Metastatic Breast CancerPhase 3NCT06383767
A Phase III Study of ESG401 for Locally Advanced or Metastatic HR+/HER2- Breast Cancer
A Phase 3 study testing ESG401 and Eribulin, capecitabine, gemcitabine or vinorelbine (Treatment of Physician's Choice) in people with Metastatic Breast Cancer, run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- ESG401 and Eribulin, capecitabine, gemcitabine or vinorelbine (Treatment of Physician's Choice)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 378 participants
- Where
- 1 siteChina
- Study dates
- 11 Jul 2024to 31 Jul 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Fei Ma, PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Metastatic Breast Cancer
- Being tested
- ESG401, Eribulin, capecitabine, gemcitabine or vinorelbine (Treatment of Physician's Choice)
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESG401Drug
IV infusion on day 1,8, and 15 of each 28 day cycle
Eribulin, capecitabine, gemcitabine or vinorelbine (Treatment of Physician's Choice)Drug
Eribulin, capecitabine, gemcitabine or vinorelbine
| Study group | Role | What they receive |
|---|---|---|
| ESG401 for injection | Experimental | IV infusion on day 1, 8 and15 of each 28 day cycle Receives: Drug: ESG401 |
| Treatment of Physician's Choice | Active comparator | 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 Receives: Drug: Eribulin, capecitabine, gemcitabine or vinorelbine (Treatment of Physician's Choice) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS) assessed by IRC per RECIST 1.1
PFS was defined as the time from randomization to PD or death, whichever occurs first.
Measured: Up to 24 months
Secondary outcomes (10)
Progression-free survival (PFS) assessed by the investigators per RECIST V 1.1
PFS was defined as the time from randomization to PD or death, whichever occurs first.
Measured: Up to 24 months
Overall Survival (OS)
OS was defined as the time from randomization to death.
Measured: Up to 24 months
Objective Response Rate (ORR)
ORR was defined as the proportion of of patients with a CR and PR assessed by IRC and investigators per RECIST v 1.1
Measured: Up to 24 months
Clinical Benefit Rate (CBR)
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
Measured: Up to 24 months
Duration of Response (DoR)
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.
Measured: Up to 24 months
Quality of life evaluated using the NCC-BC-A scale
To assess the impact of ESG401 on disease related symptoms and quality of life of patients using the NCC-BC-A scale
Measured: Up to 24 months
Adverse events(AEs) and severe adverse events (SAEs)
Incidence and severity of AEs and SAEs (per CTCAE 5.0), and clinically significant abnormal laboratory findings
Measured: From signing the ICF up to last dose plus 30 days
Clearance
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.
Measured: Up to 24 months
Volume of distribution
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.
Measured: Up to 24 months
ADA
Incidence of anti-drug antibodies
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start11 Jul 2024
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by Qilu Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 378 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fei Ma, PhD, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06383767
- Sponsor's protocol ID
- ESG401-301
- Status last verified
- May 2025
- First submitted
- 22 Apr 2024
- Last updated
- 19 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06383767
- Acronym / sponsor ID
- ESG401-301
- Conditions
- Metastatic Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 378 participants (estimated)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Jul 2024 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 25 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESG401 for injection | Experimental | Drug: ESG401IV infusion on day 1, 8 and15 of each 28 day cycle |
| Treatment of Physician's Choice | Active comparator | Drug: Eribulin, capecitabine, gemcitabine or vinorelbine (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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ESG401IV infusion on day 1,8, and 15 of each 28 day cycle | Drug | ESG401 for injection |
| Eribulin, capecitabine, gemcitabine or vinorelbine (Treatment of Physician's Choice)Eribulin, capecitabine, gemcitabine or vinorelbine | Drug | Treatment of Physician's Choice |
Primary outcome
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.
10 secondary outcomes
Progression-free survival (PFS) assessed by the investigators per RECIST V 1.1
Time frame: Up to 24 months
Overall Survival (OS)
Time frame: Up to 24 months
Objective Response Rate (ORR)
Time frame: Up to 24 months
Clinical Benefit Rate (CBR)
Time frame: Up to 24 months
Duration of Response (DoR)
Time frame: Up to 24 months
Quality of life evaluated using the NCC-BC-A scale
Time frame: 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
Clearance
Time frame: Up to 24 months
Volume of distribution
Time frame: Up to 24 months
ADA
Time frame: Up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fei Ma, PhD principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ESG401 and Eribulin, capecitabine, gemcitabine or vinorelbine (Treatment of Physician's Choice) in people with Metastatic Breast Cancer, run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yong Yuan, Master Degree (+86 13820384005, yong3.yuan@qilu-pharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) assessed by IRC per RECIST 1.1 (time frame: Up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2025.