Ductal Carcinoma in SituPhase 1NCT06218303
Prototype DAA/TAA Vaccine Targeting MUC1 for Immune Interception and Prevention in Ductal Carcinoma In Situ
A Phase 1 study testing MUC1 Peptide Vaccine, Hiltonol® and Aromatase Inhibitor in people with Ductal Carcinoma in Situ, run by Finn, Olivera, PhD at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ductal Carcinoma in Situ
- What is being tested?
- MUC1 Peptide Vaccine, Hiltonol® and Aromatase Inhibitor
- Type of treatment
- Vaccines, Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Feb 2024to 31 Dec 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UPMC Magee Womens Hospital
Pittsburgh, Pennsylvania, 15213
Kelsey Mitch, RN, BSN, 412-623-6793, adamikka2@upmc.edu
Lucia Borrasso, BS, 412-641-3304, borrlm@upmc.edu
About this study
Official title: A Clinical Study of a Prototype DAA/TAA Vaccine Targeting MUC1 for Immune Interception and Prevention in Ductal Carcinoma In Situ
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.
Read the detailed description
Ductal carcinoma in situ (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 for DCIS might facilitate therapeutic de-escalation, and allow less aggressive therapy. The TAA MUC1 is expressed in DCIS, and vaccines specific for MUC1 are safe and decrease the rate of recurrence of high-risk premalignant lesions in colon cancer. This clinical trial is designed to evaluate mechanisms of immune activation and suppression in pre and post-menopausal female patients with DCIS, both within the peripheral blood and within the DCIS lesion, and will provide data to guide the development of larger trials to evaluate the impact of a MUC1 vaccine to prevent disease recurrence. Ultimately, vaccine success in intercepting the development of breast cancer will provide critical data for the application of these strategies in breast cancer prevention in high-risk individuals.
- Conditions
- Ductal Carcinoma in Situ
- Being tested
- MUC1 Peptide Vaccine, Hiltonol®, Aromatase Inhibitor, Selective estrogen receptor modulator (SERM)
- Keywords
- T cells, cancer vaccine, immune checkpoint, lyse tumor cells
- Medical subject headings
- Carcinoma, Intraductal, Noninfiltrating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MUC1 Peptide VaccineBiological
MUC1, a therapeutic vaccine, is a transmembrane glycoprotein and a member of the mucin family of molecules.
Hiltonol®Drug
Also called POLY-ICLC
A synthetic dsRNA viral mimic and host-defense activator, mimics nature by combining the essential elements of human immunity.
Aromatase InhibitorDrug
Also called Anastrozole (Arimidex), Letrozole (Femara), Exemestane (Aromasin)
A type of hormone therapy for cancer used to inhibit aromatase to treat a hormone-related breast cancer.
Selective estrogen receptor modulator (SERM)Drug
Also called Tamoxifen
A type of hormone therapy that blocks cancer cells from being able to use estrogen to grow. prescribed for hormone receptor-positive breast cancer.
| Study group | Role | What they receive |
|---|---|---|
| MUC1 vaccine + adjuvant Hiltonol + Aromatase Inhibitor or SERM | Experimental | MUC1 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.
One of the four endocrine therapy options is selected based upon safety/adverse effect profile and patient tolerance of the medications.
For participants enrolled prior to 10/08/2026, endocrine therapy was based on menopausal status (aromatase inhibitor for post-menopausal, tamoxifen for pre-menopausal). Receives: Biological: MUC1 Peptide Vaccine; Drug: Hiltonol®; Drug: Aromatase Inhibitor; Drug: Selective estrogen receptor modulator (SERM) |
| Aromatase Inhibitor or SERM | Active comparator | 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.
One of the four endocrine therapy options is selected based upon safety/adverse effect profile and patient tolerance of the medications.
For participants enrolled prior to 10/08/2026, endocrine therapy was based on menopausal status (aromatase inhibitor for post-menopausal, tamoxifen for pre-menopausal). Receives: Drug: Aromatase Inhibitor; Drug: Selective estrogen receptor modulator (SERM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At Week 12
Secondary outcomes (2)
Adverse Events and Serious Adverse Events Related to Treatment
Number of AEs and SAEs related to study treatment using Common Terminology Criteria for Adverse Events version 5 (CTCAE v.5).
Measured: Up to 2 years
Feasibility (Time to planned surgery)
Percentage of patients who experience a greater than 4-week variation in the time to planned surgery that is related to study participation.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study start7 Feb 2024
- Primary completion22 Feb 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ductal Carcinoma in SituStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Finn, Olivera, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- A Glimmer of Hope Foundation, Breast Cancer Research Foundation
- Responsible party
- Principal investigator, Emilia J Diego, MD, University of Pittsburgh
- Investigators
- Emilia Diego, MD, Principal investigator, UPMC Magee Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06218303
- Sponsor's protocol ID
- HCC 21-208
- Status last verified
- Oct 2026
- First submitted
- 29 Dec 2023
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study of a Prototype DAA/TAA Vaccine Targeting MUC1 for Immune Interception and Prevention in Ductal Carcinoma In Situ
- ClinicalTrials.gov ID
- NCT06218303
- Acronym / sponsor ID
- HCC 21-208
- Conditions
- Ductal Carcinoma in Situ
- Keywords
- T cells, cancer vaccine, immune checkpoint, lyse tumor cells
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Finn, Olivera, PhDUniversity, hospital or other
- Collaborators
- A Glimmer of Hope Foundation, Breast Cancer Research Foundation
- Study start
- 7 Feb 2024 (actual)
- Primary completion
- 22 Feb 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 23 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Ductal carcinoma in situ (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 for DCIS might facilitate therapeutic de-escalation, and allow less aggressive therapy. The TAA MUC1 is expressed in DCIS, and vaccines specific for MUC1 are safe and decrease the rate of recurrence of high-risk premalignant lesions in colon cancer. This clinical trial is designed to evaluate mechanisms of immune activation and suppression in pre and post-menopausal female patients with DCIS, both within the peripheral blood and within the DCIS lesion, and will provide data to guide the development of larger trials to evaluate the impact of a MUC1 vaccine to prevent disease recurrence. Ultimately, vaccine success in intercepting the development of breast cancer will provide critical data for the application of these strategies in breast cancer prevention in high-risk individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MUC1 vaccine + adjuvant Hiltonol + Aromatase Inhibitor or SERM | Experimental | Biological: MUC1 Peptide Vaccine, Drug: Hiltonol®, Drug: Aromatase Inhibitor, Drug: Selective estrogen receptor modulator (SERM)MUC1 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. One of the four endocrine therapy options is selected based upon safety/adverse effect profile and patient tolerance of the medications. For participants enrolled prior to 10/08/2026, endocrine therapy was based on menopausal status (aromatase inhibitor for post-menopausal, tamoxifen for pre-menopausal). |
| Aromatase Inhibitor or SERM | Active comparator | Drug: Aromatase Inhibitor, Drug: Selective estrogen receptor modulator (SERM)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. One of the four endocrine therapy options is selected based upon safety/adverse effect profile and patient tolerance of the medications. For participants enrolled prior to 10/08/2026, endocrine therapy was based on menopausal status (aromatase inhibitor for post-menopausal, tamoxifen for pre-menopausal). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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
- 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
Key exclusion criteria (16 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MUC1 Peptide VaccineMUC1, a therapeutic vaccine, is a transmembrane glycoprotein and a member of the mucin family of molecules. | Biological | MUC1 vaccine + adjuvant Hiltonol + Aromatase Inhibitor or SERM |
| Hiltonol®Also: POLY-ICLCA synthetic dsRNA viral mimic and host-defense activator, mimics nature by combining the essential elements of human immunity. | Drug | MUC1 vaccine + adjuvant Hiltonol + Aromatase Inhibitor or SERM |
| Aromatase InhibitorAlso: Anastrozole (Arimidex), Letrozole (Femara), Exemestane (Aromasin)A type of hormone therapy for cancer used to inhibit aromatase to treat a hormone-related breast cancer. | Drug | Aromatase Inhibitor or SERM, MUC1 vaccine + adjuvant Hiltonol + Aromatase Inhibitor or SERM |
| Selective estrogen receptor modulator (SERM)Also: TamoxifenA type of hormone therapy that blocks cancer cells from being able to use estrogen to grow. prescribed for hormone receptor-positive breast cancer. | Drug | Aromatase Inhibitor or SERM, MUC1 vaccine + adjuvant Hiltonol + Aromatase Inhibitor or SERM |
Primary outcome
Immunogenicity (of MUC1 vaccine)
Time frame: At Week 12
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).
2 secondary outcomes
Adverse Events and Serious Adverse Events Related to Treatment
Time frame: Up to 2 years
Feasibility (Time to planned surgery)
Time frame: Up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emilia Diego, MD principal investigator
UPMC Magee Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MUC1 Peptide Vaccine, Hiltonol® and Aromatase Inhibitor in people with Ductal Carcinoma in Situ, run by Finn, Olivera, PhD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kelsey Mitch, RN, BSN (412-623-6793, adamkka2@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunogenicity (of MUC1 vaccine) (time frame: At Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026; AzTrials last refreshed its copy on 30 Oct 2026.