Prototype DAA/TAA Vaccine Targeting MUC1 for Immune Interception and Prevention in Ductal Carcinoma In Situ
A Clinical Study of a Prototype DAA/TAA Vaccine Targeting MUC1 for Immune Interception and Prevention in Ductal Carcinoma In Situ
1 other identifier
interventional
50
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Feb 2024
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 29, 2023
CompletedFirst Posted
Study publicly available on registry
January 23, 2024
CompletedStudy Start
First participant enrolled
February 7, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2029
March 12, 2026
March 1, 2026
2.6 years
December 29, 2023
March 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Immunogenicity (of MUC1 vaccine)
Percentage of patients with a 2-fold or greater increase in serum anti-MUC1 IgG from screening date. Serum IgG is measured using enzyme-linked immunosorbent assay (ELISA).
At Screening, Week 2, Week 4, Week 6, Week 10, Week 12, Week 16, Week 20, Up to 1 year
Secondary Outcomes (2)
Adverse Events and Serious Adverse Events Related to Treatment
Up to 2 years
Feasibility (Time to planned surgery)
Up to 2 years
Study Arms (2)
MUC1 vaccine + adjuvant Hiltonol + Aromatase Inhibitor or SERM
EXPERIMENTALMUC1 peptide vaccine with poly-ICLC adjuvant Hiltonol administered subcutaneously (SQ) Anastrozole 1 mg, letrozole 2.5 mg, or exemestane 25 mg by mouth daily or Selective estrogen receptor modulator (SERM) - Tamoxifen 20 mg by mouth daily (pre-menopausal)
Aromatase Inhibitor or SERM
ACTIVE COMPARATORAnastrozole 1 mg, letrozole 2.5 mg, or exemestane 25 mg by mouth daily (post-menopausal) or Selective estrogen receptor modulator (SERM) - Tamoxifen 20 mg by mouth daily (pre-menopausal)
Interventions
A type of hormone therapy for cancer used to inhibit aromatase to treat a hormone-related breast cancer.
A type of hormone therapy that blocks cancer cells from being able to use estrogen to grow. prescribed for hormone receptor-positive breast cancer.
A synthetic dsRNA viral mimic and host-defense activator, mimics nature by combining the essential elements of human immunity.
MUC1, a therapeutic vaccine, is a transmembrane glycoprotein and a member of the mucin family of molecules.
Eligibility Criteria
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
- +4 more criteria
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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Finn, Olivera, PhDlead
- A Glimmer of Hope Foundationcollaborator
- Breast Cancer Research Foundationcollaborator
Study Sites (1)
UPMC Magee Womens Hospital
Pittsburgh, Pennsylvania, 15213, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Emilia Diego, MD
UPMC Magee Women's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Surgery
Study Record Dates
First Submitted
December 29, 2023
First Posted
January 23, 2024
Study Start
February 7, 2024
Primary Completion (Estimated)
August 31, 2026
Study Completion (Estimated)
March 31, 2029
Last Updated
March 12, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share