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.

Trial Profile

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.

Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 06 Jun 2017

At a glance

  • Drugs AE 37 (Primary) ; HER2/Neu GP2 peptide vaccine Antigen Express (Primary) ; Sargramostim; Trastuzumab
  • Indications Early breast cancer; Male breast cancer
  • Focus Therapeutic Use
  • Sponsors Generex Biotechnology Corporation
  • Most Recent Events

    • 10 Jun 2017 Biomarkers information updated
    • 06 Jun 2017 Results of subgroup efficacy evaluations (n=298) of the AE37 HER2 vaccine, presented at the 53rd Annual Meeting of the American Society of Clinical Oncology.
    • 12 Dec 2015 Results of an pre-specified analysis (n=180) presented at the 38th Annual San Antonio Breast Cancer Symposium
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