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HER-2 Protein Vaccine in Treating Women With Breast Cancer

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.
ClinicalTrials.gov Identifier: NCT00068614
Recruitment Status : Completed
First Posted : September 11, 2003
Last Update Posted : February 5, 2014
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

Brief Summary:

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.

PURPOSE: Phase I trial to study the effectiveness of HER-2 protein vaccine in treating women who have breast cancer.

Condition or disease Intervention/treatment Phase
Breast Cancer Biological: HER-2/neu peptide vaccine Phase 1

Detailed Description:



  • Determine the safety of HER-2 protein AutoVac™ in women with breast cancer.


  • Determine the ability of this drug to bypass the tolerance to the HER-2 self-protein by raising HER-2 antibodies in these patients.
  • Determine the kinetics of the immune response to HER-2/neu in patients treated with this drug.

OUTLINE: This is an open-label, multicenter study.

Patients receive HER-2 protein AutoVac™ intramuscularly at weeks 0, 2, 6, and 10 in the absence of unacceptable toxicity.

Patients are followed for up to 6 weeks.

PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study within 3 months.

Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Trial Evaluating The Safety Of Intramuscular Injections Of HER-2 Protein AUTOVAC (PX104.1.6) In Patients With Breast Cancer
Study Start Date : July 2003
Primary Completion Date : October 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Information from the National Library of Medicine

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


  • Histologically confirmed adenocarcinoma of the breast, meeting criteria for 1 of the following:

    • Metastatic disease currently in complete or partial response or stable disease

      • Have been receiving a stable endocrine therapy regimen (e.g., aromatase inhibitor, tamoxifen, fulvestrant, or gonadotropin-releasing hormone agonist) for at least 30 days OR status post oophorectomy
    • Completed a course of local and adjuvant systemic therapy for high-risk stage II or III disease (i.e., anticipated 5-year relative survival is no greater than 50%) meeting any of the following staging criteria:

      • Stage IIB with involvement of at least 4 nodes
      • Stage IIIA (T3 disease with involvement of at least 4 nodes)
      • Any stage IIIB or IIIC disease
    • Stage IV with no evidence of disease (e.g., prior resection of local chest wall recurrence with no evidence of disease elsewhere)
  • 1+, 2+, or 3+ HER2/neu expression by immunohistochemistry
  • Treatment with trastuzumab (Herceptin®) not clinically indicated
  • Hormone receptor status:

    • Not specified



  • 18 and over


  • Female

Menopausal status

  • Not specified

Performance status

  • ECOG 0-1

Life expectancy

  • At least 6 months


  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 10 g/dL
  • Absolute neutrophil count at least 1,500/mm^3


  • ALT or AST no greater than 2.5 times upper limit of normal (ULN) (5 times ULN for patients with liver metastases)
  • Bilirubin no greater than 2 mg/dL (unless due to Gilbert's disease)


  • Creatinine no greater than 2 mg/dL


  • No history of significant cardiovascular disease
  • No myocardial infarction within the past 6 months
  • No poorly controlled cardiac arrhythmia
  • No New York Heart Association class III or IV heart disease
  • LVEF at least 50% by MUGA


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other malignancy except basal cell skin cancer or adequately treated carcinoma in situ of the cervix
  • No concurrent severe autoimmune disease
  • No other clinically significant or serious medical disease that would preclude study participation or compromise patient safety or the results of this study


Biologic therapy

  • More than 4 months since prior trastuzumab
  • No prior anticancer vaccine therapy
  • No concurrent trastuzumab
  • No concurrent immunomodulators (e.g., thalidomide or interferons/interleukins)


  • More than 4 weeks since prior chemotherapy
  • No concurrent low-dose methotrexate or cyclophosphamide
  • No concurrent cytotoxic chemotherapy

Endocrine therapy

  • See Disease Characteristics
  • No concurrent corticosteroids

    • Topical or inhaled steroids are allowed
  • No changes to current endocrine therapy regimen (e.g., discontinuation or addition of an agent)


  • More than 3 months since prior radiotherapy involving more than 25% of the bone marrow
  • No concurrent radiotherapy


  • See Disease Characteristics
  • No prior bilateral breast procedures


  • More than 4 weeks since prior immunosuppressive therapy
  • More than 30 days since prior investigational agents or clinical trial participation
  • No other concurrent experimental or investigational agents
  • No concurrent cyclosporine
  • No concurrent immunosuppressive agents

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): NCT00068614

United States, Ohio
Ireland Cancer Center
Cleveland, Ohio, United States, 44106-5055
Sponsors and Collaborators
Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: Beth A. Overmoyer, MD, FACP Case Comprehensive Cancer Center

Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00068614     History of Changes
Other Study ID Numbers: PMXA1103
CDR0000327784 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: September 11, 2003    Key Record Dates
Last Update Posted: February 5, 2014
Last Verified: February 2014

Keywords provided by Case Comprehensive Cancer Center:
stage IV breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Immunologic Factors
Physiological Effects of Drugs