PO.CTP01.03 · 进行中的临床试验

ELEGANT: Elacestrant versus standard endocrine therapy (ET) in women and men with node-positive, estrogen receptor-positive (ER+), HER2-negative (HER2-), early breast cancer (eBC) with high risk of recurrence in a global, multicenter, randomized, open-label phase 3 study

编号 CT225 展板 20 时间 4/21 09:00–12:00 区域 Section 51 主讲 Tomer Wasserman

分会场 Phase II and Phase III Clinical Trials in Progress

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作者与单位

Aditya Bardia¹, Virginia Kaklamani², Joyce O’Shaughnessy³, Peter Schmid⁴, J. Thaddeus Beck⁵, Michelino De Laurentiis⁶, Giuseppe Curigliano⁷, Hope S. Rugo⁸, Carlos H. Barcenas⁹, William J. Gradishar¹⁰, Michail Ignatiadis¹¹, David A. Cameron¹², Giulia Tonini¹³, Simona Scartoni¹³, Jennifer Crozier¹⁴, Tomer Wasserman¹⁴, Sara M. Tolaney¹⁵

¹University of California Los Angeles (UCLA) Health Jonsson Comprehensive Cancer Center, Los Angeles, CA,²University of Texas Health Sciences Center, San Antonio, TX,³Baylor University Medical Center, Texas Oncology, US Oncology, Dallas, TX,⁴Barts Cancer Institute, Queen Mary University of London, London, United Kingdom,⁵Highlands Oncology, Springdale, AR,⁶Istituto Nazionale Tumori Napoli IRCCS "Fondazione Pascale", Napoli, Italy,⁷Istituto Europeo di Oncologia, IRCCS, and University of Milano, Milano, Italy,⁸City of Hope, Women’s Cancers Program and Breast Medical Oncology Division, Los Angeles, CA,⁹The University of Texas MD Anderson Cancer Center, Houston, TX,¹⁰Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, IL,¹¹Breast Medical Oncology Clinic, Institut Jules Bordet, Université Libre de Bruxelles (ULB), Hôpital Universitaire de Bruxelles (HUB), Brussels, Belgium,¹²Institute of Genetics and Cancer and Usher Institute, University of Edinburgh, Edinburgh, United Kingdom,¹³Menarini Group, Florence, Italy,¹⁴Menarini Group, New York, NY,¹⁵Dana-Farber Cancer Institute, Boston, MA

摘要 Abstract

Background: Adjuvant ET is the standard of care (SOC) for treating ER+/HER2- eBC. Despite advances to optimize adjuvant treatment in high-risk ER+/HER2- eBC, there continues to be risk of local and metastatic recurrence that persists, new therapies with desirable safety profiles are warranted. Elacestrant is a next-generation oral SERD that provides a novel mechanism of action that has shown both SERD (degradative) and SERM (partial agonist) activity that differs from currently available adjuvant ET (Wardell, ERC 2015). In the EMERALD trial, elacestrant significantly prolonged PFS vs SOC ET in the overall population (HR 0.70; 95% CI 0.55-0.88; P=0.0018) and in patients with ESR1m tumors (HR 0.55; 95% CI 0.39-0.77; P=0.0005) (Bidard, JCO 2022). In patients with ESR1m tumors who received prior ET+CDK4/6i ≥12 mo, mPFS with elacestrant was 8.6 vs 1.9 mo with SOC ET (Bardia, CCR 2024). In patients with ER+/HER2− eBC, the SOLTI-1905-ELIPSE and SOLTI-2104-PremiERe trials showed that preoperative elacestrant was associated with a statistically significant mean change of complete cell cycle arrest rate and led to a shift in tumor biology towards a more endocrine-sensitive and less proliferative tumor phenotype in both pre- and post-menopausal women (Vidal, CCR 2025; Bellet, SABCS 2025). Given that elacestrant demonstrated efficacy in mBC regardless of ESR1m status relative to SOC ET and has shown biologic activity in eBC, it is hypothesized that elacestrant can prolong invasive breast cancer-free survival (IBCFS) in patients with high-risk eBC who received prior adjuvant ET±CDK4/6i. Design and Methods: ELEGANT (NCT06492616) is a global, multicenter, open-label Ph3 study designed to evaluate elacestrant vs SOC ET (AI or tamoxifen) in patients with eBC and high risk of recurrence. Patients will be randomized 1:1 to continue SOC ET or to elacestrant for a duration of 5 years. Eligible patients are women/men with ER+/HER2− node-positive eBC who received between 2-5 years of SOC ET±CDK4/6i and have ECOG PS ≤1. Patients who received a prior CDK4/6i or PARP inhibitor must have completed or discontinued these treatments. Pre/perimenopausal women and men will be administered a LHRH agonist. Exclusion criteria include stage IV mBC, inflammatory BC, history of prior invasive BC, history of malignancy within 3 years of randomization date, >6 mo continuous interruption of prior SOC adjuvant ET or discontinuation of adjuvant ET >6 mo prior to randomization, and received prior treatment with SERDs. The primary objective is IBCFS. Key secondary objectives are distant relapse-free survival, overall survival, invasive disease-free survival, safety, PROs-QoL, and PK. Status: Planned enrollment is 4,220 patients; recruitment is ongoing.

利益披露 Disclosure

A. Bardia, Novartis ), Other, Consulting or Advisory Role. Genentech Other, Consulting or Advisory Role. Pfizer Other, Consulting or Advisory Role. Merck Other, Consulting or Advisory Role. Sanofi Other, Consulting or Advisory Role. Daiichi Sankyo/Astra Zeneca Other, Consulting or Advisory Role. Lilly Other, Consulting or Advisory Role. Gilead Sciences Other, Consulting or Advisory Role. Menarini Other, Consulting or Advisory Role. Mersana Other, Consulting or Advisory Role. V. Kaklamani, Puma Other, Consultant; Speaker's bureau. AstraZeneca Other, Consultant; Speaker's bureau. Athenex Other, Consultant. Gilead Other, Consultant; speaker's bureau. Pfizer Other, Speaker's bureau. Genentech Other, Speaker's bureau. Genomic Health Other, Speaker's bureau. Eisai Other, Speaker's bureau. Novartis Other, Speaker's bureau. Daiichi Sankyo Other, Speaker's bureau. Seagen Other, Speaker's bureau. J. O’Shaughnessy, Abbvie; Agendia; Amgen; Aptitude Health; AstraZeneca; BioNTech; Byondis; Carrick Therapeutics; Daiichi Sankyo; DAVA Oncology; Eisai; Fishawack Health; G1 Therapeutics; Genentech; Genzyme; Gilead; GSK Other, Honoraria; Consulting or advisory role. Loxo/Lilly; Merck; Novartis; Ontada/McKesson; Pfizer; Pierre Fabre; Puma Biotechnology; Roche; Samsung; Sanofi; Seagen; Stemline Therapeutics; Taiho Oncology; Veru Other, Honoraria; Consulting. Roche; Samsung; Sanofi; Seagen; Stemline Therapeutics; Taiho Oncology; Other, Consulting or advisory role. AstraZeneca; Lilly; Novartis; Pfizer; Seagen Other, Speaker's bureau. Agendia; Aptitude Health; AstraZeneca; Daiichi Sankyo; DAVA Oncology; Eisai; Lilly; Loxo/Lilly; Merck; Novartis; Pfizer; Roche; Seagen Travel. P. Schmid, AstraZeneca; Bayer; Bayer; Boehringer Ingelheim; Celgene; Celgene; Eisai; Genentech (Inst); Gilead Sciences Hong Kong; Merck; Novartis; Oncogenex (Inst); Oncogenex (Inst); Pfizer; Puma Biotechnology Other, Honoraria. Roche; Sanofi; Stemline Therapeutics Other, Honoraria. AstraZeneca; Bayer; Boehringer Ingelheim; Celgene; Eisai; Genentech/Roche (I); Merck; Novartis; Pfizer; Puma Biotechnology Other, Consulting or advisory role. J. Beck, AbbVie (Inst); Amgen (Inst); AstraZeneca (Inst); DSi (Inst); Lilly (Inst); Nektar (Inst); Nektar (Inst); Novartis (Inst); Pfizer (Inst); Seattle Genetics/Astellas (Inst) ). M. De Laurentiis, Arvinas Stock. Roche, Novartis, Pfizer, Lilly, Pierre Fabre, AstraZeneca, MSD, Seagen, Gilead Sciences, Ipsen, Exact Sciences, TOMA Biosciences, Daiichi Sankyo Europe GmbH, Veracyte Other, Honoraria. Roche, Novartis, Pfizer, Lilly, AstraZeneca, MSD, Pierre Fabre, Seagen, Gilead Sciences, Ipsen, Daiichi Sankyo Europe GmbH Other, Consulting or advisory role. Speakers' Bureau Other, Novartis. Novartis (Inst), Roche (Inst), Lilly, Pfizer (Inst), Daiichi Sankyo (Inst), MSD (Inst), Bristol Myers Squibb (Inst), Genzyme (Inst), AstraZeneca (Inst) ). G. Curigliano, ESMO; ESMO Open; European Society of Breast Cancer Specialists Other, Leadership. Ellipses Pharma Other, Honoraria. AstraZeneca; Blueprint Medicines; Boehringer Ingelheim; Bristol-Myers Squibb; Celcuity; Daichi-Sankyo; Exact Sciences; Foundation Medicine; Gilead Sciences; GlaxoSmithKline; Guardant Health; Hengrui Other, Consulting or Advisory Role. Lilly; Menarini; Merck; Novartis; Pfizer; Roche/Genentech; Samsung; Seagen; Veracyte Other, Consulting or Advisory Role. AstraZeneca; Daiichi Sankyo; Exact Sciences; Foundation Medicine; Gilead Sciences; Lilly; Menarini; Novartis; Pfizer; Roche/Genentech; Samsung; Seagen Other, Speaker's Bureau. Merck (Inst) ). AstraZeneca; Daichii Sankyo; Pfizer; Roche/Genentech Other, Travel, accommodations, expenses. H. S. Rugo, Chugai Pharma; Mylan/Viatris Other, Honoraria. Bristol Meyer; Napo Pharmaceuticals; Sanofi Other, Consulting or Advisory Role. Ambryx (Inst); AstraZeneca (Inst); Daiichi Sankyo (Inst); Gilead Sciences (Inst); Hoffmann-La Roche AG/Genentech, Inc (Inst); Lilly (Inst); Merck (Inst); Novartis (Inst); OBI Pharma (Inst); Pfizer ). Stemline Therapeutics (Inst) ). C. H. Barcenas, Puma Biotechnology (Inst), Personalis (Inst) ). W. J. Gradishar, Genentech/Roche, AstraZeneca, Pfizer, Merck, Novartis, Gilead Sciences Other, Consulting or advisory role. M. Ignatiadis, Daichi; Gilead Sciences; Menarini Group; Novartis; Rejuveron senescence therapeutics; Seagen Other, Consulting or advisory role. Inivata (Inst); Natera (Inst); Pfizer (Inst); Roche/Genentech (Inst) ). AstraZeneca (Inst); Gilead Sciences (Inst); Novartis; Roche (Inst) Travel. D. A. Cameron, Lilly (Inst), Novartis (Inst), Research Triangle Institute RTI Health Solutions (Inst), Daiichi Sankyo (Inst), Prima BioMed (Inst), Merck Sharp & Dohme (Inst), Zymeworks (Inst), Eisai (Inst) Other, Consulting or Advisory Role. Puma Biotechnology (Inst), Pfizer (Inst), Oncolytics (Inst), Roche (Inst), Samsung Bioepis (Inst), Seattle Genetics (Inst), Synthon (Inst), Clarity Pharmaceuticals (Inst), Zymeworks (Inst), Sanofi (I Other, Consulting or Advisory Role. Roche (Inst), Novartis (Inst), AstraZeneca (Inst) ). G. Tonini, Menarini Group Employment. S. Scartoni, Menarini Group Employment. J. Crozier, Menarini Group Employment. T. Wasserman, Menarini Group Employment. S. M. Tolaney, AADi; Ambrx; Artios Biopharmaceuticals; Arvinas; AstraZeneca; Bayer; BeiGene; Bicycle Therapeutics; BioNTech; Blueprint Medicines; Bristol-Myers Squibb; Circle Pharma; Cullinan Oncology; Daiichi Sank Other, Consulting or Advisory Role. eFFECTOR Therapeutics; Eisai; Genentech; Hengrui Pharmaceutical (USA); Immunomedics/Gilead; Incyte; Jazz Pharmaceuticals; Johnson & Johnson; Launch Therapeutics; Lilly; Menarini Group; Merck; Mersana Other, Consulting or Advisory Role. Natera; Novartis; Pfizer; Reveal Genomics; Sanofi; Seagen; Sumitovant Biopharma; Summit Therapeutics; Systimmune; Tango Therapeutics; Zentalis; Zuellig Pharma; Zymeworks Other, Consulting or Advisory Role. AstraZeneca (Inst); Bristol-Myers Squibb (Inst); Daiichi Sankyo; Eisai (Inst); Exelixis (Inst); Genentech/Roche (Inst); Gilead Sciences (Inst) ). Jazz Pharmaceuticals (Inst); Lilly (Inst); Menarini/Stemlin (Inst); Merck (Inst); NanoString Technologies (Inst); Novartis (Inst); OncoPep (Inst); Pfizer (Inst); Seagen (Inst) ). Arvinas; Gilead Sciences; Jazz Pharmaceuticals; Lilly; Pfizer; Sanofi Travel.

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