drugset / Trial / NCT07528716
Artificial Intelligence Model-Guided Neoadjuvant Anti-HER2 Targeted Therapy
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pyrotinib | Small molecule | — | — |
| Subject | SHR-A1811 | Monoclonal antibody | — | — |
| Background | Carboplatin | Small molecule | — | — |
| Background | Nab-paclitaxel | Small molecule | — | — |
| Background | Pertuzumab | Monoclonal antibody | — | — |
| Background | Trastuzumab | Monoclonal antibody | — | — |