Breast Cancer Vaccine Trial, con't
The trial is being led by Colonel George Peoples, M.D., FACS, Chief of Surgical Oncology at Brooke Army Medical Center (BAMC) and Director and Principal Investigator of the Cancer Vaccine Development Program. USMCI, in collaboration with Uniformed Services University of the Health Sciences (USU) and The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc., has entered into a Clinical Trial Agreement with Antigen Express Inc., a subsidiary of Generex, to conduct this Phase II trial.
The trial will enroll up to 600 civilian and military health care beneficiaries with a diagnosis of NP or high-risk NN breast cancer who have HER2/neu+ and HLA-A2+ or HLA-A2- tumors and who have completed all primary therapies. Patients will be recruited from select Army and civilian study sites over a three-year period. Once enrolled, HLA-A2+ patients will be randomized to receive the GP2 + GM-CSF vaccine or GM-CSF alone, and HLA-A2- patients will be randomized to receive the AE37 + GM-CSF vaccine or GM-CSF alone. Both vaccines are covered under FDA-approved Investigational New Drug Applications. The main purposes of this trial are to prove if either or both of these peptide vaccines that target HER2/neu-expressing cancer cells can prevent recurrence in disease-free, conventionally treated NP and high-risk NN breast cancer patients who are at a significant risk for recurrence; and to compare the contribution of the vaccines versus GM-CSF alone to determine the differences in in vitro and in vivo immunologic responses and clinical outcome. The ultimate purpose of the Cancer Vaccine Development Program is to design a safe, efficient, exportable multi-epitope vaccine that can be used as a preventive strategy for patients at risk for breast cancer.