[alicem]

I just went back and read the criteria, and unfortunately you have to be disease free and within 1-6 months of just finishing treatment. I'm sorry Pam. Here is the inclusion and exclusion criteria . . .



Inclusion criteria:

• Meets one of the following criteria:
  • Lymph node-positive breast cancer
  • High-risk lymph node-negative breast cancer, defined by any one of the following criteria:
    • T2 disease
    • Grade 3 disease
    • Lymphovascular invasion
    • Estrogen receptor- or progesterone receptor-negative disease
    • N0 (I+) disease
  HER2/neu-expressing tumor (immunohistochemistry [IHC] 1-3+ and/or positive fluorescence in situ hybridization [FISH] > 1.2)
• Clinically cancer-free (no evidence of disease) after completion (between 1-6 months ago) 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)

Exclusion criteria:

• HER2/neu-negative breast cancers (IHC 0)
• Clinical and/or radiographic evidence of residual or persistent breast cancer

PATIENT CHARACTERISTICS:


Inclusion criteria:

• Female or male
• Menopausal status not specified
• Immunologically intact by recall anergy testing
• Negative pregnancy test

Exclusion criteria:

• Anergic by the Mantoux panel of recall antigens
• 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
Inclusion criteria:

• See Disease Characteristics

Exclusion criteria:

• <LI style="MARGIN-TOP: 0.7ex">Concurrent immunosuppressive therapy including chemotherapy, steroids, or methotrexate
• Concurrent participation in another experimental treatment (except with permission of the other study investigator)