Combination Immunotherapy for the Treatment of High-Risk HER2-Positive Breast Cancer.

摘要

The objective of the proposed research is to complete a clinical trial evaluating the ability of the combination of trastuzumab and the HER2-derived vaccine nelipepimut-S administered with the immunoadjuvant GM-CSF in the adjuvant setting to prevent metastatic disease in high-risk HER2+ breast cancer patients. Completion of the trial will allow us to test our hypothesis that combination therapy with trastuzumab plus vaccination is a therapeutic modality with minimal toxicity that will prevent disease recurrence. The most significant accomplishment during this initial year of funding, was initiation of the clinical trial (specific aim #1). The study underwent review and approval by the USAMRMCORP HRPO. The protocol was then IRB approved and activated as of 29 January 2015. The trial is currently accruing at 14 sites. Since trial initiation, a total of 60 eligible patients have been consented. Of those, 39 (65%) were of the appropriate HLA-type (HLA-A2 or A3 positive) to continue on study; the remaining 21 (35%) were considered screen failures. Of the qualified patients, 20 have been randomized and are on treatment; 10 are pending randomization, and 10 have withdrawn. Blood samples for immunologic monitoring are being collected in support of specific aims 2 and 3.