Status:
RECRUITING
Prototype DAA/TAA Vaccine Targeting MUC1 for Immune Interception and Prevention in Ductal Carcinoma In Situ
Lead Sponsor:
Finn, Olivera, PhD
Collaborating Sponsors:
A Glimmer of Hope Foundation
Breast Cancer Research Foundation
Conditions:
Ductal Carcinoma in Situ
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
Brief Summary
Post-menopausal women with biopsy-proven DCIS will be enrolled into two cohorts. One cohort will receive neoadjuvant therapy with an aromatase inhibitor alone for about 12 weeks prior to surgery at 12...
Detailed Description
DCIS is frequently detected by screening mammography, and may develop into invasive disease. However, not all DCIS will progress to invasive breast cancer, and some patients are overtreated. Vaccines ...
Eligibility Criteria
Inclusion
- Postmenopausal female, 18 years of age or older (no menstrual period for at least 12 months, biochemical menopausal by FSH/LH or S/P oophorectomy)
- 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 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
Exclusion
- 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
Key Trial Info
Start Date :
February 7 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2028
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06218303
Start Date
February 7 2024
End Date
August 31 2028
Last Update
March 21 2025
Active Locations (1)
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1
UPMC Magee Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213