A Study of Pyrotinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+Metastatic Breast Cancer Who Have Prior Received Anthracyclin, Taxane or Trastuzumab

HER2 Positive Metastatic Breast Cancer Clinical Trial

Official title: A Study of Pyrotinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+Metastatic Breast Cancer Who Have Prior Received Anthracyclin, Taxane or Trastuzumab

Status Active, not recruiting

Clinical Trial Summary

Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors. This study is a randomized, multi-center, multinational, open-label, active-controlled, parallel design study of the combination of pyrotinib plus capecitabine versus the combination of lapatinib plus capecitabine in HER2+ MBC patients who have prior received anthracyclin, taxane or trastuzumab. Patients will be stratified by weather have prior use of trastuzumab and randomized in a 1:1 ratio to one of the following treatment arms:

• Arm A: pyrotinib (400 mg once daily) + capecitabine (1000 mg/m^2 twice daily)

• Arm B: lapatinib (1250 mg once daily) + capecitabine (1000 mg/m^2 twice daily) Patients will receive either arm of therapy until the occurrence of death, disease progression, unacceptable toxicity, or other specified withdrawal criterion.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Breast Neoplasms
• HER2 Positive Metastatic Breast Cancer

• NCT number: NCT02422199
• Study type: Interventional
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: May 2015
• Completion date: December 2018