Phase II Trial of the HER2/Neu Peptide GP2 + GM-CSF Vaccine vs GM-CSF Alone in HLA-A2+ OR the Modified HER2/Neu Peptide AE37 + GM-CSF Vaccine vs GM-CSF Alone in HLA-A2- Node-Positive and High-Risk Node-Negative Breast Cancer Patients

Inclusion Criteria

DISEASE CHARACTERISTICS:

Inclusion criteria:

1. Lymph node-positive breast cancer or high-risk lymph node-negative breast cancer.
The latter is defined by any one of the following criteria:

- T2 disease

- Grade 3 disease

- Lymphovascular invasion

- Estrogen receptor- or progesterone receptor-negative disease

- HER2/neu-expressing tumor (immunohistochemistry [IHC] 3+ and/or amplified
fluorescence in situ hybridization [FISH] >2.2, or N0 (i+))

2. HER2/neu-expressing tumor (IHC 1-3+ and or positive FISH >1.2)

3. Completion of primary standard of care breast cancer therapies (i.e., surgery,
chemotherapy, immunotherapy and radiation therapy as appropriate per standard of care
for patients' specific cancer)

4. Clinically cancer-free (no evidence of disease)

5. Patients may be enrolled between 1-6 months from completion of standard primary
breast cancer therapies

6. Good performance status (as defined in Exclusion Criteria)

7. Capable of informed consent

Exclusion criteria:

1. HER2/neu-negative breast cancers (IHC 0)

2. Clinical and/or radiographic evidence of residual or persistent breast cancer

3. Receiving immunosuppressive therapy to include chemotherapy, steroids, or
methotrexate

4. In poor health (Karnofsky <60%, ECOG >/-2)

5. Total bilirubin >1.8, creatinine >2, hemoglobin <10, platelets <50,000, WBC <2,000)

6. Active interstitial lung disease; asthma requiring more than as needed
bronchodilators for management; or other autoimmune lung disease

7. Pregnancy (urine hCG)

8. Breast feeding

9. History of autoimmune disease

10. Involved in other experimental protocols (except with permission of the other study
PI)

PATIENT CHARACTERISTICS:

Inclusion criteria:

- Female or male

- Menopausal status not specified

- Immunologically intact by recall anergy testing

- Negative pregnancy test

Exclusion criteria:

- Karnofsky 0-60% or ECOG ≥ 2

- Total bilirubin > 1.8 g/dL

- Creatinine > 2.0 g/dL

- Hemoglobin < 10.0 g/dL

- Platelet count < 50,000/mm³

- WBC< 2,000/mm³

- Active pulmonary disease requiring medication that includes multiple inhalers

- Pregnancy

- Breastfeeding

- History of autoimmune disease

PRIOR CONCURRENT THERAPY:

Inclusion criteria:

- See Disease Characteristics

Exclusion criteria:

- Concurrent immunosuppressive therapy including chemotherapy, steroids, or
methotrexate

- Concurrent participation in another experimental treatment (except with permission of
the other study investigator)