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Brief Title: Study Evaluating Pyrotinib in Combination With Capecitabine In Patients With HER2 Positive Metastatic Breast Cancer
Official Title: A Phase I Study of Pyrotinib In Combination With Capecitabine In Patients With HER2 Positive Metastatic Breast Cancer
Study ID: NCT02361112
Brief 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
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Beijing, Beijing, China