HER-2 Protein Vaccine in Treating Women With Breast Cancer

This study has been completed.
Information provided by (Responsible Party):
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
First received: September 10, 2003
Last updated: February 4, 2014
Last verified: February 2014

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 Intervention Phase
Breast Cancer
Biological: HER-2/neu peptide vaccine
Phase 1

Study Type: Interventional
Study Design: Masking: 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

Resource links provided by NLM:

Further study details as provided by Case Comprehensive Cancer Center:

Study Start Date: July 2003
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
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.


Ages Eligible for Study:   18 Years and older
Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00068614

United States, Ohio
Ireland Cancer Center
Cleveland, Ohio, United States, 44106-5055
Sponsors and Collaborators
Case Comprehensive Cancer Center
Study Chair: Beth A. Overmoyer, MD, FACP Case Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00068614     History of Changes
Other Study ID Numbers: PMXA1103, CWRU-030339, CDR0000327784, PHARMEXA-PX104.1.6-101
Study First Received: September 10, 2003
Last Updated: February 4, 2014
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on April 14, 2014