drugset / Trial / NCT07528716

Artificial Intelligence Model-Guided Neoadjuvant Anti-HER2 Targeted Therapy

NCT07528716

Phase 3 Recruiting 280 enrolled Fudan University
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2026-05-06
Primary completion
2027-12
Completion
2028-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Pyrotinib Small molecule
Subject Trastuzumab Rezetecan Monoclonal antibody
Background Carboplatin Small molecule
Background Paclitaxel Small molecule
Background Pertuzumab Monoclonal antibody
Background Trastuzumab Monoclonal antibody

Indications