海报库PosterKeep
PO.CTP01.03 · 进行中的临床试验

ELEGANT：在一项全球性、多中心、随机、开放标签的3期研究中，比较依拉司群（elacestrant）与标准内分泌治疗（ET）在具有高复发风险的淋巴结阳性、雌激素受体阳性（ER+）、HER2阴性（HER2-）早期乳腺癌（eBC）女性和男性患者中的疗效

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
该海报暂无可下载的资料 AACR 官方页面

作者与单位 Authors & Affiliations

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

中文摘要
背景：辅助ET是治疗ER+/HER2- eBC的标准治疗（SOC）。尽管在优化高危ER+/HER2- eBC辅助治疗方面取得了进展，但局部和转移性复发的风险仍持续存在，需要具有理想安全性特征的新疗法。依拉司群是一种新一代口服SERD，提供了一种新颖的作用机制，已显示出SERD（降解）和SERM（部分激动剂）活性，这与目前可用的辅助ET不同（Wardell, ERC 2015）。在EMERALD试验中，依拉司群在总体人群（HR 0.70；95% CI 0.55-0.88；P=0.0018）和ESR1m肿瘤患者（HR 0.55；95% CI 0.39-0.77；P=0.0005）中相比SOC ET显著延长了PFS（Bidard, JCO 2022）。在既往接受ET+CDK4/6i≥12个月的ESR1m肿瘤患者中，依拉司群的mPFS为8.6个月，而SOC ET为1.9个月（Bardia, CCR 2024）。在ER+/HER2- eBC患者中，SOLTI-1905-ELIPSE和SOLTI-2104-PremiERe试验表明，术前使用依拉司群与完全细胞周期停滞率的统计学显著平均变化相关，并使肿瘤生物学在绝经前和绝经后女性中均向更具内分泌敏感性和更低增殖性的肿瘤表型转变（Vidal, CCR 2025；Bellet, SABCS 2025）。鉴于依拉司群相对于SOC ET在mBC中无论ESR1m状态如何均显示出疗效，并在eBC中显示出生物学活性，故假设依拉司群可延长既往接受辅助ET±CDK4/6i的高危eBC患者的浸润性乳腺癌无病生存期（IBCFS）。 设计和方法：ELEGANT（NCT06492616）是一项全球性、多中心、开放标签的3期研究，旨在评估依拉司群对比SOC ET（AI或他莫昔芬）在eBC且高复发风险患者中的疗效。患者将按1:1随机分配，继续SOC ET或接受依拉司群，疗程为5年。合格患者为患有ER+/HER2- 淋巴结阳性eBC、既往接受2-5年SOC ET±CDK4/6i且ECOG PS≤1的女性/男性。既往接受CDK4/6i或PARP抑制剂的患者必须已完成或停止这些治疗。绝经前/围绝经期女性和男性将给予LHRH激动剂。排除标准包括IV期mBC、炎性BC、既往浸润性BC病史、随机分配日期前3年内的恶性肿瘤病史、既往SOC辅助ET连续中断>6个月或在随机分配前>6个月停止辅助ET，以及既往接受过SERD治疗。主要目的是IBCFS。关键次要目的是远处无复发生存、总生存、浸润性无病生存、安全性、PRO-QoL和PK。 现状：计划入组4,220例患者；招募正在进行中。
查看英文原文 English 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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