ERADICATE: A Phase Ib/II Study of Elacestrant Plus Trastuzumab Deruxtecan in Patients With CDK4/6 Inhibitor and Endocrine-resistant HR+/HER2-low or HER2-ultralow Metastatic Breast Cancer

The goal of this study is to evaluate the safety and efficacy of elacestrant in combination with trastuzumab deruxtecan (T-DXd) in participants with hormone receptor-positive (HR+), HER2-low or HER2-ultralow, metastatic breast cancer that is resistant to prior CDK4/6 inhibitor and endocrine therapy.
The names of the study drugs involved in this study are:
* Elacestrant (a type of selective estrogen receptor degrader)
* Trastuzumab deruxtecan (a type of standard of care antibody drug conjugate)

开始日期2026-03-01

申办/合作机构

Dana-Farber Cancer Institute, Inc.

[+1]

NCT07209449

/ Recruiting临床2期IIT

Phase II Study of ELacestrant in Combination With Abemaciclib or Elacestrant Alone In p53 Wild Type, Estrogen Receptor-positive Advanced or recurrenT Endometrial Cancer (ELITE)

The researchers are doing this study to find out whether elacestrant is an effective and safe treatment alone or in combination with abemaciclib for people with advanced or recurrent ER+ endometrial cancer.

开始日期2025-10-01

申办/合作机构

Memorial Sloan Kettering Cancer Center

NCT06923527

/ Recruiting临床2期IIT

A Single Arm Phase II Trial of Circulating Tumor DNA-guided Adjuvant Therapy With Elacestrant in Hormone Receptor Positive HER2 Negative Breast Cancers at Risk for Late Recurrence (CATE)

This is a single-arm, phase II study examining elacestrant in the adjuvant treatment of patients with ER+ breast cancer who test positive for circulating tumor DNA (ctDNA) during the screening period of the trial.

开始日期2025-09-30

申办/合作机构

Yale University

[+2]

100 项与艾拉司群相关的临床结果

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100 项与艾拉司群相关的转化医学

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100 项与艾拉司群相关的专利（医药）

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项与艾拉司群相关的文献（医药）

2025-10-01·BIOORGANIC CHEMISTRY

Identification of novel selective estrogen receptor degraders (SERD) via physics-based and deep-learning-based virtual screening and Bioassys

Article

作者: Liang, Pengying ; Tian, Yuanxin ; Chen, Jun ; Zhang, Hao ; Chen, Shiyun ; Wu, Zengye ; Zhang, Jiajie ; Chen, Mengyu ; Wu, Shaoyu ; Gao, Xiaoya

Breast cancer is the most common malignant tumor among women, most of which are ERα(Estrogen Receptor alpha) positive. SERDs(Selective Estrogen Receptor Degraders), such as Fulvestrant(the first SERD), can induce degradation of this receptor, leading to overcome the acquired endocrine resistance. However, only two SERDs (Fulvestrant and Elacestrant) are currently clinically approved, highlighting an urgent demand for novel, oral, and more potent alternatives. In this study we developed a multi-tiered virtual screening combing physics-based docking methods (Glide) with deep-learning-based docking methods (Karmadock and Carsidock) to identify SERDs with novel scaffold. After ADMET and MM-GBSA screening, four purchasable candidate compounds were selected for biological evaluation in three cell lines. Among them, two compounds exhibited significant anti-proliferation activity aganist ER-positive cells. The fingerprint analysis also revealed their structural novelty, which are distinct from the known SERDs. Further study indicated F0840-0093 could directly bound to ERα and induced its proteasomal degradation (mimicking Fulvestrant). In summary, our work not only provided a feasible virtual screening approach in drug discovery but also identified some compounds, particularly F0840-0093, which can be a promising lead with new chemical scaffold for further optimization and development as SERDs.

2025-05-01·Molecular Diagnosis & Therapy

Clinical Actionability of Molecular Targets in Multi-Ethnic Breast Cancer Patients: A Retrospective Single-Institutional Study

Article

作者: Naghi, Leah ; Mortimer, Joanne ; Yost, Susan E ; Kang, Irene

BACKGROUND:

Precision oncology is making remarkable advancements in optimizing patient care by personalizing treatments. To date, the US Food and Drug Administration (FDA) has approved poly(ADP-ribose) polymerase inhibitors (PARPi) olaparib (Lynparza, AstraZeneca and Merck) and talazoparib (Talzenna, Pfizer Oncology Together™) for germline or somatic BRCA1/2-mutated metastatic breast cancer (BC) patients, and PI3K inhibitor alpelisib (Piqray, Novartis) plus fulvestrant for patients with hormone receptor-positive human epidermal growth factor receptor 2-negative (HR+HER2-) PIK3CA-mutated advanced BC. In addition, the FDA approved capivasertib (Trucap, AstraZeneca) for HR+HER2- locally advanced or metastatic BC patients with one or more AKT1, PIK3CA, or PTEN alterations. Finally, the FDA recently approved elacestrant (Orserdu, Stemline Therapeutics, Inc.) for postmenopausal patients with ER+ HER2- ESR1-mutated advanced or metastatic BC with disease progression following at least one line of endocrine therapy.

METHODS:

This study presents a single institutional retrospective review of genomic reports of patients with BC. Analysis of genomic reports of 1361 BC sequencing reports was performed for 1010 patients with BC from 2013 to 2023 (23% of patients had multiple reports). Eligible patients had at least one primary or metastatic tumor. Multiple sequencing platforms were used for FFPE specimens including Tempus xT targeted next-generation sequencing (NGS), Foundation One Medicine, HopeSeq, Ashion Analytics GEM ExTra, and Exact Sciences Oncomap. Liquid biopsies were performed by Guardant, Tempus, and Foundation One Medicine. Chart reviews were performed to collect patient characteristics. BRCA1/2-mutated, metastatic BC patients who initiated treatment with olaparib or talazoparib, and PIK3CA-mutated, HR+ metastatic BC patients who initiated treatment with alpelisib were reported. In addition, patients with ESR1 or AKT1/PIK3CA/PTEN mutations were identified. Clinical outcomes, including progression-free survival (PFS) and overall survival (OS) were analyzed for BRCA1/2 and PIK3CA-mutated patients who received PARPi or alpelisib. Survival curves were generated using the Kaplan Meier method.

RESULTS:

A cohort of 1010 BC patients with 1361 genomic reports was identified. A total of 935/1361 (69%) specimens were formalin-fixed paraffin-embedded (FFPE) tumor biopsies and 426/1361 (31%) were liquid biopsies. Receptor status included 65% HR+HER2-, 8% HR+HER2+, 4% HR-HER2+, and 23% TNBC. Racial and ethnic distribution of these patients included 50% non-Hispanic White, 26% Hispanic, 17% Asian, 6% African American, 1% other (Native Hawaiian or Other Pacific Islander, American Indian or Alaska Native, or unknown). Sequencing platforms included 30% Tempus xT, 31% Foundation One, 10% HopeSeq, 20% GEM ExTra, and 9% Exact Sciences. Liquid biopsies included 79% Guardant, 20% Tempus, and 1% Foundation One. Of 1010 patients, the most common mutations were TP53 (44%), PIK3CA (38%), ESR1 (14%), PTEN (12%), CCND1 (11%), FGFR1 (10%), CDH1 (10%), ERBB2 (9%), MYC (9%), FGF3 (8%), GATA3 (8%), FGF19 (8%), FGF4 (7%), ARID1A (6%), RB1 (5%), BRCA2 (5%), MAP3K1 (4%), AKT1 (4%), NF1 (4%), MLL3 (4%), ZNF703 (4%), CDKN2A (4%), BRCA1 (4%), MCL1 (3%), ATM (3%), PALB2 (1%), and CHEK2 (1%). The majority of reports with tumor mutation burden (TMB) results (97%) had low or intermediate TMB. A total of 784 actionable mutations in 1010 patients were reported, including 381/1010 (38%) PIK3CA; 144/1010 (14%) ESR1; 122/1010 (12%) PTEN; 48/1010 (5%) BRCA2; 36/1010 (4%) BRCA1; 41/1010 (4%) AKT1; and 12/1010 (1%) PALB2. Of the 96/1010 (10%) patients with BRCA1, BRCA2, or PALB2 mutations not including variants of uncertain significance (VUS), 33/96 (34.4%) received olaparib and 3/96 (3%) received talazoparib in the metastatic setting, and 28 were eligible for response (one had toxicity, two were lost to follow-up, and two went to hospice). Median PFS was 9.0 months and median OS was 21.8 months for patients receiving PARPi. Of the 381/1010 (38%) patients with PIK3CA mutations, 84/381 (22%) received alpelisib and 41 were eligible for response (22 had toxicity, 13 were discontinued, six were lost to follow-up, and two went to hospice). Median PFS was 7.9 months and median OS was 31.2 months for patients receiving alpelisib. A total of 544/1010 (54%) patients had AKT1, PIK3CA, or PTEN mutations which are now FDA approved for capivasertib in HR+HER2- metastatic BC patients. In addition, 144/1010 (14%) patients had ESR1 mutations which are FDA approved for elacestrant in HR+HER2- metastatic BC patients.

CONCLUSIONS:

In this study, a total of 784 clinically actionable mutations were reported for 1010 patients with genomic sequencing. Of these, 96/1010 (10%) patients had at least one actionable mutation in homologous recombination repair genes (BRCA1, BRCA2, PALB2) and 36/96 (37.5%) patients received PARP inhibitors (33 olaparib and three talazoparib). In addition, 381/1010 (38%) patients had at least one clinically actionable PIK3CA mutation, and 84/381 (22%) received alpelisib. Additionally, 544/1010 (54%) of patients had either AKT1 (41/1010), PIK3CA (381/1010), or PTEN (122/1010) alterations that were FDA approved in November 2023 for capivasertib in the treatment of HR+HER2- metastatic BC (MBC) patients. Furthermore, 144/1010 (14%) patients in this study had at least one ESR1 mutation, a clinically actionable mutation that was FDA approved in January 2023 for elacestrant in the treatment of ER+HER2- MBC patients (44% detected by liquid biopsy). Future studies are needed to determine the efficacy of elacestrant and capivasertib for patients with these mutations, and to tailor strategies for optimal patient quality of life and cancer outcome.

2025-04-01·CANCER TREATMENT REVIEWS

Post-progression treatment options after CDK4/6 inhibitors in hormone receptor-positive, HER2-negative metastatic breast cancer

Review

作者: Sahin, Taha Koray ; Aksoy, Sercan ; Guven, Deniz Can ; Rizzo, Alessandro

The combination of cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) and endocrine therapy (ET) is the standard first-line treatment for hormone receptor-positive (HR + ) and HER2-negative metastatic breast cancer (mBC). Despite their efficacy, resistance inevitably develops, necessitating alternative therapeutic strategies post-progression. This review explores current and emerging treatment options following progression on CDK4/6i, focusing on endocrine therapies, targeted therapies, combination approaches, and the continued use of CDK4/6i. Endocrine therapies, including fulvestrant and novel oral selective estrogen receptor degraders (SERDs) like elacestrant, show promise, especially in patients with ESR1 mutations. Targeted therapies such as PI3K/AKT/mTOR inhibitors, exemplified by alpelisib and capivasertib, offer potential by addressing downstream signaling pathways involved in resistance. Additionally, FGFR inhibitors like erdafitinib are under investigation for their role in overcoming specific resistance mechanisms. Combination strategies involving CDK4/6 inhibitors with immune checkpoint inhibitors or other targeted agents are also being explored, with early trials suggesting possible synergistic effects, although further validation is required. Continuation of CDK4/6 inhibitors beyond progression has shown potential benefits in selected patients, but the data are heterogeneous, and further studies are needed to clarify their role. While chemotherapy remains a standard option for patients who progress on these treatments, the goal is to delay its use through the effective utilization of endocrine and targeted therapies. Understanding resistance mechanisms and tailoring treatment to individual patient profiles is crucial for optimizing outcomes. Ongoing clinical trials are expected to provide deeper insights, guiding the development of more effective post-progression therapeutic strategies. This evolving landscape highlights the need for continuous research and individualized patient care to improve survival and quality of life in HR + mBC patients.

236

项与艾拉司群相关的新闻（医药）

2025-10-01

·药明康德

致敬时代 | 97%难治患者肿瘤稳定、缩小甚至消失！多款乳腺癌“新克星”接连登场，已改变无数患者命运

编者按：2025年，药明康德迎来创立25周年的重要里程碑。值此契机，我们向所有与我们共同书写产业变革篇章的科学家、医药人和投资者致以衷心感谢与诚挚敬意，也特别推出“致敬时代”系列，回顾全球同仁如何借助科学与合作的力量，不断拓展治疗边界、改善患者命运。四分之一个世纪的坚守，只为加速每一款新药的诞生。下一个25年，我们将继续心怀感恩与敬畏，依托独特的CRDMO模式，与全球伙伴携手同行，共赴健康未来。据世界卫生组织国际癌症研究机构（IARC）统计，乳腺癌是全球第二大高发癌症，也是全球女性中最常见的癌症。从古罗马时代开始，手术一直承担着乳腺肿瘤治疗的重任。19世纪末到20世纪上半叶，旨在减少复发的乳腺癌根治术（将切除范围从乳腺拓宽到周围的淋巴和胸肌）成为主流，消除激素依赖的“内分泌外科治疗”（即手术切除卵巢等器官）也开始萌芽。20世纪中叶以后，科学家逐渐认识到盲目扩大切除区域并不能改善患者的预后。同时，放疗与化疗快速发展，乳腺癌病理机制也逐渐被揭开，一系列新型药物得以研发问世，在传统手术和放化疗基础上形成了抗内分泌药物与抗人表皮生长因子受体2（HER2）靶向药物治疗并驾齐驱的局面，之前激进的手术方式逐渐退出历史舞台。近十多年来，随着病理学、分子生物学、基因检测等学科和技术的发展，科学家们已经认识到乳腺癌是一类分子水平上具有高度异质性的疾病，探索出了更多治疗策略，新药研发技术的更迭也带来了全新分子类型的药物。乳腺癌治疗可谓进入了“大航海时代”。图片来源：123RF 作为全球医药及生命科学行业值得信赖的合作伙伴和重要贡献者，药明康德在过去25年发展历程中，很荣幸见证了多款乳腺癌创新疗法从实验室到临床的突破历程，更通过提供一体化、端到端的新药研发和生产服务，助力全球合作伙伴加速多款乳腺癌创新疗法的研发进程、造福病患。今天这篇文章将回望近25年来乳腺癌创新疗法的发展历程，向那些帮助广大患者解锁疾病“治愈密码”的英雄们致敬。内分泌药物治疗：“最常见”乳腺癌患者的希望 20世纪60年代，随着雌激素受体（ER）被发现，科学家们逐渐认识到，大约60%~80%的乳腺癌都是激素依赖型（包括雌激素、孕激素、生长激素等），即激素受体（HR）阳性乳腺癌。因此可开发抗激素的内分泌治疗药物来抑制这类乳腺癌的生长。相比手术和放化疗，这类疗法的针对性和选择性更强，也逐渐取代了之前激进的“内分泌外科手术”。 20世纪70年代末，针对ER阳性乳腺癌的抗雌激素药物他莫昔芬（tamoxifen，商品名：Nolvadex）获FDA批准上市，拉开了乳腺癌内分泌药物治疗的序幕。多款芳香化酶抑制剂也相继登场，其中药理作用较强且耐受性较好的要数90年代末出现的第三代芳香化酶抑制剂，包括阿那曲唑（anastrozole，商品名：Arimidex）、来曲唑（letrozole，商品名：Femara）和依西美坦（exemestane，商品名：Aromasin）。同一时期，以戈舍瑞林（goserelin，商品名：Zoladex）为代表的促性腺激素释放激素激动剂类药物也开始用于HR阳性乳腺癌患者。21世纪初，新的选择性雌激素受体调节剂氟维司群（fulvestrant，商品名：Faslodex）获FDA批准上市，用于HR阳性/HER2阴性乳腺癌。传统内分泌治疗药物是通过“截断”激素供给来“饿死”癌细胞，而它的“好帮手”细胞周期蛋白依赖性激酶4/6（CDK4/6）抑制剂的出现，则推动内分泌疗法迈入了联合治疗的全新时代。 CDK4/6抑制剂通过阻断细胞周期中的关键调控蛋白，从而抑制癌细胞的增殖。相比仅内分泌治疗，内分泌治疗药物联合CDK4/6抑制剂可将患者的无进展生存期延长一倍以上。2015年以来，多款CDK4/6抑制剂陆续问世，如哌柏西利（palbociclib，商品名：Ibrance）、瑞波西利（ribociclib，商品名：Kisqali）与阿贝西利（abemaciclib，商品名：Verzenio）。这类药物不仅适用于疾病晚期，在早期乳腺癌的辅助治疗中也正在彰显潜力。近年，在中国获批用于乳腺癌的CDK4/6抑制剂还有达尔西利（商品名：艾瑞康）、吡洛西利（商品名：轩悦宁）、伏维西利（商品名：复妥宁）、来罗西利（商品名：汝佳宁）和泰瑞西利（商品名：康美纳）。首款HER2靶向疗法曲妥珠单抗的诞生除了激素这一影响因素外，一些基因也被发现与癌症的发生发展有关。在这条道路上，以HER2为靶点的曲妥珠单抗的诞生具有划时代意义——它是人类历史上第一个靶向致癌蛋白的单克隆抗体药物，也是第一个用于实体瘤治疗的靶向药物，并开创了乳腺癌靶向治疗的先河，自上市以来已惠及数百万名乳腺癌患者。曲妥珠单抗的问世还要从1985年说起，那时基因泰克（Genentech，现为罗氏旗下子公司）的科学家阿克塞尔·乌尔里希（Axel Ullrich）博士和阿特·列文森（Art Levinson）博士发现了HER2基因，并推测其可能与癌症相关。1986年，乌尔里希博士关于HER2的分享引起了加州大学洛杉矶分校丹尼斯·史莱门（Dennis J. Slamon）教授的关注，二人随即开始了多年的合作。1987年，他们在《科学》杂志上发表研究，证实HER2基因确实与乳腺癌有关——在部分乳腺癌细胞中，HER2基因表达量非常高，而HER2阳性的乳腺癌比其他亚型扩散得更快、预后更差。后续一系列研究进一步证实了HER2会促进侵袭性癌症的形成。不难想象，如果能开发一种抗体药物来阻断HER2这种受体蛋白与配体的结合，进而抑制它的功能，可能是一种不错的选择。然而，当基因泰克的迈克尔·谢泼德（H. Michael Shepard）博士和同事们成功设计出适用于人体治疗的抗体时，尚处于初创期的基因泰克因公司规划，决定停止支持尚未有成功先例的抗HER2新药开发。加上当时产业界对“单克隆抗体渗透实体肿瘤”的可能性有所犹疑，这一项目几乎到了死亡边缘。好在，谢泼德博士、史莱门教授和基因泰克参与该项目的科学家们并未死心。他们通过放射性标记实验证明，这些抗体只在HER2过表达的肿瘤细胞中积累，并开发出了识别HER2阳性女性乳腺癌患者的诊断测试。此外，史莱门教授还经常在基因泰克的办公楼附近向路人介绍HER2项目的亮眼数据，大量无药可治的患者被打动，愿意参加临床试验。史莱门教授还在机缘巧合下成功说服了基因泰克的一位副总裁成为该项目的支持者，这位副总裁的母亲被确诊乳腺癌，他也深知患者有多么需要新的治疗选择。终于，在各方齐心协力之下，HER2项目被重启了。 1998年9月，经历了长达10年的曲折研发之路后，曲妥珠单抗（trastuzumab，英文商品名：Herceptin）成为首款获得FDA批准上市的HER2靶向药物。2001年发布的一项3期临床试验显示，在患有HER2阳性转移性乳腺癌、且此前未因癌症转移进行过化疗的患者中，只接受标准化疗的患者1年死亡率是33%，联用曲妥珠单抗后，1年死亡率减少到了22%。更多HER2靶向疗法：从造福部分患者，到改变超一半患者的命运在曲妥珠单抗问世后，科学家们继续探索开发出了一系列以HER2为靶点的具有不同作用机制的靶向药物，比如2013年问世的全球首个获批用于实体瘤的抗体偶联药物（ADC）、也是首款乳腺癌ADC疗法——恩美曲妥珠单抗（trastuzumab emtansine，商品名：Kadcyla）。ADC疗法通过结合单抗的靶向能力与化疗药物的杀伤力，可以更精准有效打击癌细胞。 2019年，第二款靶向HER2的乳腺癌ADC疗法德曲妥珠单抗（trastuzumab deruxtecan，商品名：Enhertu）闪耀登场，这款疗法在ADC的细胞毒性药物和连接子上进行了多种技术创新，带来了优异的疗效数据：在接受过多种（中位数为6种）前期疗法的HER2阳性乳腺癌患者中，德曲妥珠单抗让多达97.3%的患者肿瘤缩小、消失或保持稳定（即疾病控制），患者的中位无进展生存期长达16.4个月。不过问题来了——属于HER2阳性、适合HER2靶向药的患者只占所有乳腺癌患者的约20%。但“HER2阴性”并不等于癌细胞没有表达HER2，其中大部分只是表达水平不高而已。为了让HER2低表达的患者也有靶向药可用，医药企业与科学家们又踏上了探索之路。之前已经“一战成名”的德曲妥珠单抗，也是在HER2低表达领域试水的药物之一，并于2022年再次带来了出乎意料的惊喜成果。这项临床试验的参与者都是HER2低表达的转移期乳腺癌患者，无法使用过去的HER2靶向药。试验中，相比标准疗法（化疗），德曲妥珠单抗能让患者肿瘤进展或死亡的风险降低50%。人们开始确信，真的有HER2靶向药可以打破常规限制，让HER2低表达的患者也能获益。有多少乳腺癌患者是HER2低表达呢？80%的乳腺癌患者被认为是HER2阴性，但其中超过60%是有低度HER2表达的。也就是说，德曲妥珠单抗让HER2靶向药适用人群从原来的不到20%的HER2乳腺癌患者，一下子增加到了一半以上。德曲妥珠单抗带来的这一颠覆性发现，让乳腺癌从分类与治疗都发生了翻天覆地的变化。2个月后，也就是2022年8月，美国FDA批准了德曲妥珠单抗在HER2低表达乳腺癌患者中的使用，正式开启了乳腺癌的分类与治疗变革。其他获FDA批准用于HER2阳性乳腺癌的靶向药还有：帕妥珠单抗（pertuzumab，商品名：Perjeta）、马吉妥昔单抗（margetuximab，商品名：Margenza）、拉帕替尼（lapatinib，商品名：Tykerb）、奈拉替尼（neratinib，商品名：Nerlynx）和tucatinib（商品名：Tukysa）。在中国获批上市的还有吡咯替尼（商品名：艾瑞妮）、伊尼妥单抗（商品名：赛普汀）和维迪西妥单抗(商品名：爱地希)。这些新药为HER2阳性患者带来了更丰富的治疗选择。免疫疗法和Trop-2靶向疗法：为难治患者带来新选择尽管内分泌治疗和HER2靶向治疗覆盖了绝大多数乳腺癌患者，但并不适用于号称是“最毒”的三阴性乳腺癌。三阴性乳腺癌既不表达ER或孕激素受体（PR），也不是HER2阳性，难以针对性治疗，远端转移患者的5年生存率只有15%，远远低于HR阳性/HER2阴性与HR阴性/HER2阳性患者。不过，这并不意味着三阴性乳腺癌没有任何可以靶向的靶点。近年来，免疫疗法在癌症治疗中掀起变革，也向“最难治”的三阴性乳腺癌发起了挑战，其中帕博利珠单抗（pembrolizumab，商品名：Keytruda）于2020年获FDA批准，联合化疗用于治疗有PD-L1表达的不可切除局部复发性或转移性三阴性乳腺癌。科学家们还发现，在多种恶性肿瘤中表达量上调的Trop-2，在一些三阴性乳腺癌患者的癌细胞中也有表达。2020年，针对这一靶点的ADC疗法戈沙妥珠单抗（sacituzumab govitecan，商品名：Trodelvy）获FDA加速批准上市，为三阴性乳腺癌患者带来新的治疗选择。同样靶向Trop-2的ADC疗法还有德达博妥单抗（datopotamab deruxtecan，商品名：Datroway），于今年获FDA批准用于治疗HR阳性/HER2阴性乳腺癌患者。此外，PD-1抑制剂特瑞普利单抗（商品名：拓益），以及靶向Trop-2的抗体偶联药物芦康沙妥珠单抗（商品名：佳泰莱）也于去年在中国获批三阴性乳腺癌适应症。针对遗传因素的其他靶向疗法与此同时，越来越多与乳腺癌相关的致癌突变也浮出水面。多款针对这些驱动基因的疗法陆续问世，拓展了乳腺癌治疗的蓝图。比如大家现在熟知的BRCA1和BRCA2基因，在20世纪90年代就被发现与遗传性乳腺癌有关。大约5%-10%的乳腺癌患者携带有BRCA基因突变。经过20多年的耕耘，多聚腺苷二磷酸核糖聚合酶（PARP）抑制剂破茧而出——2018年，奥拉帕利（olaparib，商品名：Lynparza）、他拉唑帕利（talazoparib，商品名：Talzenna）获FDA批准上市，让携带生殖系BRCA基因突变的HER2阴性转移性乳腺癌患者有了靶向治疗药物。PARP蛋白是BRCA基因相关的替代修复通路，在BRCA突变癌症中同时抑制PARP会出现“合成致死”效应，从而杀死癌细胞。在中国获批用于这类乳腺癌治疗的PARP抑制剂还有氟唑帕利（商品名：艾瑞颐）。在乳腺癌最常见类型（HR阳性/HER2阴性）中，还有一个基因突变极具意义——约40%的这类晚期乳腺癌患者携带PIK3CA突变，PI3K通路改变是这些患者疾病恶化、治疗耐药的最常见原因。2019年，alpelisib（商品名：Piqray）成为FDA批准的首款用于治疗乳腺癌的PI3K抑制剂。在携带PIK3CA突变的HR阳性/HER2阴性晚期乳腺癌患者中，相比仅用抗激素治疗，加用alpelisib让患者的中位无进展生存期接近翻倍。2024年，另一款PI3K抑制剂伊那利塞（inavolisib，商品名：Itovebi）也获批上市。 ESR1突变、PIK3CA/AKT1/PTEN变异同样会导致患者对内分泌疗法更容易耐药。针对这些通路，从2023年到今年9月底，共有3款疗法获FDA批准用于特定乳腺癌患者，包括两款雌激素受体降解剂艾拉司群（elacestrant，商品名：Orserdu）和imlunestrant（商品名：Inluriyo），以及一款AKT抑制剂卡匹色替（capivasertib，商品名：Truqap）。此外，ATM、PALB2和TP53等基因也被陆续发现与乳腺癌有关，目前也已有相关研究在进行中。乳腺癌管理进入“慢病”时代，探索仍在继续过去25年间，FDA共批准了至少26款治疗乳腺癌的新疗法，除上述药物之外，还有化疗药白蛋白紫杉醇（paclitaxel，商品名：Abraxane）、伊沙匹隆（ixabepilone，商品名：Ixempra）和艾立布林（eribulin，商品名：Halaven），以及mTOR抑制剂依维莫司（everolimus，商品名：Afinitor）；近25年在中国获批乳腺癌适应症的还有化疗药物表柔比星（商品名：法玛新）、长春瑞滨（商品名：诺维本）、紫杉醇脂质体（商品名：力扑素）、多西他赛（商品名：泰索帝）和优替德隆（商品名：优替帝），以及组蛋白去乙酰化酶（HDAC）抑制剂西达本胺（商品名：爱谱沙）和恩替司他（商品名：景助达）。作为新药研发一体化赋能平台，药明康德很荣幸能为其中多款疗法的研发提供赋能、助力合作伙伴的这些创新疗法来到全球患者身边。得益于这些疗法的诞生、发展和乳腺癌早期筛查的推广，自20世纪90年代起，全球乳腺癌死亡率已呈现下降趋势。如今，乳腺癌的5年生存率在部分国家和地区已达到90%以上，乳腺癌管理正在进入“慢病”时代。尤其近十年来，乳腺癌创新疗法迎来新一轮蓬勃发展，近10个不同细分治疗方向纷纷迎来“首款”疗法，让治疗更精准、更有效，更多患者的生命得以延长。图片来源：123RF 不过，人类对乳腺癌的攻坚战远未结束，产业圈仍在探索更多创新疗法以更进一步改善患者生存。当前还有800多款针对乳腺癌的新疗法正处于积极的临床研究中，其中近60款疗法已进入3期临床阶段，涵盖小分子靶向药、多肽类药物（包括环状多肽和多肽偶联药物）、非降解型分子胶和治疗性疫苗（包括多肽疫苗）等。在攻克乳腺癌的漫漫征途中，正是科学家们的坚守，以及广大患者及其家庭的信任，才让诸多创新疗法从理念变为现实。最后，让我们再次向那些不畏艰难、抗击乳腺癌的勇士们致以崇高的敬意。药明康德也期待与业界同仁继续同行，见证更多创新疗法的问世，为广大患者带去更多选择与希望。参考资料 [1] Bray, F., Laversanne, M., Sung, H., Ferlay, J., Siegel, R. L., Soerjomataram, I., & Jemal, A. (2024). Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA: a cancer journal for clinicians, 74(3), 229-263.https://doi.org/10.3322/caac.21834 [2] Global cancer burden growing, amidst mounting need for services. Retrieved Sep 17, 2025 from https://www.iarc.who.int/wp-content/uploads/2024/02/pr345_E.pdf [3] Breast cancer inequities. Retrieved Sep 17, 2025 from https://www.who.int/initiatives/global-breast-cancer-initiative/breast-cancer-inequities [4] Hongmei Zeng, et al., (2024). Cancer survival statistics in China 2019–2021: a multicenter, population-based study. Journal of the National Cancer Center, DOI: https://doi.org/10.1016/j.jncc.2024.06.005. [5] Lakhtakia, R. (2014). A brief history of breast cancer: Part I: Surgical domination reinvented. Sultan Qaboos University Medical Journal, 14(2), e166. [6] Ben-Dror, J., Shalamov, M., & Sonnenblick, A. (2022). The history of early breast cancer treatment. Genes, 13(6), 960. https://doi.org/10.3390/genes13060960 [7] Cotlar, A. M., Dubose, J. J., & Rose, D. M. (2003). History of surgery for breast cancer: radical to the sublime. Current surgery, 60(3), 329-337. https://doi.org/10.1016/S0149-7944(02)00777-8 [8] Johnston, S. J., & Cheung, K. L. (2018). Endocrine therapy for breast cancer: a model of hormonal manipulation. Oncology and Therapy, 6(2), 141-156. https://doi.org/10.6084/m9.figshare.6621512 [9] 杨名添, & 连臻强. (2007). 乳腺癌内分泌治疗的进展. 癌症, 26(4), 5. doi：10.3969/j.issn.1000-467X.2007.04.024 [10] Breast Cancer Treatment Milestones. Retrieved Sep 17, 2025 from https://www.scientificamerican.com/article/breast-cancer-treatment-milestones/ [11] FDA Approves Kadcyla for Breast Cancer. Retrieved Sep 17, 2025 from https://aacrjournals.org/cancerdiscovery/article/3/4/366/3855/FDA-Approves-Kadcyla-for-Breast-Cancer-FDA-Approves [12] Herceptin—a targeted antibody therapy for breast cancer. Retrieved Sep 17, 2025 from https://laskerfoundation.org/winners/herceptin-a-targeted-antibody-therapy-for-breast-cancer/ [13] Shepard, H. M. (2024). Trastuzumab: dreams, desperation and hope. Nature Reviews Cancer, 24(5), 287-288.https://doi.org/10.1038/s41568-024-00676-9 [14] Slamon, D. J., Clark, G. M., Wong, S. G., Levin, W. J., Ullrich, A., & McGuire, W. L. (1987). Human breast cancer: correlation of relapse and survival with amplification of the HER-2/neu oncogene. science, 235(4785), 177-182. doi:10.1126/science.3798106 [15] Carter, P., Presta, L. E. N., Gorman, C. M., Ridgway, J. B., Henner, D., Wong, W. L., ... & Shepard, H. M. (1992). Humanization of an anti-p185HER2 antibody for human cancer therapy. Proceedings of the National Academy of Sciences, 89(10), 4285-4289. doi: 10.1073/pnas.89.10.4285. [16] Targeted Therapy for Breast Cancer. Retrieved Sep 17, 2025 from https://www.cancer.org/cancer/breast-cancer/treatment/targeted-therapy-for-breast-cancer.html [17] Triple-negative Breast Cancer | Details, Diagnosis, and Signs | American Cancer Society. Retrieved Sep 17, 2025 from https://www.cancer.org/cancer/types/breast-cancer/about/types-of-breast-cancer/triple-negative.html [18] Stage IV breast cancer prognosis | LBBC. Retrieved Sep 17, 2025 from https://www.lbbc.org/about-breast-cancer/types-breast-cancer/metastatic-breast-cancer/diagnosis/prognosis [19] Lukong, K. E. (2017). Understanding breast cancer–The long and winding road. BBA clinical, 7, 64-77. https://doi.org/10.1016/j.bbacli.2017.01.001 [20] Slamon, D. J., Leyland-Jones, B., Shak, S., Fuchs, H., Paton, V., Bajamonde, A., ... & Norton, L. (2001). Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. New England journal of medicine, 344(11), 783-792.doi: 10.1056/NEJM200103153441101 [21] Modi, S., Saura, C., Yamashita, T., Park, Y. H., Kim, S. B., Tamura, K., ... & Krop, I. (2020). Trastuzumab deruxtecan in previously treated HER2-positive breast cancer. New England Journal of Medicine, 382(7), 610-621. doi: 10.1056/NEJMoa1914510 [22] Trodelvy® (sacituzumab govitecan) Granted European Commission Marketing Authorization for Treatment of Metastatic Triple-Negative Breast Cancer in Second Line (gilead.com). Retrieved Sep 19, 2025 from https://www.gilead.com/news/news-details/2021/trodelvy-sacituzumab-govitecan-granted-european-commission-marketing-authorization-for-treatment-of-metastatic-triple-negative-breast-cancer-in-second-line [23] Jacobson, A. (2022). Elacestrant improves progression-free survival after endocrine therapy for estrogen receptor-positive metastatic breast cancer. The Oncologist, 27(Supplement_1), S7-S8. doi: 10.1093/oncolo/oyac015 [24] Arvinas Announces Submission of New Drug Application to U.S. FDA for Vepdegestrant for Patients with ESR1-Mutated ER+/HER2- Advanced or Metastatic Breast Cancer. Retrieved Sep 19, 2025 from https://ir.arvinas.com/news-releases/news-release-details/arvinas-announces-submission-new-drug-application-us-fda [25] Camizestrant reduced the risk of disease progression or death by 56% in patients with advanced HR-positive breast cancer with an emergent ESR1 tumour mutation in SERENA-6 Phase III trial (astrazeneca.com) . Retrieved Sep 19, 2025 from https://www.astrazeneca.com/media-centre/press-releases/2025/camizestrant-reduced-the-risk-of-disease-progression-or-death-by-56-in-patients-with-advanced-hr-positive-breast-cancer-with-an-emergent-esr1-tumour-mutation-in-serena-6-phase-iii-trial.html 免责声明：本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

临床研究

2025-09-30

·BiG生物创新社

礼来的时代已然开启

作者｜momo 专利悬崖、政策摇摆、竞争白热化……医药圈的“水逆期”好像看不到头。但就在这一片混沌中，一条最强主线已杀出重围，到2030年，礼来将强势碾压所有对手，登顶全球药企营收榜！凭什么？就凭它用GLP-1撕开市场，用口服SERD巩固战线，再用神经科学布局未来。EvaluatePharma在《World Preview 2025》报告中预测，礼来营收将达到昔日巨头辉瑞、诺华的两倍之多，增速更是一骑绝尘，让对手望尘莫及。 01 瞄准10亿美元大药 9月25日，礼来宣布其口服雌激素受体拮抗剂Inluriyo（imlunestrant）获FDA批准，用于治疗ER阳性、HER2阴性、携带ESR1突变的晚期或转移性乳腺癌成人患者。这是全球第二款获批的口服选择性雌激素受体降解剂（SERD）药物，对标SERD领域的王牌药物年销售额超过10亿美元的氟维司群。作为第一代SERD药物，氟维司群由阿斯利康开发，于2002年获批上市。其通过阻断雌激素受体信号传导同时诱导受体降解发挥作用，能够从根本上切断乳腺癌细胞的生长信号。然而，氟维司群存在生物利用度低、患者依从性差、联合用药便利性不足等显著缺陷，为口服SERD药物的发展创造了机会。研究发现，大约30%-40%的晚期乳腺癌患者存在ESR1突变，在接受过CDK4/6抑制剂治疗的患者中，这一比例高达40%。这种突变会导致雌激素受体过度活跃，驱动癌症生长，并常常引起对传统内分泌治疗的耐药。礼来Inluriyo聚焦于ESR1突变亚群，采用每日一次的口服给药方式，极大地提高了用药的便利性。在III期EMBER-3试验中，与标准内分泌治疗相比，Inluriyo将疾病进展或死亡风险降低了38%。在携带ESR1突变的患者中，与氟维司群或依西美坦相比，Inluriyo相较于氟维司群或依西美坦显著改善了无进展生存期 (PFS)，中位PFS为5.5个月 vs 3.8个月。图1.Inluriyo III期EMBER-3试验临床数据值得注意的是，礼来意图将Inluriyo的治疗应用从晚期向前线设置扩展。目前，Inluriyo正在进行的III期EMBER-4试验计划在全球招募约8000名患者，评估Inluriyo用于ER阳性、HER2阴性早期乳腺癌辅助治疗的效果,潜在市场空间巨大。图2.全球III期及上市SERD结构随着礼来Inluriyo的加入，口服SERD赛道的竞争格局日益清晰。目前，全球已有四款口服SERD药物顺利完成III期研究，除了已上市的艾拉司群，Inluriyo还面临着来自罗氏的Giredestrant和来自阿斯利康的Camizestrant等在研口服SERD候选药物的潜在竞争。未来，礼来还需要交出足够亮眼的成绩来证明Inluriyo的差异化优势。 02 GLP-1最大赢家 2025年全球医药市场最具看点的竞争莫过于GLP-1类药物领域的“药王”之争。2025年上半年，诺和诺德的司美格鲁肽以166.32亿美元销售额暂时领跑，但礼来的替尔泊肽以121.3%的惊人增速紧追不舍，斩获147.34亿美元销售额。更具里程碑意义的是，在第二季度，替尔泊肽单季销售额（85.80亿美元）已成功反超司美格鲁肽（80.34亿美元）。2025年全球“药王”宝座极有可能易主。替尔泊肽的崛起速度令人惊叹，作为GLP-1/GIP双受体激动剂，替尔泊肽在降糖和减重方面展现出优于单靶点药物的疗效。礼来通过精准的市场策略，将替尔泊肽以降糖版Mounjaro和减重版Zepbound两个品牌推向市场。2025年H1，Mounjaro同比增长85%至90.41亿美元，Zepbound更是大卖56.93亿美元，增速高达223%。礼来在市场份额上也已取得领先，2025年Q1，礼来GLP-1产品在美国市场的处方量占比达到53.3%，超过诺和诺德的46.1%。到上半年结束时，这一差距进一步扩大至57.0%对42.5%，显示出强劲的市场渗透力。礼来还积极拓展适应症范围，Zepbound可能在2025年底解锁射血分数保留型心力衰竭（HFpEF）第三项适应症，这将为其业绩增长提供新的增量。据EvaluatePharma预测，到2030年替尔泊肽的全球销售额将达到617亿美元，这一数字将是现任“药王”帕博利珠单抗2024年销售额（295亿美元）的两倍多（图3）。图3.替尔泊肽2030预测全球销售额另外，在替尔泊肽之后，礼来正在打造新的增长引擎，口服GLP-1药物Orforglipron。与需要注射的替尔泊肽不同，Orforglipron是一种每日一次的口服小分子GLP-1受体激动剂，ACHIEVE-3 III期临床研究结果显示，Orforglipron在降糖和减重方面均表现出色。第52周时，接受12 mg、36 mg Orforglipron治疗患者的A1C水平分别平均降低1.9 %与2.2 %；而接受7 mg与14 mg活性对照药物患者的A1C则分别降低1.1%与1.4%（图4）。图4.ACHIEVE-3 III期临床研究结果在体重管理方面，接受12 mg、36 mg Orforglipron治疗患者的平均体重下降分别为14.6磅（6.7%）与19.7磅（9.2%）；而接受7 mg与14 mg活性对照药物患者的体重则分别下降7.9磅（3.7%）与11.0磅（5.3%）（图4）。在最高剂量组比较中，Orforglipron组患者的体重下降幅度相对高出73.6%。此外，Orforglipron还在非高密度脂蛋白胆固醇、收缩压与甘油三酯等关键心血管危险因素上带来具有临床意义的改善。礼来已于2025年8月公布了orforglipron的关键性III期临床（ATTAIN-1）数据，每日口服一次36毫克该药物可以让体重减轻12.4%。其计划在2025年底前向美国、英国、欧盟和日本等国递交Orforglipron的上市申请。 EvaluatePharma预测，orforglipron 2030年销售额预计将达到127亿美元。随着2025年下半年替尔泊肽增势延续，它极有可能从司美格鲁肽手中接过“药王”权杖。而Orforglipron作为便利性更强的口服制剂，将成为礼来巩固市场领导地位的关键棋子，礼来在这场竞赛中的霸主地位已经很明显了。 03 加码布局CNS赛道血脑屏障（BBB）曾是将绝大多数中枢神经系统药物拒之门外的天堑，如今正成为MNC攻坚的下一个前沿。 BBB是CNS疾病药物研发面临的主要生理障碍，它由脑毛细血管壁与神经胶质细胞构成，仅允许特定类型分子通过，阻止绝大多数小分子和大分子药物进入大脑（图5）。图5.大多数药物无法渗透血脑屏障 2025年4月，礼来与Sangamo Therapeutics达成14亿美元合作，获得的STAC-BBB技术是一种高效穿透血脑屏障的腺相关病毒（AAV）衣壳，该衣壳在非人灵长类动物模型中表现出强力穿越血脑屏障能力和神经元转导效果。根据Sangamo数据，与传统AAV9衣壳相比，STAC-BBB驱动转基因在CNS神经元中表达的能力提高了700倍。这意味着，研究人员可以开发静脉注射的基因组药物，治疗以往难以触及的CNS系统疾病。此外，礼来获得的许可是全球独家的，涵盖一个初始疾病靶点，并有权增加最多四个神经系统疾病靶点。这种灵活性使礼来能够针对多种CNS疾病开发基因疗法。然而，这只是礼来在神经科学领域布局的冰山一角。 2024年，礼来心血管代谢板块贡献了295.21亿美元收入，占总营收的66%，而神经科学板块仅占3%，业绩主要依赖偏头痛药物Galcanezumab。然而，面对激烈的市场竞争，Galcanezumab增长乏力，神经科学板块亟需新产品接棒。因此，礼来正在积极构建新的增长曲线，一方面依托内部研发，已获批的Donanemab及在研药物Remternetug有望接棒增长；另一方面，礼来也积极通过收购与合作，持续拓展其在神经科学领域的产品管线。 2020年12月，礼来以10.4亿美元收购Prevail，获得其针对帕金森病和戈谢病的GBA1基因疗法PR001； 2022年10月，以约6.1亿美元收购Akouos，加码用于额颞叶痴呆症的听力基因疗法AK-OTOF； 2024年3月，参与蛋白降解公司TRIMTECH Therapeutics的种子轮融资，该公司专注于靶向致病蛋白聚集，开发神经退行性疾病及炎症性疾病疗法； 2024年6月，礼来以超过6亿美元引进QurAlis公司的渐冻症反义寡核苷酸药物QRL-204； 2024年9月，礼来中国宣布成立独立的神经科学事业部，进一步彰显公司对该领域的重视； 2025年1月，与Alchemab合作，利用其抗体平台开发多达五种治疗肌萎缩侧索硬化症的抗体； 2025年5月，与韩国Rznomics达成13亿美元合作，共同开发用于感音神经性听力损失的RNA编辑疗法。结语在GLP-1赛道，礼来凭借替尔泊肽的惊人增速与市场渗透力，正试图从诺和诺德手中夺过“药王”权杖；在肿瘤领域，口服SERD药物Inluriyo的成功获批，进一步凸显了其在乳腺癌领域的差异化实力；而在被视为“未来战场”的神经科学领域，礼来通过收购、合作与自主研发，为中长期增长开辟新的可能性。 2025，礼来的时代依然开启。参考资料 [1]https://investor.lilly.com/news-releases/news-release-details/us-fda-approves-inluriyo-imlunestrant-adults-er-her2-esr1 [2]https://investor.lilly.com/news-releases/news-release-details/lillys-oral-glp-1-orforglipron-superior-oral-semaglutide-head [3]https://www.chemicalbook.com/ProductIndex.aspx [4]https://app.evaluate.com/ux/WebReport/Welcome2.aspx [5]https://www.fusfoundation.org/the-technology/mechanisms-of-action/blood-brain-barrier-opening/ 共建Biomedical创新生态圈！如何加入BiG会员？

临床3期

2025-09-29

·Firstwordpharma

FDA OKs Guardant Health companion diagnostic for Lilly's breast cancer drug

Guardant Health announced Monday that the FDA has cleared its Guardant360 companion diagnostic (CDx) to identify patients with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer who may benefit from Eli Lilly's Inluriyo (imlunestrant), an oral selective oestrogen receptor degrader (SERD) approved last week.The clearance "provides another treatment for breast cancer patients with ESR1 mutations for their specific type of cancer along with expanded access to comprehensive genomic profiling with a simple blood draw," said Helmy Eltoukhy, Guardant Health chairman and co-CEO. The blood-based test detects key ESR1 mutations —including E380, V422del, S463, L469, L536, Y537 and D538 — which are associated with resistance to endocrine therapy. In the Phase III EMBER-3 trial, patients selected by Guardant360 CDx and treated with Inluriyo showed a 38% reduction in disease progression or death versus standard endocrine therapy. When combined with Lilly's Verzenio (abemaciclib), the benefit increased to 43%.The clearance is Guardant360 CDx's second for breast cancer; it was previously cleared to identify patients with advanced or metastatic breast cancer with ESR1 mutations who might benefit from treatment with Menarini's Orserdu (elacestrant). It has also been authorised by the FDA to identify patients with lung cancer eligible for treatment with AstraZeneca's Tagrisso (osimertinib), Johnson & Johnson's Rybrevant (amivantamab-vmjw), Daiichi Sankyo and AstraZeneca's Enhertu (fam-trastuzumab deruxtecan-nxki) and Amgen's Lumakras (sotorasib).

临床结果临床3期上市批准

100 项与艾拉司群相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11671	艾拉司群	-	DB06374

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
晚期乳腺癌	英国	Stemline Therapeutics, Inc.	2024-01-05
转移性乳腺癌	英国	Stemline Therapeutics, Inc.	2024-01-05
ER阳性/HER2阴性/ESR1突变乳腺癌	美国	Stemline Therapeutics, Inc.	2023-01-27

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
乳腺癌	申请上市	美国	Radius Pharmaceuticals, Inc.	2022-06-22
淋巴结阳性乳腺癌	临床3期	美国	Stemline Therapeutics, Inc.	2024-09-27
淋巴结阳性乳腺癌	临床3期	阿根廷	Stemline Therapeutics, Inc.	2024-09-27
淋巴结阳性乳腺癌	临床3期	澳大利亚	Stemline Therapeutics, Inc.	2024-09-27
淋巴结阳性乳腺癌	临床3期	奥地利	Stemline Therapeutics, Inc.	2024-09-27
淋巴结阳性乳腺癌	临床3期	比利时	Stemline Therapeutics, Inc.	2024-09-27
淋巴结阳性乳腺癌	临床3期	巴西	Stemline Therapeutics, Inc.	2024-09-27
淋巴结阳性乳腺癌	临床3期	加拿大	Stemline Therapeutics, Inc.	2024-09-27
淋巴结阳性乳腺癌	临床3期	捷克	Stemline Therapeutics, Inc.	2024-09-27
淋巴结阳性乳腺癌	临床3期	丹麦	Stemline Therapeutics, Inc.	2024-09-27

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临床结果

适应症

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT06382948 (ADELA, ASCO2025)	临床3期	ER阳性/HER2阴性/ESR1突变乳腺癌 \| HER2 阴性乳腺癌 \| ER阳性乳腺癌 ... ESR1-mutated tumors 更多	240	Elacestrant 345 mg + Everolimus 7.5 mg	鏇鬱襯醖醖衊繭繭築願(遞獵蓋夢醖鏇鬱鏇製艱) = 襯蓋廠築膚襯壓選膚艱築壓夢範糧觸遞遞鹽觸 (網蓋顧糧壓憲鹽範醖繭 ) 更多	积极	2025-05-30
NCT05563220 (ELEVATE, ASCO2025)	临床1/2期	ER阳性/HER2阴性乳腺癌	-	Elacestrant + Ribociclib	齋糧願範膚鏇齋餘憲觸(憲顧鬱積窪蓋製製獵繭) = 43% (7% ≥Gr3) with Ela + Eve 窪鹹壓衊蓋淵鑰淵鏇願 (醖範廠鹽積壓膚艱獵蓋 ) 更多	-	2025-05-30
				Elacestrant + Everolimus
NCT06492616 (ELEGANT, ASCO2025)	临床3期	淋巴结阳性乳腺癌 \| ER阳性乳腺癌辅助 Ki67	-	Elacestrant	鏇鹽鏇憲餘窪壓簾選鏇(窪遞鏇糧衊顧獵膚夢製) = 鑰獵艱觸積選糧醖鬱獵艱齋襯鹹蓋鬱鬱糧網顧 (觸艱憲觸遞鹽夢鹹鑰鑰 )	积极	2025-05-30
				Standard Endocrine Therapy (AI or tamoxifen)	鏇鹽鏇憲餘窪壓簾選鏇(窪遞鏇糧衊顧獵膚夢製) = 齋鏇鑰鏇艱選鑰鬱顧憲艱齋襯鹹蓋鬱鬱糧網顧 (觸艱憲觸遞鹽夢鹹鑰鑰 )
NCT03778931 (EMERALD, ESMO_BC2025)	临床3期	转移性乳腺癌 ESR1	966	elacestrant (ESR1 mutation testing by liquid biopsy using ddPCR)	齋構艱製遞網鹽蓋鏇遞(膚觸遞壓鏇鑰顧製醖醖) = 獵製淵願糧壓憲鬱艱選網艱蓋糧鏇顧繭築憲憲 (蓋窪繭鑰淵願蓋鏇醖繭, 33.2% ~ 39.4) 更多	积极	2025-05-14
SABCS2024 人工标引	N/A	ER阳性/HER2阴性乳腺癌 HER2 Negative	212	Elacestrant	鏇蓋願蓋網簾鑰簾築繭(製鑰獵積繭積範衊網夢) = 鹹鏇艱願製壓艱夢壓繭網窪製選製構餘鏇窪構 (築鬱艱襯淵窪衊觸淵憲, 5.4 ~ NR)	积极	2024-12-10
				Elacestrant (1-2 lines of prior ET)	鏇蓋願蓋網簾鑰簾築繭(製鑰獵積繭積範衊網夢) = 鹽憲鏇觸蓋糧願膚窪糧網窪製選製構餘鏇窪構 (築鬱艱襯淵窪衊觸淵憲, 4.9 ~ NR)
NCT05563220 \| NCT05386108 (ELEVATE, SABCS2024) 人工标引	临床1/2期	ER阳性/HER2阴性乳腺癌 HER2 Negative	55	Elacestrant + Abemaciclib (all efficacy-evaluable)	製窪夢膚製製獵觸夢觸(廠構鬱廠觸構顧衊築衊) = 淵膚觸糧淵網齋顧淵鏇醖範夢願顧願觸齋蓋鹽 (廠襯壓網窪醖蓋築窪窪 )	积极	2024-12-10
				Elacestrant + Abemaciclib (ESR1-mut population)	製窪夢膚製製獵觸夢觸(廠構鬱廠觸構顧衊築衊) = 顧鏇簾糧淵觸繭鹽襯顧醖範夢願顧願觸齋蓋鹽 (廠襯壓網窪醖蓋築窪窪 )
NCT05563220 (ELEVATE, ESMO2024)	临床1/2期	ER阳性/HER2阴性乳腺癌 ER+ \| HER2-negative \| ESR1-mut	-	Elacestrant + Everolimus	糧鏇醖餘範築範糧糧繭(網願鹽壓鹹壓範範廠淵) = 10 (43) 2 (9) 壓選獵鏇淵艱鬱廠鏇繭 (齋範簾壓淵膚齋壓鏇憲 ) 更多	积极	2024-09-16
				Elacestrant + Palbociclib
NCT05563220 (ELEVATE, ASCO2024) 人工标引	临床1/2期	ER阳性/HER2阴性乳腺癌 HER2 Positive	20	Elacestrant + Ribociclibribociclib	鬱糧觸鹹蓋艱衊衊艱夢(蓋觸範鹽願繭遞獵膚鹽) = Most common (≥30%) all-grade (Gr) AEs were decreased neutrophils/neutropenia (n=6, 50%; Gr3+ n=4, 33%) in the elacestrant (86-172 mg) + ribociclib (400 mg) cohorts 壓鹹遞蓋餘衊艱憲遞願 (鑰鑰鹽願獵艱襯範淵憲 ) 更多	积极	2024-05-24
				elacestrantelacestrant (258-345 mg) + palbociclib (100 mg) cohorts
NCT05386108 (ELECTRA, ASCO2024) 人工标引	临床1/2期	ER阳性/HER2阴性乳腺癌二线 ER Positive \| HER2 Negative \| ESR1 Mutation	26	Elacestrant + Abemaciclib	築膚繭鑰衊繭壓構餘製(簾餘膚願願糧選夢築願) = 鏇願鹹窪簾鏇選鹹憲選壓築鬱廠獵繭艱膚衊艱 (廠鑰夢鬱築選繭齋淵鹽 ) 更多	积极	2024-05-24
EMERALD study (ASCO2024)	N/A	HR阳性/HER2阴性乳腺癌 ESR1-mutant	418	Elacestrant	膚獵網鹹鏇餘廠選廠鏇(鑰襯鹹繭齋構襯餘積糧) = 製醖艱顧齋艱遞齋廠艱遞蓋膚蓋顧衊餘齋衊艱 (選夢蓋遞構鑰築窪齋範, 4.2 ~ not reached [NR]) 更多	积极	2024-05-24