A Vaccine (H2NVAC) Before Surgery for the Treatment of HER2-Expressing Ductal Carcinoma In Situ

Inclusion Criteria:

• Eastern Cooperative Oncology Group (ECOG) performance status =< 2

• Patients must not have received any prior therapy for current DCIS

• Note: Patients who received tamoxifen, raloxifene, aromatase inhibitor oranother agent for prevention of breast cancer may be included as long as thepatient has discontinued the treatment at least 2 months prior to baselinestudy biopsy if they chose to have this collected

• Note: Concurrent use of endocrine therapy during the vaccination/preoperativeperiod is not allowed. However, standard adjuvant endocrine therapy withtamoxifen or aromatase inhibitor after completion of vaccination and surgery isallowed

• Any degree of HER2 expression as performed on the diagnostic clinical biopsy definedby immunohistochemistry +1, +2, or +3

• Histologically confirmed un-resected operable ductal carcinoma in situ with noevidence of lymph node involvement or distant metastasis

• Note: suspected microinvasion or definite microinvasion (< 0.1 mm invasion) oncore biopsy is allowed

• Patients will be asked to have an additional research biopsy prior to the firstvaccination. This is not mandatory for participation

• Patients must have evidence of at least 0.5 cm of disease extent based on mammogram,ultrasound, or magnetic resonance (MRI) imaging

• Absolute neutrophil count (ANC) >= 1500/mm^3 (less than or equal to 28 days prior toregistration)

• Platelet count >= 75,000/mm^3 (less than or equal to 28 days prior to registration)

• Hemoglobin >= 9.0 g/dL (less than or equal to 28 days prior to registration)

• Creatinine =< 2 x upper limit of normal (ULN) (less than or equal to 28 days priorto registration)

• Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) =< 2 x ULN (less than or equal to 28 days prior to registration)

• Albumin >= 3 g/dL (less than or equal to 28 days prior to registration)

• Negative serum pregnancy test done =< 7 days prior to Registration, for women ofchildbearing potential only

• Willing to employ adequate contraception from the time of Registration through 6months after the final vaccine cycle

• Note: Adequate contraception methods include birth control pills, barrierdevice, intrauterine device, or abstinence

• Capable of understanding the investigative nature, potential risks, and benefits ofthe study

• Capable of providing valid informed consent

• Willing to return to enrolling institution for all study visits (immunizations,blood draws, etc)

• Willing to provide blood samples for correlative research purposes

• Willing to receive a tetanus vaccination if subject has not had one within the pastyear

Exclusion Criteria:

• Any of the following because this study involves an investigational agent whosegenotoxic, mutagenic and teratogenic effects on the developing fetus and newborn areunknown:

• Pregnant women

• Nursing women unwilling to stop breast feeding

• Women of child bearing potential who are unwilling to employ adequatecontraception from the time of registration through 6 months after the finalvaccine cycle

• Co-morbid systemic illnesses or other severe concurrent disease which, in thejudgment of the investigator, would make the patient inappropriate for entry intothis study or interfere significantly with the proper assessment of safety andtoxicity of the prescribed regimens

• Immunocompromised patients including patients known to be human immunodeficiencyvirus (HIV) positive or those on chronic steroids

• Note: Must be off systemic steroids greater than or equal to 90 days prior toRegistration. However, topical steroids, inhalants or steroid eye drops arepermitted

• Uncontrolled intercurrent illness including, but not limited to, ongoing or activeinfection, symptomatic congestive heart failure, unstable angina pectoris, cardiacarrhythmia, or psychiatric illness/social situations that would limit compliancewith study requirements

• Uncontrolled acute or chronic medical conditions including, but not limited to thefollowing:

• Active infection requiring antibiotics

• Congestive heart failure with New York Heart Association class III or IVmoderate to severe objective evidence of cardiovascular disease

• Myocardial infarction or stroke less than or equal to 6 months prior toregistration

• Receiving any other investigational agent

• Other active malignancy at time of registration or less than or equal to the lastthree years prior to registration. EXCEPTIONS: Non-melanoma skin cancer orcarcinoma-in-situ (e.g. of cervix, prostate)

• NOTE: If there is a history of prior malignancy, they must not be receivingother specific treatment (cytotoxics, monoclonal antibodies, small moleculeinhibitors) for their cancer

• Known history of autoimmune disease, including type I diabetes

• Any prior hypersensitivity or adverse reaction to GM-CSF

• History of trastuzumab-related cardiac toxicity requiring interruption ordiscontinuation of therapy, even if left ventricular ejection fraction (LVEF) fullyrecovered

• Baseline LVEF with a value below 55%

• Failure to fully recover from acute, reversible effects of prior chemotherapyregardless of interval since last treatment

• History of myocardial infarction =< 168 days (6 months) prior to registration, orcongestive heart failure requiring use of ongoing maintenance therapy for lifethreatening ventricular arrhythmias

• History of ipsilateral radiation to the current affected breast with DCIS