Spots Global Cancer Trial Database for Study of Pyrotinib in Patients With Human Epidermalgrowth Factor Receptor 2 (HER2) Positive Advanced Breast Cancer
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Trial Identification
Brief Title: Study of Pyrotinib in Patients With Human Epidermalgrowth Factor Receptor 2 (HER2) Positive Advanced Breast Cancer
Official Title: A Phase I Study of Pyrotinib in Patients With HER2 Positive Advanced Breast Cancer
Study ID: NCT01937689
Conditions
Interventions
Study Description
Brief 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.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Beijing, Beijing, China
Contact Details
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