eligibility_summary
Eligible: postmenopausal women ≥18 with biopsy‑proven ER+ DCIS (adequate tissue, bilateral eligible if both ER+), lesion ≥1 cm by imaging or ≥5 mm on one core (or smaller if in ≥2 cores), AI candidate, surgery planned, ECOG 0–1, adequate marrow, renal, hepatic, and coagulation. Exclude: invasive cancer >1 mm, recent malignancy, current HRT/SERM/AI (needs 30‑day washout), recurrent ipsilateral DCIS, steroids/immunomodulators, autoimmune/immunodeficiency, active infection, HBV/HCV RNA+/HIV, live vaccine <30 d, allergy to MUC1/Hiltonol, investigational therapy <30 d.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 1 neoadjuvant trial in ER+ DCIS comparing aromatase inhibitor (AI) alone vs AI plus a MUC1 peptide vaccine with Hiltonol (poly-ICLC) adjuvant. Interventions and mechanisms: 1) MUC1 peptide vaccine (biologic, therapeutic cancer vaccine) aims to elicit MUC1-specific CD4+ and CD8+ T-cell and antibody responses against tumor-associated MUC1. 2) Hiltonol/poly-ICLC (drug, synthetic dsRNA adjuvant, TLR3/MDA5 agonist) activates dendritic cells, induces type I interferons, primes NK cells, and enhances cross-priming of CTLs. 3) Aromatase inhibitors—anastrozole, letrozole, or exemestane (small-molecule endocrine therapy)—inhibit CYP19A1 to lower estrogen, suppressing ER signaling. Targets: MUC1-expressing DCIS cells, estrogen/ER pathway in tumor cells, innate TLR3–IFN axis in APCs, adaptive CD4+/CD8+ T-cell responses to mediate tumor cell lysis.