MUC1 Vaccine for Triple-negative Breast Cancer

Inclusion Criteria:

AJCC stage I-III infiltrating adenocarcinoma of the breast who have completed standard adjuvant or neoadjuvant therapy (surgery, radiation, biologic therapy, chemotherapy) for TNBC (ER-, PR-, HER-2/neu-)
Patients who have completed standard therapy for triple-negative inflammatory BC are eligible
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Absolute neutrophil count >= 1,000/mm^3
Hemoglobin >= 10.0 g/dl
Platelet count >= 100,000/mm^3
Total bilirubin must be within normal limits
Transaminases (aspartate aminotransferase [AST] and/or alanine aminotransferase [ALT]) may be up to 2.5 x institutional upper limit of normal (ULN) if alkaline phosphatase is =< ULN
Alkaline phosphatase may be up to 4 x ULN if transaminases are =< ULN
Normal creatinine and blood urea nitrogen (BUN); if abnormal, calculated creatinine clearance must be >= 60 mg/dL
Human immunodeficiency virus (HIV)(-), antinuclear antibody (ANA)(-), hepatitis panel (-), normal thyroid function tests; these tests will be performed at the discretion of the Investigator if warranted by history or clinical presentation
Patients must be disease-free of prior invasive malignancies for >= 5 years, with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
All patients must have completed surgery with sentinel and/or axillary lymph node dissection according to participating institutional guidelines
All patients must have completed adjuvant radiation therapy according to participating institutional guidelines
All patients must have completed either adjuvant or neoadjuvant chemotherapy according to participating institutional guidelines; the choice of chemotherapy is at the discretion of the treating physician
Women of childbearing potential must have a negative pregnancy test and must be willing to consent to using an accepted and effective barrier form method of contraception during participation in the study and for a reasonable period thereafter
Patients must provide written informed consent

Exclusion Criteria:

Known metastatic BC
Radiotherapy, chemotherapy, biologic therapy, or other investigational therapy within the preceding 4 weeks
Previous splenectomy or radiotherapy to spleen
Coexisting or previous malignancies except carcinoma in situ of the cervix or basal cell carcinoma of the skin
Active or uncontrolled infection
Psychiatric, addictive, or any disorder that compromises the ability to give informed consent to participate in or to comply with the requirements of the study
Concurrent systemic corticosteroid treatment - must be off all steroids for at least 4 weeks prior to vaccine administration
Any condition or behavior that in the judgment of the Investigator, would compromise the patient's ability to participate in the study