Phase II Study of a HER-2/Neu (HER2) Intracellular Domain (ICD) Peptide-Based Vaccine Administered to Patients With Locally Advanced or Stage IV HER2 Positive Breast Cancer
1. To estimate the RFS in patients with HER2 positive locally advanced breast cancer
vaccinated with a HER2 ICD peptide-based vaccine.
1. To assess the safety of a HER2 ICD peptide-based vaccine administered concurrently with
2. To determine the immunogenicity of the HER2 ICD peptide based vaccine when given within
one year of initiating standard treatment which includes trastuzumab.
1. To determine the incidence of the development of T cell immunity specific for the
2. To determine the incidence of the development of intramolecular epitope
3. To determine the magnitude of the HER2 ICD specific CD4+ and CD8+ immune response
generated with immunization.
3. To assess whether there is an association between RFS and the development of an immune
response (HER2 specific T cell immunity and/or the development of intramolecular
Patients receive HER-2/neu intracellular domain peptide-based vaccine mixed with GM-CSF
intradermally (ID) once monthly for 6 months in the absence of disease progression or
After completion of study treatment, patients are followed up at 1, 4, 8, and 12 months and
then annually thereafter for up to 5 years.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
At 4 years
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Food and Drug Administration
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