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Vaccine Therapy in Treating Patients With Stage IV HLA-A2 and HER2 Positive Breast or Ovarian Cancer Receiving Trastuzumab

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ClinicalTrials.gov Identifier: NCT00194714
Recruitment Status : Active, not recruiting
First Posted : September 19, 2005
Results First Posted : June 21, 2022
Last Update Posted : June 21, 2022
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mary (Nora) Disis, University of Washington

Brief Summary:
This phase I/II trial studies the side effects of vaccine therapy and to see how well it works in treating patients with stage IV major histocompatibility complex, class I, A2 antigen (HLA-A2) and human epidermal growth factor receptor 2 (HER2) positive breast or ovarian cancer who are receiving trastuzumab. Giving booster vaccines made from HER2 peptides may help increase HER2 specific immunity and immune memory cells.

Condition or disease Intervention/treatment Phase
HER2/Neu Positive HLA-A2 Positive Cells Present Stage IV Breast Cancer Stage IV Ovarian Cancer Biological: HER-2/neu Peptide Vaccine Other: Laboratory Biomarker Analysis Phase 1 Phase 2

Detailed Description:


I. To evaluate the safety of administering a HER2 cytotoxic T-cell (CTL) peptide-based vaccine (HER-2/neu peptide vaccine) to stage IV breast and ovarian cancer patients receiving maintenance trastuzumab.

II. To quantify and characterize antigen specific T cell subsets specific to HER2 in peripheral blood mononuclear cell (PBMC) of patients after vaccination with a HER2 CTL peptide-based vaccine while receiving maintenance trastuzumab.


I. To evaluate overall survival (OS) in patients who complete a vaccination series with a HER2 CTL peptide-based vaccine while receiving maintenance trastuzumab.


Patients receive HER-2/neu peptide vaccine intradermally (ID) once per month for 6 months in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 1, 3, 6, and 12 months, and then yearly for up to 5 years.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Study of Combination Immunotherapy for the Generation of HER-2/Neu (HER2) Specific Cytotoxic T Cells (CTL) in Vivo
Study Start Date : May 2016
Actual Primary Completion Date : March 31, 2021
Estimated Study Completion Date : September 30, 2023

Arm Intervention/treatment
Experimental: Treatment (HER-2/neu peptide vaccine)
Patients receive HER-2/neu peptide vaccine ID once per month for 6 months in the absence of disease progression or unacceptable toxicity.
Biological: HER-2/neu Peptide Vaccine
Given ID
Other Names:
  • HER-2-Neu Peptide Vaccine
  • HER-2/neu Helper-Peptide Vaccine

Other: Laboratory Biomarker Analysis
Correlative studies

Primary Outcome Measures :
  1. Immune Response Measured by IFN-gamma Secreting PBMC Precursor Frequency by ELIspot and HLA-A2 Major Histocompatibility Complex Tetramer Analysis [ Time Frame: Up to 1.5 years (12 months following the last vaccination) ]

    ELIspot: Increased immune response is defined as spots per well (SPW) greater than 2 standard deviations (SD) above baseline value, remained the same if the mean SPW was within 2 SD of the previous value, or decreased if the mean SPW was greater than 2 SD below the previous value. Two SD is equivalent to a P value of .05 in that there is a 95% probability that the values are statistically significant. T is reported as percentage of patients and their corresponding results.

    HLA-A2 Major Histocompatibility Complex Tetramer Analysis is evaluated using a non-radioactive assay for cell lysis. The HLA-A2 transfected human HER2/neu expressing breast cancer cell line, SKBR3-A2 T cells, expanded after stimulation with immunizing peptide, were added in an effector/target ratio of 40:1. Percent specific lysis was calculated as: ([experimental release-spontaneous releases of cytotoxic T-lymphocyte cells and target cells]/[maximum release-spontaneous release of target cells])X100.

  2. Number of Adverse Events Graded Using National Cancer Institute (NCI) Cancer Therapy Evaluation Program (CTEP) Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0 [ Time Frame: Up to 7 months (30 days following the last vaccination) ]

    Descriptive statistics will be used to summarize changes from baseline. At the point the participant signs consent and before they start vaccine we record their existing baseline events (symptoms and diagnoses) and assign a grade to them (see below). Once a participant starts vaccine treatment adverse event AEs were recorded if they are new to the participant or if they increased in severity over their baseline.

    Grade refers to the severity of the AE. The CTCAE v3.0 displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline:

    Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE

Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: Up to 5 years ]
    Survival for the Stage IV breast cancer patients will be compared to historical control.

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subjects must have either stage IV breast or ovarian cancer in remission or with stable disease on trastuzumab monotherapy
  • HER2 overexpression by immunohistocytochemistry (IHC) of 2+ or 3+, in the primary tumor or metastasis; if overexpression is 2+ by IHC, then patients must have HER2 gene amplification documented by fluorescence in situ hybridization (FISH)
  • Subjects must be HLA-A2 positive
  • Eligible subjects must have completed appropriate treatment for their primary disease and be off cytotoxic chemotherapy and any immunosuppressive agents such as systemic steroids for at least 30 days prior to enrollment; patients should continue trastuzumab monotherapy throughout the course of this protocol; concurrent hormonal and biphosphonate therapies are allowed
  • Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status score = 0 or 1
  • Male subjects must agree to contraceptive use during the study period (7 months) and non-menopausal female subjects must agree to contraception for the remainder of their childbearing years
  • Hematocrit >= 30 performed within 60 days of enrollment
  • Platelet count >= 100,000 performed within 60 days of enrollment
  • White blood cells (WBC) >= 3000/ul performed within 60 days of enrollment
  • Stable creatinine =< 2.0 mg/dL or creatinine clearance >= 60 ml/min performed within 60 days of enrollment
  • Serum bilirubin < 1.5 mg/dl performed within 60 days of enrollment
  • Serum glutamic-oxaloacetic transaminase (SGOT) < 2 x upper limit of normal (ULN) 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 a significant active concurrent medical illness precluding protocol treatment or survival
  • Patients must have a baseline left ventricular ejection fraction (LVEF) measured by multi-gated acquisition scan (MUGA) equal to or greater than the lower limit of normal for the radiology facility and if there are two consecutive MUGAS performed while on trastuzumab from the same radiology facility, there cannot be a decrease in LVEF of > 15% from the original MUGA scan

Exclusion Criteria:

  • Subjects cannot be simultaneously enrolled on other treatment studies
  • Any contraindication to receiving granulocyte-macrophage colony-stimulating factor (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 cannot have an active immunodeficiency disorder, e.g. human immunodeficiency virus (HIV)

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 ClinicalTrials.gov identifier (NCT number): NCT00194714

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United States, Washington
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Sponsors and Collaborators
University of Washington
National Cancer Institute (NCI)
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Principal Investigator: Mary Disis Fred Hutch/University of Washington Cancer Consortium
  Study Documents (Full-Text)

Documents provided by Mary (Nora) Disis, University of Washington:
Informed Consent Form  [PDF] April 6, 2016

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mary (Nora) Disis, Professor, University of Washington, University of Washington
ClinicalTrials.gov Identifier: NCT00194714    
Other Study ID Numbers: 6304
NCI-2016-00895 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
6304 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
P30CA015704 ( U.S. NIH Grant/Contract )
RG1000607 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
First Posted: September 19, 2005    Key Record Dates
Results First Posted: June 21, 2022
Last Update Posted: June 21, 2022
Last Verified: May 2022
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Immunologic Factors
Physiological Effects of Drugs