NCT00524277

Vaccine Therapy in Treating Patients With Breast Cancer

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 456 (actual)
• Sponsor: San Antonio Military Medical Center · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

OBJECTIVES: * To determine if the GP2 peptide/GM-CSF vaccine reduces the recurrence rate in HLA-A2-positive, HER2/neu-positive, node-positive, or high-risk node-negative breast cancer patients randomized to receive the vaccine versus the immunoadjuvant, sargramostim (GM-CSF), alone. * To determine if the AE37 peptide/GM-CSF vaccine reduces the recurrence rate in HLA-A2-negative, HER2/neu-positive, node-positive or high-risk node-negative breast cancer patients randomized to receive the vaccine versus the immunoadjuvant, GM-CSF, alone. * To monitor the invitro and invivo immunologic responses to the vaccines and correlate these responses with the clinical outcomes. * To monitor for any unexpected toxicities with the vaccines. OUTLINE: This is a multicenter study. Patients are stratified according to nodal status. Patients are randomized to 1 of 4 treatment arms. * Arm I: HLA-A2-positive patients receive GP2 peptide/GM-CSF vaccine intradermally (ID) every 3-4 weeks for a total of up to 6 inoculations. * Arm II: HLA-A2-positive patients receive solely GM-CSF ID * Arm III: HLA-A2-negative patients receive AE37 peptide/GM-CSF vaccine ID every 3-4 weeks for a total of up to 6 inoculations. * Arm IV: HLA-A2-negative patients receive solely GM-CSF ID After completion of study therapy, patients are followed every 3 months for the first 24 months and then every 6 months for an additional 36 months. Booster inoculations are administered at 12, 18, 24, and 30 months from the date of patients' enrollment into the study. One booster inoculation is administered at each timepoint (+/- 2 weeks) and will be the same inoculation (vaccine or GM-CSF only) as what patients received during their regular inoculation series.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
BIOLOGICAL	GP2 peptide + GM-CSF vaccine	Given intradermally every 3-4 weeks for a total of up to 6 inoculations
BIOLOGICAL	GM-CSF (sargramostim)	GM-CSF given intradermally very 3-4 weeks for a total of up to 6 inoculations
BIOLOGICAL	AE37 + GM-CSF vaccine	Given intradermally every 3-4 weeks for a total of up to 6 inoculations
BIOLOGICAL	GM-CSF (sargramostim)	Given intradermally every 3-4 weeks for a total of up to 6 inoculations

Timeline

• Start date: 2007-01-01
• Primary completion: 2014-12-31
• Completion: 2017-03-31
• First posted: 2007-09-03
• Last updated: 2020-03-30

Locations

13 sites across 3 countries: United States, Germany, Greece