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Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer

Breast Cancer Clinical Trial

Official title:
A Randomised, Multicenter, Open-label, Phase II Study Evaluating Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in Early Stage or Locally Advanced Human Epidermal Growth Factor Receptor (HER) 2 - Positive Breast Cancer

Clinical Trial Summary

This study aims to evaluate the efficacy and safety of pyrotinib in combination with nab-paclitaxel or trastuzumab with nab-paclitaxel as neoadjuvant therapy in early stage or locally advanced HER2-positive breast cancer.

Clinical Trial Description

The study evaluate the pathological complete response rate, event-free survival, disease-free survival, overall survival and safety of pyrotinib in combination with nab-paclitaxel or trastuzumab with nab-paclitaxel as neoadjuvant therapy in early stage or locally advanced HER2-positive breast cancer. Patients will receive 4 cycles of pyrotinib in combination with nab-paclitaxel or 4 cycles of trastuzumab with nab-paclitaxel as neoadjuvant therapy, then undergo surgery, then receive 4 cycles of epirubicin in combination with cyclophosphamide, then complete 1 year of trastuzumab. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04066790
Study type Interventional
Source Shanghai Jiao Tong University School of Medicine
Contact
Status Terminated
Phase Phase 2
Start date September 9, 2019
Completion date April 30, 2020
View Details
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