A Phase IB Trial of Neoadjvuant Multi-epitope HER2 Peptide Vaccine in Patients with HER2-expressing DCIS
This protocol details an interventional clinical study examining the safety and efficacy of a degenerate subdominant HER2 specific helper T cell epitope vaccine (H2NVAC) in patients with HER2-expressing ductal carcinoma in situ (DCIS). The ultimate goal of this vaccine is to prevent future invasive breast cancer among patients who are diagnosed with DCIS. However, the focus of this study is safety and efficacy. The vaccine consists of 4 peptide epitopes (15-18 amino acids in length) derived from the HER2 protein. These peptides are derived from HER2 and were selected based upon their recognition by lymphocytes from women with prior HER-2 positive breast cancer. To enhance immunity, the peptides are admixed with the adjuvant GM-CSF. Patients will receive four bi-monthly vaccinations followed by surgery as diagrammed below; observation includes periodic blood draws to assess toxicity and immune responses, as well as periodic echocardiography to assess left ventricular ejection fraction.