50 REFERENCES ........................................................................................................ 51 TABLES Table 1: Herceptin Infusion Time and Post-Infusion Observation Period ......... 26 TRIAL APPENDICES Appendix A: Herceptin and Vaccination Timeline Appendix B: NCI Common Terminology Criteria for Adverse Events, v4.03 Appendix C.1: Study Flowchart Appendix C.2: Patient Visit Chart Appendix D: HFSA Guidelines for CHF Treatment Appendix E: NCCN Guidelines for Adjuvant Breast Cancer Treatment Appendix F: Study Randomization and Stratification Schema Appendix G: E75 + GM-CSF and DTH Formulation Plan Appendix H: Leukine Package Insert Appendix I: Performance Status Criteria Appendix J: Case Report Forms (Free standing electronic documents) CONFIDENTIAL Page 4 of 102 Protocol: HERCEPTIN® + E75/GM-CSF Version 3.1 ML25749 05 March 2017 Appendix K: Data Safety Monitoring Plan (Free standing document) Appendix L: Adverse Event Reporting Algorithm Appendix M: FDA Medwatch 3500A Form Link Appendix N: Genentech Drug Safety – Reporting instructions for IND Sponsor Appendix O: PI Agreement and Signature Page CONFIDENTIAL Page 5 of 102 Protocol: HERCEPTIN® + E75/GM-CSF Version 3.1 ML25749 05 March 2017 1. INTRODUCTION 1.1 DISEASE BACKGROUND Breast cancer is, by far, the most commonly diagnosed malignancy in women (excluding cancers of the skin), and it is the second leading cause of cancer mortality among women.