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Vaccine Therapy in Treating Patients With Previously Treated Stage II or Stage III 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: NCT00640861
Recruitment Status : Completed
First Posted : March 21, 2008
Last Update Posted : October 31, 2018
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic

Brief Summary:

RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. It is not yet known which vaccine is most effective in treating breast cancer.

PURPOSE: This randomized clinical trial is studying the side effects of three different vaccine therapies and comparing the vaccines to see how well they work in treating patients with previously treated stage II or stage III breast cancer.

Condition or disease Intervention/treatment Phase
Breast Cancer Biological: CpG oligodeoxynucleotide Biological: HER-2/neu peptide vaccine Biological: MUC-1 peptide vaccine Biological: incomplete Freund's adjuvant Biological: sargramostim Other: immunoenzyme technique Other: immunologic technique Early Phase 1

Detailed Description:



  • To determine the safety and immunization efficacy of MUC1 and HER-2/neu peptide vaccines combined with CpG oligodeoxynucleotide, sargramostim (GM-CSF), or both, as immune adjuvants suspended in Freund's incomplete adjuvant in patients with previously treated stage II or III adenocarcinoma of the breast.


  • To describe the impact of immunization on clinical outcomes in patients with MUC1-positive breast cancer in terms of disease-free survival and overall survival.

OUTLINE: Patients are stratified according to Her-2/neu status (positive vs negative). Patients are randomized to 1 of 3 treatment arms.

  • Arm A: Patients receive a vaccine comprising incomplete Freund's adjuvant, MUC1 antigen vaccine, two Her-2/neu peptide-based vaccines, and sargramostim (GM-CSF) subcutaneously (SC) on day 1.
  • Arm B: Patients receive a vaccine comprising incomplete Freund's adjuvant, MUC1 antigen vaccine, two Her-2/neu peptide-based vaccines (one of them different than in arm A), and CpG oligodeoxynucleotide SC on day 1.
  • Arm C: Patients receive a vaccine comprising incomplete Freund's adjuvant, MUC1 antigen vaccine, two Her-2/neu peptide-based vaccines (one of them different than in arm A; the same as in arm B), GM-CSF, and CpG oligodeoxynucleotide SC on day 1.

In all arms, treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients who complete 6 courses of treatment without disease recurrence or a second primary or intolerable toxicity will go to the observation phase of the study for up to 2 years. Patients who develop recurrent disease during the observational phase will go to the event monitoring phase for up to 2 years.

Blood samples are collected periodically. Blood samples and tissue samples from the patient's most recent surgery are used for correlative studies including immune responses to T helper and CTL epitopes by Elispot and tetramer analysis; and antigenic profiling by expression analysis of class I HLA antigens, MUC1, and HER-2 in tumor tissue.

After completion of study treatment, patients are followed periodically until disease recurrence or for up to 2 years.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Primary Purpose: Treatment
Official Title: MUC1/HER-2/Neu Peptide Based Immunotherapeutic Vaccines for Breast Adenocarcinomas
Actual Study Start Date : August 28, 2008
Actual Primary Completion Date : April 21, 2015
Actual Study Completion Date : April 21, 2015

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Percentage of CD4+ T cells, CD8+ T cells, B cells, monocytes, and dendritic cells in a patient's peripheral blood sample as estimated by flow cytometry with a panel of monoclonal antibodies
  2. Frequency of peptide-specific IFN-gamma producing T cells and peptide-specific IL-5 producing T cells estimated by ELISPOT after in vitro stimulation with peptide-sensitized stimulator cells for MUC1 and HER-2 peptides
  3. Number and severity of hematologic and non-hematologic toxicities reported using the NCI-CTC version 3.0 criteria

Secondary Outcome Measures :
  1. Disease-free survival, defined as the time from registration to the documentation of a first failure where a failure is the recurrence of breast cancer or a diagnosis of a second primary cancer
  2. Overall survival, defined as the time from registration to death due to any cause

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed adenocarcinoma of the breast

    • Clinical stage II or III disease
    • No radiographic evidence of disease at the time of enrollment
    • Has undergone surgery, adjuvant chemotherapy, and/or radiotherapy

      • Completed "standard first-line therapy" only (including adjuvant therapy) for breast cancer within the past 3 months and currently with no evidence of disease
    • Patients with stage I breast cancer with high-risk features are eligible provided 1 of the following criteria are met:

      • HER2 over-expression or amplification
      • Triple-negative (i.e., no expression of ER, PR, or over-expression of HER2 on routine immunohistochemical staining)
  • .
  • MUC1-positive breast cancer
  • HLA-A2 positive
  • Hormone receptor status not specified


  • Menopausal status not specified
  • ECOG performance status 0-2
  • Hemoglobin ≥ 8.0 g/dL
  • Platelet count ≥ 75,000/μL
  • ANC ≥ 1,500/uL
  • Creatinine ≤ 2 times upper limit of normal (ULN)
  • AST ≤ 2 times ULN
  • No uncontrolled infection
  • No known HIV infection
  • No other circumstances (e.g., concurrent use of systemic immunosuppressants or immunocompromising condition) that in the opinion of the physician would render the patient a poor candidate for this trial
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No prior invasive malignancies within the past 5 years (with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix)


  • See Disease Characteristics
  • Fully recovered from acute, reversible effects of any prior breast cancer therapy
  • No more than 3 years since prior surgery for primary breast cancer
  • Concurrent anti-estrogen therapy is allowed
  • No other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational (utilized for a non-FDA-approved indication and in the context of a research investigation)
  • No concurrent enrollment in any other study involving a pharmacologic agent (drugs, biologics, immunotherapy approaches, gene therapy) whether for symptom control or therapeutic intent

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): NCT00640861

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United States, Arizona
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259-5499
United States, Florida
Mayo Clinic in Florida
Jacksonville, Florida, United States
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
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Study Chair: Svetomir Markovic, MD, PhD Mayo Clinic
Principal Investigator: Barbara A Pockai, M.D. Mayo Clinic
Principal Investigator: Edith A Perez, M.D. Mayo Clinic
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Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT00640861    
Other Study ID Numbers: CDR0000589446
P30CA015083 ( U.S. NIH Grant/Contract )
MC0338 ( Other Identifier: Mayo Clinic Cancer Center )
NCI-2009-01342 ( Registry Identifier: NCI-CTRP )
782-05 ( Other Identifier: Mayo Clinic IRB )
First Posted: March 21, 2008    Key Record Dates
Last Update Posted: October 31, 2018
Last Verified: October 2018
Keywords provided by Mayo Clinic:
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
stage IA breast cancer
stage IB breast cancer
triple-negative breast cancer
HER2-positive breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Freund's Adjuvant
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic