Prototype DAA/TAA Vaccine Targeting MUC1 for Immune Interception and Prevention in Ductal Carcinoma In Situ

Recruiting now · Phase 1

Conditions studied: Ductal Carcinoma in Situ

In brief

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.

Key facts

Study ID: NCT06218303
Run by: Finn, Olivera, PhD
People needed: 50
Starts: 2024-02-07
Expected to finish: 2029-03-31
Last updated by the study team: 2026-03-12

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

Females, 18 years of age or older. Pre-menopausal women must use an effective method of contraception during the study.
Capable of providing informed consent and willing to comply with study procedures
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
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
Candidate for selective estrogen receptor modulator or aromatase inhibitor
Surgery planned as part of definitive local therapy
ECOG PS 0-1
Absolute neutrophil count ≥ 1.5 x 109/L
Platelet count ≥ 100 x 109/L
Hemoglobin ≥ 9 g/dl or ≥ 5.6 mmol/L
Creatinine ≤ 1.5X the upper limit of normal OR creatinine clearance ≥ 60 ml/min
Total bilirubin ≤ 1.5X the ULN; ≤ 2x ULN for patients with Gilbert's disease
AST and ALT ≤ 2.5X ULN
INR/PT/aPTT ≤ 1.5X ULN or within the therapeutic range if on anti-coagulation
If pre-menopausal, negative urine or serum pregnancy test

You may not qualify if…

Invasive breast cancer > 1mm on pathologic evaluation
Second malignancy within the last 5 years (definitively treated superficial non-melanoma skin cancer, melanoma in situ, cervical carcinoma in situ allowed)
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
Recurrent ipsilateral DCIS
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)
Current Immunomodulator therapy (includes anti-CD20 antibodies)
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.
History of immune deficiency
Active infection requiring systemic therapy
Any medical or psychiatric condition, substance abuse disorder, medical therapy, or laboratory abnormality that might interfere with the patient's participation for the full duration of the study or compliance with the requirements of the study
Known active hepatitis B (hepatitis B surface antigen-reactive) or hepatitis C (hepatitis C virus RNA positive). Patients who are hepatitis B core antibody positive without hepatitis B surface antigen reactivity are eligible. Patients who have antibody for hepatitis C are eligible only if hepatitis C RNA is negative by PCR.
Known history of HIV (presence of HIV antibodies for HIV 1 and HIV 2)
Received a live vaccine within 30 days of the first dose of treatment
History of allergies to any component of the MUC1 vaccine or HiltonolR adjuvant
Participation on any investigational vaccine, drug, or device trial within the last 30 days
Pregnant or breastfeeding

Where it is running

UPMC Magee Womens Hospital — Pittsburgh, Pennsylvania, United States (enrolling)

Full record on ClinicalTrials.gov

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