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Artificial Intelligence Model-Guided Neoadjuvant Anti-HER2 Targeted Therapy

StatusRecruiting
PhasePhase 3
Started2026-05-06
View on ClinicalTrials.gov ↗

Amendment history

2026-07-05
notable
Study Status, Contacts/Locations v1
Recruitment opened
Start dateestimated 2026-05→confirmed 2026-05-06
Study sitesdetails revised at 1 of 1 site
2026-04-09
minor
Original filing
624 trials monitored
See 9 trials at risk
5,180 trials monitored
See 256 trials at risk
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.
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