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RECRUITING
NCT06832904
PHASE2

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

Sponsor: First Affiliated Hospital of Zhejiang University

View on ClinicalTrials.gov

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.

Official title: Neoadjuvant Chemotherapy Plus Pyrotinib and Trastuzumab for HER2-positive Breast Cancer (NEOTORCH-BREAST05): A Prospective, Single-arm, Multi-center Clinical Study

Key Details

Gender

FEMALE

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

33

Start Date

2024-12-03

Completion Date

2030-01

Last Updated

2025-02-18

Healthy Volunteers

No

Interventions

DRUG

pyrotinib and trastuzumab in combinition with neoadjuvant chemotherapy

Receive four neoadjuvant cycles of oral pyrotinib (400 mg) once daily, plus intravenous trastuzumab (8 mg/kg loading dose, followed by 6 mg/kg) , nab-paclitaxel (260 mg/m2) and carboplatin(AUC=5)every 3 weeks.

Locations (1)

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, China