Prototype DAA/TAA Vaccine Targeting MUC1 for Immune Interception and Prevention in Ductal Carcinoma In Situ
Sponsor: Finn, Olivera, PhD • ClinicalTrials.gov ID: NCT06218303
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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.
Interventions
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MUC1 Peptide Vaccine
(Biological)
MUC1, a therapeutic vaccine, is a transmembrane glycoprotein and a member of the mucin family of molecules.
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Hiltonol®
(Drug)
A synthetic dsRNA viral mimic and host-defense activator, mimics nature by combining the essential elements of human immunity.
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Aromatase Inhibitor
(Drug)
A type of hormone therapy for cancer used to inhibit aromatase to treat a hormone-related breast cancer.
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Selective estrogen receptor modulator (SERM)
(Drug)
A type of hormone therapy that blocks cancer cells from being able to use estrogen to grow. prescribed for hormone receptor-positive breast cancer.
Eligibility criteria
Conditions
Locations
- UPMC Magee Womens Hospital — Pittsburgh, Pennsylvania, United States
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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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