Last reviewed · How we verify
Phase II Trial of the HER2/Neu Peptide GP2 + GM-CSF Vaccine vs GM-CSF Alone in HLA-A2+ OR the Modified HER2/Neu Peptide AE37 + GM-CSF Vaccine vs GM-CSF Alone in HLA-A2- Node-Positive and High-Risk Node-Negative Breast Cancer Patients
RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells that express HER2/neu. Biological therapies, such as GM-CSF, may stimulate the immune system in different ways and stop tumor cells from growing. It is not yet known whether vaccine therapy is more effective than GM-CSF in treating breast cancer. PURPOSE: This randomized phase II trial is studying vaccine therapy to see how well it works compared with GM-CSF in treating patients with breast cancer.
Details
| Lead sponsor | San Antonio Military Medical Center |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 456 |
| Start date | 2007-01 |
| Completion | 2017-03-31 |
Conditions
- Breast Cancer
Interventions
- GP2 peptide + GM-CSF vaccine
- GM-CSF (sargramostim)
- AE37 + GM-CSF vaccine
- GM-CSF (sargramostim)
Primary outcomes
- Disease recurrence — Five years (from date of enrollment to the study through the end of the follow-up period)
The following will be compared: 1. disease recurrence rates between HLA-A2-negative patients receiving the AE37 + GM-CSF vaccine and HLA-A2-negative patients receiving GM-CSF alone 2. disease recurrence rates between HLA-A2-positive patients receiving the GP2 + GM-CSF vaccine and HLA-A2-positive patients receiving GM-CSF alone 3. disease recurrence rates between all four arms of the trial.
Countries
United States, Germany, Greece