RecruitingPhase 1

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Biopsies

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Women with biopsy-proven ductal carcinoma in situ (DCIS) will be enrolled into two cohorts."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests hormone-blocking medicine with or without a MUC1 vaccine before breast surgery. It is for women with estrogen receptor-positive (ER+) ductal carcinoma in situ (DCIS), abnormal cells inside the breast milk ducts that respond to estrogen. Surgery is planned for about 12 weeks later, and women in the vaccine group may choose an extra vaccine dose 6 months after surgery.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Women age 18 or older who can give consent and follow study steps.
  • A biopsy must show ER+ DCIS, with enough tissue left for research. Possible tiny areas of spread outside the ducts are allowed.
  • If DCIS is in both breasts, both areas must be ER+ and meet the tissue requirements.
  • DCIS must measure at least 1 cm on a breast scan, at least 5 mm in one biopsy sample, or less than 5 mm if found in at least two samples.
  • Must be able to take hormone-blocking medicine and have breast surgery planned.
  • Must be fully active or able to walk and do light work despite some limits on hard physical activity.
  • Blood tests must meet study limits for blood cells, kidney and liver health, and blood clotting.
  • Women who have not gone through menopause must use effective birth control and have a negative pregnancy test.

Who can't join

  • Breast cancer that has spread more than 1 mm outside the ducts, or DCIS that has returned in the same breast.
  • Another cancer within 5 years, except certain fully treated surface skin cancers or melanoma or cervical cancer that has not spread beyond its starting layer.
  • Current hormone replacement or hormone-blocking medicine unless stopped at least 30 days before the study's starting biopsy; current steroid or immune-changing medicine, with some steroid exceptions.
  • An active autoimmune disease, where the immune system attacks the body, or a history of one needing whole-body immune-suppressing treatment; a history of weak immune defenses. Certain hormone replacement treatments are allowed.
  • An active infection needing whole-body treatment, active hepatitis B or C, or a known history of HIV. Some past hepatitis infections are allowed based on blood tests.
  • Pregnancy or breastfeeding, or another health condition, mental health condition, substance use problem, treatment, or test result that could prevent full participation.
  • A live vaccine within 30 days before treatment, or participation in another trial of an experimental vaccine, drug, or device within the past 30 days.
  • An allergy to any part of the MUC1 vaccine or Hiltonol, an ingredient used with the vaccine.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 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 5. Candidate for selective estrogen receptor modulator or aromatase inhibitor 6. Surgery planned as part of definitive local therapy 7. ECOG PS 0-1 8. Absolute neutrophil count ≥ 1.5 x 109/L 9. Platelet count ≥ 100 x 109/L 10. Hemoglobin ≥ 9 g/dl or ≥ 5.6 mmol/L 11. Creatinine ≤ 1.5X the upper limit of normal OR creatinine clearance ≥ 60 ml/min 12. Total bilirubin ≤ 1.5X the ULN; ≤ 2x ULN for patients with Gilbert's disease 13. AST and ALT ≤ 2.5X ULN 14. INR/PT/aPTT ≤ 1.5X ULN or within the therapeutic range if on anti-coagulation 15. If pre-menopausal, negative urine or serum pregnancy test Exclusion Criteria: 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 9. Active infection requiring systemic therapy 10. 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 11. 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. 12. Known history of HIV (presence of HIV antibodies for HIV 1 and HIV 2) 13. Received a live vaccine within 30 days of the first dose of treatment 14. History of allergies to any component of the MUC1 vaccine or HiltonolR adjuvant 15. Participation on any investigational vaccine, drug, or device trial within the last 30 days 16. Pregnant or breastfeeding

Study sites (1)

PA