Iparomlimab and Tuvonralimab (QL1706) in Patients With HR-positive, HER2-negative Advanced Breast Cancer
Recruiting · NCT07180160 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 growth factor receptor 2-negative advanced breast cancer.
Who can take part
Age range
18 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- During pregnancy and lactation
- Patients with central nervous system metastasis
Where it is running
1 location listed.
- Renji Hospital, School of Medicine, Shanghai Jiaotong University - Shanghai, China