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HER2 Negative Breast Cancer / Elacestrant / Anastrozole 1mg · Phase 3 Trial
ClinicalTrials.gov · August 10, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 3 registration for an active, multicentre, randomised superiority trial comparing elacestrant to standard endocrine therapy in ER+/HER2− breast cancer patients with ctDNA relapse but no distant metastasis. No efficacy or safety results are yet available in this registry record.
Phase 3, Interventional, Randomized, Parallel, Open label, Treatment purpose. ER-positive Breast Cancer, HER2-negative Breast Cancer, Stage IIB Breast Cancer, Stage III Breast Cancer; age from 18 Years. Intervention: Experimental arm. Compared with: Control arm — Active Comparator. n = 220. 111 sites across 12 countries.
This is a Phase 3 registration for an active, multicentre, randomised superiority trial comparing elacestrant to standard endocrine therapy in ER+/HER2− breast cancer patients with ctDNA relapse but no distant metastasis. No efficacy or safety results are yet available in this registry record.
This is a study registration only; no efficacy, safety, or outcome data are reported.
The source did not state who this applies to in practice.
This is a recruiting Phase 3 trial registration with no results posted; the study design is rigorous but outcomes are not yet reported, making it a planned intervention study only.
As stated by the source record.
Quoted from the source exactly as published.
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 (NCT05512364). This is a study registration, not published results. Lead sponsor: European Organisation for Research and Treatment of Cancer - EORTC. Recruitment status: RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 220 participants (ESTIMATED). Conditions: ER-positive Breast Cancer, HER2-negative Breast Cancer, Stage IIB Breast Cancer, Stage III Breast Cancer. Interventions: DRUG: Elacestrant; DRUG: Tamoxifen; DRUG: Letrozole 2.5mg; DRUG: Anastrozole 1mg; DRUG: Exemestane 25 MG. Primary outcome measures: Distant metastasis free survival (DMFS) , Final DFMS will be 6.25 years after the first patient randomised.. Brief summary: This is an international, multi-center, randomised, open label, superiority phase III trial of elacestrant vs standard endocrine therapy in patients with ER+/HER2- breast cancer and ctDNA relapse. During the ctDNA screening phase, patients will be tested at different timepoints to detect the presence of ctDNA in their blood. Patients who are found to be ctDNA-positive and have no evidence of distant metastasis, will be randomised 1:1 between standard endocrine treatment (the same they were receiving when tested ctDNA positive) versus elacestrant, provided they meet all eligibility criteria. After completion of the protocol treatment period, treatment will be left at the discretion of the treating physician.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.