Clinical Trial

Neoadjuvant Therapy for Early Triple-Negative Breast Cancer: A Response-Guided Approach Using Iparomlimab and Tuvonralimab Injection in Combination With Chemotherapy

Not Yet Recruiting Phase 2
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Summary
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.
Trial Details
NCT Number NCT07372079
Lead Sponsor Tianjin Medical University Cancer Institute and Hospital
Conditions Breast Cancer, Neoadjuvant Therapy, Immune Checkpoint Inhibitors, QL1706
Enrollment 40 participants
Start Date 2026-04-05
Primary Completion 2028-12-30 (estimated)
Study Completion 2029-12-30 (estimated)
Updated on ClinicalTrials.gov 2026-01-28