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A Phase III Study of ESG401 for Locally Advanced or Metastatic HR+/HER2- Breast Cancer - Trial NCT06383767

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.

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NCT06383767
Phase 3
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov • NCT06383767
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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

Study Focus

Metastatic Breast Cancer

ESG401

Interventional

drug

Sponsor & Location

Shanghai Escugen Biotechnology Co., Ltd

Beijing, China

Timeline & Enrollment

Phase 3

Jun 30, 2024

Dec 31, 2026

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 breast
Malignant neoplasm of breast
Malignant neoplasm: Breast, unspecified
Malignant neoplasm: Central portion of breast
Malignant neoplasm: Overlapping lesion of breast

Data Source

ClinicalTrials.gov

NCT06383767

Non-Device Trial