RecruitingPhase 1NCT06218303

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


Sponsor

Finn, Olivera, PhD

Enrollment

50 participants

Start Date

Feb 7, 2024

Study Type

INTERVENTIONAL

Conditions

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. 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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new vaccine designed to train the immune system to recognize and potentially eliminate ductal carcinoma in situ (DCIS) — a very early, non-invasive form of breast cancer — before it can progress. The vaccine targets a protein called MUC1 that is abnormally expressed on DCIS cells. **You may be eligible if...** - You are a woman 18 or older with a confirmed biopsy diagnosis of estrogen receptor-positive (ER+) DCIS at least 1 cm in size - You are planning to have surgery as part of your treatment - You are a candidate for hormone-blocking medications (SERMs or aromatase inhibitors) - Your blood counts and organ function are within acceptable ranges **You may NOT be eligible if...** - Your biopsy showed invasive breast cancer greater than 1 mm - You have had another cancer within the past 5 years (some exceptions apply) - You are currently on hormone replacement therapy or related medications without a 30-day washout period - You have had a prior DCIS in the same breast - You are on immunosuppressive medications or have an active autoimmune disease - You are pregnant or pre-menopausal without adequate contraception Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALMUC1 Peptide Vaccine

MUC1, a therapeutic vaccine, is a transmembrane glycoprotein and a member of the mucin family of molecules.

DRUGHiltonol®

A synthetic dsRNA viral mimic and host-defense activator, mimics nature by combining the essential elements of human immunity.

DRUGAromatase Inhibitor

A type of hormone therapy for cancer used to inhibit aromatase to treat a hormone-related breast cancer.

DRUGSelective estrogen receptor modulator (SERM)

A type of hormone therapy that blocks cancer cells from being able to use estrogen to grow. prescribed for hormone receptor-positive breast cancer.


Locations(1)

UPMC Magee Womens Hospital

Pittsburgh, Pennsylvania, United States

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NCT06218303


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