Vaccine Therapy in Preventing Recurrence in Patients with Her-2 Positive Stage I-III Breast Cancer

Inclusion Criteria

• Clinical stage I-III HER-2 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 (excluding ado-trastuzumab emtansine [T-DM1]) or radiation > 30 days with resolution of all acute toxic effects of prior therapy to grade =< 2 (except alopecia)
• Currently on HER-2 targeted therapy (e.g. trastuzumab +/- pertuzumab or per standard of care) or has completed HER-2 targeted therapy less than 6 months from registration
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
• Absolute neutrophil count (ANC) >= 1,000/ uL
• Platelets >= 75,000/ uL
• 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
• Aspartate aminotransferase (AST)/alanine aminotransferase (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 multi-gated acquisition [MUGA] scan within 90 days of registration)
• Female patients of child-bearing potential must agree to use dual methods of contraception and have a negative serum pregnancy test at screening, and male patients must use an effective barrier method of contraception if sexually active with a female of child-bearing potential; acceptable methods of contraception are condoms with contraceptive foam, oral, implantable or injectable contraceptives, contraceptive patch, intrauterine device, diaphragm with spermicidal gel, or a sexual partner who is surgically sterilized or post-menopausal; for both male and female patients, effective methods of contraception must be used throughout the study and for three months following the last dose; to be considered of non-childbearing potential, postmenopausal women must be amenorrheic for at least 12 months naturally (not in the setting of post chemotherapy) or patients must be surgically sterile
• 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 human immunodeficiency virus (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 extended use of immunosuppressive agents or systemic corticosteroids. Topical, ocular, intra-articular, intranasal, inhalational corticosteroids (with minimal systemic absorption) are allowed. A brief course of corticosteroids for prophylaxis (e.g., for contrast dye allergy) or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by a contact allergen) is permitted.
• Patient is currently on active treatment in any other clinical protocol or investigational trial that involves administration of experimental therapy and/or therapeutic devices, or investigational drug