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

June 17, 2025 updated by: Qilu Pharmaceutical Co., Ltd.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a open-label, randomized, multicenter Phase 3 study to evaluate ESG401 versus Treatment of Physician's Choice (TPC) in subjects with unresectable locally advanced or metastatic HR+/HER2- breast cancer who had failed at least one line of systemic chemotherapy.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
378

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100021
        • Recruiting
        • Cancer Hospital Chinese Academy of Medical Sciences
        • Contact:
          • Fei Ma, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Individuals able to understand and give written informed consent.
  • Males or females aged ≥ 18 years ;
  • Histologically and/or cytologically confirmed HR+/HER2- breast cancer who had failed at least one line of systemic chemotherapy in metastatic settings;
  • Patients who are eligible for a chemotherapy regimen in the control group;
  • Patients with at least one measurable lesion per RECIST 1.1 criteria;
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1;
  • Expected survival ≥ 12 weeks;
  • Patients with adequate organ and bone marrow function;
  • Female patients of childbearing potential and male patients with partners of childbearing potential who use effective medical contraception from the time of signing the informed consent form until 180 days after the last dose.

Exclusion Criteria:

  • Received chemotherapy, targeted therapy, immunotherapy, interventional therapy or other systemic anti-cancer therapie within 4 weeks before the first investigational product administration;
  • Toxicities from prior anti-tumor therapy not recovering to ≤ Grade 1;
  • Received major surgeries 4 weeks prior to the first dose of study treatment or planned to receive major surgeries during the study ;
  • Prior topoisomerase I inhibitor therapy, including antibody-drugconjugate(ADC) therapy, or prior TROP2 targeted therapy, or use of any investigational anti-cancer drug within 28 days or 5 half-lives before the first investigational product administration;
  • New thromboembolic events, intestinal obstruction, gastrointestinal bleeding or perforation within 6 months;
  • Uncontrolled systemic bacterial, viral or fungal infections;
  • Subjects with symptomatic or untreated CNS metastases, or those requiring ongoing treatment for CNS metastases;
  • Patients with Primary CNS malignancy；or patients with other malignancies within 3 years prior to the first dose;
  • Patients with uncontrollable systemic diseases;
  • Patients with gastrointestinal diseases (such as chronic gastritis, chronic enteritis or gastric ulcers), or with a previous history of severe or chronic diarrhea;
  • Subjects with clinically significant cardiovascular disease;
  • Human Immunodeficiency Virus (HIV) infection;
  • Active hepatitis B or hepatitis C;
  • Known immediate or delayed hypersensitivity reaction to irinotecan or other camptocampin derivatives such as topotecan or to have had grade ≥3 gastrointestinal reactions associated with irinotecan, or allergies, or to any investigational drug or excipient ingredient;
  • Pregnant or lactating women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ESG401 for injection
IV infusion on day 1, 8 and15 of each 28 day cycle
Drug: ESG401
IV infusion on day 1,8, and 15 of each 28 day cycle
Active Comparator: Treatment of Physician's Choice

Eribulin 1.4 mg/m2, IV infusion on day 1 and 8 of each 21 day cycle

Capecitabine 1000 or 1250 mg/m2, po, from day 1 to 14 of each 21 day cycle

Vinorelbine 25 mg/m2, IV infusion on day 1 and 8 of each 21 day cycle

Gemcitabine 1000 mg/m2, IV infusion on day 1,8 and 15 of each 28day cycle
Drug: Eribulin, capecitabine, gemcitabine or vinorelbine (Treatment of Physician's Choice)
Eribulin, capecitabine, gemcitabine or vinorelbine

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS) assessed by IRC per RECIST 1.1
Time Frame: Up to 24 months
PFS was defined as the time from randomization to PD or death, whichever occurs first.
Up to 24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS) assessed by the investigators per RECIST V 1.1
Time Frame: Up to 24 months
PFS was defined as the time from randomization to PD or death, whichever occurs first.
Up to 24 months
Overall Survival (OS)
Time Frame: Up to 24 months
OS was defined as the time from randomization to death.
Up to 24 months
Objective Response Rate (ORR)
Time Frame: Up to 24 months
ORR was defined as the proportion of of patients with a CR and PR assessed by IRC and investigators per RECIST v 1.1
Up to 24 months
Clinical Benefit Rate (CBR)
Time Frame: Up to 24 months
CBR was defined as the proportion of patients with a CR or PR or with SD at Week 24 assessed by IRC and investigators per RECIST v 1.1
Up to 24 months
Duration of Response (DoR)
Time Frame: Up to 24 months
From the date that response criteria are first met to the first occurrence of PD as determined by BIRC and investigators per RECIST v1.1 or death from any cause, whichever occurs first.
Up to 24 months
Quality of life evaluated using the NCC-BC-A scale
Time Frame: Up to 24 months
To assess the impact of ESG401 on disease related symptoms and quality of life of patients using the NCC-BC-A scale
Up to 24 months
Adverse events(AEs) and severe adverse events (SAEs)
Time Frame: From signing the ICF up to last dose plus 30 days
Incidence and severity of AEs and SAEs (per CTCAE 5.0), and clinically significant abnormal laboratory findings
From signing the ICF up to last dose plus 30 days
Clearance
Time Frame: Up to 24 months
Mean population clearance will be derived from pooled data of drug concentrations. Covariates of influence on drug clearance will be incorporated within a population pharmacokinetic model.
Up to 24 months
Volume of distribution
Time Frame: Up to 24 months
Mean population volume of distribution will be derived from pooled data of drug concentrations. Covariates of influence on volume of distribution will be incorporated within a population pharmacokinetic model.
Up to 24 months
ADA
Time Frame: Up to 24 months
Incidence of anti-drug antibodies
Up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Qilu Pharmaceutical Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Fei Ma, PhD, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 11, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 22, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 25, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 19, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 17, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ESG401-301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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