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
PRIMARY OBJECTIVES:
1. To estimate the RFS in patients with HER2 positive locally advanced breast cancer
vaccinated with a HER2 ICD peptide-based vaccine.
SECONDARY OBJECTIVES:
1. To assess the safety of a HER2 ICD peptide-based vaccine administered concurrently with
trastuzumab.
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
HER2 ICD.
2. To determine the incidence of the development of intramolecular epitope
spreading.
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
epitope spreading).
OUTLINE:
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
unacceptable toxicity.
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.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Relapse-free survival
At 4 years
No
Mary Disis
Principal Investigator
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Food and Drug Administration
6166
NCT00343109
March 2004
Name | Location |
---|---|
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle, Washington 98109 |