← Back to Search

Cancer Vaccine

MUC1 vaccine + adjuvant Hiltonol + Aromatase Inhibitor for Ductal Carcinoma

Phase 1
Recruiting
Led By Emilia Diego, MD
Research Sponsored by Finn, Olivera, PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Postmenopausal female, 18 years of age or older (no menstrual period for at least 12 months, or S/P oophorectomy)
Candidate for aromatase inhibitor
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at screening, week 2, week 4, week 6, week 10, week 12, week 16, week 20, up to 1 year
Awards & highlights

Study Summary

This trial is enrolling post-menopausal women with a condition called DCIS. There are two groups in the trial. One group will receive a medication called an aromatase inhibitor for about

Who is the study for?
This trial is for post-menopausal women who have been diagnosed with a type of breast cancer known as Ductal Carcinoma In Situ (DCIS). The key eligibility criteria are not provided, but typically participants would need to meet certain health standards and agree to the treatment schedule.Check my eligibility
What is being tested?
The study is testing two approaches in treating DCIS. One group will receive an aromatase inhibitor alone, while the other will get both an aromatase inhibitor and a new MUC1 peptide vaccine combined with Hiltonol® before surgery. There's also an optional booster shot of the vaccine six months after surgery.See study design
What are the potential side effects?
While specific side effects are not listed, vaccines can cause reactions at the injection site, flu-like symptoms, and allergic responses. Aromatase inhibitors may lead to joint pain, hot flashes, and osteoporosis.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a woman over 18 and have not had a period for at least 12 months or have had my ovaries removed.
Select...
I am eligible for aromatase inhibitor therapy.
Select...
I am fully active or can carry out light work.
Select...
My kidney function is within the normal range.
Select...
My biopsy shows I have ER+ ductal carcinoma in situ.
Select...
I have a tissue sample with DCIS available for research.
Select...
I am scheduled for surgery as part of my main cancer treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at screening, week 2, week 4, week 6, week 10, week 12, week 16, week 20, up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and at screening, week 2, week 4, week 6, week 10, week 12, week 16, week 20, up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Immunogenicity (of MUC1 vaccine)
Secondary outcome measures
Adverse Events and Serious Adverse Events Related to Treatment
Feasibility (Time to planned surgery)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: MUC1 vaccine + adjuvant Hiltonol + Aromatase InhibitorExperimental Treatment3 Interventions
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
Group II: Aromatase InhibitorActive Control1 Intervention
Anastrozole 1 mg, letrozole 2.5 mg, or exemestane 25 mg by mouth daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aromatase Inhibitor
2012
Completed Phase 4
~910

Find a Location

Who is running the clinical trial?

Finn, Olivera, PhDLead Sponsor
A Glimmer of Hope FoundationUNKNOWN
Breast Cancer Research FoundationOTHER
69 Previous Clinical Trials
137,717 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new patients currently being enrolled in this ongoing medical study?

"According to the details provided on clinicaltrials.gov, this particular trial is not currently seeking participants. The trial was first listed on 1/31/2024 and last updated on 1/11/2024. However, it's important to note that there are presently 2535 other trials actively enrolling patients at this time."

Answered by AI

Has the combination therapy involving MUC1 vaccine, adjuvant Hiltonol, and Aromatase Inhibitor received approval from the FDA?

"Based on the trial phase being Phase 1, our team at Power rates the safety of MUC1 vaccine + adjuvant Hiltonol + Aromatase Inhibitor as a 1. This indicates that there is only limited data available to support both safety and efficacy."

Answered by AI

Who else is applying?

What site did they apply to?
UPMC Magee Womens Hospital
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I have not had treatment yet for DCIS.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Prototype DAA/TAA Vaccine Targeting MUC1 for Immune Interception and Prevention in Ductal Carcinoma In Situ
Emilia J Diego, MD 2024. "Prototype DAA/TAA Vaccine Targeting MUC1 for Immune Interception and Prevention in Ductal Carcinoma In Situ". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06218303.
All > Paid Studies Pittsburgh > Dcis
~33 spots leftby Jan 2026
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top