RecruitingPhase 2NCT07396324

Neoadjuvant QL1706 in Patients With Hormone Receptor Positive, HER2-negative Breast Cancer

NEOadjuvant Iparomlimab and Tuvonralimab (QL1706) Plus Chemotherapy in Patients With Hormone Receptor Positive And HER2-Negative Breast Cancer: a Prospective, Single Arm, Multicenter Clinical Trial


Sponsor

RenJi Hospital

Enrollment

55 participants

Start Date

May 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This is an prospective, open label, multicenter study to evaluate the efficacy and safety of neoadjuvant Iparomlimab and Tuvonralimab (QL1706) in patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative breast cancer.


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • Aged ≥18 years
  • Histologically confirmed hormone receptor positive and human epidermal growth factor receptor 2 (HER2) negative breast cancer
  • Subjects with at least one evaluable lesion
  • ECOG 0-1
  • Adequate organ function

Exclusion Criteria2

  • Metastatic disease (Stage IV)
  • Female patients who are pregnancy, lactation or women who are of childbearing potential tested positive in baseline pregnancy test;Female patients of childbearing age that are reluctant to take effective contraceptive measures throughout the trial period

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Interventions

DRUGIparomlimab and Tuvonralimab

5.0mg/kg qw, start from C1D15

DRUGPaclitaxel

80mg/m\^2 qw

DRUGCarboplatin

AUC=1.5, D1, 8, 15, every 28 days


Locations(1)

Renji Hospital, School of Medicine, Shanghai Jiaotong University

Shanghai, China

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NCT07396324


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