NCT00343109

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

June 20, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 22, 2006

Completed
8.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Last Updated

February 12, 2020

Status Verified

May 1, 2019

Enrollment Period

11.3 years

First QC Date

June 20, 2006

Last Update Submit

February 7, 2020

Conditions

HER2-positive Breast CancerMale Breast CancerStage IIIB Breast CancerStage IIIC Breast CancerStage IV Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Relapse-free survival

    At 4 years

Secondary Outcomes (3)

  • Safety as assessed by NCI CTCAE version 3.0

    Baseline and 1 month following last vaccination

  • Immune response as assessed by HER2 specific T cell immunity and/or intramolecular epitope spreading

    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

    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

Study Arms (1)

Arm I

EXPERIMENTAL

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 proteinProcedure: leukapheresisOther: laboratory biomarker analysisBiological: sargramostimOther: immunologic techniqueBiological: synthetic tumor-associated peptide vaccine therapy

Interventions

HER-2/neu intracellular domain proteinBIOLOGICAL

Given ID

Also known as: HER-2 ICD Peptide, HER-2/neu ICD Protein
Arm I
leukapheresisPROCEDURE

Optional correlative studies

Arm I
laboratory biomarker analysisOTHER

Correlative studies

Arm I
sargramostimBIOLOGICAL

Given ID

Also known as: GM-CSF, Leukine, Prokine
Arm I
immunologic techniqueOTHER

Correlative studies

Also known as: immunological laboratory methods, laboratory methods, immunological
Arm I
synthetic tumor-associated peptide vaccine therapyBIOLOGICAL

Given ID

Arm I

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Stage IIIB or Stage IIIC breast cancer who are within 1 year of diagnosis and initiating treatment with chemotherapy and trastuzumab; and are in complete remission
  • Stage IV breast cancer in first complete remission and defined as NED (no evidence of disease) or with stable bone only disease who are within 6 months of initiating maintenance trastuzumab
  • NED status should be documented by chest/abdominal CT, PET or PET/CT within the last 90 days
  • Bone only disease documented as stable or healed by PET, PET/CT, or MRI within the last 90 days; stable bone-only disease must be documented with bone scan performed within the last 6 months
  • HER2 overexpression by IHC of 2+ or 3+, in the primary tumor or metastasis or documented gene amplification by FISH analysis; if overexpression is 2+ by IHC, then patients must have HER2 gene amplification documented by FISH
  • Eligible subjects must have been treated to NED or stable bone only disease status with trastuzumab and/or chemotherapy and be off cytotoxic chemotherapy or immunosuppressive agents (e.g. systemic steroids) for at least 30 days prior to enrollment (concurrent hormonal therapy allowed; concurrent bisphosphonate therapy allowed)
  • Patients on trastuzumab should continue trastuzumab monotherapy per standard of care (the dosing and schedule of trastuzumab should follow standard guidelines as described below: trastuzumab 2mg/kg IV weekly or trastuzumab 6mg/kg IV every 3 weeks)
  • Subjects must have an ECOG Performance Status Score =\< 1
  • Non-menopausal female subjects must agree to contraception for the remainder of their childbearing years
  • Male subjects must use an acceptable form of contraception throughout the course of the study
  • Hematocrit \>= 30,000
  • Platelet count \>= 100,000
  • WBC \>= 3000/mcl
  • Stable creatinine =\< 2.0 mg/dl or a creatinine clearance greater than 60 ml/min
  • Serum bilirubin \< 1.5 mg/dl
  • +4 more criteria

You may not qualify if:

  • Subjects cannot be simultaneously enrolled in other treatment studies
  • Patients cannot be receiving any other concurrent immunomodulators besides trastuzumab
  • Any contraindication to receiving GM-CSF based vaccine products
  • Cardiac disease, specifically restrictive cardiomyopathy, unstable angina within the last 6 months prior to enrollment, New York Heart Association functional class III-IV heart failure on active treatment with normalized LVEF on therapy, and symptomatic pericardial effusion
  • Active autoimmune disease
  • Subjects can not have active immunodeficiency disorder, e.g. HIV
  • Cannot be pregnant or breast feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Breast Neoplasms, MaleBreast Neoplasms

Interventions

LeukapheresissargramostimGranulocyte-Macrophage Colony-Stimulating FactorImmunologic Techniques

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

CytapheresisBiological TherapyTherapeuticsBlood Component RemovalLeukocyte Reduction ProceduresCell SeparationCytological TechniquesClinical Laboratory TechniquesInvestigative TechniquesColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Mary Disis

    Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2006

First Posted

June 22, 2006

Study Start

March 1, 2004

Primary Completion

June 1, 2015

Last Updated

February 12, 2020

Record last verified: 2019-05

Locations

US(1)