ESG401 as first-line treatment 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

This trial will test whether ESG401 works and is safe as a first-line treatment for adults with unresectable recurrent or metastatic triple-negative breast cancer who have not had prior systemic therapy for advanced disease.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 504 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Qilu Pharmaceutical Co., Ltd. (industry)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Beijing)
• Trial ID: NCT06732323 on ClinicalTrials.gov

What this trial studies

This is a randomized, open-label, multicenter Phase 3 comparison of ESG401 versus investigator's choice chemotherapy as first-line therapy for unresectable recurrent or metastatic triple-negative breast cancer. Eligible participants have histologically confirmed TNBC, at least one measurable lesion per RECIST v1.1, ECOG performance status 0–1, and no prior systemic therapy for advanced disease. The protocol includes specific PD-L1-related eligibility rules and allows common chemotherapy options (paclitaxel, nab-paclitaxel, capecitabine, eribulin, or carboplatin) as the comparator. Primary outcomes focus on treatment efficacy and safety measures typical for a Phase 3 oncology trial.

Who should consider this trial

Good fit: Adults (≥18) with histologically confirmed unresectable recurrent or metastatic TNBC, no prior systemic therapy for advanced disease, at least one measurable lesion, ECOG 0–1, adequate organ function, and meeting the trial's PD-L1 and chemotherapy-eligibility criteria are ideal candidates.

Not a fit: Patients who have already received systemic therapy for unresectable or metastatic disease, have poor performance status (ECOG ≥2), inadequate organ function, or contraindications to the study treatments are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, ESG401 could offer a more effective or better-tolerated first-line option that prolongs disease control and survival for patients with advanced TNBC.

How similar studies have performed: Some novel agents and chemotherapy regimens have shown benefits in subsets of TNBC, but ESG401's efficacy in this first-line metastatic setting has not yet been established in Phase 3.

Eligibility criteria

Key Inclusion Criteria:

1. Males or females aged ≥ 18 years ;
2. Histologically and/or cytologically confirmed TNBC;
3. De novo metastatic or relapsed ≥ 6 months post completion of treatment with curative intent;
4. No prior systemic anti-cancer therapy for unresectable recurrent or metastatic disease;
5. 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;
6. Eligible for the chemotherapy options listed as investigator's choice chemotherapy (paclitaxel, nab-paclitaxel, capecitabine, eribulin, or carboplatin) as assessed by the investigator;
7. At least one measurable lesion per RECIST v1.1;
8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 with no worsening within 2 weeks prior to randomization;
9. A life expectancy of at least 12 weeks;
10. Adequate organ and bone marrow function.

Key Exclusion Criteria:

1. Use of any investigational anti-cancer drug within 28 days or 5 half-lives before the first investigational product administration.
2. Toxicities from prior anti-tumor therapy not recovering to ≤ Grade 1.
3. Prior topoisomerase I inhibitor therapy, including antibody-drug conjugate(ADC) therapy, or prior TROP2 targeted therapy.
4. New thromboembolic events, intestinal obstruction, gastrointestinal bleeding or perforation within 6 months.
5. Subjects with symptomatic or untreated CNS metastases, or those requiring ongoing treatment for CNS metastases.
6. Patients with Primary CNS malignancy, or patients with other malignancies within 3 years prior to the first dose.
7. Patients with uncontrollable systemic diseases.
8. Patients with gastrointestinal diseases (such as chronic gastritis, chronic enteritis or gastric ulcers), or with a previous history of severe or chronic diarrhea.
9. Subjects with clinically significant cardiovascular disease.
10. Human Immunodeficiency Virus (HIV) infection.
11. Active hepatitis B or hepatitis C.
12. 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.
13. Pregnant or lactating women.

Where this trial is running

Beijing

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences — Beijing, China (RECRUITING)

Study contacts

• Principal investigator: Fei Ma — Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Study coordinator: Xiaoyan Xing, PhD

Conditions: Triple-Negative Breast Cancer