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CompletedNCT00343109Updated Feb 12, 2020

Vaccine Therapy in Treating Patients Receiving Trastuzumab For HER2-Positive Stage IIIB-IV Breast Cancer

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

Phase
Phase 2
Study type
Interventional
Enrollment
38
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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

Read the detailed description

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.

02

Conditions studied

  • HER2-positive Breast Cancer
  • Male Breast Cancer
  • Stage IIIB Breast Cancer
  • Stage IIIC Breast Cancer
  • Stage IV Breast Cancer
03

In context

Breast Neoplasms

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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
  • SGOT \< 2x ULN
  • Laboratory tests should be performed within 60 days of enrollment
  • Subjects must have recovered from major infections and/or surgical procedures and, in the opinion of the investigator, not have any significant active concurrent medical illnesses precluding protocol treatment
  • Patients on trastuzumab monotherapy must have adequate cardiac function as demonstrated by normal ejection fraction (EF) on MUGA scan or echocardiogram performed within last 6 months

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
38 participants (actual)

Study arms

  • Experimental
    Arm I

    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

Interventions

  • BiologicalHER-2/neu intracellular domain protein

    Given ID

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

  • Procedureleukapheresis

    Optional correlative studies

  • Otherlaboratory biomarker analysis

    Correlative studies

  • Biologicalsargramostim

    Given ID

    Also known as: GM-CSF, Leukine, Prokine

  • Otherimmunologic technique

    Correlative studies

    Also known as: immunological laboratory methods, laboratory methods, immunological

  • Biologicalsynthetic tumor-associated peptide vaccine therapy

    Given ID

06

What researchers measure

Primary outcomes

  1. Relapse-free survival

    Time frame: At 4 years

Secondary outcomes

  1. Safety as assessed by NCI CTCAE version 3.0

    Time frame: Baseline and 1 month following last vaccination

  2. 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

  3. 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

07

Study locations

1 site
  • Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
    Seattle, Washington 98109, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 12, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00343109
Lead sponsor
University of Washington
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Jun 22, 2006
Start date
Mar 2004
Primary completion
Jun 2015
Last update
Feb 12, 2020

Study contacts

Mary Disis
principal investigator · Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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