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Ductal Carcinoma in Situ / MUC1 Peptide Vaccine / Selective estrogen receptor modulator (SERM) · Phase 1 Trial
ClinicalTrials.gov · August 18, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 1 trial registration for a novel MUC1 peptide vaccine combined with hormone therapy in women with ductal carcinoma in situ. The trial is actively recruiting and aims to assess immunogenicity by week 12; no results are yet reported in this registry record, and clinical efficacy outcomes are not listed as primary endpoints.
Phase 1, Interventional, Randomized, Parallel, Open label, Treatment purpose. Ductal Carcinoma in Situ; Female; age from 18 Years. Intervention: MUC1 vaccine + adjuvant Hiltonol + Aromatase Inhibitor or S…. Compared with: Aromatase Inhibitor or SERM — Active Comparator. n = 50. 1 site: United States.
This is a Phase 1 trial registration for a novel MUC1 peptide vaccine combined with hormone therapy in women with ductal carcinoma in situ. The trial is actively recruiting and aims to assess immunogenicity by week 12; no results are yet reported in this registry record, and clinical efficacy outcomes are not listed as primary endpoints.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
This early-phase work aims to establish whether a MUC1 vaccine can be safely administered and generate an immune response in DCIS; results are not yet available and clinicians should not base any treatment decisions on this registry record alone.
Phase 1 trial in early-stage development testing immunogenicity of a novel MUC1 vaccine in DCIS; no efficacy or clinical outcomes reported, and results are not yet posted in this registry record.
As stated by the source record.
Quoted from the source exactly as published.
This early-phase work aims to establish whether a MUC1 vaccine can be safely administered and generate an immune response in DCIS; results are not yet available and clinicians should not base any treatment decisions on this registry record alone.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT06218303). This is a study registration, not published results. Lead sponsor: Finn, Olivera, PhD. Recruitment status: RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 50 participants (ESTIMATED). Conditions: Ductal Carcinoma in Situ. Interventions: BIOLOGICAL: MUC1 Peptide Vaccine; DRUG: Hiltonol®; DRUG: Aromatase Inhibitor; DRUG: Selective estrogen receptor modulator (SERM). Primary outcome measures: Immunogenicity (of MUC1 vaccine) , At Week 12. Brief 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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.