Sites that have enrolled large numbers of patients relative to other trial centers will be identified to see if the results obtained at those investigative sites are influential. Investigative sites that individually represent fewer than ten patients will be combined for this exploratory analysis; geographic region will be substituted if the average number of patients per site is fewer than ten. Secondary Efficacy Secondary efficacy objectives include the same analysis (DFS) at 36 months and comparison of the immunologic responses to the target antigen in both the treatment and control groups with correlation to clinical outcomes. The immunologic recognition by T-cells of the E75 peptide may be evaluated using a 2-sample t-test to evaluate the mean increase in cell populations from the dimer assay and peptide-specific IFN-gamma release from pre-vaccination (R0) to each of the following time points: before the 4th inoculation (R3), one month after completion of the six inoculation vaccine series (R6), six months after completion of the primary vaccine series (RC6), 12 months after completion of the primary vaccine series (RC12), 18 months after completion of the primary vaccine series (RC18), 24 months after completion (RC24), and 30 months after completion (RC30) (Appendix A). Booster inoculations will be administered after the RC6, RC12, RC18, and RC24 blood samples have been drawn. The response to the booster inoculations may be measured one month after each successive booster inoculation: Month 13 (RB1), Month 19 (RB2), Month 25 (RB3), and Month 31 (RB4) (Appendix A). The R3, R6, RC6, RC12, RC18, RC24, and RC30 assessments can be compared to pre-vaccination (R0) levels thereby using the patients as their own controls. RB1, RB2, RB3, and RB4 can be compared to the pre-booster responses. Evidence of in vivo immunologic response will also be assessed with the DTH reaction for each treatment group. The treatment groups will be compared with respect to the percentage with a positive post-vaccination DTH as well as absolute DTH reaction sizes within the groups. Expression percents will be compared using a two-sided Fisher Exact test while continuous outcomes such as mean DTH response will be compared using a paired t-test (using the patients as their own controls) and using an unpaired t-test to compare treatment groups for post-inoculation outcomes. All of the above analyses will also be performed comparing safety, immunologic response and clinical outcomes between study patients based on HLA type. The HLA-A2 and/or HLA-A3 positive patients are the primary study population. The HLA-A24 and/or HLA-26 positive patients are an exploratory study population. If these patient populations respond comparably to the vaccine, then all vaccinated patients will be included in the final analysis. 4.8.4 Safety Analysis Safety parameters will be analyzed and summarized for the Safety Population. CONFIDENTIAL Page 40 of 102 Protocol: HERCEPTIN® + E75/GM-CSF Version 3.1 ML25749 05 March 2017 Adverse events will be classified and graded using the NCI CTCAE version 4.03 for both local and systemic toxicities. Only treatment-emergent AEs will be tabulated.