Statistics analysis
REGRESSION
The study was conducted using a two-stage Simon design. Based on previous data of trastuzumab and docetaxel as a first-line treatment in HER2-positive MBC, the null hypothesis for the ORR was set at 60%The ITT population included all patients who received at least one dose of pyrotinib and docetaxel. The PP population included patients who received at least one dose of pyrotinib and docetaxel and did not have any major protocol violations. Efficacy was analyzed in both ITT and PP populations. The safety analysis set included patients who received at least one dose of pyrotinib and docetaxel and had safety records. The biomarker set included patients who received at least one dose of pyrotinib and were evaluable for biomarker analysis.Continuous data were presented as median and range or interquartile range (IQR), while categorical data were described as numbers and percentages. The 95% CI of ORR and CBR were estimated using the Clopper-Pearson method. For time-to-event data, the Kaplan–Meier method was utilized, and the median time and their 95% CIs were estimated. These analyses were conducted using SAS version 9.3. For the biomarker analysis, Wilcoxon rank sum test was applied to compare the difference of continuous variable between sample groups, while Fisher’s exact test was applied to test for the independence between categorical variables. Univariate Cox regression model and log-rank test wrapped in the R package named survival (v3.3.1) were used to perform survival analysis. Multiple testing correction was performed using the method of Benjamini & Hochberg. A two-sided 