NCT07528716

Artificial Intelligence Model-Guided Neoadjuvant Anti-HER2 Targeted Therapy

Artificial Intelligence Model-Guided Neoadjuvant Anti-HER2 Targeted Therapy: A Randomized, Controlled, Open-Label, Multicenter Phase III Clinical Study

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 280 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	SHR- A1811	the experimental group consists of different neoadjuvant treatment regimens matched by the artificial intelligence model
DRUG	PCbHP	Standard neoadjuvant treatment regimen for HER2-positive breast cancer
DRUG	SHR- A1811+ Pyrotinib	the investigational arm consists of different neoadjuvant treatment regimens matched by the artificial intelligence model

Timeline

• Start date: 2026-05-01
• Primary completion: 2027-12-01
• Completion: 2028-06-01
• First posted: 2026-04-14
• Last updated: 2026-04-14

Locations

1 site across 1 country: China