Clinical Trial

Artificial Intelligence Model-Guided Neoadjuvant Anti-HER2 Targeted Therapy

Recruiting Phase 3
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Summary
Based on total pathologic complete response (tpCR) after surgery, to evaluate the efficacy of an artificial intelligence model-matched anti-HER2 targeted treatment strategy (investigational arm) versus nab-paclitaxel + carboplatin + trastuzumab + pertuzumab (PCbHP, control arm) as neoadjuvant therapy for patients with early or locally advanced human epidermal growth factor receptor 2 (HER2)-positive breast cancer.
Protocol Amendment History 1 change
critical Recruitment opened 2026-07-09
Trial Details
NCT Number NCT07528716
Lead Sponsor Fudan University
Conditions Breast Cancer
Enrollment 280 participants
Start Date 2026-05-06
Primary Completion 2027-12 (estimated)
Study Completion 2028-06 (estimated)
Updated on ClinicalTrials.gov 2026-07-08