Neoadjuvant Chemotherapy Plus Pyrotinib and Trastuzumab for HER2-positive Breast Cancer (NEOTORCH-BREAST05)

This study is a prospective, single arm, multi-center clinical trial. The primary study objective is to evaluate the pathologic complete response (pCR）and clinical complete response（cCR) of neodjuvant treatment of HER2-positive breast cancer with pyrotinib and trastumab combined with neoadjuvant chemotherapy. The secondary study objective is to observe and evaluate the disease-free survival (DFS), Progression-Free-Survival (PFS ),and Objective Response Rate(ORR). The study also observes the incidence and types of adverse events.

NCT Number	NCT06832904
Lead Sponsor	First Affiliated Hospital of Zhejiang University
Conditions	HER2-positive Breast Cancer, Neoadjuvant Therapy, Pyrotinib
Enrollment	33 participants
Start Date	2024-12-03
Primary Completion	2028-01 (estimated)
Study Completion	2030-01 (estimated)
Updated on ClinicalTrials.gov	2025-02-18