In the instance of a subject withdrawing consent, any data collected will be excluded from analysis. Primary Efficacy The primary efficacy endpoint analysis of 24-month DFS will be compared between the two treatment arms using a proportional hazard model including the stratification factors to estimate the hazard ratio. Hazard ratios and 95% two-sided confidence intervals will be presented. The model will also examine two-way treatment interactions with the baseline stratification factors. Kaplan-Meier curves will be generated to display time to events for each treatment group. The null and alternative hypotheses are: H0: hV / hC = 1 Ha: hV / hC ≠ 1 where hV is the constant Herceptin + E75/GM-CSF hazard rate and hC is the constant Herceptin + GM-CSF alone hazard rate. Herceptin + E75/GM-CSF efficacy is demonstrated when hV / hC < 1; the alternative hypothesis is a 0.35 hazard ratio. A difference in the recurrence rate of 5% in patients treated with Herceptin + E75/GM-CSF versus 15% in those treated with Herceptin and GM-CSF alone will be considered significant. The PP population analyses will be the primary while ITT analyses will be confirmatory. The stratification factors are the following: • Nodal status (N0 or N1 versus N2 or N3) • HER2 1+ versus HER2 2+ Stratification will be performed to balance the treatment arms; however, the trial is designed to detect vaccine efficacy as measured by DFS at 24 months between the two treatment groups. The study is not powered for subgroup analysis. CONFIDENTIAL Page 39 of 102 Protocol: HERCEPTIN® + E75/GM-CSF Version 3.1 ML25749 05 March 2017 Confirmatory analyses will be performed using a stratified log rank test for each of the stratification factors. To explore the possibility of a treatment by investigative site interaction, the primary analysis will also be conducted by site for the ITT and PP populations.