Actively Recruiting
A Phase III Study of ESG401 for Unresectable Recurrent or Metastatic Triple-Negative Breast Cancer
Led by Qilu Pharmaceutical Co., Ltd. · Updated on 2025-09-23
504
Participants Needed
1
Research Sites
147 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Phase III Study of ESG401 for Unresectable Recurrent or Metastatic Triple-Negative Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males or females aged 18 years or older
- Histologically or cytologically confirmed triple-negative breast cancer
- Newly diagnosed metastatic or relapsed cancer at least 6 months after completing curative treatment
- No prior systemic anti-cancer treatment for unresectable recurrent or metastatic disease
- Tumors that are PD-L1-negative, or PD-L1-positive with relapse after prior PD-1/PD-L1 inhibitor therapy or with contraindications to such therapy
- Eligible for investigator's choice chemotherapy options (paclitaxel, nab-paclitaxel, capecitabine, eribulin, or carboplatin)
- At least one measurable tumor lesion per RECIST v1.1 criteria
- Eastern Cooperative Oncology Group performance status of 0 or 1 with no worsening within 2 weeks before randomization
- Life expectancy of at least 12 weeks
- Adequate organ and bone marrow function
You will not qualify if you...
- Use of any investigational anti-cancer drug within 28 days or 5 half-lives before receiving study treatment
- Unresolved toxicities from previous anti-cancer therapy above Grade 1
- Prior treatment with topoisomerase I inhibitors, including antibody-drug conjugates or TROP2 targeted therapy
- New blood clots, intestinal obstruction, gastrointestinal bleeding, or perforation within 6 months
- Symptomatic or untreated central nervous system metastases, or ongoing treatment for them
- Primary central nervous system malignancy or other cancers within 3 years before study treatment
- Uncontrolled systemic diseases
- Gastrointestinal diseases such as chronic gastritis, enteritis, ulcers, or history of severe or chronic diarrhea
- Significant cardiovascular disease
- HIV infection
- Active hepatitis B or C infection
- Known severe allergic reactions to irinotecan, camptothecin derivatives, investigational drugs, or excipients
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, China
Actively Recruiting
Research Team
X
Xiaoyan Xing, PhD
CONTACT
F
Fei Ma, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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