Actively Recruiting
A Clinical Study of a 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
134 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
This research aims to evaluate immune responses and prevention strategies in women diagnosed with ductal carcinoma in situ (DCIS), a breast condition detected by screening mammography that can develop into invasive cancer. The study focuses on using a prototype vaccine targeting the MUC1 protein, which is found in DCIS, to potentially reduce the need for aggressive treatments. It also examines immune activation and suppression in both pre- and post-menopausal women to inform future larger trials on preventing breast cancer recurrence. Participants are divided into two groups: one receives hormone therapy alone using either aromatase inhibitors or selective estrogen receptor modulators (SERMs), while the other group receives the same hormone therapy combined with the MUC1 vaccine and an immune-stimulating adjuvant called Hiltonol. The vaccine is given before surgery at baseline, week 2, and week 10, with surgery planned around 12 weeks. Those in the vaccine group may also opt for a booster vaccine six months after surgery. During the study, participants will undergo multiple assessments including blood tests to measure immune response to the vaccine at various time points up to one year. Researchers will monitor adverse events and the timing of planned surgery for up to two years to evaluate safety and feasibility. Overall, this phase 1 trial seeks to gather important data on how the vaccine affects the immune system and potentially prevents disease progression in women with DCIS.
CONDITIONS
Brief 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 at least 1 cm by imaging or at least 5 mm in one biopsy core
- Candidate for selective estrogen receptor modulator or aromatase inhibitor therapy
- Surgery planned as part of local treatment
- Eastern Cooperative Oncology Group performance status 0-1
- Adequate blood counts and organ function as specified
- Negative pregnancy test if pre-menopausal
You will not qualify if you...
- Invasive breast cancer larger than 1 mm
- Second cancer within the last 5 years except certain treated skin or cervical cancers
- Current hormone replacement, SERM, or aromatase inhibitor therapy without 30-day washout
- Recurrent DCIS in the same breast
- Current steroid or immunomodulator therapy except specific low-dose uses
- History of autoimmune disease needing immunosuppression or active autoimmune disease
- Immune deficiency or active infection requiring treatment
- Medical or psychiatric conditions interfering with study participation
- Active hepatitis B or C infection or HIV infection
- Live vaccine within 30 days before study start
- Allergy to vaccine components
- Participation in other investigational drug or vaccine trials within 30 days
- Pregnant or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 20 weeks
Participants receive the MUC1 peptide vaccine with Hiltonol and hormone therapy or hormone therapy alone to evaluate immune activation and prevention of disease recurrence.
Visits at Week 2, Week 4, Week 6, Week 10, Week 12, Week 16, and Week 20
Duration - Up to 2 years
Participants are monitored for adverse events and feasibility of planned surgery after treatment completion.
Periodic visits during follow-up
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
L
Lucia Borrasso, BS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here