ELAINE 3: phase 3 study of lasofoxifene plus abemaciclib to treat ER+/HER2-, ESR1-mutated, metastatic breast cancer.

IF 3 4区医学 Q2 ONCOLOGY

Future oncology Pub Date : 2025-05-01 Epub Date: 2025-04-13 DOI:10.1080/14796694.2025.2481825

Matthew P Goetz, Seth A Wander, Thomas Bachelot, Alexandre de Nonneville, Einav Nili Gal-Yam, Sarah L Sammons, Sherry Shen, Chris Twelves, Gina Boruta, David J Portman, Senthil Damodaran

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引用次数: 0

Abstract

Endocrine therapy (ET) is recommended for patients with estrogen receptor-positive (ER+) metastatic breast cancer (mBC), but most patients will develop treatment resistance, often due to mutations in the ER-α-coding gene, ESR1. Therapeutic options are limited for endocrine-resistant mBC, particularly following treatment with a cyclin-dependent kinase 4/6 inhibitor (CDK4/6i). Lasofoxifene had anti-tumor activity in two separate phase 2, open-label studies (ELAINE 1 and 2) when given as monotherapy or combined with abemaciclib. The phase 3, randomized ELAINE 3 trial will evaluate the efficacy and safety of lasofoxifene/abemaciclib versus fulvestrant/abemaciclib for locally advanced or metastatic, ER+/HER2- breast cancer with an ESR1 mutation that progressed after ET-CDK4/6i treatment. Enrollment is planned for up to 500 patients to evaluate progression-free survival as the primary endpoint.Clinical trial registration: www.clinicaltrials.gov identifier is NCT05696626.

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ELAINE 3: lasofoxifene联合abemaciclib治疗ER+/HER2-， esr1突变的转移性乳腺癌的3期研究

内分泌治疗（ET）被推荐用于雌激素受体阳性（ER+）转移性乳腺癌（mBC）患者，但大多数患者会出现治疗耐药，通常是由于ER-α编码基因ESR1的突变。内分泌抵抗性mBC的治疗选择有限，特别是在使用周期蛋白依赖性激酶4/6抑制剂（CDK4/6i）治疗后。在两项独立的2期开放标签研究（ELAINE 1和2）中，拉索昔芬在单独治疗或与阿贝马昔利布联合使用时具有抗肿瘤活性。3期随机ELAINE 3试验将评估lasofoxifene/abemaciclib与fulvestrant/abemaciclib对ET-CDK4/6i治疗后进展的ESR1突变的局部晚期或转移性ER+/HER2-乳腺癌的疗效和安全性。计划招募多达500名患者，以评估无进展生存期作为主要终点。临床试验注册：www.clinicaltrials.gov标识符：NCT05696626。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Future oncology ONCOLOGY-

CiteScore

5.40

自引率

3.00%

发文量

335

审稿时长

4-8 weeks

期刊介绍： Future Oncology (ISSN 1479-6694) provides a forum for a new era of cancer care. The journal focuses on the most important advances and highlights their relevance in the clinical setting. Furthermore, Future Oncology delivers essential information in concise, at-a-glance article formats - vital in delivering information to an increasingly time-constrained community. The journal takes a forward-looking stance toward the scientific and clinical issues, together with the economic and policy issues that confront us in this new era of cancer care. The journal includes literature awareness such as the latest developments in radiotherapy and immunotherapy, concise commentary and analysis, and full review articles all of which provide key findings, translational to the clinical setting.