Clinical trial results of a HER2/neu (E75) vaccine to prevent recurrence in high-risk breast cancer patients

George E. Peoples*, Jennifer M. Gurney, Matthew T. Hueman, Mike M. Woll, Gayle B. Ryan, Catherine E. Storrer, Christine Fisher, Craig D. Shriver, Constantin G. Ioannides, Sathibalan Ponniah

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

215 Scopus citations


Purpose: E75 is an immunogenic peptide from the HER2/neu protein that is highly expressed in breast cancer. We are conducting a clinical trial of an E75 + granulocyte-macrophage colony-stimulating factor vaccine to assess safety, immunologic response, and the prevention of clinical recurrences in patients with disease-free, node-positive breast cancer (NPBC). Patients and Methods: Fifty-three patients with NPBC were enrolled and HLA typed. HLA-A2+ patients (n = 24) were vaccinated, and HLA-A2- patients (n = 29) are observed prospectively as clinical controls. Local/systemic toxicities, immunologic responses, and time to recurrence are being measured. Results: Only minor toxicities have occurred (one grade 3 [4%]). All patients have demonstrated clonal expansion of E75-specific CD8+T cells that lysed HER2/neu-expressing tumor cells. An optimal dosage and schedule have been established. Patients have developed delayed-type hypersensitivity reactions to E75 postvaccination compared with controls (33 v 7 mm; P < .01). HLA-A2 + patients have been found to have larger, more poorly differentiated, and more hormonally insensitive tumors compared to HLA-A2 - patients. Despite this, the only two deaths have occurred in the control group. The disease-free survival in the vaccinated group is 85.7% compared to 59.8% in the controls at 22 months' median follow-up with a recurrence rate of 8% compared to 21%, respectively (P < .19). Median time to recurrence in the vaccinated patients was prolonged (11 v 8 months), and recurrence correlated with a weak delayed-type hypersensitivity response. Conclusion: This HER2/neu (E75) vaccine is safe and effective in eliciting a peptide-specific immune response in vivo. Induced HER2/neu immunity seems to reduce the recurrence rate in patients with NPBC.

Original languageEnglish
Pages (from-to)7536-7545
Number of pages10
JournalJournal of Clinical Oncology
Issue number30
StatePublished - 2005
Externally publishedYes


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