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Iparomlimab and Tuvonralimab Injection (QL1706) is a bifunctional combination antibody targeting both programmed cell death protein 1 (PD-1) and cytotoxic T-lymphocyte antigen 4 (CTLA-4). This is a prospective clinical study that plans to enroll screened, eligible early-stage breast-cancer patients to receive neoadjuvant QL1706 plus chemotherapy (four cycles of TP ± four cycles of AC). After the four TP cycles, imaging and core biopsy will be performed. Patients who achieve radiologic complete response will proceed directly to surgery; those who do not will receive four additional AC cycles before surgery. A key feature is the incorporation of an response-guided neoadjuvant therapy(RGN)model to identify sensitive patients who can forgo anthracyclines, thereby reducing long-term cardiotoxicity.
Age
18 - 75 years
Sex
FEMALE
Healthy Volunteers
No
Tianjin Medical University Cancer Institute & Hospital
Tianjin, China
Start Date
April 5, 2026
Primary Completion Date
December 30, 2028
Completion Date
December 30, 2029
Last Updated
January 28, 2026
40
ESTIMATED participants
QL1706 combined with Chemotherapy
DRUG
Lead Sponsor
Tianjin Medical University Cancer Institute and Hospital
NCT04550494
NCT04704661
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