Phase 2 Study of a HER-2/neu Intracellular Domain Peptide-Based Vaccine Administered to Stage IV HER2 Positive Breast Cancer Patients Receiving Trastuzumab

摘要

The primary objective of this grant was to determine the relapse free survival benefit with locally advanced and Stage IV HER2+ breast cancer patients vaccinated with a HER2 ICD peptide-based vaccine while receiving maintenance trastuzumab. The scope of work includes a Phase II single arm study of a HER2 ICD peptide-based vaccine given concurrently with trastuzumab. Thirty six subjects have been enrolled to this study. All adverse events reported for are of low grade and there is no adverse cardiac toxicity with the combination of vaccine and trastuzumab. Patients have developed significant T-cell immune responses to the vaccine as well as epitope spreading indicating a Type I immune response is being elicited. Preliminary interim analysis on the first 25 subjects, suggests clinical benefit with a 2-year RFS estimate of 63% and the one-year RFS estimate is 82%. Overall survival evaluation in the first 25 subjects is due November 2011. Relapse free survival evaluation is ongoing as this follow-up will be 4 years after last vaccine for the last enrolled subject.