Safety and Efficacy Study of HER2/Neu (E75) Vaccine in Breast Cancer

PHASE1CompletedINTERVENTIONAL
Enrollment

95

Participants

Timeline

Start Date

December 31, 2002

Primary Completion Date

May 31, 2012

Study Completion Date

March 31, 2013

Conditions
Breast Cancer
Interventions
BIOLOGICAL

E75 + GM-CSF vaccine

The 1 ml by volume vaccine is administered intradermally in 0.5 ml inoculums at two different sites within 5 cm of each other on an extremity. Vaccinations will be given according to the schedule the patient has been assigned and will be administered in the same lymph node draining area (same arm or thigh). In addition, an optional booster inoculation as requested by previously vaccinated patients will be offered every 6 months for the duration of the protocol. The dose will be determined by the PI based on the patient's response to the initial vaccination series.

Trial Locations (2)

15963

Windber Medical Center, Windber

20307-5001

Walter Reed Army Medical Center, Washington D.C.

All Listed Sponsors
collaborator

Uniformed Services University of the Health Sciences

FED

lead

COL George Peoples, MD, FACS

FED

NCT00854789 - Safety and Efficacy Study of HER2/Neu (E75) Vaccine in Breast Cancer | Biotech Hunter | Biotech Hunter