A Single-arm Exploratory Study of the Efficacy and Safety of CDK4/6 Inhibitors in Combination with Endocrine Therapy in the Neoadjuvant Treatment of HR+/HER2- Early Breast Cancer

To explore the efficacy and safety of CDK4/6 inhibitors combined with endocrine neoadjuvant therapy for stage II-III HR-positive/HER2-negative breast cancer.
This study adopts a single-arm, open-label design, and plans to include 40 patients with stage II-III HR+/HER2- breast cancer.

开始日期2025-04-01

申办/合作机构

湖北省肿瘤医院（湖北省肿瘤研究所）

NCT06711094

/ Not yet recruitingN/AIIT

Single-arm,Exploratory Clinical Study of Albumin-bound Paclitaxel Combination With Dalpiciclib and AI in the Treatment of ER-Low (1%-10%), HER2-negative Advanced Breast Cancer

This is a prospective, single-arm, single-center, open, exploratory clinical study.. Screening for histopathologically confirmed recurrent or metastatic ER-Low positive (1%-10%) and HER2-negative breast cancer patients who meet the inclusion criteria and have not previously received any systemic anticancer therapy for advanced disease, He was treated with albumin-bound paclitaxel in combination with Dalpiciclib and AI.

开始日期2025-01-01

申办/合作机构

福建医科大学

NCT06650748

/ Not yet recruiting临床2期IIT

Multigene Risk Score Combined With Ki-67 Dynamic Assessment in Stratified Neoadjuvant Endocrine Therapy Treatment With or Without CDK4/6 Inhibitors in HR+/HER2- Breast Cancer: a Randomize-controlled Study

This is a prospective, single-center, randomize-controlled study. The purpose of this study is to evaluate the efficacy of neoadjuvant CDK4/6 inhibitors in patients with high-risk EPclin multigene risk analysis and non-response to Ki-67 2W, and to explore predictive biomarkers for sensitivity to CDK4/6 inhibitor therapy.

开始日期2024-11-15

申办/合作机构

北京大学

100 项与羟乙磺酸达尔西利相关的临床结果

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100 项与羟乙磺酸达尔西利相关的转化医学

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100 项与羟乙磺酸达尔西利相关的专利（医药）

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项与羟乙磺酸达尔西利相关的文献（医药）

2025-04-01·Cancer Communications

A prospective, phase II, neoadjuvant study based on chemotherapy sensitivity in HR+/HER2‐ breast cancer‐FINEST study

Article

作者: Liu, Guang‐Yu ; Li, Jun‐Jie ; Wu, Wen‐Ya ; Liang, Fei ; Wu, Jiong ; Chen, Li ; Yu, Ke‐Da ; Wang, Zhong‐Hua ; Di, Gen‐Hong ; Shao, Zhi‐Ming ; Fan, Lei

Abstract:

Background:

Hormone receptor‐positive (HR+)/humaal growth factor receptor 2‐negative (HER2‐) breast cancer, the most common breast cancer type, has variable prognosis and high recurrence risk. Neoadjuvant therapy is recommended for median‐high risk HR+/HER2‐ patients. This phase II, single‐arm, prospective study aimed to explore appropriate neoadjuvant treatment strategies for HR+/HER2‐ breast cancer patients.

Methods:

Eligible female patients with newly diagnosed, untreated HR+/HER2‐ breast cancer received 2 cycles of nab‐paclitaxel and carboplatin (nabPCb). Magnetic resonance imaging (MRI) was performed to assess tumor responses, and 40% regression of the maximal tumor diameter was deemed chemo‐sensitive. Chemo‐sensitive patients continued nabPCb for 4 more cycles (group A). Chemo‐insensitive patients were randomized to groups B, C, and D at a ratio of 1:3:1 to receive a new chemotherapy for 4 cycles or endocrine‐immune‐based therapy (dalpiciclib, letrozole and adebrelimab, with goserelin if patients were premenopausal) for 4 cycles or to undergo surgery. Peripheral blood and core‐needle biopsy (CNB) samples were collected before treatment, followed by a next‐generation sequencing (NGS) panel detection and similarity network fusion (SNF) typing through digital pathology data. The primary endpoint was the pathological complete response (pCR) rate, and the secondary endpoint was the clinical objective response rate (ORR).

Results:

A total of 121 patients were enrolled (67.8% with stage III disease), with 76, 9, 27, and 9 patients in groups A, B, C and D, respectively. The total pCR rate was 4.1%, and all patients who received pCR were in group A. Group C had a better ORR than Group B (81.5% vs. 66.7%). Exploratory analysis revealed that patients with the SNF4 subtype were the most sensitive to nabPCb (pCR rate of 21.1% vs. 1.8% in group A), whereas patients in group C with the SNF2 subtype were more sensitive to endocrine‐immune‐based therapy (Miller‐Payne grade 4‐5, 45.5% vs. 6.3%).

Conclusions:

Converting to endocrine‐immune‐based therapy improved the ORR, but not the pCR rate in chemo‐insensitive patients. Neoadjuvant chemotherapy and endocrine therapy are not mutually exclusive. The SNF4 subtype of HR+/HER2‐ breast cancer was more chemo‐sensitive, whereas the SNF2 subtype might be more sensitive to immunotherapy.

2025-02-01·BREAST

Influence of ethnicity on cyclin-dependent kinase inhibitor efficacy and toxicity: A systematic review and meta-analysis

Review

作者: De Santis, Pierluigi ; Pagliuca, Martina ; Arpino, Grazia ; De Laurentiis, Michelino ; Giuliano, Mario ; De Angelis, Carmine ; Pavone, Giuliana ; Longobardi, Alessandra ; Caputo, Roberta ; Caltavituro, Aldo ; Del Mastro, Lucia ; Puglisi, Fabio ; Tafuro, Margherita ; Buonaiuto, Roberto

BACKGROUND:

The combination of cyclin-dependent kinase 4 and 6 inhibitors (CDK4/6i) with endocrine therapy (ET) is the standard of care for patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced breast cancer (aBC). While the efficacy and safety profiles of CDK4/6i and ET have been extensively evaluated in phase II and III trials worldwide, it remains unclear whether the response to CDK4/6i and toxicity profile vary among Asian and non-Asian patients. Therefore, we aimed to assess the treatment efficacy of ET with and without CDK4/6i by comparing outcomes in Asian and non-Asian subgroups included in these clinical trials. In addition, we evaluated the toxicity profiles of the treatments by estimating the risk of treatment-related adverse events (AEs).

METHODS:

We conducted a meta-analysis including the most recent randomized trial data systematically searched from PubMed, Embase, Web of Science, Cochrane CENTRAL (from inception to May 31st, 2024) or presented in abstracts or oral presentations at the ESMO, ASCO, and SABCS international congresses. We included studies comparing CDK4/6i (palbociclib, ribociclib, abemaciclib, dalpiciclib) + ET versus placebo + ET. Progression-free survival (PFS) and overall survival (OS), hazard ratios (HR), and 95 % confidence intervals (CI) were extracted for the two subgroups of interest. To evaluate the treatment-related toxicity profiles, we extracted the number of side effects to estimate the risk of treatment-emergent AEs.

RESULTS:

Eleven studies (n = 5129) were included in this meta-analysis. The addition of CDK4/6i to ET consistently improved PFS in both Asian (HR = 0.52, 95 % CI 0.47-0.60; p < 0.001) and non-Asian (HR = 0.58, 95 % CI 0.52-0.64; p < 0.001) groups. Similarly, the combination of CDK4/6i + ET led to an OS improvement in both Asian (HR = 0.75, 95 % CI 0.62-0.91; p = 0.003) and non-Asian (HR = 0.81, 95 % CI 0.73-0.89; p < 0.001) patients. The risk of treatment related toxicity was higher in the CDK4/6i + ET arm in both Asian and non-Asian groups. Interestingly, a numerically higher rate of treatment-related hematological toxicity was observed in Asian patients, although no significant interethnic difference was found in the relative risk of these events.

CONCLUSIONS:

The combination of CDK4/6i and ET significantly improves PFS and OS compared to ET alone in both Asian and non-Asian patients with HR+/HER2-aBC. Although the magnitude of benefit appears to be independent of ethnicity, future clinical trials should devise a standardized method for stratifying patients by ethnicity to more effectively assess potential differences in treatment benefits.

SYSTEMATIC REVIEW REGISTRATION:

PROSPERO registration number: CRD42024543217.

2025-01-23·JOURNAL OF MEDICINAL CHEMISTRY

Elucidating Binding Selectivity in Cyclin-Dependent Kinases 4, 6, and 9: Development of Highly Potent and Selective CDK4/9 Inhibitors

Article

作者: Xing, Yajie ; Cao, Qixiong ; Chen, Jiean ; Wang, Rui ; Yang, Qianqian ; Pan, Shuqiong ; Feng, Meixi ; He, Zhipeng ; Huang, Yong ; Jiang, Chenran ; Lian, Chenshan ; Kang, Wei ; Yang, Jinglei ; Liu, Zhihong ; Yin, Feng ; Wu, Yun-Dong ; Ye, Yuxin ; Song, Chunli ; Zhao, Juan

CDK4/6 inhibitors are effective in treating HR⁺/HER2^- breast cancer but face limitations due to therapeutic resistance and hematological toxicity, particularly from strong CDK6 inhibition. To address these challenges, designing selective inhibitors targeting specific cyclin-dependent kinases (CDK) members could offer clinical advantages and broaden CDK inhibitor indications. However, the highly conserved binding pockets of CDKs complicate selective targeting. This study leverages in silico modeling and structural analysis of cocrystal data to identify subtle differences in key CDK binding pockets. Notably, a sequence difference in the αD-helix motif between CDK4 and CDK6 provides a targetable "sweet spot" for selectivity. By incorporating a 1,4-trans-cyclohexanediamine side chain, we designed molecules that favor interactions with CDK4 over CDK6 and explored potential dual CDK4/9 inhibition. This approach yielded a lead compound with distinct in vitro selectivity and promising in vivo pharmacokinetics, offering valuable insights for the development of selective next-generation CDK inhibitors.

280

项与羟乙磺酸达尔西利相关的新闻（医药）

16 小时之前

·微信

【产业周报】京东健康联合中国生物制药加速推进新药首发与疾病教育合作；复星医药换帅，陈玉卿出任董事长

WEEKLY REPORT05/092025产业简报本期导读本周要闻产业洞察产业研报近期活动最新课程本周要闻SHINE CONSULTANT行业快讯News Flashes战略携手！京东健康联合中国生物制药加速推进新药首发与疾病教育合作5月6日,京东健康与中国生物制药正式签署战略合作协议。双方将在疾病知识普及、新品首发等多个领域展开深度合作,共同促进优质医疗资源下沉。中国生物制药董事会主席谢其润表示,期待与京东健康携手,让更多好药走进千家万户,惠及更多患者,让“健康科技,温暖更多生命”。京东集团SEC委员、京东健康CEO金恩林也表示,期待双方能够携手共进,为公众提供更加优质、便捷的医疗健康服务。（新浪财经）海南海药：富马酸伏诺拉生获得化学原料药上市申请批准通知书海南海药(000566)5月7日晚间公告，控股子公司重庆天地药业有限责任公司近日获得国家药品监督管理局核准签发的富马酸伏诺拉生《化学原料药上市申请批准通知书》。目前富马酸伏诺拉生国内适应症为：反流性食管炎（RE），与适当的抗生素联用以根除幽门螺杆菌。（每日经济新闻）罗氏制药全新生物制药生产基地投资项目启动：预计投资20.4亿5月8日，罗氏制药在上海举办全新生物制药生产基地投资项目启动仪式。全新生物制药生产基地预计投资20.4亿元，将用于眼底病创新药物法瑞西单抗（商品名：罗视佳）的本地化生产，用地约53亩，建筑面积2.5万平方米，预计2029年落成，2031年投产。（新京报）百济神州(06160)第一季度总收入11.17亿美元同比增加49%百济神州(06160)发布2025年第一季度业绩，该集团取得总收入11.17亿美元，同比增加49%;GAAP净利润127万美元，去年同期则亏损2.51亿美元;经调整净利润1.36亿美元，去年同期则取得亏损1.46亿美元; GAAP基本每股美国存托股份(ADS)收益0.01美元。（智通财经）恒瑞医药：药品上市许可申请获受理恒瑞医药(600276.SH)公告称，公司自主研发的CDK4/6抑制剂羟乙磺酸达尔西利片药品上市许可申请获国家药监局受理。该药品拟定适应症为联合内分泌治疗用于激素受体（HR）阳性，人表皮生长因子受体2（HER2）阴性的早期或局部晚期乳腺癌的辅助治疗。羟乙磺酸达尔西利片是公司自主研发的化学药品1类新药，已在国内获批两项适应症。截至目前，相关项目累计研发投入约120,042万元。（财联社）人事变动Personnel Changes川宁生物：段胜国辞任副总经理川宁生物5月6日公告，公司董事会近日收到副总经理段胜国的书面辞职报告，段胜国因到龄退休申请辞去公司副总经理等职务，辞职后将不再担任公司任何职务。段胜国的辞职报告自送达公司董事会之日起生效。（界面新闻）复星医药换帅，陈玉卿出任董事长近日，复星医药发布公告宣布董事会分工的调整，吴以芳不再担任复星医药执行董事、董事长职务，改任复星医药非执行董事，并将担任复星国际执行总裁；王可心不再担任复星医药联席董事长，继续担任复星医药执行董事，并将担任复星国际执行总裁；陈玉卿担任复星医药董事长、执行董事，关晓晖担任复星医药联席董事长、执行董事，CEO文德镛担任复星医药副董事长、执行董事。（经济观察网）产业洞察SHINE CONSULTANT01奥朋医疗完成近亿元C轮融资，以AI+泛血管介入机器人领航全球医疗科技新浪潮02【捷报】中国创新心血管器械破局海外市场：希毅医学上市后临床跟踪试验，助力中国器械欧盟商业化突破点击阅读全文产业研报SHINE CONSULTANT012023年中国企业医疗健康管理白皮书022022年中国康复医疗行业研究报告03合成生物学产业链及应用场景042023年家用医疗智能器械商业路径发展报告05医疗产业链中数字化场景发展现况及挑战062022年药品市场生命周期研究之GLP-1RA篇07中国医疗器械蓝皮书（2023版）点击阅读全文活动预告SHINE CONSULTANT2025(第九届)亚太生物医药合作峰会，7月8日-9日 · 上海2025医药行业合规数智创新论坛，7月30日-31日 · 上海最新课程SHINE CONSULTANT生物医药行业研究与投资逻辑（点击查看）全面汇总：医药全行业研究分析框架与投资逻辑详解（点击查看）联系我们Sunny Sun 孙女士T:021 6095 0241M:189 6294 0579（微信同号）E:sunny.sun@shine-consultant.com会议咨询媒体合作商务合作欢迎详询洽谈！SHINE CONSULTANT上海士研管理咨询有限公司成立于2005年，致力于为组织领导者提供沟通交流与专家智库平台。通过二十年沉淀与积累，覆盖了金融与投资、交通与运输、消费与文旅、医药与医疗、能源与资源、高科与电信、公用与政府等产业领域，服务着全球500强和万余家领导型企业，汇聚了百万余名机构决策者，并与千余家产业权威机构建立了战略伙伴关系。士研咨询秉承专业立身的理念发展队伍，现拥有百余名专业的资深人员，核心管理团队都具有十五年以上的专业经验。

高管变更财报

2025-05-08

·Insight数据库

恒瑞 CDK4/6 抑制剂递交第 3 项适应症上市申请

5 月 8 日，恒瑞医药宣布达尔西利的新适应症上市申请获得 NMPA 受理，具体适应症为：达尔西利联合内分泌治疗用于激素受体（HR）阳性，人表皮生长因子受体 2（HER2）阴性的早期或局部晚期乳腺癌的辅助治疗。截图来源：恒瑞官微达尔西利（商品名：艾瑞康）是恒瑞医药自主研发的口服、选择性的小分子 CDK4/6 抑制剂，也是中国首个自主研发的新型高选择性 CDK4/6 抑制剂。此前，达尔西利已获 NMPA 批准两项适应症：1）与氟维司群联合用于既往曾接受内分泌治疗后出现疾病进展的 HR 阳性、HER2 阴性复发或转移性乳腺癌患者；2）与芳香化酶抑制剂联合使用作为初始内分泌治疗用于 HR 阳性、HER2 阴性局部晚期或转移性乳腺癌患者。本次申报的新适应症是基于一项多中心、随机、双盲的 III 期临床试验 DAWNA-A 的结果。该研究旨在评估达尔西利联合内分泌治疗在 HR 阳性、HER2 阴性女性乳腺癌辅助治疗中的效果，共入组超 5000 例受试者。研究的主要终点为患者无侵袭性疾病生存期（IDFS）。2025 年 2 月，DAWNA-A 研究已达到主要研究终点。研究结果显示，与安慰剂联合内分泌治疗相比，达尔西利联合内分泌治疗可显著降低患者复发风险，提高患者无侵袭性疾病生存期。封面来源：企业 Logo免责声明：本文仅作信息分享，不代表 Insight 立场和观点，也不作治疗方案推荐和介绍。如有需求，请咨询和联系正规医疗机构。编辑：馨药PR 稿对接：微信 insightxb投稿：微信 insightxb；邮箱 insight@dxy.cn

临床3期临床结果上市批准

2025-05-08

·恒瑞医药

恒瑞创新药达尔西利HR阳性乳腺癌辅助治疗适应症上市申请获受理

近日，恒瑞医药收到国家药品监督管理局下发的《受理通知书》，公司自主研发的CDK4/6抑制剂羟乙磺酸达尔西利片药品上市许可申请获国家药监局受理，具体适应症为：本品联合内分泌治疗用于激素受体（HR）阳性，人表皮生长因子受体2（HER2）阴性的早期或局部晚期乳腺癌的辅助治疗。本次申报上市，是基于羟乙磺酸达尔西利片联合内分泌治疗在激素受体（HR）阳性、人表皮生长因子受体2（HER2）阴性女性乳腺癌辅助治疗中的一项多中心、随机、双盲的III期临床试验（研究代号：DAWNA-A），该研究此前达到主要研究终点，研究结果显示，达尔西利联合内分泌治疗，较安慰剂联合内分泌治疗，可显著降低患者复发风险，提高患者无侵袭性疾病生存期（IDFS）[1]。01关于DAWNA-A研究这项III期临床试验主要研究目的为评价达尔西利（SHR6390）联合内分泌治疗在HR阳性、HER2阴性乳腺癌辅助治疗中的有效性。由复旦大学附属肿瘤医院及天津市肿瘤医院牵头约150家中心完成。DAWNA-A研究入组超5000例受试者，按照1:1随机入组，分别接受达尔西利联合内分泌治疗或安慰剂联合内分泌治疗。每位受试者将接受标准内分泌药物治疗5年，在入组后的前2年将同时使用试验药物（达尔西利或安慰剂）进行治疗，直至完成所有规定的研究治疗、出现疾病局部复发或远处转移、毒性不可耐受、受试者退出研究或研究者判断必须终止研究用药。研究的主要终点为患者无侵袭性疾病生存期（Invasive Disease-Free Survival，IDFS），即从随机之日起至第一次出现以下事件的时间，包括同侧或对侧复发的乳腺癌、区域及远处复发、任何原因导致的死亡。研究结果显示，达尔西利联合内分泌治疗，较安慰剂联合内分泌治疗，可显著降低患者复发风险，提高患者无侵袭性疾病生存期（IDFS）[1]。02关于乳腺癌乳腺癌是世界范围第二大常见肿瘤，是女性最常见的恶性肿瘤之一[2]。在我国，乳腺癌发病率增长迅速。2020年乳腺癌新确诊人数约41.6万例，较2015年新确诊人数增长近12万例，在最普遍确诊的肿瘤中位列第四[3]。对于早期HR阳性、HER2阴性乳腺癌，目前仍以手术切除为主，之后给予术后辅助治疗，包括辅助化疗以及辅助内分泌治疗[4]。按照国内外指南以及共识，针对早期HR阳性、HER2阴性乳腺癌中具有低复发风险的患者推荐可以免除术后辅助化疗，仅予以辅助内分泌治疗即可。但对于具有高复发风险的患者，可以在辅助化疗基础上给予辅助内分泌治疗[4-5]。超过一半的乳腺癌患者过表达细胞周期蛋白D（Cyclin D），且大部分为雌激素受体阳性（ER+）乳腺癌患者[6]。细胞周期蛋白D直接作用于细胞周期依赖性蛋白激酶4/6（CDK4和CDK6），因此CDK4和CDK6也成为HR阳性乳腺癌患者的重要分子靶点[7]。已有多项临床研究证实，CDK4/6抑制剂可为高复发风险患者带来进一步临床获益[8-9]。03关于羟乙磺酸达尔西利片羟乙磺酸达尔西利片（商品名：艾瑞康®）是恒瑞医药自主研发的口服、选择性的小分子CDK4/6抑制剂，也是中国首个自主研发的新型高选择性 CDK4/6 抑制剂。达尔西利可选择性地抑制CDK4/6激酶活性，使其与Cyclin D组成的复合物不能磷酸化下游Rb蛋白，阻止细胞由G1期进入S期，从而发挥抑制细胞增殖和抗肿瘤的作用。基于两项确证性III期临床研究（DAWNA-1和DAWNA-2），达尔西利已于国内获批2项适应症，即本品适用于激素受体（HR）阳性、人表皮生长因子受体2（HER2）阴性局部晚期或转移性乳腺癌患者：1.与芳香化酶抑制剂联合使用作为初始内分泌治疗；2.与氟维司群联合用于既往曾接受内分泌治疗后出现疾病进展的患者。参考文献：[1]根据研究资料整理.[2]Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, Jemal A. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024 May-Jun;74(3):229-263.[3]Cao W, Chen HD, Yu YW, Li N, Chen WQ. Changing profiles of cancer burden worldwide and in China: a secondary analysis of the global cancer statistics 2020. Chinese Medical Journal. 2021 Apr 5;134(07):783-91.[4]中国临床肿瘤学会指南工作委员会. 中国临床肿瘤学会(CSCO)乳腺癌诊疗指南 2024[M]. 北京 :人民卫生出版社, 2024. [5]Gradishar WJ, Moran MS, Abraham J, Abramson V, Aft R, Agnese D, Allison KH, Anderson B, Bailey J, Burstein HJ, Chen N, Chew H, Dang C, Elias AD, Giordano SH, Goetz MP, Jankowitz RC, Javid SH, Krishnamurthy J, Leitch AM, Lyons J, McCloskey S, McShane M, Mortimer J, Patel SA, Rosenberger LH, Rugo HS, Santa-Maria C, Schneider BP, Smith ML, Soliman H, Stringer-Reasor EM, Telli ML, Wei M, Wisinski KB, Yeung KT, Young JS, Schonfeld R, Kumar R. Breast Cancer, Version 3.2024, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2024 Jul;22(5):331-357.[6]Mohammadizadeh F, Hani M, Ranaee M, Bagheri M. Role of cyclin D1 in breast carcinoma. Journal of research in medical sciences: the official journal of Isfahan University of Medical Sciences. 2013 Dec;18(12):1021.[7]Finn RS, Aleshin A, Slamon DJ. Targeting the cyclin-dependent kinases (CDK) 4/6 in estrogen receptor-positive breast cancers. Breast Cancer Research. 2016 Dec;18(1):1-1.[8]Johnston SRD, Harbeck N, Hegg R, Toi M, Martin M, Shao ZM, Zhang QY, Martinez Rodriguez JL, Campone M, Hamilton E, Sohn J, Guarneri V, Okada M, Boyle F, Neven P, Cortés J, Huober J, Wardley A, Tolaney SM, Cicin I, Smith IC, Frenzel M, Headley D, Wei R, San Antonio B, Hulstijn M, Cox J, O'Shaughnessy J, Rastogi P; monarchE Committee Members and Investigators. Abemaciclib Combined With Endocrine Therapy for the Adjuvant Treatment of HR+, HER2-, Node-Positive, High-Risk, Early Breast Cancer (monarchE). J Clin Oncol. 2020 Dec 1;38(34):3987-3998.[9]Slamon D, Lipatov O, Nowecki Z, McAndrew N, Kukielka-Budny B, Stroyakovskiy D, Yardley DA, Huang CS, Fasching PA, Crown J, Bardia A, Chia S, Im SA, Ruiz-Borrego M, Loi S, Xu B, Hurvitz S, Barrios C, Untch M, Moroose R, Visco F, Afenjar K, Fresco R, Severin I, Ji Y, Ghaznawi F, Li Z, Zarate JP, Chakravartty A, Taran T, Hortobagyi G. Ribociclib plus Endocrine Therapy in Early Breast Cancer. N Engl J Med. 2024 Mar 21;390(12):1080-1091.声明：1.本新闻旨在分享研发注册进展信息，仅供医疗卫生专业人士参阅，非广告用途。2.恒瑞医药不对任何药品和/或适应症作推荐。3.本新闻中涉及的信息仅供参考，请遵从医生或其他医疗卫生专业人士的意见或指导。医疗卫生专业人士作出的任何与治疗有关的决定应根据患者的具体情况并遵照药品说明书。撰稿：王玲排版：程梦真责编：王玲往期精选| 研发创新 |恒瑞创新药、中国首个自主研发JAK1抑制剂硫酸艾玛昔替尼片获批上市全球首个超长效PCSK9单抗！恒瑞降脂创新药瑞卡西单抗获批上市| 国际化 |恒瑞医药与默沙东就Lp(a)抑制剂HRS-5346签订独家许可协议| 重磅奖项 |喜报！恒瑞医药荣获2023年度国家科技进步奖恒瑞医药连续六年入选全球制药企业50强榜单！| 社会公益 |“健康中国行·重走长征路”项目启动仪式圆满举行！恒瑞提供公益支持，助力健康中国恒瑞医药集团向中国扶贫基金会捐赠3000万设立“健康帮扶基金”

临床3期临床结果

100 项与羟乙磺酸达尔西利相关的药物交易

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研发状态

批准上市

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适应症	国家/地区	公司	日期
HR阳性/HER2阴性乳腺癌	中国	江苏恒瑞医药股份有限公司	2021-12-31

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适应症	最高研发状态	国家/地区	公司	日期
去势敏感前列腺癌	临床3期	中国	江苏恒瑞医药股份有限公司	2023-10-19
HER2 阴性乳腺癌	临床3期	中国	江苏恒瑞医药股份有限公司	2021-04-30
HR阳性乳腺癌	临床3期	中国	江苏恒瑞医药股份有限公司	2021-04-30
淋巴结阳性乳腺癌	临床3期	中国	江苏恒瑞医药股份有限公司	2021-04-30
晚期乳腺癌	临床3期	中国	江苏恒瑞医药股份有限公司	2019-06-13
HR阳性HER2阴性淋巴结阳性乳腺癌	临床3期	中国	江苏恒瑞医药股份有限公司	2019-06-13
转移性去势抵抗性前列腺癌	临床2期	中国	江苏恒瑞医药股份有限公司	2024-07-31
晚期非小细胞肺癌	临床2期	中国	天津市肿瘤医院（天津医科大学肿瘤医院）	2024-04-09
ER阳性/HER2阴性乳腺癌	临床2期	中国	山东盛迪医药有限公司	2023-12-20
尤文肉瘤	临床2期	中国	江苏恒瑞医药股份有限公司	2023-07-01

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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


NCT05512780 (DARLING 01, Pubmed \| Breast Cancer Res) 人工标引	临床2期	HR阳性/HER2阴性乳腺癌新辅助 HER2 Negative \| Hormone Receptor Positive	29	Dalpiciclib + Letrozole	夢夢鹹艱夢襯鹹觸齋壓(網窪齋選憲壓齋範憲鬱) = 積淵衊範觸膚鑰簾蓋鑰廠醖範襯憲衊艱顧膚膚 (齋糧選願襯艱壓繭鬱選 ) 更多	积极	2025-02-13
NCT03966898 (DAWNA-2, SABCS2024) 人工标引	临床3期	HR阳性/HER2阴性乳腺癌一线 Hormone Receptor Positive \| HER2 Negative	456	Dalpiciclib + Letrozole/Anastrozole	觸範簾膚顧觸鹹窪夢簾(遞艱餘選醖淵鬱遞鑰衊) = 願蓋積繭構蓋糧襯範簾選網夢網構獵壓獵蓋醖 (窪膚壓膚膚繭簾糧構築, 29.6 ~ 39.0) 更多	积极	2024-12-12
				Placebo + Letrozole/Anastrozole	觸範簾膚顧觸鹹窪夢簾(遞艱餘選醖淵鬱遞鑰衊) = 構糧網簾艱齋鏇襯鏇製選網夢網構獵壓獵蓋醖 (窪膚壓膚膚繭簾糧構築, 16.5 ~ 22.5) 更多
NCT05431504 (SABCS2024 \| NEWS) 人工标引	临床2期	HR阳性/HER2阴性乳腺癌 Hormone Receptor Positive \| HER2 Negative	53	Dalpiciclib plus ET	窪壓壓齋壓襯鹽鏇襯淵(衊鏇廠觸顧鏇鑰襯製鏇) = 鏇壓築衊製衊膚觸餘鹽廠築膚壓壓築願蓋壓衊 (獵網繭餘獵築蓋廠餘顧, 7.59 ~ NE) 更多	积极	2024-11-26
				Chemotherapy (external control group)	窪壓壓齋壓襯鹽鏇襯淵(衊鏇廠觸顧鏇鑰襯製鏇) = 鹽鹽鑰淵夢鑰獵餘壓鹽廠築膚壓壓築願蓋壓衊 (獵網繭餘獵築蓋廠餘顧, 2.92 ~ 5.91) 更多
NCT06009627 (ESMO2024) 人工标引	临床2期	绝经前乳腺癌新辅助 HER2 Negative \| Hormone Receptor Positive	32	Dalpiciclib, Exemestane, and Goserelin	繭膚衊廠鬱艱襯顧鏇齋(衊襯衊製顧鹹願繭鏇廠) = 壓艱鏇築齋壓醖窪艱製築淵網鑰壓顧願夢構壓 (鑰鬱窪膚繭選醖齋築顧 )	积极	2024-09-16
				TAC (docetaxel, doxorubicin, and cyclophosphamide)	繭膚衊廠鬱艱襯顧鏇齋(衊襯衊製顧鹹願繭鏇廠) = 憲積築餘艱鬱壓構範遞築淵網鑰壓顧願夢構壓 (鑰鬱窪膚繭選醖齋築顧 )
NCT05721443 (ESMO2024)	临床2期	头颈部鳞状细胞癌 p16-negative	14	Dalpiciclib 150 mg	鹹襯憲淵齋廠遞齋簾獵(鑰簾蓋衊積遞餘鏇夢襯) = 遞築遞齋憲範蓋築膚積廠膚構鏇繭選齋壓築選 (範範觸願顧觸餘廠製淵, 38.6 ~ 83.8) 更多	积极	2024-09-14
NCT05640778 (DANCER, ASCO2024) 人工标引	临床2期	HER2 阴性乳腺癌新辅助 HER2 Negative \| Hormone Receptor Positive	23	Dalpiciclib + Letrozolelanastrozole	繭鹽膚鏇願齋鹽製鬱網(窪選膚鹹醖構夢鬱艱繭) = 積蓋窪齋夢鑰衊遞觸製鬱鹹繭鏇艱艱憲網構糧 (鹹壓憲壓蓋獵襯糧築鹹, 76.0% ~ 98.8) 更多	积极	2024-05-24
NCT05806671 (ASCO2024) 人工标引	临床2期	HR阳性/HER2低表达乳腺癌 Hormone Receptor Positive	30	dalpiciclib 12fulvestrantpyrotinib	觸鬱憲艱鹽窪簾製製選(願觸構築鹽積壓鹹鏇積) = Not reached. 選構膚糧選積繭鹽齋淵 (製構齋餘繭壓夢艱積網 ) 未达到更多	积极	2024-05-24
ChiCTR2200062868 (phase 2, ASCO2024)	临床2期	去分化脂肪肉瘤	32	Dalpiciclib 150 mg	鬱膚選繭艱鏇遞膚繭鬱(糧衊簾鑰壓廠窪鹽簾範) = 繭構顧醖窪選鑰壓鹽遞壓鏇衊顧觸膚餘鏇繭鹹 (糧製廠遞夢遞鹹窪遞壓, 10.65 ~ 24.15)	积极	2024-05-24
NCT03481998 (phase Ib, Pubmed \| Ther Adv Med Oncol)	临床1期	HR阳性HER2阴性淋巴结阳性乳腺癌 HR-positive \| HER2-negative	-	Dalpiciclib 125 mg	簾窪鹹鏇簾襯範襯餘窪(鹽淵壓積鹽繭鹹膚簾獵) = 鑰齋鑰鏇築簾遞蓋顧夢顧築選獵餘糧鬱網壓簾 (選選鑰鏇壓糧窪膚夢餘 ) 更多	积极	2024-01-01
				Dalpiciclib 150 mg	簾窪鹹鏇簾襯範襯餘窪(鹽淵壓積鹽繭鹹膚簾獵) = 簾顧鬱醖窪齋膚糧鑰醖顧築選獵餘糧鬱網壓簾 (選選鑰鏇壓糧窪膚夢餘 ) 更多
NCT04095390 (ASCO2023) 人工标引	临床2期	晚期 HER2 阳性乳腺癌 HER2 Positive	33	Pyrotinib+Dalpiciclib+Letrozole	廠蓋顧蓋鏇廠製襯範繭(網廠艱糧鏇遞淵壓顧艱) = 廠膚顧壓衊鬱範繭簾蓋壓鑰獵鹹蓋選淵憲艱蓋 (廠廠窪獵夢壓鏇繭壓憲 ) 更多	积极	2023-05-31
				Pyrotinib+Dalpiciclib+Capecitabine	廠蓋顧蓋鏇廠製襯範繭(網廠艱糧鏇遞淵壓顧艱) = 淵鑰選衊艱鏇窪願構襯壓鑰獵鹹蓋選淵憲艱蓋 (廠廠窪獵夢壓鏇繭壓憲 ) 更多