Study of Pyrotinib in Patients With Human Epidermalgrowth Factor Receptor 2 (HER2) Positive Advanced Breast Cancer
Status:
Completed
Trial end date:
2016-12-01
Target enrollment:
Participant gender:
Summary
Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors. This
study is designed to evaluate the safety and tolerability of Pyrotinib in patients with HER2
positive advanced breast cancer:
- To evaluate the safety and tolerability of pyrotinib, and the maximum tolerated dose
(MTD)
- To determine the dose-limiting toxicity (DLT)
- To determine the pharmacokinetic profile of Pyrotinib and its metabolites
- To assess preliminary antitumor activity
- To determine preliminary regimen dose for phase II study
- To explore the relationship between biomarkers and the toxicity/efficacy of Pyrotinib.