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MUC1/HER-2/Neu Peptide Based Immunotherapeutic Vaccines for Breast Adenocarcinomas

18 Years
Open (Enrolling)
Breast Cancer

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Trial Information

MUC1/HER-2/Neu Peptide Based Immunotherapeutic Vaccines for Breast Adenocarcinomas



- 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.

Inclusion Criteria


- 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

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

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

Safety Issue:


Principal Investigator

Svetomir Markovic, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Food and Drug Administration

Study ID:




Start Date:

August 2008

Completion Date:

Related Keywords:

  • Breast Cancer
  • 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
  • Breast Neoplasms



Mayo Clinic Rochester, Minnesota  55905
Mayo Clinic in Arizona Scottsdale, Arizona  85259-5404
Mayo Clinic in Florida Jacksonville, Florida  32224