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2025-04-01

申办/合作机构

Yale University

[+2]

NCT06201234

/ Recruiting临床2期

Phase II Study Evaluating the Addition of Elacestrant, an Oral Selective Estrogen Receptor Degrader (SERD), to Standard-of-care Olaparib in Patients with Hormone Receptor (HR)-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer with GBRCA1/2 Mutations

Trial design:
Phase II, prospective, multi-center, randomized, open label, parallel group study in patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer with gBRCA1/2 mutation, with 2:1 randomization into Arm A (olaparib + elacestrant) or arm B (olaparib). Treatment in either arm will be given until disease progression, unacceptable toxicity, withdrawal of patient´s consent to study participation, or end of study.
Trial population:
Patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer with gBRCA1/2 mutation, with an indication for standard-of-care PARP inhibitor therapy and planned treatment with olaparib, an ECOG performance status of 0-2 and life expectancy of > 6 months, with normal bone marrow and kidney functions and no active or newly diagnosed central nervous system (CNS) metastases or symptomatic metastatic visceral disease at risk of life-threatening complications.
Interventions:
Patients randomized to Arm A will receive 600 mg olaparib daily and 400 mg elacestrant daily, while patients randomized to Arm B will receive 600 mg olaparib daily. Blood tests (hematology, biochemistry) will be performed at the beginning of every cycle, and imaging for tumor assessment (chest and abdominopelvic imaging) as well as QoL assessments will be performed every three months and in case of suspicion of progression/end of study.

开始日期2024-12-13

申办/合作机构

GBG Forschungs GmbH

[+1]

NCT06382948

/ Recruiting临床3期

A Randomized Phase 3, Double-Blind, Placebo-Controlled Study of Elacestrant Plus Everolimus Versus Elacestrant in Patients With ER+/HER2-, ESR1mut Advanced Breast Cancer Progressing to Endocrine Therapy and CDK4/6 Inhibitors

This trial will study a type of advanced breast cancer (ABC) defined as endocrine receptor (ER)-positive/human epidermal growth factor receptor 2(HER2)-negative and estrogen receptor 1 (ESR1)-mutated. Patients will be treated with elacestrant, a compound that acts as a selective estrogen receptor degrader, and everolimus (or placebo), a kinase inhibitor indicated for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer.
The main purpose of the study is to analyze the efficacy (to find out how effective a treatment is) of elacestrant plus everolimus therapy in patients who have ER-positive/HER2-negative, ESR1-mutated, ABC progressing to endocrine therapy and cyclin-dependent kinase 4/6 (CDK4/6) inhibitor. The efficacy of elacestrant plus everolimus combination will be determined by assessing the period from elacestrant plus everolimus (or placebo) treatment initiation until to the first occurrence of disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason, whichever occurs first, defined as progression free survival.
Rigorous eligibility criteria based on specific co-morbidities and clinicopathologic features of their disease have been designed to minimize the risk of patients participating in this study. The anticipated favorable clinical benefits of elacestrant combined with everolimus are projected to outweigh the risks of this treatment. This study will be performed in full compliance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and all applicable local Good Clinical Practice (GCP) and regulations.

开始日期2024-12-05

申办/合作机构

Medica Scientia Innovation Research SL

[+1]

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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100

项与艾拉司群相关的文献（医药）

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.

2025-04-01·CLINICAL CANCER RESEARCH

Elacestrant in Women with Estrogen Receptor–Positive and HER2-Negative Early Breast Cancer: Results from the Preoperative Window-of-Opportunity ELIPSE Trial

Article

作者: Bellet, Meritxell ; Cortadellas, Tomás ; Gonzalez-Farré, Xavier ; Muñoz-Mateu, Montserrat ; Falato, Claudette ; Siso, Christian ; Pascual, Tomás ; Amillano, Kepa ; Bergamino, Milana A. ; Luna, Miguel A. ; Espinosa Guerrero, Alejandra ; Salvador, Fernando ; Cebrecos, Isaac ; Galván, Patricia ; Ferrero-Cafiero, Juan M. ; Sanfeliu, Esther ; Prat, Aleix ; Margelí Vila, Mireia ; Sanchez-Bayona, Rodrigo ; Vidal, Maria ; Pare, Laia

Abstract:

Purpose::

Elacestrant has shown significantly prolonged progression-free survival compared with standard-of-care endocrine therapy in estrogen receptor–positive (ER-positive), HER2-negative metastatic breast cancer, whereas potential benefit in early-stage disease requires further exploration. The SOLTI-ELIPSE window-of-opportunity trial investigated the biological changes induced by a short course of preoperative elacestrant in postmenopausal women with early breast cancer.

Patients and Methods::

Eligible patients with untreated T1c (≥1.5 cm)-T3, N0, ER-positive/HER2-negative breast cancer with locally assessed Ki67 ≥10% received elacestrant at a daily dose of 345 mg for 4 weeks. The primary efficacy endpoint was complete cell cycle arrest, defined as Ki67 ≤2.7%, on day 28.

Results::

Overall, 22 patients were evaluable for the primary endpoint. Elacestrant was associated with a complete cell cycle arrest rate of 27.3% and a statistically significant Ki67 geometric mean change of −52.9% (P = 0.007; 95% confidence interval, −67.4 to −32.1). Notably, the treatment with elacestrant led to a shift toward a more endocrine-sensitive and less proliferative tumor phenotype based on PAM50-based gene signatures. Elacestrant increased the expression of immune-response genes (GZMB, CD4, and CD8A) and suppressed proliferation and estrogen-signaling genes (MKI67, ESR1, and AR). These biological changes were independent of the levels of Ki67 suppression on day 28. The most common adverse events were grade 1 anemia (21.7%), hot flushes (8.7%), constipation (8.7%), and abdominal pain (8.7%). One patient experienced a grade 3 cutaneous rash, leading to treatment discontinuation. No other serious adverse events were reported.

Conclusions::

Preoperative treatment with elacestrant in early breast cancer demonstrated relevant biological and molecular responses and exhibited a manageable safety profile. These findings support further investigation of elacestrant in the early setting.

2025-03-17·The Journal of Clinical Endocrinology & Metabolism

Somatic Activating ESR1 Mutation in an Aggressive Prolactinoma

Article

作者: Bi, Wenya Linda ; Meredith, David M ; Paes, Ticiana ; Abreu, Ana Paula ; Stamatiades, George A ; Laws, Edward R ; Buelvas Mebarak, Jacobo ; Carroll, Rona S ; Grosek, Natalie ; Jeselsohn, Rinath ; Marcondes Lerario, Antonio ; Kuang, Yanan ; Magnotto, John C ; Paweletz, Cloud P ; Kaiser, Ursula B ; Reardon, David A ; Mohan, Dipika R ; Truong, Minh T

Abstract:

Context and Objective:

The genetic profile of prolactinomas remains poorly understood. Our objective is to identify somatic genetic alterations associated with prolactinomas and to report the identification of an activating ESR1 mutation (ESR1Y537S) in an aggressive prolactinoma.

Setting:

Brigham and Women's Hospital.

Design:

Massively parallel-sequencing panel (OncoPanel) was performed in a cohort of patients with prolactinomas to identify mutations and copy number variation.

Results:

Twenty subjects (mean age, 38.6 years; 12 women and 8 men) were included in this study. A somatic ESR1Y537S mutation was identified in an aggressive prolactinoma in a postmenopausal woman. No SF3B1 or other somatic mutations were identified. The median number of copy number variation events identified in our samples was 46; the prolactinoma with ESR1Y537S had the highest number with 233 events. In breast cancer, ESR1Y537S has been shown to activate estrogen receptor alpha independent of ligand binding. In patients with resistant breast cancer and ESR1Y537S, elacestrant, a second-line estrogen receptor degrader, improves progression-free survival. Therefore, given the lack of response to multimodality therapies, elacestrant was initiated in this patient after the third cycle of radiotherapy. Elacestrant, along with radiotherapy, controlled tumor growth and significantly reduced prolactin levels.

Conclusion:

Molecular profiling allowed the identification of ESR1Y537S, in an aggressive prolactinoma. ESR1Y537S was not detected early in the course of the disease and is likely conferring tumor aggressiveness. This finding emphasizes the significance of estrogen receptor signaling in prolactinomas. It also allowed the use of targeted therapy with successful control of disease progression.

213

项与艾拉司群相关的新闻（医药）

2025-03-31

·同写意

第一三共 vs 阿斯利康，乳腺癌治疗，殊途同归

100+创始人齐聚海南，对话“先行先试”政策机会，共探 CGT全产业发展之路，欢迎报名！从2020年开始，乳腺癌发病率超过了肺癌发病率，成为全球第一大恶性肿瘤，是药企必争之地。罗氏曾凭借HER2单抗——曲妥珠单抗、帕妥珠单抗、HER2 ADC药物T-DM1（恩美曲妥珠单抗）等，使乳腺癌患者的生存获益显著提高，自己也成为该领域的主导者。不过花无百日红，随着核心产品迎来专利悬崖，T-DM1被DS-8201头对头击败，罗氏在乳腺癌领域的辉煌逐渐成为过去式。在后续一众虎视眈眈的围猎者中，第一三共和阿斯利康是其中的佼佼者。1DS-8201横空出世，重塑乳腺癌治疗体系作为日本百年药企，第一三共独有的DXd ADC技术平台已成为ADC新药开发的一面旗帜。其首款重磅ADC药物Enhertu（德曲妥珠单抗，DS-8201）的横空出世，更是重新点燃了全球ADC药物的研发热情。德曲妥珠单抗是一款靶向HER2的抗体偶联药物（ADC），由第一三共研发，并由第一三共和阿斯利康共同开发和商业化。HER2是一种酪氨酸激酶受体促生长蛋白，在多种肿瘤细胞表面均有表达。作为一款HER2靶向ADC，德曲妥珠单抗采用第一三共独有的DXd ADC技术设计，由靶向HER2的人源化单克隆抗体通过四肽可裂解连接子与拓扑异构酶1抑制剂（喜树碱类衍生物，DXd）有效载荷连接组成。自2019年获FDA批准上市以来（用于治疗接受过2种或以上抗HER2疗法的治疗的无法切除或转移性HER2阳性乳腺癌患者），德曲妥珠单抗就不断书写它的传奇，并一步步重塑乳腺癌治疗格局。首次惊艳业界的是与恩美曲妥珠单抗的头对头随机对照研究。DESTINY-Breast03是首个头对头比较德曲妥珠单抗和恩美曲妥珠单抗在 HER2 阳性晚期乳腺癌二线治疗中疗效的 Ⅲ 期临床研究。在2022 年圣安东尼奥国际乳腺癌研讨会（SABCS）上公布的研究结果显示，德曲妥珠单抗组无进展生存期（PFS）获益明显（28.8 个月 vs 6.8 个月），约为恩美曲妥珠单抗组的 4 倍，并且降低患者疾病进展或死亡风险67%。2022年5月，德曲妥珠单抗扩展适应症获美FDA批准，用于治疗无法切除或转移性HER2+乳腺癌患者，这些患者曾经接受过一种抗HER2靶向疗法的治疗。德曲妥珠单抗重塑了HER2+乳腺癌的二线治疗标准。随后的DESTINY-Breast04研究则更进一步，将HER2低表达（IHC 1+或2+/ISH阴性）乳腺癌确立为新的治疗亚型，开创了HER2低表达晚期乳腺癌治疗的新时代。研究结果显示，在激素受体（HR）阳性/HER2低表达乳腺癌患者中，德曲妥珠单抗组的中位PFS绝对值较化疗组延长了近5个月（10.1个月 vs 5.4个月，HR=0.51，95%CI：0.40-0.64）；中位总生存期（OS）也显著延长（23.9个月 vs 17.5个月，HR=0.64，95%CI：0.48-0.86）；德曲妥珠单抗组客观缓解率（ORR）达52.6%，而化疗组仅为16.3%。基于DESTINY-Breast04研究的出色结果，德曲妥珠单抗获得了国内外权威指南的一致推荐。美国NCCN乳腺癌指南（2022.V4版）将“HER2低表达乳腺癌（IHC 1+或IHC 2+/ISH-）”作为一种全新的治疗分型，将德曲妥珠单抗作为伴有内脏危象/内分泌难治HER2低表达乳腺癌的二线治疗方案。随后德曲妥珠单抗获批HER2低表达转移性乳腺癌适应症，使得乳腺癌治疗从传统的非阴即阳二分法时代迈入更加精准的三分法时代（阳性/低表达/阴性），不仅将受益人群扩大至60%-70%，更是推动整个抗HER2乳腺癌治疗模式的革新。据第一三共2024财年业绩，德曲妥珠单抗在HER2阳性乳腺癌二线治疗和HER2低表达乳腺癌适应症上，都实现了两位数的增长（德曲妥珠单抗2024全球销售额约34.77亿美元）。DESTINY-Breast系列研究还在继续。今年1月27日，FDA批准德曲妥珠单抗用于治疗不可切除或转移性、激素受体（HR）阳性且HER2低表达（IHC 1+或IHC 2+/ISH-）或超低表达（IHC 0但具有膜染色）的乳腺癌患者。这一批准基于DESTINY-Breast06研究，结果显示，在总人群中，德曲妥珠单抗相比标准治疗组，将中位PFS显著延长了5.1月（13.2个月 vs 8.1个月，HR=0.63，P<0.0001）；在HER2低表达患者亚组中，德曲妥珠单抗相比标准治疗组，中位PFS显著延长（13.2个月 vs 8.1个月，HR=0.62，P<0.0001），OS达到12个月的比例更高（87.6% vs 81.7%，HR=0.83）；在HER2超低表达患者亚组中，德曲妥珠单抗展现出与HER2低表达亚组相似的获益趋势，相比标准治疗组，中位PFS显著延长（13.2个月 vs 8.3个月，HR=0.78），OS达到12个月的比例更高（84.0% vs 78.7%，HR=0.75）。至此，德曲妥珠单抗从HER2阳性到HER2低表达、超低表达，都已积累了循证医学证据，重新塑造了乳腺癌治疗格局。2阿斯利康不语，只一味卷自己在乳腺癌治疗领域，阿斯利康是不能被忽视的存在。阿斯利康瞄准HR+乳腺癌患者这一大群体，陆续推出了他莫昔芬、戈舍瑞林、阿那曲唑和氟维司群四款内分泌治疗基石药物，并不断在此基础上超越自己。以经典药物氟维司群（fulvestrant）为例，这是一款选择性雌激素受体降解剂（SERD），其通过与癌细胞表面的ER相结合，降低ER的稳定性，诱导它们被细胞正常的蛋白降解机制降解，从而降低雌激素受体水平，抑制癌细胞的生长。其优势在于能够更全面地抑制雌激素受体的功能，并且可能解决雌激素受体突变产生的耐药性。2002年4月，Faslodex（氟维司群）获FDA批准上市，用于雌激素治疗（如他莫昔芬）后疾病进展的绝经后乳腺癌患者。作为全球首款SERD药物，氟维司群可将达到总生存期5年的晚期乳腺癌患者的比例，由22.5%提升至50%。在二十年的时间中，氟维司群独占SERD市场，销售峰值达到10.28亿美元。不足的是，氟维司群只能肌肉注射给药，生物利用度低且可及性欠佳。所以业界开始追求效果更强、可及性更好、极具替代潜力的SERD口服药，不过，这一路走来并不顺利。2022年，赛诺菲的SERD口服药Amcenestrant在用于局部晚期或转移性HR+/HER2-乳腺癌患者的II期临床研究，以及联合CDK4/6抑制剂哌柏西利用于HR+/HER2-晚期乳腺癌的III期研究均失败。赛诺菲遂终止Amcenestrant项目的所有临床试验。同一年，罗氏宣布其SERD口服药Giredestrant在II期研究中未能达到PFS主要终点，OS尚不成熟。2023年，在经历14年临床开发后，美纳里尼集团旗下子公司美纳里尼集团的ORSERDU（Elacestrant，艾拉司群）获FDA批准上市，用于治疗局部晚期或转移性乳腺癌的绝经后女性或者成年男性，患者具有HR+/HER2-和ESR1突变，并且接受了至少一种内分泌治疗后病情出现进展。艾拉司群成为首个成功上市的SERD口服药物。看来，SERD口服药的研发远不如想象般容易。幸运的是，阿斯利康近日也传来好消息。2月26日，阿斯利康宣布，其SERD口服药物camizestrant在治疗HR+局部进展或转移性乳腺癌患者的III期SERENA-6临床研究中达到主要终点。即camizestrant 联合CDK4/6抑制剂在PFS的主要终点方面显示出具有统计学意义和临床意义的改善。该试验新颖之处在于，利用ctDNA监测来识别患者的内分泌耐药性早期迹象和ESR1突变的出现。ESR1基因突变是内分泌耐药的关键驱动因素，大约30%的内分泌敏感HR+疾病患者在一线治疗期间出现ESR1突变。SERENA-6研究表明，在检测到ESR1突变（尚无疾病进展）后，从芳香化酶抑制剂（阿那曲唑或来曲唑）转换为camizestrant联合CDK4/6抑制剂，可以延缓疾病进展并延长一线治疗的益处。至此，Camizestrant成为了首个证明与CDK4/6抑制剂联用时具有一线治疗获益的新一代SERD口服药物。在内分泌治疗领域，阿斯利康还率先推出了AKT抑制剂Capivasertib，该药于2023年11月，获FDA批准用于治疗HR+/HER2-局部晚期或转移性乳腺癌患者，这些患者在接受内分泌基础方案治疗过程中或之后疾病复发或进展。除在内分泌治疗不断进行自我迭代外，阿斯利康还推出了全球首款PARP抑制剂——奥拉帕利，也是首个利用DNA损伤修复通路缺陷来杀死癌细胞的靶向治疗药物。目前，在乳腺癌领域，奥拉帕利获批用于辅助治疗BRCA生殖系突变（gBRCAm）的HER2阴性高危早期乳腺癌患者，这是首款也是唯一一款获得批准治疗BRCA突变早期乳腺癌患者的疗法。在乳腺癌领域，阿斯利康产品已覆盖从早期到晚期、从绝经前到绝经后的HR+乳腺癌患者。3深耕技术平台 vs 多元合作创新，都有“美好的未来”第一三共在乳腺癌领域的异军突起，来自于对平台技术数十年磨一剑的专注。其ADC研发最早可追溯至20世纪80年代，经过40年迭代，其通过靶点选择及连接子、细胞毒药物的技术优化等，打造了独特的DXd-ADC技术平台，以实现精准靶向、高效低毒的技术优势。依托该平台，第一三共改良的DXd以10倍药物活性与极强的渗透细胞膜的能力，能够更好地发挥“旁观者效应”，这也是德曲妥珠单抗对于HER2低表达乳腺癌有优异疗效的关键因素。除德曲妥珠单抗之外，第一三共还布局了6款ADC药物，包括Dato-DXd（靶向TROP2 ADC），HER3-DXd（靶向HER3 ADC）， I-DXd（B7H3 ADC）和 R-DXd（CDH6 ADC）等。其中Dato-DXd 由第一三共研发，第一三共和阿斯利康共同开发和商业化，是一款新型TROP2 ADC，具有抗肿瘤旁观者效应，且药物安全性更高。目前Dato-DXd已被日本药品与医疗器械管理局（PMDA）、FDA批准用于治疗既往接受过化疗和内分泌治疗的不可切除或转移性HR+/HER2阴性（IHC 0、IHC 1+或IHC 2+/ISH-）乳腺癌成人患者（商品名：Datroway）。此外，Dato-DXd的研究布局还拓展至三阴性乳腺癌（TNBC）的早期和晚期治疗领域。这类乳腺癌为雌激素受体（ER）阴性、孕激素受体（PR）阴性、以及HER2阴性，由于缺乏有效治疗靶点，且预后差，素有“乳腺癌之王”之称。对于TNBC，寻找新的有效疗法刻不容缓。第一三共和阿斯利康已经启动多项III期临床研究评估Dato-DXd单药或联合疗法治疗TNBC的潜力。第一三共凭借独有的DXd-ADC技术平台，在乳腺癌治疗领域后来居上，用创新实力重新定义疾病分类，重塑了乳腺癌治疗体系。阿斯利康则通过自研和外部合作，在乳腺癌领域成功搭建出了一个有规模有层次的产品管线。从他莫昔芬到氟维司群，从奥拉帕利到Capivasertib，再从氟维司群到Camizestrant，阿斯利康的产品覆盖多个前沿靶点，同时在现有药物基础上不断改良升级，占领创新高地，实现治疗场景全覆盖。对比第一三共和阿斯利康，两家药企虽然模式不同，但都心系研发，最终印证了创新突破与商业的共振逻辑。大浪淘沙，乳腺癌药物市场虽大，最终也只能奖赏专注研发、不断自我超越的真创新药企。参考文献：1.Latest global cancer data: Cancer burden rises to 19.3 million new cases and 10.0 million cancer deaths in 2020. Retrieved Nov 16 ,2020,fromhttps://www.iarc.who.int/faq/latest-global-cancer-data-2020-qa/.2.Trastuzumab Deruxtecan in Previously Treated HER2-Low Advanced Breast Cancer. The New England Journal of Medicine. 2022; 387(1):9-20.3.Curigliano G, Hu XC, Dent R, et al. Trastuzumab deruxtecan (T-DXd) vs physicians choice of chemotherapy (TPC) in patients (pts) with hormone receptor-positive (HR+), human epidermal growth factor receptor 2 (HER2)-low or HER2-ultralow metastatic breast cancer (mBC) with prior endocrine therapy (ET): Primary results from DESTINY-Breast06 (DB-06). 2024 ASCO. LBA1000.4.https://www.daiichisankyo.com/files/news/pressrelease/pdf/202412/20241227_E.pdf.

抗体药物偶联物临床3期临床结果上市批准引进/卖出

2025-03-20

·美通社

美纳里尼集团宣布与VisualDx合作，帮助识别可能患有浆细胞样树突状细胞瘤(BPDCN)的人

BPDCN是一种侵袭性血液恶性肿瘤，预后较差 VisualDx是全球2,300多家医院、诊所和医学院使用的临床决策支持系统 VisualDx的系统旨在利用BPDCN皮肤病变的实际图像和集成到VisualDx平台中的人工智能/机器学习（ AI/ML ）技术，增强对可能患有BPDCN的人的识别意大利佛罗伦萨和纽约 2025年3月21日 /美通社/ -- 美纳里尼集团（ “美纳里尼” ）是一家领先的国际制药和诊断公司， Stemline Therapeutics, Inc. （ “Stemline” ）是美纳里尼集团的全资子公司，专注于为癌症患者提供转化性肿瘤治疗。他们今天宣布，他们正在与VisualDx合作，以加强对可能患有BPDCN的人的识别。这是一个创新的公司合作引入人工智能/机器学习（ AI/ML ）工具以帮助识别BPDCN作为可能的早期鉴别诊断的例子。该项目包括利用整合到VisualDx平台中的BPDCN皮肤病变的实际图像和AI/ML技术。 AI模型现已在VisualDx中上线。 VisualDx是一家以医生为主导的公司，致力于改善医疗决策、医学教育和研究。 VisualDx工具是全球2,300多家医院、诊所和医学院使用的临床决策支持系统。该软件包括一个全面的临床图像数据库，通过与学习机构和其他机构合作提交，并经临床医生审查，以帮助医疗保健专业人员识别所有皮肤类型的皮肤问题。通过人工智能图像搜索，临床医生可以更好地了解不同的皮肤状况，以支持患者在整个护理过程中获得更准确的诊断。 BPDCN是一种侵袭性孤儿血液恶性肿瘤，预后不良（诊断后约8.7至14个月 [1] ），通常表现为皮肤病变，也可能累及骨髓、血液、中枢神经系统、淋巴结和内脏。皮肤科医生可能是第一个识别BPDCN和活检可疑病变迹象的人。然后，病理学家可以通过测试在BPDCN细胞上高度表达的某些生物标志物来测试BPDCN。 Tagraxofusp-erzs是美国、欧洲和全球其他地区唯一获批的BPDCN患者治疗药物，也是首个也是唯一获批的CD123靶向治疗药物。 “BPDCN是一种罕见的临床侵袭性血液恶性肿瘤，通常表现为皮肤病变。由于其侵袭性和未成熟的细胞参与，如果不及时治疗，预后可能会很差。”爱因斯坦血液癌症研究所分子药理学教授、白血病项目主任兼联合主任Marina Konopleva博士说。 “早期诊断在改善患者预后方面发挥着关键作用，新兴的AI/ML技术可能为BPDCN的鉴别诊断和早期识别提供有价值的支持。” “BPDCN通常首先表现为皮肤病变，通常预后不良。美纳里尼集团首席执行官Elcin Barker Ergun表示： “迫切需要早期诊断，以便患者可以获得适当的治疗选择。 “我们很高兴与VisualDx合作，为医疗团队提供使用最新人工智能/机器学习（ AI/ML ）技术的工具，以帮助解释具有挑战性的皮肤病变。” VisualDx不会存储临床医生拍摄患者皮肤检查照片上传的任何图像。这有助于保护患者的隐私。关于BPDCN BPDCN ，以前称为芽肿性NK细胞淋巴瘤，是一种侵袭性孤儿血液恶性肿瘤，通常具有皮肤表现，预后历史上较差。 BPDCN通常表现为皮肤病变，也可能涉及骨髓、血液、中枢神经系统、淋巴结和内脏。 BPDCN起源细胞是浆细胞样树突状细胞（ pDC ）前体。 BPDCN的诊断基于CD123、CD4和CD56的免疫表型诊断三联体以及其他标志物。世界卫生组织（ WHO ）在2008年将这种疾病称为“BPDCN” ；以前的名称包括芽肿性NK细胞淋巴瘤和CD4 +/CD56 +血液皮肤肿瘤。关于ELZONRIS ® (Tagraxofusp-erzs) 美国适应症： ELZONRIS是一种用于治疗2岁及以上成人和儿童患者的母细胞性浆细胞样树突细胞肿瘤(BPDCN)的处方药。有关美国的完整处方信息，请访问 www.elzonris.com 重要的安全信息， ELZONRIS ® 盒装警告：毛细血管泄漏综合征可能危及生命或致命的毛细血管泄漏综合征(CLS)可能发生在接受ELZONRIS的患者身上。监测CLS的体征和症状，并采取建议的措施。警告和注意事项毛细血管泄漏综合征在接受ELZONRIS治疗的患者中已有毛细血管泄漏综合征（ CLS ）的报道，包括危及生命和致命的病例。在临床试验中接受ELZONRIS的患者中， CLS的总发病率为53% （ 65/122 ），其中43% （ 52/122 ）的患者为1级或2级， 7% （ 8/122 ）的患者为3级， 1% （ 1/122 ）的患者为4级， 4例死亡（ 3% ）。发病的中位时间为4天（范围- 1至46天），除5名患者外，所有患者在第1周期都经历了一次事件。在开始使用ELZONRIS治疗之前，请确保患者具有足够的心脏功能，并且血清白蛋白大于或等于3.2 g/dL。在ELZONRIS治疗期间，在开始每次ELZONRIS给药前和给药后根据临床指征监测血清白蛋白水平，并评估患者是否存在CLS的其他体征或症状，包括体重增加、新发水肿或水肿恶化，包括肺水肿、低血压或血流动力学不稳定。超敏反应 ELZONRIS可引起严重的超敏反应。在临床试验中接受ELZONRIS的患者中， 43% (53/122)接受ELZONRIS治疗的患者报告了超敏反应， 7% (9/122)中≥ 3级。在≥ 5%的患者中报告的超敏反应表现包括皮疹、瘙痒和口腔炎。监测患者在使用ELZONRIS治疗期间的超敏反应。如果发生超敏反应，请中断ELZONRIS输注，并根据需要提供支持性护理。肝毒性 ELZONRIS治疗与肝酶升高相关。在临床试验中接受ELZONRIS的患者中， ALT升高发生在79% （ 96/122 ），应用安全测试升高发生在76% （ 93/122 ）。 26% （ 32/122 ）的患者报告了3级ALT升高。 30% （ 36/122 ）的患者报告了3级应用安全测试升高， 3% （ 4/122 ）的患者报告了4级应用安全测试升高。在第1周期中，大多数患者的肝酶升高，并且在剂量中断后是可逆的。在每次输注ELZONRIS之前监测丙氨酸氨基转移酶(ALT)和天冬氨酸氨基转移酶(AST)应用安全测试。如果转氨酶升高到超过正常上限的5倍，则暂停ELZONRIS ，并在正常化或解决后恢复治疗。不良反应最常见的不良反应（发生率≥ 30% ）是毛细血管泄漏综合征、恶心、疲劳、发热、外设水肿和体重增加。最常见的实验室异常（发生率≥ 50% ）是白蛋白、血小板、血红蛋白、钙和钠的降低，以及葡萄糖、ALT和应用安全测试（ AST ）的增加。请参阅完整处方信息，包括盒装警告。如需报告疑似不良反应，请通过 1-877-332-7961 联系Stemline Therapeutics, Inc. ，或通过 1-800-FDA-1088 或 www.fda.gov/medwatch 联系FDA。关于美纳里尼集团美纳里尼集团是一家领先的国际制药及诊断公司，营业额超过47亿美元，员工超过17,000人。美纳里尼专注于心脏病、癌症、肺病、胃肠病、传染病、糖尿病、炎症和镇痛方面等产品需求缺口巨大的治疗领域。美纳里尼拥有18个生产基地和9个研发中心，产品遍布全球140个国家\/地区。如需了解更多信息，请访问 menarini.com 。关于Stemline Therapeutics Inc. Stemline Therapeutics, Inc. ("Stemline")是美纳里尼集团旗下的一家全资子公司，是一家专注于为患者提供转化性肿瘤治疗的商业化生物制药公司。 Stemline实现elacestrant的商业化，这种口服内分泌治疗药物适用于治疗美国、欧洲和全球其他地区患雌激素受体(ER)阳性、人表皮生长因子受体2 (HER2)阴性、 ESR1 突变晚期或转移性乳腺癌且接受过至少一种内分泌疗法后疾病进展的绝经后女性或成年男性。 Stemline还在美国、欧洲和全球其他地区实现针对CD123的新型靶向治疗药物tagraxofusp-erzs的商业化，用于治疗一种侵袭性血液癌--母细胞性浆细胞样树突细胞肿瘤(BPDCN)。此外， Stemline还在欧洲实现selinexor的商业化，这是一种用于多发性骨髓瘤的XPO1抑制剂。该公司还在乳腺癌和血液癌适应症中分别使用elacestrant和tagraxofusp进行多项标签扩展研究，并且拥有众多处于不同开发阶段且针对多种实体和血液癌的其他候选药物的临床试验项目。关于VisualDx VisualDx是一家致力于通过增强思维和及时可视化来改善医疗决策的公司。它致力于缩小医学差距，并相信技术可以弥合知识差距，以实现更公平的护理。 VisualDx已成为全球2,300多家医院、诊所和医学院的专业标准资源，它将面向问题的临床搜索与世界上最好的精心策划的医学图像库相结合，再加上专家的医学知识和复杂的机器学习算法，以帮助进行鉴别诊断、变异、治疗和患者沟通。如需了解更多信息，请访问 www.visualdx.com [1] Pagano L, et al Haematological. 2013; 98 (2): 239-246和Pemmaraju N Curr Hematol Malig Rep. 2017; 12 (6): 510-512

孤儿药临床研究

2025-03-20

·GlobeNewswire-Health Care

Menarini Group Announces Collaboration with VisualDx to Aid in Identifying People Who May Have Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)

BPDCN is an aggressive hematologic malignancy with a historically poor prognosisVisualDx is a clinical decision support system used by more than 2,300 hospitals, clinics, and medical schools around the world VisualDx’s system seeks to enhance identification of people who may have BPDCN, leveraging actual images of BPDCN skin lesions and artificial intelligence/machine learning (AI/ML) technologies incorporated into the VisualDx platform FLORENCE, Italy and NEW YORK, March 20, 2025 (GLOBE NEWSWIRE) -- The Menarini Group ("Menarini"), a leading international pharmaceutical and diagnostics company, and Stemline Therapeutics, Inc. ("Stemline"), a wholly-owned subsidiary of the Menarini Group focused on bringing transformational oncology treatments to cancer patients, today announced that they are collaborating with VisualDx to enhance identification of people who may have BPDCN. This is an example of innovative companies working together to bring artificial intelligence/machine learning (AI/ML) tools to help identify BPDCN as a possible early differential diagnosis. The project includes leveraging actual images of BPDCN skin lesions and AI/ML technologies incorporated into the VisualDx platform. The AI model is now live within VisualDx. VisualDx is a physician-led company committed to improving medical decision-making, medical education and research. The VisualDx tool is a clinical decision support system used by more than 2,300 hospitals, clinics, and medical schools around the world. The software includes a comprehensive database of clinical images, submitted through partnerships with learning institutions and others, and vetted by clinicians, to assist healthcare professionals to identify skin concerns across all skin types. Through the AI image search, clinicians can better understand different skin conditions with the goal of supporting patients to get more accurate diagnoses throughout their care journeys. BPDCN is an aggressive orphan hematologic malignancy with a historically poor prognosis (approximately 8.7 to 14 months post diagnosis1) that typically presents skin lesions and can also involve the bone marrow, blood, central nervous system, lymph nodes and viscera. Dermatologists may be the first to recognize the signs of BPDCN and biopsy suspicious lesions. Pathologists can then test for BPDCN by testing for certain biomarkers which are highly expressed on BPDCN cells. Tagraxofusp-erzs is the only approved treatment for patients with BPDCN, and the first and only approved CD123-targeted therapy, in the United States, Europe and other global regions. "BPDCN is a rare and clinically aggressive hematologic malignancy, often presenting with cutaneous lesions. Due to its aggressive nature and the immature cell involvement, the prognosis can be poor if not treated promptly,” said Marina Konopleva, MD, Phd, Professor, Molecular Pharmacology, Director, Leukemia Program and Co-Director, Blood Cancer Institute, at Montefiore Einstein. “Early diagnosis plays a critical role in improving patient outcomes, and emerging AI/ML technologies may offer valuable support in the differential diagnosis and early identification of BPDCN." “BPDCN often first presents as a skin lesion and usually has a poor prognosis. There is a dire need for early diagnosis so that patients may access appropriate treatment options,” said Elcin Barker Ergun, CEO of the Menarini Group. “We are delighted to collaborate with VisualDx to provide healthcare teams with a tool using the latest artificial intelligence/machine learning (AI/ML) technology to help interpret challenging skin lesions.” VisualDx does not store any images uploaded by clinicians taking a picture of their patients’ skin exams. This helps maintain the patient’s privacy. About BPDCNBPDCN, formerly blastic NK-cell lymphoma, is an aggressive, orphan hematologic malignancy, often with cutaneous manifestations, with historically poor outcomes. BPDCN typically presents skin lesions and may also involve bone marrow, blood, central nervous system, lymph nodes and viscera. The BPDCN cell of origin is the plasmacytoid dendritic cell (pDC) precursor. The diagnosis of BPDCN is based on the immunophenotypic diagnostic triad of CD123, CD4, and CD56, as well as other markers. The World Health Organization (WHO) termed this disease “BPDCN” in 2008; previous names included blastic NK cell lymphoma and CD4+/CD56+ hematodermic neoplasm. About ELZONRIS® (Tagraxofusp-erzs)U.S. Indication: ELZONRIS is a prescription medicine used to treat blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and pediatric patients 2 years and older. Full prescribing information for the U.S. can be found at www.elzonris.com IMPORTANT SAFETY INFORMATION, ELZONRIS®Boxed WARNING: CAPILLARY LEAK SYNDROME Capillary Leak Syndrome (CLS) which may be life-threatening or fatal, can occur in patients receiving ELZONRIS. Monitor for signs and symptoms of CLS and take actions as recommended. Warnings and Precautions Capillary Leak Syndrome Capillary leak syndrome (CLS), including life-threatening and fatal cases, has been reported among patients treated with ELZONRIS. In patients receiving ELZONRIS in clinical trials, the overall incidence of CLS was 53% (65/122), including Grade 1 or 2 in 43% (52/122) of patients, Grade 3 in 7% (8/122) of patients, Grade 4 in 1% (1/122) of patients, and four fatalities (3%). The median time to onset was 4 days (range - 1 to 46 days), and all but 5 patients experienced an event in Cycle 1. Before initiating therapy with ELZONRIS, ensure that the patient has adequate cardiac function and serum albumin is greater than or equal to 3.2 g/dL. During treatment with ELZONRIS, monitor serum albumin levels prior to the initiation of each dose of ELZONRIS and as indicated clinically thereafter, and assess patients for other signs or symptoms of CLS, including weight gain, new onset or worsening edema, including pulmonary edema, hypotension or hemodynamic instability. Hypersensitivity Reactions ELZONRIS can cause severe hypersensitivity reactions. In patients receiving ELZONRIS in clinical trials, hypersensitivity reactions were reported in 43% (53/122) of patients treated with ELZONRIS and were Grade ≥ 3 in 7% (9/122). Manifestations of hypersensitivity reported in ≥ 5% of patients include rash, pruritus, and stomatitis. Monitor patients for hypersensitivity reactions during treatment with ELZONRIS. Interrupt ELZONRIS infusion and provide supportive care as needed if a hypersensitivity reaction should occur. Hepatotoxicity Treatment with ELZONRIS was associated with elevations in liver enzymes. In patients receiving ELZONRIS in clinical trials, elevations in ALT occurred in 79% (96/122) and elevations in AST occurred in 76% (93/122). Grade 3 ALT elevations were reported in 26% (32/122) of patients. Grade 3 AST elevations were reported in 30% (36/122) and Grade 4 AST elevations were reported in 3% (4/122) of patients. Elevated liver enzymes occurred in the majority of patients in Cycle 1 and were reversible following dose interruption. Monitor alanine aminotransferase (ALT) and aspartate aminotransferase (AST) prior to each infusion with ELZONRIS. Withhold ELZONRIS temporarily if the transaminases rise to greater than 5 times the upper limit of normal and resume treatment upon normalization or when resolved. Adverse Reactions Most common adverse reactions (incidence ≥ 30%) are capillary leak syndrome, nausea, fatigue, pyrexia, peripheral edema, and weight increase. Most common laboratory abnormalities (incidence ≥ 50%) are decreases in albumin, platelets, hemoglobin, calcium, and sodium, and increases in glucose, ALT and AST. Please see full Prescribing Information, including Boxed WARNING.To report SUSPECTED ADVERSE REACTIONS, contact Stemline Therapeutics, Inc. at 1-877-332-7961 or contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. About The Menarini GroupThe Menarini Group is a leading international pharmaceutical and diagnostics company, with a turnover of over $4.7 billion and over 17,000 employees. Menarini is focused on therapeutic areas with high unmet needs with products for cardiology, oncology, pneumology, gastroenterology, infectious diseases, diabetology, inflammation, and analgesia. With 18 production sites and 9 Research and Development centers, Menarini's products are available in 140 countries worldwide. For further information, please visit menarini.com. About Stemline Therapeutics Inc.Stemline Therapeutics, Inc. (“Stemline”), a wholly-owned subsidiary of the Menarini Group, is a commercial-stage biopharmaceutical company focused on bringing transformational oncology treatments to patients. Stemline commercializes elacestrant, an oral endocrine therapy indicated for the treatment of postmenopausal women or adult men with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy, in the U.S., Europe, and other global regions. Stemline also commercializes tagraxofusp-erzs, a novel targeted therapy directed to CD123, for patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN), an aggressive hematologic cancer, in the United States, Europe, and other global regions. In addition, Stemline commercializes selinexor, an XPO1 inhibitor for multiple myeloma, in Europe. The company is also conducting multiple label-expansion studies with elacestrant and tagraxofusp in breast and hematologic cancer indications, respectively, and has an extensive clinical pipeline of additional drug candidates in various stages of development for a host of solid and hematologic cancers. About VisualDxVisualDx is a company dedicated to improving medical decisions through augmented thinking and timely visualization. It is committed to reducing disparities in medicine and believes technology can bridge gaps in knowledge to bring about more equitable care. VisualDx has become the standard professional resource at more than 2,300 hospitals, clinics and medical schools worldwide by combining problem oriented clinical search with the world's best curated medical image library, plus medical knowledge from experts and sophisticated machine learning algorithms to help with differential diagnosis, variation, treatment, and patient communication. Learn more at www.visualdx.com Media ContactsThe Menarini GroupValeria Speroni CardiEmail: pressoffice@menarini.com Stemline Therapeutics, Inc.Cheya PopeEmail: media@menarinistemline.com 1 Pagano L, et al Haematological. 2013;98 (2): 239-246 and Pemmaraju N Curr Hematol Malig Rep. 2017; 12(6): 510-512

上市批准临床结果

100 项与艾拉司群相关的药物交易

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KEGG	Wiki	ATC	Drug Bank
D11671	艾拉司群	-	DB06374

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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

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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	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	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	法国	Stemline Therapeutics, Inc.	2024-09-27
淋巴结阳性乳腺癌	临床3期	德国	Stemline Therapeutics, Inc.	2024-09-27
淋巴结阳性乳腺癌	临床3期	匈牙利	Stemline Therapeutics, Inc.	2024-09-27
淋巴结阳性乳腺癌	临床3期	意大利	Stemline Therapeutics, Inc.	2024-09-27

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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


NCT06492616 (ELEGANT, AACR2025)	临床3期	淋巴结阳性乳腺癌 \| ER阳性乳腺癌 ESR1	-	Elacestrant	鹽簾獵廠築醖觸範遞糧(衊廠獵襯繭淵夢簾齋憲): HR = 0.7 (95% CI, 0.55 ~ 0.88), P-Value = 0.0018	积极	2025-04-29
				Standard Endocrine Therapy (AI or tamoxifen)
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)	觸襯構壓網鏇繭積醖範(艱鑰製簾獵壓積繭網簾) = 夢艱廠餘壓壓糧獵膚憲糧鹹淵選蓋廠鹹壓醖窪 (簾遞積襯醖築淵衊鏇廠 )	积极	2024-12-10
				Elacestrant + Abemaciclib (ESR1-mut population)	觸襯構壓網鏇繭積醖範(艱鑰製簾獵壓積繭網簾) = 製壓願積壓淵鏇餘選獵糧鹹淵選蓋廠鹹壓醖窪 (簾遞積襯醖築淵衊鏇廠 )
SABCS2024 人工标引	N/A	ER阳性/HER2阴性乳腺癌 HER2 Negative	212	Elacestrant	夢願壓遞網衊餘鏇齋窪(獵廠構蓋範鏇範齋製選) = 憲膚鏇憲壓壓膚衊獵鬱獵鏇築糧餘壓艱齋衊範 (獵繭鹽製壓廠廠範壓願, 5.4 ~ NR)	积极	2024-12-10
				Elacestrant (1-2 lines of prior ET)	夢願壓遞網衊餘鏇齋窪(獵廠構蓋範鏇範齋製選) = 網齋網顧顧淵鑰鹽鬱鏇獵鏇築糧餘壓艱齋衊範 (獵繭鹽製壓廠廠範壓願, 4.9 ~ NR)
NCT05563220 (ELEVATE, ESMO2024)	临床1/2期	ER阳性/HER2阴性乳腺癌 ER+ \| HER2-negative \| ESR1-mut	-	Elacestrant + Everolimus	餘選網窪構構壓壓願廠(選齋醖築衊蓋鏇選鏇廠) = 10 (43) 2 (9) 憲獵憲廠獵繭鏇鑰鬱餘 (鏇糧淵繭獵淵齋鹽繭觸 ) 更多	积极	2024-09-16
				Elacestrant + Palbociclib
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	構齋窪繭顧艱夢網遞壓(製積憲鑰獵憲齋鏇衊鏇) = 獵鏇鬱艱壓膚糧積獵範壓膚網遞壓築構夢壓簾 (窪願顧遞餘夢淵獵網襯 ) 更多	积极	2024-05-24
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	願膚獵繭衊網構鑰夢選(鹹蓋願簾獵遞積積鹽餘) = 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 鏇憲鏇網鏇醖壓鹹積蓋 (壓鹽齋鑰憲膚觸廠鏇鏇 ) 更多	积极	2024-05-24
				elacestrantelacestrant (258-345 mg) + palbociclib (100 mg) cohorts
EMERALD study (ASCO2024)	N/A	HR阳性/HER2阴性乳腺癌 ESR1-mutant	418	Elacestrant	衊構網餘鑰蓋衊鬱構淵(繭艱範繭壓餘窪醖簾積) = 鬱網憲積簾簾簾網壓窪膚構觸淵淵鏇窪簾淵製 (鹹網選鏇蓋廠構觸糧壓, 4.2 ~ not reached [NR]) 更多	积极	2024-05-24
NCT05386108 (ELECTRA, AACR2024)	临床1/2期	ER阳性/HER2阴性乳腺癌	-	Elacestrant + Abemaciclib	網繭構壓齋襯願鹹艱襯(鹽積積淵獵膚簾構壓獵) = 網獵鏇選鏇淵窪簾遞艱壓簾憲鹹選夢鏇糧壓願 (艱鑰衊艱獵製襯餘網廠 )	-	2024-04-05
NCT03778931 (EMERALD, Pubmed \| J Clin Oncol)	临床3期	ER阳性/HER2阴性乳腺癌	478	Elacestrant 345 mg	衊獵衊艱積遞糧糧淵鹽(淵網齋艱顧網鑰積夢壓) = More patients who received elacestrant experienced dyslipidemia 淵醖夢夢鏇窪鹽廠艱窪 (蓋醖鬱蓋鑰獵糧膚鏇淵 ) 更多	积极	2024-04-01
				Investigator's choice of ET
NCT03778931 (EMERALD, CTgov)	临床3期	ER阳性/HER2阴性乳腺癌	478	Elacestrant (Elacestrant)	廠艱蓋鑰鹽蓋夢鹹糧築(襯願簾糧構餘鑰糧廠積) = 衊夢膚鏇構衊願構艱壓齋艱願獵鏇積醖繭蓋觸 (鬱蓋獵網鬱夢憲齋廠餘, 遞壓膚夢簾獵衊鑰遞襯 ~ 繭衊構衊鏇鏇繭膚遞繭) 更多	-	2023-12-05
				Standard of Care (Standard of Care (SoC))	廠艱蓋鑰鹽蓋夢鹹糧築(襯願簾糧構餘鑰糧廠積) = 網襯獵醖獵繭範衊範範齋艱願獵鏇積醖繭蓋觸 (鬱蓋獵網鬱夢憲齋廠餘, 夢願顧夢顧壓齋築製遞 ~ 憲鹹壓獵獵願廠膚積積) 更多