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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

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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

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 04 Aug 2022

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At a glance

  • Drugs AE 37 (Primary) ; HER2/Neu GP2 vaccine Greenwich LifeSciences Inc/NuGenerex Immuno-Oncology (Primary) ; Sargramostim; Trastuzumab
  • Indications Early breast cancer; HER2 negative breast cancer; HER2 positive breast cancer; Male breast cancer
  • Focus Therapeutic Use
  • Sponsors Generex Biotechnology Corporation

    • Most Recent Events

    • 28 Jul 2022 According to a Greenwich LifeSciences Inc media release, an update on the transition from the published Phase IIb data to future publications of open label Phase III data is expected to be provided shortly.
    • 07 Jun 2022 Results evaluating booster injections in maintaining peak immunity in this phase IIb study presented at the 58th Annual Meeting of the American Society of Clinical Oncology
    • 07 Jun 2022 Results (n=180) assessing immune response as an independent prognostic factor in patients with HER2 3+ positive and low HER2 expressors (1-2+) presented at the 58th Annual Meeting of the American Society of Clinical Oncology

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