For the past decade, researchers from the U.S. Military have been busy developing a vaccine against breast cancer, and are now looking to enlist subjects for a new phase of clinical trials to determine if the vaccine can inhibit a recurrence. The clinical trials are open internationally, with hospitals and cancer centers in Washington State, Washington D.C., Hawaii, Maryland, Texas and North Carolina already signed up to participate.
This research was prompted by the alarmingly high incidences of breast cancer among female soldiers, noted to be about 20-40% higher compared to civilians.
Although this number could be because of the more regular medical screening in the military, the vaccine appears to be promising. According to Lt. Col. David Van Echo, M.D. from the Walter Reed National Military Medical Center, their initial tests showed a reduction in the risk of recurrence of breast cancer by half.
In line with this update and with Breast Cancer Awareness Month, the FDA has approved Perjeta – a pre-surgical treatment option, which is currently used in advanced stages of breast cancer, and has shown the ability to shrink early stage tumors in clinical trials.
About the Clinical Trials:
Peptide vaccines are helpful in eliciting a powerful immune response that can help in killing ‘HER2/neu’ expressing tumor cells. Currently, GM CSF is used by healthcare providers and researchers to control the growth of tumor cells; however, it is yet to be determined if peptide vaccines are more efficient than GM CSF in managing breast cancers and in preventing recurrence.
After achieving desired results in the Phase 1 clinical trial of this vaccine, scientists are now working on the Phase II trials to compare:
– Rate of disease recurrence in patients receiving GM CSF and those that are receiving AE37 (modified HER/neu peptide in HLA-A2-negative patients.
– Rate of disease recurrence in patients receiving GM CSF alone and those that are receiving GP2 + GM-CSF in HLA-A2-positive patients.
The measure of primary outcomes is to determine the recurrence rate in all 4 groups of the clinical trial.
The results of this study are expected to be available by the end of 2014. Since it is a multi-center study, the subjects will be enrolled according to the nodal status and will be followed for an additional 5 years after the completion of study (once in 3 months for first 2 years and once in 6 months following 3 years).
Besides the San Antonio Army Medical Center, other trial centers in Texas where recruitment is currently active are University of Texas MD Anderson Cancer Center, Carl R. Darnall Army Medical Center and STOH Clinical Research.
MD Anderson Cancer Center researcher Dr. Elizabeth A Mittendorf is the principal investigator and George E. Peoples from Brooke Army Medical Center is the Study Director of trial that is being funded and collaborated by San Antonio Military Medical Center, Norwell, Inc and Antigen Express, Inc.