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 a

Trial Details

NCT ID
NCT06218303
Phase
PHASE1
Sponsor
Finn, Olivera, PhD
Status
RECRUITING
Cancer Type
Lobular Carcinoma Breast Cancer
Interventions
  • MUC1 Peptide Vaccine
  • Hiltonol®
  • Aromatase Inhibitor
  • Selective estrogen receptor modulator (SERM)
Locations (sample)
  • Pittsburgh, Pennsylvania, United States|40.44062,-79.99589

Key Eligibility Criteria

  • 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

For full eligibility, visit ClinicalTrials.gov.

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