Study Evaluating Pyrotinib in Combination With Capecitabine In Patients With HER2 Positive Metastatic Breast Cancer
Status:
Completed
Trial end date:
2016-12-01
Target enrollment:
Participant gender:
Summary
Pyrotinib is an oral tyrosine kinase inhibitor targeting both EGFR and HER-2 receptors. This
study is designed to evaluate the safety and tolerability of Pyrotinib in combination with
capecitabine in patients with HER2 positive metastatic 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 To assess preliminary antitumor activity To determine preliminary regimen dose for
phase II study
Phase:
Phase 1
Details
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Collaborator:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences