Study design and treatment
This multicenter, open‐label, phase I dose escalation study was conducted in China from September 2014 (ClinicalTrials. gov, NCT02378389). The study was approved by the ethics committee of each study center and performed in accordance with the International Conference on Harmonization Guidelines for Good Clinical Practice and Declaration of Helsinki.The phase I study was composed of two parts: dose escalation of pyrotinib monotherapy and in combination with docetaxel. This study followed a standard “3+3” design (Figure Study design.