Pilot Study of a MUCI Peptide and Poly-ICLC 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