A Phase 2 interventional study of HER-2/neu intracellular domain protein and leukapheresis in HER2-positive Breast Cancer, Male Breast Cancer and Stage IIIB Breast Cancer, sponsored by University of Washington. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-12.
Sponsored by University of Washington · Phase 2, Interventional, and Prevention
This phase II trial is studying how well vaccine therapy works in treating patients receiving trastuzumab for HER2-positive stage IIIB- IV breast cancer. Vaccines made from peptides may help the body build an effective immune response to kill tumor cells
PRIMARY OBJECTIVES:
SECONDARY OBJECTIVES:
To determine the immunogenicity of the HER2 ICD peptide based vaccine when given within one year of initiating standard treatment which includes trastuzumab.
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 38 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →University of Washington is the lead sponsor of 1,397 studies on the registry; 225 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 132 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients receive HER-2/neu intracellular domain peptide-based vaccine mixed with GM-CSF intradermally once monthly for 6 months in the absence of disease progression or unacceptable toxicity.
Biological: HER-2/neu intracellular domain protein · Procedure: leukapheresis · Other: laboratory biomarker analysis · Biological: sargramostim · Other: immunologic technique · Biological: synthetic tumor-associated peptide vaccine therapy
Given ID
Also known as: HER-2 ICD Peptide, HER-2/neu ICD Protein
Optional correlative studies
Correlative studies
Given ID
Also known as: GM-CSF, Leukine, Prokine
Correlative studies
Also known as: immunological laboratory methods, laboratory methods, immunological
Given ID
Relapse-free survival
Time frame: At 4 years
Safety as assessed by NCI CTCAE version 3.0
Time frame: Baseline and 1 month following last vaccination
Immune response as assessed by HER2 specific T cell immunity and/or intramolecular epitope spreading
Time frame: Baseline, midpoint in the immunization schedule (prior to the 4th vaccine), 1 month after the 6th and last immunization and at 4, 8 and 12 months after the end of vaccinations
Correlation of RFS to the generation of an immune response
Time frame: Prior to the 4th vaccine, 1 month after the 6th and last immunization and at 4, 8 and 12 months after the end of vaccinations
This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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University of Washington