Clinical Trial

Elacestrant in Patients With ER+ HER2- ESR1-mutated Locally Advanced or Metastatic Breast Cancer

Study acronym: ELENI
Recruiting
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Summary
The objective of this non-interventional study (NIS) is to evaluate prevalence of ESR1 mutation after endocrine therapy in the palliative setting, quality of life, tolerability, and safety and to describe treatment detail and adverse event (AE) management in postmenopausal women with locally advanced and/or metastatic ER+ HER2- ESR1-mutated breast cancer and second line treatment with elacestrant according to SmPC (Summary of product characteristics) in a real-world setting.
Protocol Amendment History 3 changes
critical Recruitment opened 2026-06-26
notable Primary completion pushed: 2028-05 -> 2028-06 2026-06-26
minor Completion moved earlier: 2029-07 -> 2028-06 2026-06-26
Trial Details
NCT Number NCT07563595
Lead Sponsor iOMEDICO AG
Collaborators: Berlin Chemie AG
Conditions Breast Cancer
Enrollment 500 participants
Start Date 2026-06-19
Primary Completion 2028-06 (estimated)
Study Completion 2028-06 (estimated)
Updated on ClinicalTrials.gov 2026-06-25