RecruitingPhase 3NCT06383767

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 Investigator's Choice Chemotherapy in Patients With Locally Advanced or Metastatic HR+/HER2- Breast Cancer Who Had Failed at Least One Line of Chemotherapy


Sponsor

Qilu Pharmaceutical Co., Ltd.

Enrollment

378 participants

Start Date

Jul 11, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Phase 3 study is testing a new cancer drug called ESG401 compared to standard chemotherapy in people with hormone receptor-positive, HER2-negative breast cancer that has spread to other parts of the body and has already been treated with at least one round of chemotherapy. **You may be eligible if...** - You are 18 or older (any gender) - You have HR+/HER2- breast cancer that has spread and stopped responding to chemotherapy - You have at least one measurable tumor on imaging - You are in generally good health (performance score 0–1) - Your blood counts and organ function are adequate **You may NOT be eligible if...** - You have received certain prior therapies including topoisomerase inhibitors or TROP2-targeted treatments - You have untreated or active brain metastases - You have active infections, HIV, or active hepatitis B or C - You had a blood clot, bowel blockage, or gastrointestinal bleeding within the last 6 months - You are pregnant or breastfeeding 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

DRUGEribulin, capecitabine, gemcitabine or vinorelbine (Treatment of Physician's Choice)

Eribulin, capecitabine, gemcitabine or vinorelbine


Locations(1)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

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NCT06383767


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