Safety and Efficacy Study of HER2/Neu (E75) Vaccine in Node-Positive Breast Cancer Patients

PHASE1CompletedINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

July 31, 2001

Primary Completion Date

September 30, 2012

Study Completion Date

March 31, 2013

Conditions
Breast Cancer
Interventions
BIOLOGICAL

E75 + GM-CSF vaccine

Dose escalation scheme involving three patients each receiving injection of 100, 500, or 1,000 mcg E75 + GM-CSF monthly for 6 months. HLA-A2 and HLA-A3 status determined. HLA-A2+ and HLA-A3+ patients receive the vaccine; HLA-A2- and HLA-A3- enrolled to the control arm.

Trial Locations (2)

15963

Windber Medical Center, Windber

20889

Walter Reed National Military Medical Center, Bethesda

All Listed Sponsors
collaborator

Uniformed Services University of the Health Sciences

FED

lead

COL George Peoples, MD, FACS

FED

NCT00841399 - Safety and Efficacy Study of HER2/Neu (E75) Vaccine in Node-Positive Breast Cancer Patients | Biotech Hunter | Biotech Hunter