Results of cardiac testing will be reviewed by the research nurses or study coordinators and any abnormal results will be reviewed by the study investigators. 7Urine HCG waived if hysterectomy, bilateral oopherectomy, tubal ligation, documented absence of menses for two years, or FSH lab results verifying menopause. 8Disease status will be determined by patients’ own physicians at the individual study sites during routine follow-up. This will include physical examination every 3-6 months for all patients and yearly mammogram for patients undergoing breast conserving therapy (per ASCO guidelines) 9Toxicity evaluation done during 30 minutes observation after vaccine administration with vital signs taken as needed and during return visit or by phone call 48-72 hours after inoculation. Delayed adverse event reporting per protocol. 10Final study assessment in month 36 by study nurse with toxicity assessment and disease status update 63 Protocol: 2014-0443 Version 2.1 Version Date: 11 April 2016 Appendix K PROTOCOL TITLE: Phase II Trial of Combination Immunotherapy with nelipepimut-S + GM-CSF (NeuVax™) and Trastuzumab in high-risk HER2+ Breast Cancer Patients (2014-0443) STUDY DRUG: Nelipepimut-S + GM-CSF (NeuVax™) PRINCIPAL INVESTIGATOR: Elizabeth A. Mittendorf, MD, PhD PROGRAM DIRECTOR SPONSOR/INVESTIGATOR: George E.