Triple-Negative Breast Cancer (TNBC)Phase 3NCT06732323
A Phase III Study of ESG401 for Unresectable Recurrent or Metastatic Triple-Negative Breast Cancer
A Phase 3 study testing ESG401 and Investigator's Choice Chemotherapy in people with Triple-Negative Breast Cancer (TNBC), 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 as first-line treatment in patients with unresectable recurrent or metastatic triple-negative breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Triple-Negative Breast Cancer (TNBC)
- What is being tested?
- ESG401 and Investigator's Choice Chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 504 participants
- Where
- 1 siteChina
- Study dates
- 4 Sep 2025to 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
- Males or females aged ≥ 18 years ;
- Histologically and/or cytologically confirmed TNBC;
- De novo metastatic or relapsed ≥ 6 months post completion of treatment with curative intent;
- No prior systemic anti-cancer therapy for unresectable recurrent or metastatic disease;
- Participants whose tumours are PD-L1-negative, or Participants whose tumours are PD-L1-positive and have relapsed after prior PD-1/PD-L1 inhibitor therapy for early-stage breast cancer, or comorbidities precluding PD-1/PD-L1 inhibitor therapy;
- Eligible for the chemotherapy options listed as investigator's choice chemotherapy (paclitaxel, nab-paclitaxel, capecitabine, eribulin, or carboplatin) as assessed by the investigator;
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- At least one measurable lesion per RECIST v1.1;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 with no worsening within 2 weeks prior to randomization;
- A life expectancy of at least 12 weeks;
- Adequate organ and bone marrow function.
Who cannot join
- Use of any investigational anti-cancer drug within 28 days or 5 half-lives before the first investigational product administration.
- Toxicities from prior anti-tumor therapy not recovering to ≤ Grade 1.
- Prior topoisomerase I inhibitor therapy, including antibody-drug conjugate(ADC) therapy, or prior TROP2 targeted therapy.
- New thromboembolic events, intestinal obstruction, gastrointestinal bleeding or perforation within 6 months.
- 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.
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- 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.
Fei Ma, PhD contact
China1 site, 1 recruiting
- Recruiting
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing
Fei Ma, PhD, 8610-8778-8120, drmafei@126.com
About this study
Official title: 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
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.
Read the detailed description
This is a randomized, open-label, multicenter Phase 3 study to evaluate ESG401 versus Investigator's Choice Chemotherapy (ICC) as first-line treatment in subjects with unresectable recurrent or metastatic triple-negative breast cancer.
- Conditions
- Triple-Negative Breast Cancer (TNBC)
- Being tested
- ESG401, Investigator's Choice Chemotherapy
- Medical subject headings
- Triple Negative 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
Investigator's Choice ChemotherapyDrug
Paclitaxel, Nab-paclitaxel, Capecitabine, Eribulin, or Carboplatin
| 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 |
| Investigator's Choice Chemotherapy | Active comparator | If no prior taxane, or prior taxane in the (neo)adjuvant setting and disease-free interval (DFI) >12 months: paclitaxel or nab-paclitaxel. Note: If subjects are intolerant or contraindicated to receive paclitaxel or albumin-paclitaxel, the investigator may choose other chemotherapy options listed in the study protocol) If prior taxane and DFI ≤ 12 months: capecitabine, eribulin. If known BRCA1/2 mutation: carboplatin Receives: Drug: Investigator's Choice Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS) assessed by Blinded Independent Central Review (BICR)
Defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on BICR or death due to any cause, whichever occurs first.
Measured: Randomization up to approximately 28 months
Overall Survival (OS)
Defined as the time from randomization until the date of death due to any cause.
Measured: Randomization up to approximately 41 months
Secondary outcomes (14)
Progression-Free Survival (PFS) assessed by Investigator
Defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on investigator or death due to any cause, whichever occurs first.
Measured: Randomization up to approximately 28 months
Objective Response Rate (ORR) assessed by Blinded Independent Central Review (BICR)
Defined as the percentage of patients who achieve complete response(CR) or partial response (PR), as assessed by BICR per RECIST 1.1
Measured: Randomization up to approximately 28 months
Disease control rate (DCR) assessed by Blinded Independent Central Review (BICR)
Defined as the percentage of patients who achieve CR, PR or stable disease (SD), as assessed by BICR per RECIST 1.1
Measured: Randomization up to approximately 28 months
Duration of Response (DoR) assessed by Blinded Independent Central Review (BICR)
Defined as the time from the date of first documented CR or PR until date of documented disease progression per RECIST 1.1, as assessed by BICR or death due to any cause, whichever occurs first.
Measured: Randomization up to approximately 28 months
Time to Response (TTR) assessed by Blinded Independent Central Review (BICR)
Defined as the time from the date of randomization until the first documentation of CR or PR as assessed by BICR per RECIST 1.1.
Measured: Randomization up to approximately 28 months
Objective Response Rate (ORR) assessed by Investigator
Defined as the percentage of patients who achieve complete response(CR) or partial response (PR), as assessed by investigator per RECIST 1.1
Measured: Randomization up to approximately 28 months
Disease control rate (DCR) assessed by Investigator
Defined as the percentage of patients who achieve CR, PR or stable disease (SD), as assessed by investigator per RECIST 1.1
Measured: Randomization up to approximately 28 months
Duration of Response (DoR) assessed by Investigator
Defined as the time from the date of first documented CR or PR until date of documented disease progression per RECIST 1.1, as assessed by investigator or death due to any cause, whichever occurs first.
Measured: Randomization up to approximately 28 months
Time to Response (TTR) assessed by Investigator
Defined as the time from the date of randomization until the first documentation of CR or PR as assessed by investigator per RECIST 1.1.
Measured: Randomization up to approximately 28 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: Randomization up to approximately 28 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: Randomization up to approximately 28 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: Randomization up to approximately 28 months
Anti-drug Antibodies
Incidence of anti-drug antibodies.
Measured: Randomization up to approximately 28 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2024
- Study start4 Sep 2025
- Primary completionJun 2027 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple-Negative Breast Cancer (TNBC)Studies 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
- 504 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fei Ma, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06732323
- Sponsor's protocol ID
- ESG401-302
- Status last verified
- Dec 2024
- First submitted
- 10 Dec 2024
- Last updated
- 23 Sep 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 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06732323
- Acronym / sponsor ID
- ESG401-302
- Conditions
- Triple-Negative Breast Cancer (TNBC)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 504 participants (estimated)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Sep 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 13 Dec 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 as first-line treatment in patients with unresectable recurrent or metastatic triple-negative breast cancer.
Detailed description
This is a randomized, open-label, multicenter Phase 3 study to evaluate ESG401 versus Investigator's Choice Chemotherapy (ICC) as first-line treatment in subjects with unresectable recurrent or metastatic triple-negative breast cancer.
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 |
| Investigator's Choice Chemotherapy | Active comparator | Drug: Investigator's Choice ChemotherapyIf no prior taxane, or prior taxane in the (neo)adjuvant setting and disease-free interval (DFI) >12 months: paclitaxel or nab-paclitaxel. Note: If subjects are intolerant or contraindicated to receive paclitaxel or albumin-paclitaxel, the investigator may choose other chemotherapy options listed in the study protocol) If prior taxane and DFI ≤ 12 months: capecitabine, eribulin. If known BRCA1/2 mutation: carboplatin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Males or females aged ≥ 18 years ;
- Histologically and/or cytologically confirmed TNBC;
- De novo metastatic or relapsed ≥ 6 months post completion of treatment with curative intent;
- No prior systemic anti-cancer therapy for unresectable recurrent or metastatic disease;
- Participants whose tumours are PD-L1-negative, or Participants whose tumours are PD-L1-positive and have relapsed after prior PD-1/PD-L1 inhibitor therapy for early-stage breast cancer, or comorbidities precluding PD-1/PD-L1 inhibitor therapy;
Key exclusion criteria (13 listed)
- Use of any investigational anti-cancer drug within 28 days or 5 half-lives before the first investigational product administration.
- Toxicities from prior anti-tumor therapy not recovering to ≤ Grade 1.
- Prior topoisomerase I inhibitor therapy, including antibody-drug conjugate(ADC) therapy, or prior TROP2 targeted therapy.
- New thromboembolic events, intestinal obstruction, gastrointestinal bleeding or perforation within 6 months.
- Subjects with symptomatic or untreated CNS metastases, or those requiring ongoing treatment for CNS metastases.
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 |
| Investigator's Choice ChemotherapyPaclitaxel, Nab-paclitaxel, Capecitabine, Eribulin, or Carboplatin | Drug | Investigator's Choice Chemotherapy |
Primary outcome
Progression Free Survival (PFS) assessed by Blinded Independent Central Review (BICR)
Time frame: Randomization up to approximately 28 months
Defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on BICR or death due to any cause, whichever occurs first.
Overall Survival (OS)
Time frame: Randomization up to approximately 41 months
Defined as the time from randomization until the date of death due to any cause.
14 secondary outcomes
Progression-Free Survival (PFS) assessed by Investigator
Time frame: Randomization up to approximately 28 months
Objective Response Rate (ORR) assessed by Blinded Independent Central Review (BICR)
Time frame: Randomization up to approximately 28 months
Disease control rate (DCR) assessed by Blinded Independent Central Review (BICR)
Time frame: Randomization up to approximately 28 months
Duration of Response (DoR) assessed by Blinded Independent Central Review (BICR)
Time frame: Randomization up to approximately 28 months
Time to Response (TTR) assessed by Blinded Independent Central Review (BICR)
Time frame: Randomization up to approximately 28 months
Objective Response Rate (ORR) assessed by Investigator
Time frame: Randomization up to approximately 28 months
Disease control rate (DCR) assessed by Investigator
Time frame: Randomization up to approximately 28 months
Duration of Response (DoR) assessed by Investigator
Time frame: Randomization up to approximately 28 months
Time to Response (TTR) assessed by Investigator
Time frame: Randomization up to approximately 28 months
Quality of life evaluated using the NCC-BC-A scale
Time frame: Randomization up to approximately 28 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: Randomization up to approximately 28 months
Volume of distribution
Time frame: Randomization up to approximately 28 months
Anti-drug Antibodies
Time frame: Randomization up to approximately 28 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 23 Sep 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 contact
Fei Ma 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 Investigator's Choice Chemotherapy in people with Triple-Negative Breast Cancer (TNBC), 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 10 inclusion and 13 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 23 Sep 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 Xiaoyan Xing, PhD (+86 21 5855 6098, xingxiaoyan@escugen.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 Blinded Independent Central Review (BICR) (time frame: Randomization up to approximately 28 months). The study lists 2 primary outcomes in all. 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 23 Sep 2025.