A Clinical Study of a Prototype DAA/TAA Vaccine Targeting MUC1 for Immune Interception and Prevention in Ductal Carcinoma In Situ
Post-menopausal women with biopsy-proven DCIS will be enrolled into two cohorts. One cohort will receive neoadjuvant therapy with an aromatase inhibitor alone for about 12 weeks prior to surgery at 12 weeks. The second cohort will receive neoadjuvant therapy with an aromatase inhibitor and MUC1 vaccination (MUC1 peptide + Hiltonol®) pre-operatively at baseline, and weeks 2 and 10, followed by surgery at about 12 weeks. Patients in the vaccine cohort will be offered an optional boost vaccine 6 months after surgery.
• Postmenopausal female, 18 years of age or older (no menstrual period for at least 12 months, biochemical menopausal by FSH/LH or 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
• ECOG PS 0-1
• Absolute neutrophil count ≥ 1.5 x 109/L
• Platelet count ≥ 100 x 109/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 ULN; ≤ 2x ULN for patients with Gilbert's disease
⁃ AST and ALT ≤ 2.5X ULN
⁃ INR/PT/aPTT ≤ 1.5X ULN or within the therapeutic range if on anti-coagulation