Correlation of HER2/neu antibody response to clinical response in a Phase II trial of the ae37+gm-csf her2 peptide vaccine

Background We are conducting a Phase II clinical trial of the HER2 peptide vaccine AE37+GM-CSF for prevention of breast cancer recurrence in disease-free, node-positive or highrisk node-negative patients, who have completed standard of care therapy. AE37, an Ii-Key hybrid of the HER2/neu derived peptide AE36 (aa:776-790), is an MHC Class II epitope capable of stimulating CD4 helper T cells. Here, we examine the relationship between HER2 antibody response (AR) and clinical recurrence (CR).