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Treating ER+/HER2− ESR1m mBC: EMERALD Subgroup Analyses in Clinical Cancer Research

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Publication update: Phase III trial investigated a treatment for ER+/HER2− ESR1m metastatic breast cancer. Hear key findings from an exploratory subgroup analyses.

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  • Overview

    Elacestrant, the first oral selective estrogen receptor degrader, shows improved efficacy over endocrine monotherapy for the management of ER-positive/HER2-negative advanced or metastatic breast cancer in the randomized Phase III EMERALD trial.1 Post hoc analyses sought to better define treatment selection in subgroups of patients with ESR1-mutated tumors, examining factors like prior treatment duration and clinically relevant tumor characteristics.2 Joining Dr. Jennifer Caudle to discuss the key findings of these analyses and their implications is Dr. Komal Jhaveri. Dr. Jhaveri is a breast medical oncologist and early drug development specialist at Memorial Sloan Kettering Cancer Center in New York.

  • INDICATION

    Elacestrant is indicated for the treatment of postmenopausal women or adult men with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.

  • IMPORTANT SAFETY INFORMATION

    Warnings and Precautions

    • Dyslipidemia: Hypercholesterolemia and hypertriglyceridemia occurred in patients taking elacestrant at an incidence of 30% and 27%, respectively. The incidence of Grade 3 and 4 hypercholesterolemia and hypertriglyceridemia were 0.9% and 2.2%, respectively. Monitor lipid profile prior to starting and periodically while taking elacestrant.
    • Embryo-Fetal Toxicity: Based on findings in animals and its mechanism of action, elacestrant can cause fetal harm when administered to a pregnant woman. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with elacestrant and for 1 week after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with elacestrant and for 1 week after the last dose.

    Adverse Reactions

    • Serious adverse reactions occurred in 12% of patients who received elacestrant. Serious adverse reactions in >1% of patients who received elacestrant were musculoskeletal pain (1.7%) and nausea (1.3%). Fatal adverse reactions occurred in 1.7% of patients who received elacestrant, including cardiac arrest, septic shock, diverticulitis, and unknown cause (one patient each).
    • The most common adverse reactions (≥10%), including laboratory abnormalities, of elacestrant were musculoskeletal pain (41%), nausea (35%), increased cholesterol (30%), increased AST (29%), increased triglycerides (27%), fatigue (26%), decreased hemoglobin (26%), vomiting (19%), increased ALT (17%), decreased sodium (16%), increased creatinine (16%), decreased appetite (15%), diarrhea (13%), headache (12%), constipation (12%), abdominal pain (11%), hot flush (11%), and dyspepsia (10%).

    Drug Interactions

    • Concomitant use with CYP3A4 inducers and/or inhibitors: Avoid concomitant use of strong or moderate CYP3A4 inhibitors with elacestrant. Avoid concomitant use of strong or moderate CYP3A4 inducers with elacestrant.

    Use in Specific Population

    • Lactation: Advise lactating women to not breastfeed during treatment with elacestrant and for 1 week after the last dose.
    • Hepatic Impairment: Avoid use of elacestrant in patients with severe hepatic impairment (Child-Pugh C). Reduce the dose of elacestrant in patients with moderate hepatic impairment (Child-Pugh B).

    The safety and effectiveness of elacestrant in pediatric patients have not been established.

    Elacestrant is available as 345 mg tablets and 86 mg tablets.

    To report SUSPECTED ADVERSE REACTIONS, contact Stemline Therapeutics, Inc. at 1-877-332-7961 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    Please see full Prescribing Information, including Patient Information.

    References:

    1. Bidard FC, Kaklamani VG, Neven P, et al. Elacestrant (oral selective estrogen receptor degrader) versus standard endocrine therapy for estrogen receptor–positive, human epidermal growth factor receptor 2–negative advanced breast cancer: results from the randomized phase III EMERALD trial. J Clin Oncol. 2022;40(28):3246-3256. doi:10.1200/JCO.22.00338
    2. Bardia A, Cortés J, Bidard FC, et al. Elacestrant in ER+, HER2− metastatic breast cancer with ESR1 -mutated tumors: subgroup analyses from the phase III EMERALD trial by prior duration of endocrine therapy plus CDK4/6 inhibitor and in clinical subgroups. Clin Cancer Res. 2024;30(19):4299-4309. doi:10.1158/1078-0432.CCR-24-1073

     

    MED-05284 / Copyright 2025 - Stemline Therapeutics, Inc.
    All rights reserved. 03/25

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