A Vaccine (MUC1 Peptide-Poly-ICLC) for the Treatment of Estrogen Receptor Positive Breast Ductal Carcinoma in Situ

Inclusion Criteria

• Postmenopausal female, 18 years of age or older (no menstrual period for at least 12 months, or status/post [S/P] oophorectomy)
• Capable of providing informed consent and willing to comply with study procedures
• Biopsy-proven ER+ DCIS * The signed pathology report from the attending pathologist will be used to determine eligibility * Sufficient amount of DCIS remaining in the diagnostic core biopsy block(s) and available for research * Patients with DCIS suspicious for microinvasion on core biopsy will be eligible because many of these patients will not have invasion on final pathology * Women presenting with concurrent bilateral DCIS are eligible only if both the right and left DCIS lesions are ER+, and tissue from both sides will be analyzed and must meet the criteria below
• DCIS must be >= 1cm based on the extent of calcifications on mammogram, the presence of a mass on ultrasound or enhancement on MRI OR * DCIS >= 5mm on one single core by pathologic evaluation OR * DCIS < 5mm if identified in >= 2 cores
• Candidate for aromatase inhibitor
• Surgery planned as part of definitive local therapy
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
• Absolute neutrophil count >= 1.5 x 10^9/L
• Platelet count >= 100 x 10^9/L
• Hemoglobin >= 9 g/dl or >= 5.6 mmol/L
• Creatinine =< 1.5X the upper limit of normal OR creatinine clearance >= 60 ml/min
• Total bilirubin =< 1.5X the upper limit of normal (ULN); =< 2x ULN for patients with Gilbert’s disease
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5X ULN
• International normalized ratio (INR)/prothrombin time (PT)/activated partial thromboplastin time (aPTT) =< 1.5X ULN or within the therapeutic range if on anti-coagulation

Exclusion Criteria

• Invasive breast cancer > 1mm on pathologic evaluation
• Second malignancy within the last 5 years (definitively treated superficial non-melanoma skin cancer, melanoma in situ, cervical carcinoma in situ allowed)
• Current hormone replacement therapy, selective estrogen receptor modulator therapy, or aromatase inhibitor therapy--if yes, wash out of 30 days must occur prior to baseline biopsy for the study
• Recurrent ipsilateral DCIS
• Current steroid therapy (doses for physiologic replacement in adrenal dysfunction or for contrast allergy pre-medication for contrast allergy or similar indication allowed, topical, ocular and intranasal steroids allowed)
• Current immunomodulator therapy (includes anti-CD20 antibodies)
• History of autoimmune disease requiring systemic immunosuppression, or active autoimmune disease. Replacement therapy with thyroxine, insulin, and physiologic corticosteroids for adrenal or pituitary insufficiency is acceptable
• History of immune deficiency
• Active infection requiring systemic therapy
• Any medical or psychiatric condition, substance abuse disorder, medical therapy, or laboratory abnormality that might interfere with the patient’s participation for the full duration of the study or compliance with the requirements of the study
• Known active hepatitis B (hepatitis B surface antigen-reactive) or hepatitis C (hepatitis C virus ribonucleic acid [RNA] positive). Patients who are hepatitis B core antibody positive without hepatitis B surface antigen reactivity are eligible. Patients who have antibody for hepatitis C are eligible only if hepatitis C RNA is negative by polymerase chain reaction (PCR)
• Known history of HIV (presence of HIV antibodies for HIV 1 and HIV 2)
• Received a live vaccine within 30 days of the first dose of treatment
• History of allergies to any component of the MUC1 vaccine or Hiltonol registered trademark adjuvant
• Participation on any investigational vaccine, drug, or device trial within the last 30 days