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HER2 Negative Breast Cancer / DC1 native/mutated ESR1 / Elacestrant · Phase 1 Trial
ClinicalTrials.gov · August 18, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 1 pilot study registration for a combination of dendritic cell vaccines targeting ESR1 mutations with elacestrant in hormone receptor-positive HER2-negative metastatic breast cancer. The study is designed to evaluate feasibility and safety over 2 years; no results are reported in this registry record.
Phase 1, Interventional, Single Group, Open label, Treatment purpose. Breast Cancer Metastatic Breast Cancer, HER2-negative Breast Cancer; age from 18 Years. Intervention: Elacestrant + DC1. n = 18. 1 site: United States.
This is a Phase 1 pilot study registration for a combination of dendritic cell vaccines targeting ESR1 mutations with elacestrant in hormone receptor-positive HER2-negative metastatic breast cancer. The study is designed to evaluate feasibility and safety over 2 years; no results are reported in this registry record.
No efficacy endpoints reported; primary outcomes are feasibility and safety, not clinical benefit.
This pilot study will inform feasibility and safety of combining dendritic cell immunotherapy with elacestrant; results are not yet available and cannot guide clinical practice at this time.
Phase 1 pilot study of a novel dendritic cell vaccine combined with elacestrant in metastatic breast cancer; designed to assess feasibility and safety, not efficacy, with no results yet reported in this registry record.
As stated by the source record.
Quoted from the source exactly as published.
This pilot study will inform feasibility and safety of combining dendritic cell immunotherapy with elacestrant; results are not yet available and cannot guide clinical practice at this time.
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 (NCT06691035). This is a study registration, not published results. Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 18 participants (ACTUAL). Conditions: Breast Cancer Metastatic Breast Cancer, HER2-negative Breast Cancer. Interventions: DRUG: Elacestrant; BIOLOGICAL: DC1 native/mutated ESR1. Primary outcome measures: Rate of Successful Completion , Up to 2 years; Occurrence Rate , Up to 2 years; Occurrence of Treatment Related Adverse Events , Up to 2 years. Brief summary: This is a pilot study to determine feasibility and safety of the combination of Dendritic Cell (DC1) vaccines and elacestrant in patients with hormone positive HER2 negative metastatic breast cancer.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.