4.8.3 Efficacy Analysis a. Primary Endpoint The primary efficacy endpoint of the trial is DFS at 24 months, compared between the two treatment arms (Herceptin + E75/GM-CSF versus Herceptin + GM-CSF alone). Time to recurrence will be measured from the date of the first Herceptin infusion. b. Secondary Endpoints Secondary endpoints of the trial are: • DFS at 36 months compared between the two treatment arms CONFIDENTIAL Page 38 of 102 Protocol: HERCEPTIN® + E75/GM-CSF Version 3.1 ML25749 05 March 2017 • Immunologic responses to vaccination between treatment arms will be measured and compared using the DTH reaction, secondary comparisons may be made using the dimer and ELISPOT assays. • Comparison of safety measures (MUGA or ECHO) related to combination therapy Efficacy parameters will be analyzed and summarized for both the ITT and PP populations.