Status:
RECRUITING
Iparomlimab and Tuvonralimab (QL1706) in Patients With HR-positive, HER2-negative Advanced Breast Cancer
Lead Sponsor:
Wenjin Yin
Conditions:
Advanced Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
This is a prospective, randomised, controlled, multicentre study to evaluate the efficacy and safety of Iparomlimab and Tuvonralimab (QL1706) in patients with hormone receptor-positive/human epidermal...
Eligibility Criteria
Inclusion
- Female, age≥18 years old
- Expected survival ≥12 weeks
- ECOG 0-1
- Pathologically confirmed recurrent or metastatic breast cancer not amenable to curative surgery
- ER and/or PR positive, HER2 negative
- At least one measurable lesion or bone-only disease (osteolytic or mixed) according to RECIST v1.1
- Previously treated with ≤2 lines chemotherapy for advanced disease; previously treated with ≤2 CDK4/6 inhibitors
- Adequate organ function
Exclusion
- During pregnancy and lactation
- Patients with central nervous system metastasis
Key Trial Info
Start Date :
September 25 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2028
Estimated Enrollment :
123 Patients enrolled
Trial Details
Trial ID
NCT07180160
Start Date
September 25 2025
End Date
March 1 2028
Last Update
November 18 2025
Active Locations (1)
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1
Renji Hospital, School of Medicine, Shanghai Jiaotong University
Shanghai, China, 200127