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

NCT06732323 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 504

Last updated 2025-09-23

No results posted yet for this study

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.

Conditions

  • Triple-Negative Breast Cancer (TNBC)

Interventions

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

Sponsors & Collaborators

  • Qilu Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Fei Ma · 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
2025-09-04
Primary Completion
2027-06-30
Completion
2028-07-31

Countries

  • China

Study Locations

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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 NCT06732323 on ClinicalTrials.gov