NCT00363012

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Apr 2006

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 10, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 15, 2006

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

April 5, 2017

Status Verified

April 1, 2017

Enrollment Period

3.9 years

First QC Date

August 10, 2006

Last Update Submit

April 3, 2017

Conditions

Breast Cancer

Keywords

stage IIIA breast cancerstage IIIB breast cancerstage IIIC breast cancerstage IV breast cancermale breast cancer

Outcome Measures

Primary Outcomes (1)

  • Immunologic memory response to HER-2/neu (HER2) intracellular domain protein

    6 months after active immunization

Secondary Outcomes (2)

  • Characterization of memory T-cell population by intracellular cytokine staining

    3, 6, and 12 months after active immunization

  • Quantitate memory precursor frequency by intracellular cytokine staining

    3, 6, and 12 months after active immunization

Interventions

HER-2/neu intracellular domain proteinBIOLOGICAL

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.

flow cytometryOTHER

This is a laboratory test used to assess the antigen specific T cell population.

immunohistochemistry staining methodOTHER

This is a laboratory test used to identify CD3+, CD4+, CD45R0+, CD8+, and DC1a+ present in the skin biopsy.

biopsyPROCEDURE

A 3mm punch biopsy is taken of the vaccine site. This is taken for laboratory analysis for immunohistochemical staining.

Sterile water placementOTHER

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * 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 PATIENT CHARACTERISTICS: * Male or female (male patients are not excluded) * Menopausal status not specified * Zubrod performance status 0 * Unable to bear children (female patients) PRIOR CONCURRENT THERAPY: * 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Seattle, Washington, 98109-1024, United States

Location

Tumor Vaccine Group at the University of Washington

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsBreast Neoplasms, Male

Interventions

Flow CytometryImmunohistochemistryBiopsy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cell SeparationCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisCytophotometryFluorometryLuminescent MeasurementsPhotometryChemistry Techniques, AnalyticalInvestigative TechniquesHistocytochemistryHistological TechniquesImmunologic TechniquesCytodiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, Operative

Study Officials

  • Lupe G. Salazar, MD

    Tumor Vaccine Group at the University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 10, 2006

First Posted

August 15, 2006

Study Start

April 1, 2006

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

April 5, 2017

Record last verified: 2017-04

Locations

US(2)