Prototype DAA/TAA Vaccine Targeting MUC1 for Immune Interception and Prevention in Ductal Carcinoma In Situ

Inclusion Criteria:

1. Females, 18 years of age or older. Pre-menopausal women must use an effective method of contraception during the study.
2. Capable of providing informed consent and willing to comply with study procedures

3. 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
4. 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
5. Candidate for selective estrogen receptor modulator or aromatase inhibitor
6. Surgery planned as part of definitive local therapy
7. ECOG PS 0-1
8. Absolute neutrophil count ≥ 1.5 x 109/L
9. Platelet count ≥ 100 x 109/L
10. Hemoglobin ≥ 9 g/dl or ≥ 5.6 mmol/L
11. Creatinine ≤ 1.5X the upper limit of normal OR creatinine clearance ≥ 60 ml/min
12. Total bilirubin ≤ 1.5X the ULN; ≤ 2x ULN for patients with Gilbert's disease
13. AST and ALT ≤ 2.5X ULN
14. INR/PT/aPTT ≤ 1.5X ULN or within the therapeutic range if on anti-coagulation
15. If pre-menopausal, negative urine or serum pregnancy test

Exclusion Criteria:

1. Invasive breast cancer > 1mm on pathologic evaluation
2. Second malignancy within the last 5 years (definitively treated superficial non-melanoma skin cancer, melanoma in situ, cervical carcinoma in situ allowed)
3. 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
4. Recurrent ipsilateral DCIS
5. 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)
6. Current Immunomodulator therapy (includes anti-CD20 antibodies)
7. 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.
8. History of immune deficiency
9. Active infection requiring systemic therapy
10. 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
11. Known active hepatitis B (hepatitis B surface antigen-reactive) or hepatitis C (hepatitis C virus 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 PCR.
12. Known history of HIV (presence of HIV antibodies for HIV 1 and HIV 2)
13. Received a live vaccine within 30 days of the first dose of treatment
14. History of allergies to any component of the MUC1 vaccine or HiltonolR adjuvant
15. Participation on any investigational vaccine, drug, or device trial within the last 30 days
16. Pregnant or breastfeeding