Immune Response in Patients Who Have Undergone Vaccine Therapy for Stage III or Stage IV Breast Cancer That Overexpresses HER2

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00363012
Recruitment Status : Completed
First Posted : August 15, 2006
Last Update Posted : April 5, 2017
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mary (Nora) Disis, University of Washington

Brief Summary:

RATIONALE: Studying the immune response to a vaccine made from HER2/neu protein may help doctors plan better treatment for patients with breast cancer that overexpresses HER2.

PURPOSE: This clinical trial is studying the immune response in patients who have undergone vaccine therapy for stage III or stage IV breast cancer that overexpresses HER2.

Condition or disease Intervention/treatment Phase
Breast Cancer Biological: HER-2/neu intracellular domain protein Other: flow cytometry Other: immunohistochemistry staining method Procedure: biopsy Other: Sterile water placement Not Applicable

Detailed Description:



  • Determine whether immunologic memory to the HER-2/neu (HER2) intracellular domain (ICD) protein has been generated by active immunization with a HER2 ICD plasmid-based vaccine by assessing the delayed-type hypersensitivity response to HER2 ICD peptides 6 months after vaccination in patients with HER2-overexpressing stage III or IV breast cancer.


  • Characterize the memory T-cell population and quantitate memory precursor frequency at 3, 6, and 12 months after active immunization using intracellular cytokine staining.

OUTLINE: This is an open-label study.

Patients receive HER2 intracellular domain (ICD) protein mixture intradermally and sterile water injected intradermally (as a negative control) at 6 months post-vaccination with pNGVL3-hICD vaccine. Vital signs and injection site will be monitored prior to skin test and at 60 minutes post-test. Patients return 48-72 hours after skin test for delayed-type hypersensitivity (DTH) measurements. The injection site is biopsied and examined by immunohistochemistry for infiltrating T-cell and antigen-presenting cell populations.

Blood is drawn at 3, 6, and 12 months post-vaccination for assessment of immune memory response. Blood draws are coordinated with parent study. Blood samples are examined by flow cytometry for the presence of memory markers including L-selectin, CD45 isoforms, cytokines, and CCR7.

PROJECTED ACCRUAL: A total of 56 patients will be accrued for this study.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Development of HER-2/Neu (HER2) ICD Memory Immunity After Vaccination With a Plasmid Encoding HER2 ICD in Patients With Advanced Stage HER2 Overexpressing Breast and Ovarian Cancers
Study Start Date : April 2006
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Intervention Details:
  • Biological: HER-2/neu intracellular domain protein
    300mcg (100mcg/peptide) of the HER2 ICD peptide mixture per skin test. This will be injected intradermally on the back at 6 months post active immunization.
  • Other: flow cytometry
    This is a laboratory test used to assess the antigen specific T cell population.
  • Other: immunohistochemistry staining method
    This is a laboratory test used to identify CD3+, CD4+, CD45R0+, CD8+, and DC1a+ present in the skin biopsy.
  • Procedure: biopsy
    A 3mm punch biopsy is taken of the vaccine site. This is taken for laboratory analysis for immunohistochemical staining.
  • Other: Sterile water placement
    100mcg of sterile water will be administered intradermally on the back and serves as a negative control for the laboratory analysis. This will be injected intradermally on the back at 6 months post active immunization.

Primary Outcome Measures :
  1. Immunologic memory response to HER-2/neu (HER2) intracellular domain protein [ Time Frame: 6 months after active immunization ]

Secondary Outcome Measures :
  1. Characterization of memory T-cell population by intracellular cytokine staining [ Time Frame: 3, 6, and 12 months after active immunization ]
  2. Quantitate memory precursor frequency by intracellular cytokine staining [ Time Frame: 3, 6, and 12 months after active immunization ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Diagnosis of stage III/IV breast cancer

    • Completed chemotherapy
    • Receiving trastuzumab (Herceptin®) monotherapy
  • Successful completion of HER-2/neu (HER2) intracellular domain (ICD) plasmid-based vaccine trial (Protocol 01-9773-D06: "A Phase I Safety and Efficacy Trial of a DNA Plasmid Based Vaccine Encoding the HER-2/neu Intracellular Domain In Subjects With HER-2/neu-Overexpressing Tumors") within the past 3 months
  • Hormone receptor status not specified


  • Male or female (male patients are not excluded)
  • Menopausal status not specified
  • Zubrod performance status 0
  • Unable to bear children (female patients)


  • See Disease Characteristics
  • No cytoreductive chemotherapy within the past 30 days
  • No cytotoxic treatment and/or systemic corticosteroids within the past month
  • Concurrent local radiotherapy or hormonal therapy allowed

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00363012

United States, Washington
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109-1024
Tumor Vaccine Group at the University of Washington
Seattle, Washington, United States, 98109
Sponsors and Collaborators
University of Washington
National Cancer Institute (NCI)
Principal Investigator: Lupe G. Salazar, MD Tumor Vaccine Group at the University of Washington

Responsible Party: Mary (Nora) Disis, Principal Investigator, University of Washington Identifier: NCT00363012     History of Changes
Other Study ID Numbers: 6271
P30CA015704 ( U.S. NIH Grant/Contract )
K23CA100691 ( U.S. NIH Grant/Contract )
CDR0000492707 ( Registry Identifier: PDQ )
First Posted: August 15, 2006    Key Record Dates
Last Update Posted: April 5, 2017
Last Verified: April 2017

Keywords provided by Mary (Nora) Disis, University of Washington:
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
stage IV breast cancer
male breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases