Actively Recruiting
Open-label, Randomized Phase III Study of ESG401 Versus Investigator's Choice Chemotherapy in Patients With Locally Advanced or Metastatic HR+/HER2- Breast Cancer After Prior Chemotherapy
Led by Qilu Pharmaceutical Co., Ltd. · Updated on 2025-06-19
378
Participants Needed
1
Research Sites
56 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of ESG401 in patients with unresectable locally advanced or metastatic HR+/HER2- breast cancer who have previously undergone at least one line of systemic chemotherapy. This Phase 3 open-label, randomized, multicenter study compares ESG401 to treatments chosen by physicians to determine which approach may better manage this type of breast cancer. Participants will receive ESG401 as an intravenous infusion on days 1, 8, and 15 of each 28-day cycle. The comparison group will receive one of several chemotherapy options including eribulin, capecitabine, vinorelbine, or gemcitabine, given on schedules ranging from 21 to 28-day cycles. The study is designed to monitor and compare responses over time while patients undergo these treatments. During the study, participants will be closely monitored through various assessments including imaging scans to measure tumor progression, survival rates, response rates, and quality of life evaluations using the NCC-BC-A scale. Safety will be tracked by documenting any adverse events up to 30 days after the last dose. The main outcome measured is progression-free survival for up to 24 months, with additional follow-up to assess overall survival and other clinical responses. Participants' organ and bone marrow functions will also be evaluated regularly to ensure safety throughout the study period.
CONDITIONS
Brief 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
- Failed at least one line of systemic chemotherapy for metastatic disease
- Eligible for chemotherapy regimen in the control group
- At least one measurable lesion per RECIST 1.1 criteria
- ECOG performance status score of 0 to 1
- Expected survival of at least 12 weeks
- Adequate organ and bone marrow function
- Use of effective contraception for females 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...
- Received chemotherapy, targeted therapy, immunotherapy, interventional therapy, or other systemic anti-cancer therapy within 4 weeks before first study treatment
- Toxicities from prior anti-tumor therapy not recovered to Grade 1 or lower
- Major surgery within 4 weeks before first dose or planned major surgery during the study
- Prior topoisomerase I inhibitor or TROP2 targeted therapy, or investigational anti-cancer drug use within 28 days or 5 half-lives before first study treatment
- Recent thromboembolic events, intestinal obstruction, gastrointestinal bleeding, or perforation within 6 months
- Uncontrolled systemic infections
- Symptomatic or untreated CNS metastases or ongoing treatment for CNS metastases
- Primary CNS malignancy or other malignancies within 3 years prior to first dose
- Uncontrollable systemic diseases
- Gastrointestinal diseases or history of severe or chronic diarrhea
- Clinically significant cardiovascular disease
- HIV infection
- Active hepatitis B or C
- Known hypersensitivity to irinotecan, camptothecin derivatives, or investigational drug components
- Pregnant or lactating women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months
Participants receive either ESG401 or a chemotherapy regimen chosen by their physician. ESG401 is given as an IV infusion on days 1, 8, and 15 of each 28-day cycle. Chemotherapy options include eribulin, capecitabine, gemcitabine, or vinorelbine with varying schedules.
Visits on days 1, 8, and 15 of each 28-day cycle for ESG401; chemotherapy visit schedules vary by drug regimen
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
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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