Iparomlimab and Tuvonralimab (QL1706) in Patients With HR-positive, HER2-negative Advanced Breast Cancer

Iparomlimab and Tuvonralimab (QL1706) in Patients With Hormone Receptor-positive, Human Epidermal Growth Factor Receptor 2-negative Advanced Breast Cancer: a Prospective, Randomised, Controlled, Multicentre Clinical Trial

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.

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