Recruiting

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

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.

ClinicalTrials.gov IDNCT07396324

PhasePHASE2

Enrollment55

SponsorRenJi Hospital

Age18 Years and older

SexALL

I'm interested View official listing

Conditions studied

HR-positive/HER2-negative Breast Cancer

About this study

Interventions

Drug: Iparomlimab and Tuvonralimab — 5.0mg/kg qw, start from C1D15
Drug: Paclitaxel — 80mg/m\^2 qw
Drug: Carboplatin — AUC=1.5, D1, 8, 15, every 28 days

Primary outcomes

Proportion of patients with pCR (1-2 weeks after surgery)

Eligibility information

Inclusion Criteria: * 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 Criteria: * 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

Study locations

Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, 200127 China

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-05.