Vaccine to Prevent Recurrence in Patients With HER-2 Positive Breast Cancer

The total duration of the study will be 6 years (4 years of patient enrollment and 2
additional years of clinical follow-up). Assessment for disease recurrence and survival will
be conducted every 6 months (with a phone call/secure email, medical records or follow up
visit) from the end of treatment for a total of 2 years, until the completion of the trial or
until documented disease recurrence.

Inclusion Criteria:

- Clinical stage I-III HER2 positive breast cancer treated with neoadjuvant chemotherapy
including HER-2 directed treatment for at least 12 weeks.

- Residual invasive carcinoma in the breast or axillary nodes in the final pathology
from resected tumor following neoadjuvant chemotherapy.

- Completed last cycle of cytotoxic chemotherapy or radiation > 30 days with resolution
of all acute toxic effects of prior therapy to grade ≤ 2 (except alopecia)

- Less than 6 months from the completion of last trastuzumab maintenance infusion.

- Age ≥ 18 years.

- Eastern Cooperative Group (ECOG) performance status 0 or 1.

- Must have normal organ and marrow function as defined below within 2 weeks of
registration:

- Absolute neutrophil count (ANC) ≥ 1,500/ μL

- Platelets ≥ 75,000/ μL

- Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN), except
patients with Gilbert's syndrome in whom total bilirubin must be <3.0 mg/dL

- AST/ALT ≤ 3 x institutional upper limit of normal (ULN)

- Creatinine ≤ 1.5 x institutional upper limit of normal (ULN)

- Hemoglobin A1C <6.5%

- Left ventricular ejection fraction (LVEF) above institutional lower limit of normal
(by echocardiogram or MUGA scan within 90 days of registration).

- Females of child-bearing potential must agree to use dual methods of contraception and
have a negative serum pregnancy test at screening, and males must use an effective
barrier method of contraception if sexually active with a female of child-bearing
potential. For both male and female participants, effective methods of contraception
must be used throughout the study and for three months following the last dose.

- Ability to understand and willingness to sign a written informed consent document
prior to initiation of any screening or study-specific procedures.

Exclusion Criteria:

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, congenital prolonged QT syndrome, symptomatic congestive heart failure,
unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations
that would limit compliance with study requirements.

- Uncontrolled autoimmune disease requiring active systemic treatment.

- Known hypersensitivity reaction to the Granulocyte-macrophage colony stimulating
factor (GM-CSF) adjuvant; any known contraindication to GM-CSF.

- Pregnant or breast feeding.

- Known HIV-positive.

- Known current or a history of hepatitis B or C virus, including chronic and dormant
states, unless disease has been treated and confirmed cleared.

- Major surgery within 4 weeks of initiation of study drug.

- Current use of immunosuppressive agents or systemic corticosteroids. Topical, ocular,
intra-articular, intranasal, inhalational corticosteroids (with minimal systemic
absorption) are allowed. Patients who have received systemic corticosteroids ≤ 30days
prior to starting study drug will be excluded.

- Potential participant is currently enrolled in any other clinical protocol or
investigational trial that involves administration of experimental therapy and/or
therapeutic devices, or investigational drug.