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Prevention study for Ductal Carcinoma in Situ
Official title Prototype DAA/TAA Vaccine Targeting MUC1 for Immune Interception and Prevention in Ductal Carcinoma In Situ
ClinicalTrials.gov ID: NCT06218303
What this study is testing
What is MUC1 Peptide Vaccine?
MUC1 Peptide Vaccine is an investigational medicine, being studied as a potential treatment for ductal carcinoma in situ.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Time commitment: about 12 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join 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
You likely can't join 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...
- Current hormone replacement therapy, selective estrogen receptor modulator therapy, or aromatase inhibitor therapy--if yes, wash out of 30 days must...
- Recurrent ipsilateral DCIS
- Current steroid therapy (doses for physiologic replacement in adrenal dysfunction or for contrast allergy pre-medication for contrast allergy or...
- Current Immunomodulator therapy (includes anti-CD20 antibodies)
See the full eligibility criteria
- 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...
- 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
- 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...
- 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Pittsburgh, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Pittsburgh, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.