The reason for any premature discontinuation of a patient from the study will be recorded on the appropriate Case Report Form. 4.7 Study discontinuation The IND sponsor Dr. George E. Peoples, the financial sponsor Galena Biopharma, the Data Safety Monitoring Board, and the Principal Investigator have the right to terminate this study at any time. Reasons for terminating the study may include the following: • The incidence or severity of AEs in this or other studies indicates a potential health hazard to patients. While vaccine related toxicity has been shown to be low, and the safety profile of Herceptin is known, the safety of the concurrent use is yet to be proven. As such, toxicities will be carefully monitored per treatment group in real time.