Prototype DAA/TAA Vaccine Targeting MUC1 for Immune Interception and Prevention in Ductal Carcinoma In Situ
Eligible age
18+ yrs
Accepts
Women
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: Finn, Olivera, PhD
You may qualify if…
- ✓ 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 invasion on final pathology
- ✓ Women presenting with concurrent bilateral DCIS are eligible only if both the right and left DCIS lesions are ER+, and tissue from both sides will be analyzed and must meet the criteria below
- ✓ 4. DCIS must be ≥ 1cm based on the extent of calcifications on mammogram, the presence of a mass on ultrasound or enhancement on MRI OR DCIS ≥ 5mm on one single core by pathologic evaluation OR DCIS \< 5mm if identified in ≥ 2 cores
You may not qualify if…
- ✕ 1. Invasive breast cancer \> 1mm on pathologic evaluation
- ✕ 2. Second malignancy within the last 5 years (definitively treated superficial non-melanoma skin cancer, melanoma in situ, cervical carcinoma in situ allowed)
- ✕ 3. Current hormone replacement therapy, selective estrogen receptor modulator therapy, or aromatase inhibitor therapy--if yes, wash out of 30 days must occur prior to baseline biopsy for the study
- ✕ 4. Recurrent ipsilateral DCIS
- ✕ 5. Current steroid therapy (doses for physiologic replacement in adrenal dysfunction or for contrast allergy pre-medication for contrast allergy or similar indication allowed, topical, ocular and intranasal steroids allowed)
- ✕ 6. Current Immunomodulator therapy (includes anti-CD20 antibodies)
- ✕ 7. History of autoimmune disease requiring systemic immunosuppression, or active autoimmune disease. Replacement therapy with thyroxine, insulin, and physiologic corticosteroids for adrenal or pituitary insufficiency is acceptable.
- ✕ 8. History of immune deficiency
Where it's recruiting
Pittsburgh
Source: ClinicalTrials.gov · NCT06218303 · last updated 2026-03-12