0 256

Cited 209 times in

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

 Francois-Clement Bidard  ;  Virginia G Kaklamani  ;  Patrick Neven  ;  Guillermo Streich  ;  Alberto J Montero  ;  Frédéric Forget  ;  Marie-Ange Mouret-Reynier  ;  Joo Hyuk Sohn  ;  Donatienne Taylor  ;  Kathleen K Harnden  ;  Hung Khong  ;  Judit Kocsis  ;  Florence Dalenc  ;  Patrick M Dillon  ;  Sunil Babu  ;  Simon Waters  ;  Ines Deleu  ;  José A García Sáenz  ;  Emilio Bria  ;  Marina Cazzaniga  ;  Janice Lu  ;  Philippe Aftimos  ;  Javier Cortés  ;  Shubin Liu  ;  Giulia Tonini  ;  Dirk Laurent  ;  Nassir Habboubi  ;  Maureen G Conlan  ;  Aditya Bardia 
 JOURNAL OF CLINICAL ONCOLOGY, Vol.40(28) : 3246-3256, 2022-10 
Journal Title
Issue Date
Antineoplastic Combined Chemotherapy Protocols / adverse effects ; Breast Neoplasms* / drug therapy ; Breast Neoplasms* / genetics ; Breast Neoplasms* / metabolism ; Cyclin-Dependent Kinase 4 ; Estrogen Antagonists / therapeutic use ; Female ; Humans ; Receptor, ErbB-2 / metabolism ; Receptors, Estrogen / metabolism ; Tetrahydronaphthalenes
Purpose: Patients with pretreated estrogen receptor (ER)-positive/human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer have poor prognosis. Elacestrant is a novel, oral selective ER degrader that demonstrated activity in early studies.

Methods: This randomized, open-label, phase III trial enrolled patients with ER-positive/HER2-negative advanced breast cancer who had one-two lines of endocrine therapy, required pretreatment with a cyclin-dependent kinase 4/6 inhibitor, and ≤ 1 chemotherapy. Patients were randomly assigned to elacestrant 400 mg orally once daily or standard-of-care (SOC) endocrine monotherapy. Primary end points were progression-free survival (PFS) by blinded independent central review in all patients and patients with detectable ESR1 mutations.

Results: Patients were randomly assigned to elacestrant (n = 239) or SOC (n = 238). ESR1 mutation was detected in 47.8% of patients, and 43.4% received two prior endocrine therapies. PFS was prolonged in all patients (hazard ratio = 0.70; 95% CI, 0.55 to 0.88; P = .002) and patients with ESR1 mutation (hazard ratio = 0.55; 95% CI, 0.39 to 0.77; P = .0005). Treatment-related grade 3/4 adverse events occurred in 7.2% receiving elacestrant and 3.1% receiving SOC. Treatment-related adverse events leading to treatment discontinuations were 3.4% in the elacestrant arm versus 0.9% in SOC. Nausea of any grade occurred in 35.0% receiving elacestrant and 18.8% receiving SOC (grade 3/4, 2.5% and 0.9%, respectively).

Conclusion: Elacestrant is the first oral selective ER degrader demonstrating a significant PFS improvement versus SOC both in the overall population and in patients with ESR1 mutations with manageable safety in a phase III trial for patients with ER-positive/HER2-negative advanced breast cancer.

Trial registration: ClinicalTrials.gov NCT03778931.
Full Text
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Sohn, Joo Hyuk(손주혁) ORCID logo https://orcid.org/0000-0002-2303-2764
사서에게 알리기


Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.