Elacestrant versus standard endocrine therapy in women and men with early-stage, lymph node-positive, estrogen receptor-positive, HER2-negative breast cancer at high risk of recurrence: a Phase 3, global, multicenter, randomized, open-label study (ELEGANT).
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Status
ATTIVO
Objective of the study
This trial is being conducted to evaluate the efficacy of elacestrant compared with standard endocrine therapy in participants with early-stage, lymph node-positive, estrogen receptor-positive, HER2-negative breast cancer who are at high risk of recurrence.
ClinicalTrials.gov ID NCT06492616
Sponsor: Stemline Therapeutics, Inc.
Medication
Elacestrant
Who is eligible to participate in the study?
Patients who are 18 years of age or older and who meet the study’s eligibility criteria may participate in this study.
Patients with early-stage, lymph node-positive, ER-positive/HER2-negative breast cancer who have received at least 2 years of adjuvant endocrine therapy, including an aromatase inhibitor (AI) or tamoxifen, with or without a CDK 4/6 inhibitor, and who are currently receiving endocrine therapy, considered to be at high risk of recurrence and recurrence-free (as assessed by the investigator) 2–6 years after curative surgical resection of the primary tumor.
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