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

NCT06383767 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 378

Last updated 2025-06-19

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Qilu Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Fei Ma, PhD · Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-11
Primary Completion
2027-06-30
Completion
2028-07-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06383767 on ClinicalTrials.gov