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MUC1 peptide vaccine with poly-ICLC adjuvant Hiltonol administered subcutaneously (SQ) Anastrozole 1 mg, letrozole 2.5 mg, or exemestane 25 mg by mouth daily

Anastrozole 1 mg, letrozole 2.5 mg, or exemestane 25 mg by mouth daily

MUC1, a therapeutic vaccine, is a transmembrane glycoprotein and a member of the mucin family of molecules.

MUC1 Peptide Vaccine

A synthetic dsRNA viral mimic and host-defense activator, mimics nature by combining the essential elements of human immunity.

Hiltonol®

A type of hormone therapy for cancer used to inhibit aromatase to treat a hormone-related breast cancer.

Aromatase Inhibitor

Kelsey Mitch, RN, BSN

Lucia Borrasso, BS

Emilia Diego, MD

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.

DCIS is frequently detected by screening mammography, and may develop into invasive disease. However, not all DCIS will progress to invasive breast cancer, and some patients are overtreated. Vaccines for DCIS might facilitate therapeutic de-escalation, and allow less aggressive therapy. The TAA MUC1 is expressed in DCIS, and vaccines specific for MUC1 are safe and decrease the rate of recurrence of high-risk premalignant lesions in colon cancer. This clinical trial is designed to evaluate mechanisms of immune activation and suppression in patients with DCIS, both within the peripheral blood and within the DCIS lesion, and will provide data to guide the development of larger trials to evaluate the impact of a MUC1 vaccine to prevent disease recurrence. Ultimately, vaccine success in intercepting the development of breast cancer will provide critical data for the application of these strategies in breast cancer prevention in high-risk individuals.

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

A Clinical Study of a Prototype DAA/TAA Vaccine Targeting MUC1 for Immune Interception and Prevention in Ductal Carcinoma In Situ

Percentage of patients with a 2-fold or greater increase in serum anti-MUC1 IgG from screening date. Serum IgG is measured using enzyme-linked immunosorbent assay (ELISA).

Number of AEs and SAEs related to study treatment using Common Terminology Criteria for Adverse Events version 5 (CTCAE v.5).

Percentage of patients who experience a greater than 4-week variation in the time to planned surgery that is related to study participation.

A Glimmer of Hope Foundation

Breast Cancer Research Foundation

Finn, Olivera, PhD

Associate Professor of Surgery

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Prototype DAA/TAA Vaccine Targeting MUC1 for Immune Interception and Prevention in Ductal Carcinoma In Situ	NCT06218303	Ductal Carcinom...	MUC1 Peptide Va... Hiltonol® Aromatase Inhib...	18 Years -	University of Pittsburgh
Prototype DAA/TAA Vaccine Targeting MUC1 for Immune Interception and Prevention in Ductal Carcinoma In Situ	NCT06218303	Ductal Carcinom...	MUC1 Peptide Va... Hiltonol® Aromatase Inhib...	18 Years -	University of Pittsburgh

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