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
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- RenJi Hospital
- Enrollment
- 55
- Locations
- 1
- Primary Endpoint
- Proportion of patients with pCR
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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
Arms & Interventions
neoadjuvant Iparomlimab and Tuvonralimab (QL1706)
Iparomlimab and Tuvonralimab (QL1706) in combination with weekly paclitaxel and carboplatin as neoadjuvant therapy
Intervention: Iparomlimab and Tuvonralimab (Drug)
neoadjuvant Iparomlimab and Tuvonralimab (QL1706)
Iparomlimab and Tuvonralimab (QL1706) in combination with weekly paclitaxel and carboplatin as neoadjuvant therapy
Intervention: Paclitaxel (Drug)
neoadjuvant Iparomlimab and Tuvonralimab (QL1706)
Iparomlimab and Tuvonralimab (QL1706) in combination with weekly paclitaxel and carboplatin as neoadjuvant therapy
Intervention: Carboplatin (Drug)
Outcomes
Primary Outcomes
Proportion of patients with pCR
Time Frame: 1-2 weeks after surgery
Number of patients with pathological complete response/Number of all eligible patients
Secondary Outcomes
- Proportion of patients with adverse events(From the date of starting neoadjuvant therapy to the end of the treatment (up to approximately 1 year))
Investigators
Wenjin Yin
Deputy Chief of Breast Surgery Department
RenJi Hospital