Vaccine Therapy in Preventing Cancer Recurrence in Patients With Non-Metastatic, Node Positive, HER2 Negative Breast Cancer That is in Remission

PRIMARY OBJECTIVES:

I. To assess the safety of 3 escalating doses of a deoxyribonucleic acid (DNA) plasmid based
vaccine encoding three breast cancer antigens (insulin-like growth factor-binding protein
[IGFBP]-2, HER2, and insulin-like growth factor [IGF]-1 receptor [1R]) in patients with
breast cancer.

SECONDARY OBJECTIVES:

I. To determine the immunogenicity of pUMVC3-IGFBP2-HER2-IGF1R (WOKVAC) T helper cells (Th)
polyepitope plasmid based vaccine in patients with breast cancer at 3 escalating doses.

II. To determine whether a WOKVAC Th polyepitope plasmid based vaccine elicits a persistent
memory T cell response.

III. To evaluate whether WOKVAC vaccination modulates T regulatory cells (Treg) and myeloid
derived suppressor cells (MDSC).

IV. To evaluate changes in mammographic density using clinically available images prior to
Baseline and post vaccination as an exploratory analysis.

V. To determine a recommended phase 2 WOKVAC dose for further breast cancer prevention
studies.

OUTLINE: This is a dose escalation study of WOKVAC.

Patients receive WOKVAC with sargramostim intradermally (ID) on day 1. Courses repeat every
28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.

Patients with axillary lymph node dissection (ALND) will have vaccine administered to the
contralateral arm. Patients with bilateral ALND will have vaccine administered in the thigh.
As much as possible each vaccine dose will be given within the same draining lymph node
site. Patients will be monitored for a minimum of 60 minutes post vaccine administration.

After completion of study treatment, patients are followed up at 1 month, 6 months and
annually for up to 5 years thereafter.

Inclusion Criteria:

- Patients with non-metastatic, node positive, HER2 negative breast cancer, confirmed
by pathology report, who are in remission and defined as having no evidence of
disease (NED); HER2 negative is defined as

- 0-1+ HER2 expression by immunohistochemistry (IHC) OR

- Fluorescence in situ hybridization (FISH) negative OR

- HER2 2+ and FISH negative

- Patients must be at least 28 days post cytotoxic chemotherapy, radiotherapy,
monoclonal antibody and/or other biologic therapy, prior to enrollment; patients on
bisphosphonates, denosumab, and/or endocrine therapy and may continue throughout
duration of study

- Patients must be at least 28 days post systemic steroids prior to enrollment

- Patients must have Eastern Cooperative Oncology Group (ECOG) performance status score
of =< 2

- White blood cell (WBC) >= 3000/mm^3

- Hemoglobin (Hgb) >= 10 g/dl

- Lymphocyte count >= 800/mm^3

- Platelet count >= 75,000/mm^3

- Serum creatinine =< 2.0 mg/dl or creatinine clearance > 60 ml/min

- Total bilirubin =< 1.5 mg/dl

- Aspartate aminotransferase (AST)/Serum glutamic oxaloacetic transaminase (SGOT) =< 2
times upper limit of normal (ULN)

- Glycosylated hemoglobin measurement (HbA1c) < 5.7%

- Patients must have recovered from major infections and/or surgical procedures, and in
the opinion of the investigator, not have any significant active concurrent medical
illnesses precluding protocol treatment

- Patients who are having sex that can lead to pregnancy must agree to use adequate
contraception (hormonal, barrier method of birth control, or abstinence) for the
duration of study participation; should a woman become pregnant while participating
in the study, she should inform her study doctor immediately and will not receive any
more study treatment

- Left ventricular ejection fraction (LVEF) results must be >= lower limit of normal
(LLN) for institution performing based on results from the multi-gated acquisition
(MUGA) or echocardiogram (ECHO) done at baseline

- Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

- Patients with any of the following cardiac conditions:

- Symptomatic restrictive cardiomyopathy

- Dilated cardiomyopathy

- Unstable angina within 4 months prior to enrollment

- New York Heart Association functional class III-IV heart failure on active
treatment

- Symptomatic pericardial effusion

- Patients may not be receiving any other investigational agents

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to WOKVAC

- Patients with any contraindication or known hypersensitivity to receiving
sargramostatin (recombinant human granulocyte macrophage colony stimulating factor
[rhuGM-CSF]) or other yeast based products

- Pregnant women are excluded from this study; breastfeeding should be discontinued if
the mother is treated with this vaccine

- History of diabetes

- Known history of human immunodeficiency virus (HIV) infection, hepatitis B, or
hepatitis C

- History of autoimmunity that has not been controlled with treatment in the last 12
months