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Vaccine Therapy in Treating Patients With Stage III or Stage IV 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. Identifier: NCT00304096
Recruitment Status : Completed
First Posted : March 17, 2006
Results First Posted : April 9, 2013
Last Update Posted : April 9, 2013
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Virginia

Brief Summary:

RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Giving booster vaccinations may make a stronger immune response and kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects of vaccine therapy in treating patients with stage III or stage IV breast cancer.

Condition or disease Intervention/treatment Phase
Breast Cancer Biological: synthetic breast cancer peptides-tetanus toxoid-Montanide ISA-51 vaccine Phase 1

Detailed Description:



  • Determine the safety of a vaccine comprising multiple synthetic breast cancer-associated peptides and a tetanus toxoid helper peptide emulsified in Montanide ISA-51 in patients with stage III or IV adenocarcinoma of the breast.
  • Determine, preliminarily, the frequency of immune responses against the 9 class I MHC-restricted peptides in patients treated with the vaccine.
  • Determine, preliminarily, the cytotoxic responses of T-cells to allogeneic breast cancer cells and autologous breast cancer cells (when available).

OUTLINE: This is an open-label study.

Patients receive peptide vaccine comprising 9 synthetic breast cancer peptides and tetanus toxoid helper peptide emulsified in Montanide ISA-51 subcutaneously and intradermally once daily on days 1, 8, 15, 36, 57, and 78 in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 1 year.

PROJECTED ACCRUAL: A total of 12 patients will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Safety and Immunogenicity of Vaccination With Multiple Synthetic Peptides in Participants With Advanced Breast Cancer
Study Start Date : December 2005
Actual Primary Completion Date : June 2007
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Stratum 1: Receiving Hormone Therapy
Patients treated with 9 peptide vaccine who received hormone therapy
Biological: synthetic breast cancer peptides-tetanus toxoid-Montanide ISA-51 vaccine
Experimental: Stratum 2: Not receiving hormone therapy
Patients receiving 9 peptide vaccine who did not receive hormone therapy
Biological: synthetic breast cancer peptides-tetanus toxoid-Montanide ISA-51 vaccine

Primary Outcome Measures :
  1. The Number of Participants Who Experienced Dose-limiting Adverse Events [ Time Frame: 30 days post administration of last vaccine ]
    Safety of the 9-peptide mixture if fewer than 33% of patients experience a dose-limiting toxicity

Secondary Outcome Measures :
  1. The Number of Participants With T-cell Responses Against the Vaccine as Measured by Elispot Assay After 14 Day in Vitro Sensitization [ Time Frame: Days 1-78 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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


  • Histologically or cytologically confirmed adenocarcinoma of the breast

    • Stage III or IV disease
    • Primary or recurrent disease
    • Invasive lobular carcinoma allowed
  • HLA-A1, -A2, -A3, or -A31 positive
  • Underwent and recovered from prior primary therapy

    • Patients with no clinical or radiological evidence of disease who had a previous diagnosis of stage III or IV breast cancer must have undergone prior antineoplastic therapy including, but not limited to, surgery, chemotherapy, and radiotherapy within the past 36 months
  • Must have at least one undissected axillary and/or inguinal lymph node basin
  • No history of brain metastases
  • Hormone receptor status

    • Estrogen receptor-positive or -negative tumor


  • ECOG performance status of 0 or 1
  • Body weight > 110 lbs (without clothes)
  • Male or female
  • Menopausal status not specified
  • Absolute neutrophil count > 1000/mm^3
  • Platelet count > 100,000/mm^3
  • Hemoglobin > 9 g/dL
  • Hemoglobin A1c < 7%
  • AST and ALT ≤ 2.5 x upper limit of normal (ULN)
  • Bilirubin ≤ 2.5 x ULN
  • Alkaline phosphatase ≤ 2.5 x ULN
  • Creatinine ≤ 1.5 x ULN
  • HIV negative
  • Hepatitis C negative
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No known or suspected allergies to any component of the vaccine
  • No active infection requiring antibiotics
  • No New York Heart Association class III or IV heart disease
  • No autoimmune disorders requiring cytotoxic or immunosuppressive therapy or autoimmune disorders with visceral involvement, except the following:

    • Laboratory evidence of autoimmune disease (e.g., positive ANA titer) without symptoms
    • Clinical evidence of vitiligo
    • Other forms of depigmenting illness
    • Mild arthritis requiring nonsteroidal antiinflammatory drugs
  • No medical contraindication or potential problem that would preclude study participation


  • More than 4 weeks since prior surgery
  • More than 4 weeks since prior and no concurrent chemotherapy and radiotherapy
  • More than 4 weeks since prior and no concurrent allergy desensitization injections
  • More than 4 weeks since prior parenteral, oral, or inhaled corticosteroids

    • No concurrent inhaled steroids (e.g., Advair® or triamcinolone acetonide)
    • Prior or concurrent topical corticosteroids allowed
  • More than 4 weeks since prior and no concurrent growth factors (e.g., epoetin alfa, darbepoetin alfa, or pegfilgrastim)
  • More than 4 weeks since prior and no concurrent other investigational medication
  • More than 4 weeks since prior and no concurrent other agents with putative immunomodulating activity except for non-steroidal anti-inflammatory agents
  • Prior and concurrent hormonal therapy (e.g., tamoxifen, raloxifene, toremifene, fulvestrant, letrozole, anastrozole, or exemestane) allowed
  • No prior vaccination with any synthetic peptides in this protocol

    • Vaccines for infectious disease (e.g., influenza) allowed, provided they are administered ≥ 2 weeks prior to or ≥ 2 weeks after study vaccine
  • Short term therapy for acute conditions not related to breast cancer allowed
  • No concurrent illegal drugs

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 identifier (NCT number): NCT00304096

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United States, Virginia
University of Virginia Cancer Center
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
University of Virginia
National Cancer Institute (NCI)
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Principal Investigator: David R. Brenin, MD, FACS University of Virginia
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Responsible Party: University of Virginia Identifier: NCT00304096    
Other Study ID Numbers: 11992
First Posted: March 17, 2006    Key Record Dates
Results First Posted: April 9, 2013
Last Update Posted: April 9, 2013
Last Verified: February 2013
Keywords provided by University of Virginia:
recurrent breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
stage IV breast cancer
male breast cancer
invasive lobular breast carcinoma
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases