Actively Recruiting
Prototype DAA/TAA Vaccine Targeting MUC1 for Immune Interception and Prevention in Ductal Carcinoma In Situ
Led by Finn, Olivera, PhD · Updated on 2026-03-12
50
Participants Needed
1
Research Sites
268 weeks
Total Duration
On this page
Sponsors
F
Finn, Olivera, PhD
Lead Sponsor
A
A Glimmer of Hope Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Prototype DAA/TAA Vaccine Targeting MUC1 for Immune Interception and Prevention in Ductal Carcinoma In Situ
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female, 18 years of age or older
- Pre-menopausal women must use effective contraception during the study
- Able to provide informed consent and willing to follow study procedures
- Biopsy-proven estrogen receptor-positive ductal carcinoma in situ (DCIS)
- Sufficient DCIS tissue available for research
- DCIS size 1cm by mammogram/ultrasound/MRI, or 5mm on one core biopsy, or less than 5mm if identified in at least 2 cores
- Candidate for treatment with selective estrogen receptor modulator or aromatase inhibitor
- Surgery planned as part of local therapy
- Eastern Cooperative Oncology Group performance status 0-1
- Absolute neutrophil count 1.5 x 10^9/L
- Platelet count 100 x 10^9/L
- Hemoglobin 9 g/dl or 5.6 mmol/L
- Creatinine 1.5 times upper limit of normal or creatinine clearance 60 ml/min
- Total bilirubin 1.5 times upper limit of normal, or 2 times for Gilbert's disease
- AST and ALT 2.5 times upper limit of normal
- INR/PT/aPTT 1.5 times upper limit of normal or within therapeutic range if on anticoagulation
- Negative pregnancy test if pre-menopausal
You will not qualify if you...
- Invasive breast cancer larger than 1 mm
- A second cancer within the last 5 years (except treated superficial non-melanoma skin cancer, melanoma in situ, or cervical carcinoma in situ)
- Current hormone replacement therapy, SERM, or aromatase inhibitor without a 30-day washout
- Recurrent ipsilateral DCIS
- Current steroid therapy except for physiologic replacement or allergy pre-medication
- Current immunomodulator therapy including anti-CD20 antibodies
- Autoimmune disease requiring systemic immunosuppression or active autoimmune disease
- History of immune deficiency
- Active infection requiring systemic treatment
- Medical or psychiatric conditions, substance abuse, or lab abnormalities interfering with participation
- Active hepatitis B or hepatitis C infection (except certain antibody-positive patients without active infection)
- Known HIV infection
- Received live vaccine within 30 days before treatment
- Allergies to MUC1 vaccine or Hiltonol adjuvant components
- Participation in another investigational vaccine, drug, or device trial within 30 days
- Pregnant or breastfeeding
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
UPMC Magee Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
Research Team
K
Kelsey Mitch, RN, BSN
CONTACT
L
Lucia Borrasso, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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