E. Experimental Agent Accountability The HER2 vaccine, GM-CSF and PSK will be managed by the UW IDS. UW IDS will be responsible for study drug disposition (drug receipt, dispensing, transfer or return). Once IDS receives notification of the subject visit they will begin thawing the vaccine and prepare the appropriate number of syringes ready for injection as described in Section 5. C. UW IDS will deliver the HER2 vaccine, PSK and/or the placebo to the Clinical Research Center , where patients will be seen . The disposal of clinical trial materials that are in UW IDS will be incinerated under a state contract through an EPA licensed facility. Unused PSK pouches will be destroyed. As part of our Data Safety Monitoring Plan (DSMP) (see Appendix C) an independent monitor will be assigned by the Fred Hutchinson Cancer Research Center Clinical Trials Support Office to monitor our study twice per year , which includes a review of the UW IDS dispensing logs for the vaccine and PSK. 6.