RGD Reference Report - Combined Clinical Trial Results of a HER2/neu (E75) Vaccine for the Prevention of Recurrence in High-Risk Breast Cancer Patients: U.S. Military Cancer Institute Clinical Trials Group Study I-01 and I-02. - Rat Genome Database

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Combined Clinical Trial Results of a HER2/neu (E75) Vaccine for the Prevention of Recurrence in High-Risk Breast Cancer Patients: U.S. Military Cancer Institute Clinical Trials Group Study I-01 and I-02.

Authors: Peoples, GE  Holmes, JP  Hueman, MT  Mittendorf, EA  Amin, A  Khoo, S  Dehqanzada, ZA  Gurney, JM  Woll, MM  Ryan, GB  Storrer, CE  Craig, D  Ioannides, CG  Ponniah, S 
Citation: Peoples GE, etal., Clin Cancer Res. 2008 Feb 1;14(3):797-803.
RGD ID: 2289924
Pubmed: PMID:18245541   (View Abstract at PubMed)
DOI: DOI:10.1158/1078-0432.CCR-07-1448   (Journal Full-text)

PURPOSE: E75 is an immunogenic peptide from the HER2/neu protein, which is overexpressed in many breast cancer patients. We have conducted two overlapping E75 vaccine trials to prevent recurrence in node-positive (NP) and node-negative (NN) breast cancer patients. EXPERIMENTAL DESIGN: E75 (HER2/neu 369-377) + granulocyte macrophage colony-stimulating factor was given intradermally to previously treated, disease-free NP breast cancer patients in a dose escalation safety trial and to NN breast cancer patients in a dose optimization study. Local and systemic toxicity was monitored. Immunologic responses were assessed using in vitro assays and in vivo delayed-type hypersensitivity responses. Clinical recurrences were documented. RESULTS: One hundred and eighty-six patients were enrolled in the two studies (NP, 95; NN, 91). Human leucocyte antigen A2 (HLA-A2) and HLA-A3 patients were vaccinated (n = 101), whereas all others (n = 85) were followed prospectively as controls. Toxicities were minimal, and a dose-dependent immunologic response to the vaccine was shown. Planned primary analysis revealed a recurrence rate of 5.6% in vaccinated patients compared with 14.2% in the controls (P = 0.04) at a median of 20 months follow-up. As vaccine-specific immunity waned over time, the difference in recurrence lost significance at 26 months median follow-up (8.3% versus 14.8%); however, a significant difference in the pattern of recurrence persisted. CONCLUSIONS: E75 is safe and effective in raising a dose-dependent HER2/neu immunity in HLA-A2 and HLA-A3 NP and NN breast cancer patients. More importantly, E75 may reduce recurrences in disease-free, conventionally treated, high-risk breast cancer patients. These findings warrant a prospective, randomized phase III trial of the E75 vaccine with periodic booster to prevent breast cancer recurrences.

RGD Manual Disease Annotations    Click to see Annotation Detail View
TermQualifierEvidenceWithReferenceNotesSourceOriginal Reference(s)
Breast Neoplasms  IDA 2289924 RGD 
Breast Neoplasms  ISOERBB2 (Homo sapiens)2289924; 2289924 RGD 

Objects Annotated

Genes (Rattus norvegicus)
Erbb2  (erb-b2 receptor tyrosine kinase 2)

Genes (Mus musculus)
Erbb2  (erb-b2 receptor tyrosine kinase 2)

Genes (Homo sapiens)
ERBB2  (erb-b2 receptor tyrosine kinase 2)


Additional Information