RecruitingPhase 3NCT06732323

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

A Randomized, Open-label, Phase III Study of ESG401 Versus Investigator's Choice Chemotherapy as First-line Treatment in Patients With Unresectable Recurrent or Metastatic Triple-Negative Breast Cancer


Sponsor

Qilu Pharmaceutical Co., Ltd.

Enrollment

504 participants

Start Date

Sep 4, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Phase III study is testing a new drug called ESG401 against standard chemotherapy in people with triple-negative breast cancer (TNBC) that has spread (metastatic) or cannot be removed surgically and has either not responded to immunotherapy or is not eligible for it. **You may be eligible if...** - You are 18 or older - You have confirmed triple-negative breast cancer (TNBC) - Your cancer is newly metastatic or returned more than 6 months after completing curative-intent treatment - You have not received prior systemic treatment for metastatic disease - Your tumor is either PD-L1 negative, or you had PD-1/PD-L1 treatment for early-stage disease that failed, or you cannot have immunotherapy due to other health reasons - You have measurable disease on imaging **You may NOT be eligible if...** - You have already received treatment for metastatic TNBC - You have active brain metastases - You have serious organ dysfunction or other active cancers Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGESG401

IV infusion on day 1,8, and 15 of each 28 day cycle

DRUGInvestigator's Choice Chemotherapy

Paclitaxel, Nab-paclitaxel, Capecitabine, Eribulin, or Carboplatin


Locations(1)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, China

View Full Details on ClinicalTrials.gov

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NCT06732323


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