A Clinical Study of a Prototype DAA/TAA Vaccine Targeting MUC1 for Immune Interception and Prevention in Ductal Carcinoma In Situ
Finn, Olivera, PhD
Summary
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.
Description
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 fema…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
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 invas…
Interventions
- BiologicalMUC1 Peptide Vaccine
MUC1, a therapeutic vaccine, is a transmembrane glycoprotein and a member of the mucin family of molecules.
- DrugHiltonol®
A synthetic dsRNA viral mimic and host-defense activator, mimics nature by combining the essential elements of human immunity.
- DrugAromatase Inhibitor
A type of hormone therapy for cancer used to inhibit aromatase to treat a hormone-related breast cancer.
- DrugSelective estrogen receptor modulator (SERM)
A type of hormone therapy that blocks cancer cells from being able to use estrogen to grow. prescribed for hormone receptor-positive breast cancer.
Location
- UPMC Magee Womens HospitalPittsburgh, Pennsylvania