drugset / Trial / NCT06832904

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

NCT06832904 ↗

Phase 2 Recruiting 33 enrolled First Affiliated Hospital of Zhejiang University
NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2024-12-03
Primary completion
2028-01
Completion
2030-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Carboplatin Small molecule — —
Subject Nab-paclitaxel Small molecule 260 mg/m2 —
Subject Pyrotinib Small molecule 400 mg Oral
Subject Trastuzumab Monoclonal antibody 6 mg/kg Intravenous