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

Inclusion Criteria:

1. Postmenopausal female, 18 years of age or older (no menstrual period for at least 12months, biochemical menopausal by FSH/LH or S/P oophorectomy)

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 todetermine eligibility

• Sufficient amount of DCIS remaining in the diagnostic core biopsy block(s) andavailable for research

• Patients with DCIS suspicious for microinvasion on core biopsy will be eligiblebecause many of these patients will not have invasion on final pathology

• Women presenting with concurrent bilateral DCIS are eligible only if both theright and left DCIS lesions are ER+, and tissue from both sides will beanalyzed and must meet the criteria below

4. DCIS must be ≥ 1cm based on the extent of calcifications on mammogram, the presenceof a mass on ultrasound or enhancement on MRI OR DCIS ≥ 5mm on one single core bypathologic evaluation OR DCIS < 5mm if identified in ≥ 2 cores

5. Candidate for 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

Exclusion Criteria:

1. Invasive breast cancer > 1mm on pathologic evaluation

2. Second malignancy within the last 5 years (definitively treated superficialnon-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 tobaseline biopsy for the study

4. Recurrent ipsilateral DCIS

5. Current steroid therapy (doses for physiologic replacement in adrenal dysfunction orfor contrast allergy pre-medication for contrast allergy or similar indicationallowed, topical, ocular and intranasal steroids allowed)

6. Current Immunomodulator therapy (includes anti-CD20 antibodies)

7. History of autoimmune disease requiring systemic immunosuppression, or activeautoimmune disease. Replacement therapy with thyroxine, insulin, and physiologiccorticosteroids 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, orlaboratory abnormality that might interfere with the patient's participation for thefull 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 antibodypositive without hepatitis B surface antigen reactivity are eligible. Patients whohave antibody for hepatitis C are eligible only if hepatitis C RNA is negative byPCR.

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