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

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

Recruiting
18 years and older
Female
Phase 2
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Overview

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.

Eligibility

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

Study details
    Advanced Breast Cancer

NCT07180160

Wenjin Yin

1 February 2026

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