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Elacestrant / Standard-of-care endocrine treatment / Breast Cancer · Phase 3 Trial
ClinicalTrials.gov · August 7, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 3 randomized controlled trial registration for adjuvant elacestrant versus standard endocrine therapy in HR+/HER2− early breast cancer patients selected for intermediate to high genomic or clinical risk. No results are posted in this registry record; the trial is actively recruiting and outcome data are not yet available.
Phase 3, Interventional, Randomized, Parallel, Open label, Treatment purpose. Breast Cancer, HR+/HER2- Breast Cancer; age from 18 Years. Intervention: Elacestrant upfront (ELA). Compared with: Standard-of-care endocrine treatment (SoC-ET) — Active Comparator. n = 1,520. 33 sites: Germany.
This is a Phase 3 randomized controlled trial registration for adjuvant elacestrant versus standard endocrine therapy in HR+/HER2− early breast cancer patients selected for intermediate to high genomic or clinical risk. No results are posted in this registry record; the trial is actively recruiting and outcome data are not yet available.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
This trial will assess whether adjuvant elacestrant (with or without CDK 4/6 inhibitors) followed by standard endocrine therapy improves 5-year invasive disease-free survival compared to standard endocrine therapy alone in genomically or clinically high-risk HR+/HER2− early breast cancer. Results are not yet available and clinicians should await outcome reporting.
This is a Phase 3 trial registration with no posted results; the study is actively recruiting and has not yet generated outcome data.
As stated by the source record.
Quoted from the source exactly as published.
This trial will assess whether adjuvant elacestrant (with or without CDK 4/6 inhibitors) followed by standard endocrine therapy improves 5-year invasive disease-free survival compared to standard endocrine therapy alone in genomically or clinically high-risk HR+/HER2− early breast cancer. Results are not yet available and clinicians should await outcome reporting.
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 (NCT07242352). This is a study registration, not published results. Lead sponsor: Women's Cancer Study Group GmbH. Recruitment status: RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 1520 participants (ESTIMATED). Conditions: Breast Cancer, HR+/HER2- Breast Cancer. Interventions: DRUG: Elacestrant; DRUG: Standard-of-care endocrine treatment. Primary outcome measures: 5-year invasive disease-free survival (iDFS) , iDFS 5 years. Brief summary: In this clinical trial, the Sponsor plans to investigate whether patients with HR+/HER2- eBC identified during routine clinical assessments and treatments as having intermediate to high-risk (based on Oncotype DX® or similar tests and on response assessment to 2-6 weeks of preoperative ET) achieve a survival benefit from an initial 5-years use of elacestrant (with or without a CDK 4/6 inhibitor) followed by SoC ET for further 0-2.5 years in comparison to at least 5 up to 7.5 years SoC ET therapy (+/- CDK4/6 inhibitor). Based on several studies in the metastatic setting, it is reasonable to assume that the adjuvant use of elacestrant with or without CDK 4/6 inhibitors will prevent or delay the activation of mechanisms conferring resistance to ET (e.g., ESR1 mutations).
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.