NCT02422199

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: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 128 (estimated)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HER2 Positive Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	pyrotinib
DRUG	Lapatinib
DRUG	capecitabine

Timeline

• Start date: 2015-05-01
• Primary completion: 2016-10-01
• Completion: 2018-12-01
• First posted: 2015-04-21
• Last updated: 2018-07-09

Locations

2 sites across 1 country: China