Women with biopsy-proven ductal carcinoma in situ (DCIS) will be enrolled into two cohorts. One cohort will receive neoadjuvant therapy with an aromatase inhibitor or selective estrogen receptor modulator (SERM) for about 12 weeks prior to surgery at 12 weeks. The second cohort will receive neoadjuvant therapy with an aromatase inhibitor or selective estrogen receptor modulator 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.
Ductal carcinoma in situ (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 pre and post-menopausal female 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
MUC1, a therapeutic vaccine, is a transmembrane glycoprotein and a member of the mucin family of molecules.
A synthetic dsRNA viral mimic and host-defense activator, mimics nature by combining the essential elements of human immunity.
A type of hormone therapy for cancer used to inhibit aromatase to treat a hormone-related breast cancer.
A type of hormone therapy that blocks cancer cells from being able to use estrogen to grow. prescribed for hormone receptor-positive breast cancer.
UPMC Magee Womens Hospital
Pittsburgh, Pennsylvania, United States
RECRUITINGImmunogenicity (of MUC1 vaccine)
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).
Time frame: At Week 12
Adverse Events and Serious Adverse Events Related to Treatment
Number of AEs and SAEs related to study treatment using Common Terminology Criteria for Adverse Events version 5 (CTCAE v.5).
Time frame: Up to 2 years
Feasibility (Time to planned surgery)
Percentage of patients who experience a greater than 4-week variation in the time to planned surgery that is related to study participation.
Time frame: Up to 2 years
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