Actively Recruiting
A Phase III Study of ESG401 for Locally Advanced or Metastatic HR+/HER2- Breast Cancer
Led by Qilu Pharmaceutical Co., Ltd. · Updated on 2025-06-19
378
Participants Needed
1
Research Sites
211 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 in patients with unresectable locally advanced or metastatic HR+/HER2- breast cancer.
CONDITIONS
Official Title
A Phase III Study of ESG401 for Locally Advanced or Metastatic HR+/HER2- Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and provide written informed consent
- Male or female aged 18 years or older
- Histologically or cytologically confirmed HR+/HER2- breast cancer with failure of at least one systemic chemotherapy line in metastatic setting
- Eligible for chemotherapy in the control group
- At least one measurable lesion according to RECIST 1.1 criteria
- ECOG performance status of 0 or 1
- Expected survival of 12 weeks or more
- Adequate organ and bone marrow function
- Use of effective contraception by female patients of childbearing potential and male patients with partners of childbearing potential from consent until 180 days after last dose
You will not qualify if you...
- Receipt of chemotherapy, targeted therapy, immunotherapy, interventional therapy, or other systemic anticancer treatment within 4 weeks before first study drug dose
- Toxicities from prior anti-tumor therapy not recovered to Grade 1 or less
- Major surgery within 4 weeks before first study drug dose or planned major surgery during study
- Prior topoisomerase I inhibitor therapy, TROP2 targeted therapy, or investigational anticancer drug within 28 days or 5 half-lives before first dose
- New thromboembolic events, intestinal obstruction, gastrointestinal bleeding, or perforation within 6 months
- Uncontrolled systemic bacterial, viral, or fungal infections
- Symptomatic or untreated central nervous system metastases, or requiring ongoing CNS metastases treatment
- Primary CNS malignancy or other malignancies within 3 years before first dose
- Uncontrollable systemic diseases
- Gastrointestinal diseases like chronic gastritis, enteritis, gastric ulcers, or history of severe or chronic diarrhea
- Clinically significant cardiovascular disease
- HIV infection
- Active hepatitis B or C
- Hypersensitivity to irinotecan, camptothecin derivatives, or investigational drug ingredients
- Pregnant or lactating women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
Actively Recruiting
Research Team
Y
Yong Yuan, Master Degree
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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