A Pilot Study of the Immunogenicity of a 9-Peptide Breast Cancer Vaccine Plus Poly-ICLC in Stage IB-IIIA Breast Cancer

Inclusion Criteria

Inclusion:

- AJCC clinical or pathologic stage IB-IIIA adenocarcinoma of the breast (male or
female) who have completed primary surgery and/or chemotherapy and/or radiation
therapy and/or anti-Her2 therapy.

- >45 days and <6months (180 days) from completion of their last dose/treatment of any
single treatment or combination of surgery, chemotherapy, radiation or trastuzumab..

- Participants must have tumor pathology report demonstrating breast cancer (from
breast tumor or lymph node).

- ECOG performance status of 0 -1

- HLA-A1, -A2, -A3, or -A31 positive

- Adequate marrow function, to include: ANC >1000/mm3, Platelets >100,000/mm, Hgb >9
g/dL

- Adequate organ function to include:

- AST and ALT ≤ 2.5 x upper limits of normal (ULN)

- Bilirubin ≤ 2.5 x ULN

- Alkaline phosphatase ≤ 2.5 x ULN

- Creatinine ≤ 1.5 x ULN

- HIV and Hepatitis C negative

Exclusion Criteria

- Participants with known or suspected allergies to any component of the vaccine

- Participants who have an active infection requiring antibiotics.

- Allergy desensitization injections

- Corticosteroids, administered parenterally, orally, or inhaled. Inhaled steroids
(e.g., Advair®, Flovent®, Azmacort®) are not permitted while patient is on study or
within the 6 weeks (42 days) prior to consenting. Topical corticosteroids are
acceptable.

- Growth factors (e.g., Procrit®, Aranesp®, Neulasta®) while patient is on study

- Other agents with putative immunomodulating activity (with the exception of
non-steroidal anti-inflammatory agents)

- Active autoimmune disorders requiring cytotoxic or immunosuppressive therapy within
the 6 weeks (42 days) prior to consenting.