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Study of Pyrotinib in Patients With Human Epidermalgrowth Factor Receptor 2 (HER2) Positive Advanced Breast Cancer
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.
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