global AI's free database. This Phase 3 trial is sponsored by Shanghai Escugen Biotechnology Co., Ltd and is currently Not yet recruiting. The study focuses on Metastatic Breast Cancer. Target enrollment is 378 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.