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

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.

Timeline

Start

2013-01

Primary completion

2016-07

Completion

2016-12

Publications

• Guan X, Ma F, Li Q, Chen S, Lan B, Fan Y, Wang J, Luo Y, Cai R, Zhang P, Li Q, Xu B. Survival benefit and biomarker analysis of pyrotinib or pyrotinib plus capecitabine for patients with HER2-positive metastatic breast cancer: a pooled analysis of two phase I studies. Biomark Res. 2023 Feb 20;11(1):21. doi: 10.1186/s40364-023-00453-0.
• Ma F, Zhu W, Guan Y, Yang L, Xia X, Chen S, Li Q, Guan X, Yi Z, Qian H, Yi X, Xu B. ctDNA dynamics: a novel indicator to track resistance in metastatic breast cancer treated with anti-HER2 therapy. Oncotarget. 2016 Oct 4;7(40):66020-66031. doi: 10.18632/oncotarget.11791.

Drugs

Indications