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

Inclusion Criteria

DISEASE CHARACTERISTICS:

- 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

PATIENT CHARACTERISTICS:

- 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)

PRIOR CONCURRENT THERAPY:

- 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