Professor Division of Oncology, UW Member FHCRC (206) 616-1823 Lupe G. Salazar, M.D. Associate Professor Division of Oncology, UW (206) 616-8503 William R. Gwin , M.D. Acting Instructor Division of Oncology , UW (206) 221-5956 Andrew Coveler, M.D. Assistant Professor Division of Oncology, UW (206) 221-7509 John Liao, M.D. Assistant Professor GYN/ONC, UW (206) 543-3915 Sasha Stanton, M.D. Acting Instructor Division of Oncology, UW (206) 685-8849 Doreen Higgins, B.S.N. Research Nurse Division of Oncology, UW (206) 616-9538 Jennifer Childs, M.P.H. Research Coordinator Division of Oncology, UW (206) 616-2305 Chara Hokama, B.S. Research Coordinator Division of Oncology, UW (206) 543-3829 Emergency (24 hour) pager: Dr. Sasha Stanton (206-797-3524) IRO received 03/23/21 FHCRC IRB Approval 04/20/2021 Document Released Date 6304p 04/06/2016 Table of Contents Page Synopsis 1 List of Appendices 3 List of Abbreviations 4 List of Figures 5 Introduction 6 Background 6 Rationale 9 Objectives 9 Vaccine Prepara tion 9 Subject Selection / Inclusion and Exclusion criteria 11 Experimental Design Study Design 12 Sample Size 12 Outcome Measures 12 Plan of Treatment Pre Screen 12 Initial Evaluation 13 Monthly Immunizations 13 Evaluation after Final Vaccine 13 Long Term Follow up 13 Evaluati on and Management of Toxicity 13 Dose Modi fications 14 Criteria for Premature Study Termination 14 Statistical Consideration 15 Administrative Considerations 16 References 18 Figures 20 Appendices 6304p Protoc ol 118 04/06/2016 1 SYNOPSIS Title Phase I -II Study of Combination Immunotherapy for the Generation of HER -2/neu (HER2) Specific Cytotoxic T Cells (CTL) in vivo Study Population Patients with HER2 overexpressing Stage IV breast cancer who are on maintenance trastuzumab alone after be ing treated with chemotherapy and trastuzumab until there is no evidence of disease (NED) or stable disease. Stage IV HER2 overexpressing ovarian cancer patients who are on maintenance trastuzumab alone or after being treated with chemotherapy and trastuz umab until there is no evidence of disease (NED) or stable disease.