This trial will study a type of breast cancer defined by the expression of hormone receptor in the cancer cells (HR+). Patients will be treated with ribociclib, a cyclin-dependent kinase inhibitor, and camizestrant, a selective estrogen receptor degrader (SERD) and complete ER antagonist. The main purpose of the Study is to analyze the efficacy (to find out how effective a treatment is) of ribociclib in combination with camizestrant in patients with advanced HR+ breast cancer who have received endocrine therapy (ET) in early breast cancer setting for at least 5 years, of which at least 2 years with aromatase inhibitor (AI). Ribociclib plus camizestrant efficacy will be determined by assessing the period from treatment initiation until disease progression, defined as progression free survival (PFS).
The anticipated favorable clinical benefits of the combination of ribociclib and camizestrant therapy 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2025-12-01

申办/合作机构

Medica Scientia Innovation Research SL

NCT07085767

/ Not yet recruiting临床3期

A Phase 3 Randomized, Double-Blind, Active-Controlled Study of Palazestrant With Ribociclib Versus Letrozole With Ribociclib for the First-Line Treatment of ER+, HER2- Advanced Breast Cancer (OPERA-02)

This phase 3 clinical trial compares the efficacy and safety of palazestrant with ribociclib to letrozole and ribociclib in women and men who have not received prior systemic anti-cancer treatment for advanced breast cancer.

开始日期2025-10-31

申办/合作机构

Olema Pharmaceuticals, Inc.

[+1]

NCT07164976

/ Not yet recruiting临床1/2期IIT

Phase Ib/II Trial of Ribociclib Plus Anastrozole in Patients With Hormone Receptor-Positive, HER2-Negative Metastatic or Recurrent Breast Cancer

This document outlines an investigator-initiated Phase Ib/II clinical trial in Japan, focusing on the combination therapy of ribociclib and anastrozole for patients with hormone receptor-positive (HR-positive), HER2-negative metastatic or recurrent breast cancer. The trial aims to evaluate the efficacy (specifically, overall response rate) and safety of this combination in the Japanese patient population. Nagoya City University is the sponsor of this trial, with funding provided by Novartis Pharma K.K..
Study Design and Endpoints: The trial is structured into two parts:
* Phase Ib: The primary endpoint for this phase is tolerability, which is assessed by dose-limiting toxicities (DLT). Secondary endpoints include pharmacokinetics (PK) of the drugs, as well as the incidence of adverse events (AE) and serious adverse events (SAE).
* Phase II: The primary endpoint for Phase II is the Overall Response Rate (ORR), which will be determined by a blinded central imaging review based on RECIST version 1.1 criteria. Secondary endpoints encompass PK (for the initial 20 patients), ORR as assessed by the investigator, progression-free survival (PFS), overall survival (OS), and the overall incidence of adverse events

开始日期2025-10-01

申办/合作机构

Nagoya City University

[+1]

100 项与琥珀酸瑞波西利相关的临床结果

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100 项与琥珀酸瑞波西利相关的转化医学

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100 项与琥珀酸瑞波西利相关的专利（医药）

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1,300

项与琥珀酸瑞波西利相关的文献（医药）

2026-01-01·BIOCHIMICA ET BIOPHYSICA ACTA-MOLECULAR BASIS OF DISEASE

Multi-omics integrative analysis elucidates the molecular characteristics of SMARCA4-deficient lung adenocarcinoma and the derived therapeutic options

Article

作者: Dong, Wei ; Chi, Yuxiang ; Du, Jiajun ; Wang, Kai ; Sun, Shijie ; Guo, Deyu

SMARCA4-deficient lung adenocarcinoma (LUAD) is highly aggressive with multiple oncogene mutations, and has low sensitivity to chemotherapy, targeted therapy and immunotherapy. By integrating multi-omics analysis and machine learning analysis on 20 lung adenocarcinoma datasets, we characterized SMARCA4 mutation in clinical prognosis, metabolic level, immune infiltration and pathway enrichment. The key role of SMARCA4 in LUAD development was confirmed by several in vitro and in vivo experiments. SMARCA4 is highly expressed in LUAD tissues compared with adjacent tissues, and SMARCA4 mutation is a poor prognostic factor. Although SMARCA4-deficient LUAD patients are not sensitive to common chemotherapeutic drugs, immunotherapy is an alternative treatment for lung adenocarcinoma. SMARCA4 deletion is associated with a high rate of oncogene co-mutation. Co-mutation of KRAS was found to have a significant impact on the response to multiple types of chemotherapy. Unique metabolic profiles, abnormal cell cycle and hyperactivation of oxidative phosphorylation were hallmarks of SMARCA4 mutant LUAD. We screened four chemotherapeutic agents targeting MTOR pathway, oxidative stress, DNA replication or cell cycle, including rapamycin and ribociclib, as potential chemotherapeutic agents for SMARCA4-deficient lung adenocarcinoma. In vitro assays showed that SMARCA4 knockdown significantly inhibited DNA replication, cell cycle and cell proliferation in lung adenocarcinoma cells, and significantly promoted oxidative stress and apoptosis in lung adenocarcinoma cells. Our comprehensive findings advance our understanding of SMARCA4 mutant LUAD gene mutation and immune microenvironment, providing insights into potential therapeutic approaches and research directions for SMARCA4-deficient LUAD.

2025-12-01·Eating Behaviors

Medications as precipitating factors for potential eating disorders: A disproportionality analysis using FDA adverse event reports

Article

作者: Zhang, Shuang ; Zheng, Liyun

OBJECTIVE:

Compared to psychosocial factors, medications remain less well recognized as precipitating factors for eating disorders. This study aims to identify medications potentially associated with eating disorders using the U.S. Food and Drug Administration's Adverse Event Reporting System (FAERS) database.

METHODS:

FAERS reports related to potential eating disorders from January 2004 to December 2024 were retrieved. Reporting odds ratios (RORs) were calculated to detect disproportionate signals, with Fisher's exact test and Bonferroni correction applied for adjustments in multiple comparisons. Drugs exhibiting significant positive signals (ROR 95 % confidence interval lower bound >1, adjusted p-value < 0.01) with over 100 reports were selected for LASSO regression analysis. Logistic regression, adjusted for age, sex, and reporter type, was employed to identify precipitating drugs.

RESULTS:

Among 20,145 reports, 62.7 % involved females, with a median age of 59 years (interquartile range: 42-71). Thirty drugs showed significant positive signals. Nine potential precipitating medications were identified through LASSO and logistic regression, including octreotide, ribociclib, sunitinib, rivastigmine, everolimus, quetiapine, palbociclib, esomeprazole, and pregabalin.

CONCLUSION:

This study identifies certain medications that may act as precipitating factors for potential eating disorders, particularly in middle-aged and older populations. Clinicians should monitor these medications that affect appetite, weight, or carry abuse potential to prevent harm, especially in patients with eating disorders or at-risk populations.

2025-10-01·CURRENT PROBLEMS IN CANCER

Advances in breast cancer therapy: “Exploring the therapeutic potential of CDK 4/6 inhibitors and their clinical impact.”

Review

作者: Ambere, Gayatri D ; Mathure, Dyandevi ; Prajapati, Devesh N ; Kumar, Dileep

One of the most common malignancies diagnosed globally is breast cancer, a condition that is impacted by both environmental and genetic causes, there are three distinct molecular subtypes of breast cancer: hormone receptor-positive (HR+), HER2-positive (HER2+), and triple-negative (TNBC). About 70-75 % of instances of breast cancer are HR+, whereas 15-25 % of cases are HER2+ tumours, which can be successfully treated with targeted therapy. TNBC poses specific treatment problems and is linked to an increased risk of early recurrence because it lacks expression of ER, PR, and HER2. With the discovery of Inhibitors of cyclin-dependent kinases 4 and 6 (CDK4/6), such as ribociclib, palbociclib, and abemaciclib, the treatment of advanced HR+/HER2- breast cancer has shifted. These drugs are essential for arresting the cell cycle and limiting tumour growth. These inhibitors particularly target the cell cycle development from the G1 to the S phase, which is frequently dysregulated in breast cancer. CDK4/6 inhibitors' full potential is still being investigated, including the way they might be applied to various breast cancer subtypes and in conjunction with other treatments. This review comprehensively examines the utilization strategies of CDK 4/6 inhibitors across various breast cancer subtypes, explores the mechanism of resistance, and highlights potential applications in combination with other treatments. Through a detailed analysis of clinical trials and real-world data, The review highlights how CDK4/6 inhibitors have revolutionized the treatment landscape for breast cancer, paving the way for optimized treatment outcomes.

813

项与琥珀酸瑞波西利相关的新闻（医药）

2025-09-28

·ioncology

瞭望·大咖说丨张聚良教授：HR+/HER2-乳腺癌术后辅助强化治疗解析

点击蓝字，关注我们编者按：HR阳性/HER2阴性（HR+/HER2-）乳腺癌是乳腺癌中最常见的亚型，尽管该亚型患者整体预后较好，但由于这一亚型患者具有高度异质性，部分患者仍面临复发风险。近年来，术后辅助治疗策略不断优化，从内分泌治疗延长至CDK4/6抑制剂的强化应用，显著提升了患者生存获益。对于HR+/HER2-乳腺癌术后辅助强化治疗，肿瘤瞭望特邀空军军医大学西京医院张聚良教授分享其观点。 Part.1 HR+/HER2-早期乳腺癌术后辅助强化治疗的整体格局是怎样的？ HR+/HER2-乳腺癌是临床中最常见的乳腺癌分子亚型。尽管不同文献报道的数据略有差异，但普遍认为该亚型约占乳腺癌总数的三分之二，具有较高的发病比例。因此，这一亚型的治疗策略备受关注。从疾病特征来看，HR+/HER2-乳腺癌虽整体预后相对较好，且可选择的治疗手段较其他亚型更丰富。然而，这一亚型本身具有高度异质性，即使是早期确诊并接受规范治疗的患者，仍有相当一部分可能出现疾病进展，最终发展为转移性乳腺癌。因此，临床治疗的关键在于尽可能在早期阶段实现有效控制，争取治愈，避免疾病进展。近年来，HR+/HER2-早期乳腺癌术后辅助强化治疗取得了显著进展。从最早的卵巢功能抑制剂（OFS）联合芳香化酶抑制剂相较于传统的他莫昔芬治疗，显著改善了患者的生存预后。随后，内分泌治疗的持续时间也不断延长，从5年延长至10年甚至更久，进一步提升了治疗效果。多项Meta分析结果也证实，延长和强化治疗对于HR+/HER2-早期乳腺癌具有明确的临床获益。此外，近年来CDK4/6抑制剂在术后辅助治疗中的应用也取得了突破性进展。大量临床研究证据表明，该类药物在HR+/HER2-早期乳腺癌中具有良好的疗效。例如，monarchE[1]研究中的阿贝西利和NATALEE[2]研究中的瑞波西利均已获批早期乳腺癌辅助治疗的适应症。国产CDK4/6抑制剂达尔西利在DAWNA-A[3]研究中也公布了积极的早期数据，但目前尚未获得早期适应症的正式批准。这些研究成果进一步巩固了CDK4/6抑制剂在HR+/HER2-早期乳腺癌术后辅助强化治疗中的重要地位，为该亚型患者带来了更多治疗选择和更大的获益。 Part.2 在HR+/HER2-早期乳腺癌术后患者中，如何科学判定高危人群？对于哪些患者应优先考虑使用CDK4/6抑制剂进行辅助强化治疗？在乳腺癌治疗领域，精准医学的理念正逐步深入人心。无论是晚期治疗、早期治疗，甚至手术决策，精准分层都成为临床决策的重要依据。尤其对于HR+/HER2-早期乳腺癌术后的患者，如何识别高危人群，是决定是否开展辅助强化治疗的关键。目前已有三项阳性结果的临床研究——monarchE[1]、NATALEE[2]和DAWNA-A[3]——为我们提供了重要参考。这三项研究在入组标准上各有差异，但都聚焦于中高危患者，尤其是monarchE研究，其设计与现行指南中的高危分层标准高度一致，为临床筛选高危人群提供了明确依据。根据现行指南[4]，高危患者主要包括以下几类：一是淋巴结转移≥4枚的患者；二是1-3枚淋巴结阳性，且伴有肿瘤直径≥5cm、组织学分级为G3或Ki-67增殖指数≥20%的情况。这些标准在临床实践中具有高度可操作性，也被广泛认可。值得注意的是，已有研究数据显示，1-3枚淋巴结阳性且伴有上述高危特征的患者，其复发风险与≥4枚淋巴结阳性的患者相近[5]，因此在临床风险评估中，不应低估这一人群的复发可能性。monarchE研究也正是基于这一认识，将这类患者纳入研究范围，并证实其在接受CDK4/6抑制剂辅助治疗后能够获得显著的临床获益。因此，对于符合monarchE研究入组条件的患者，无论是淋巴结转移数量较多，还是数量较少但伴有高危病理特征，我们通常都会考虑使用CDK4/6抑制剂进行辅助强化治疗，以最大程度降低复发风险，提升长期生存率。除了上述病理指标，还有一些临床因素也提示高复发风险。例如，年龄小于40岁的患者通常被归类为“年轻乳腺癌”，这类患者往往具有更高的肿瘤侵袭性，治疗难度也更大，对治疗的需求更为迫切[6]。年龄本身即构成一个独立的高危因素。因此，我个人认为，这部分患者有必要接受辅助强化治疗。此外，脉管癌栓的存在也提示肿瘤具有更强的转移潜能，也是我们在临床中会关注的指标。同时，多基因检测结果也为风险评估提供了一定的补充信息。在NATALEE[2]研究中，部分N0的患者因基因检测提示复发风险较高而被纳入研究，使用CDK4/6抑制剂后也观察到了一定的临床获益。综上所述，对于HR+/HER2-早期乳腺癌术后的治疗，高危分层仍是制定辅助强化治疗策略的重要依据。随着相关研究的不断推进，未来，我们在这一方向上还有很多值得探索的空间。 Part.3 目前已有多个CDK4/6抑制剂公布了术后辅助治疗的疗效数据，在临床实践中，如何选择最合适的药物，以帮助患者获得更多、更好的治疗获益？这是我们在临床实践中非常关注的问题。可以说，这是一个“甜蜜的烦恼”——因为我们拥有了更多的治疗选择。不同的CDK4/6抑制剂在作用机制、研究入组人群、疗效数据以及不良反应方面都存在差异，因此如何选择最合适的药物，确实需要综合考量。在我的临床实践中，首先会关注药物所依据的临床研究入组人群。如果患者的情况与某项研究的入组标准高度契合，那么我会优先考虑该研究所验证的药物。其次是药物的毒副反应情况，不同药物在安全性方面的表现也会影响患者的依从性和耐受性。第三个重要因素是医保覆盖情况——是否纳入医保，往往直接影响患者的可及性和治疗的可持续性，这在实际决策中非常关键。从目前的证据来看，阿贝西利是首个获批用于HR+/HER2-早期乳腺癌术后辅助强化治疗的CDK4/6抑制剂[7]，且在早期和晚期治疗中均已纳入医保。它采用足剂量起始，疗程为两年，目前的数据支持也最为充分。例如，其5年IDFS绝对获益达到了7.6%[1]，据悉即将公布7年的IDFS和OS数据，我们也非常期待。值得关注的是，阿贝西利在多个亚组中均显示出与整体人群一致的治疗获益。今年公布的年轻患者亚组数据[8]显示，其5年IDFS获益高达10.3%；在中国人群中也有持续披露的数据，5年IDFS获益为6.8%[9]。此外，monarchE研究中有32%的患者接受了新辅助化疗，在这一亚组中，4年IDFS获益为9.1%，复发风险降低了约40%。这些稳定、持续且一致的临床获益，极大增强了我们对该药物的信心。整体而言，HR+/HER2-乳腺癌的治疗近年来取得了显著进展，治疗手段不断丰富，患者的长期获益也在持续提升。随着多个CDK4/6抑制剂在术后辅助治疗中的应用，我们的治疗布局正变得更加精准和多元。在临床决策过程中，我们不仅关注患者的高危分层，还会结合病理特征、治疗耐受性、依从性以及医保覆盖情况等多维度因素，进行个体化的药物选择。这种综合评估的方式，不仅提升了治疗的科学性，也更贴近患者的实际需求。未来，随着更多真实世界数据的积累和长期随访结果的公布，我们对CDK4/6抑制剂的理解将更加深入，也将进一步优化其在不同人群中的应用策略。我们期待在精准治疗的道路上，为HR+/HER2-乳腺癌患者带来更持久、更稳定的生存获益。 ▌参考文献： [1] Rastogi P, et al. J Clin Oncol 2024; 42(9):987-993. [2] Fasching PA, et al. 2024 ESMO abstract LBA13. [3] Shao ZM, et al. 2025 ASCO, Abstract 515. [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》 2025. [5] Tolaney SM, et al. 2024 SABCS P1-11-02. [6] Gnerlich JL, et al. J Am Coll Surg. 2009 Mar;208(3):341-7. [7] 阿贝西利FDA说明书 (2021年10月21日更新). [8] Harbeck N, et al. 2025 ESMO BC, abstract 149P. [9] Zhang Qingyuan, et al. Ther Adv Med Oncol 2024 Oct 23:16:17588359241286775. 张聚良教授空军军医大学西京医院甲乳血管外科副主任医师、副教授、博士、硕士研究生导师中华医学会肿瘤学分会乳腺学组委员中国抗癌协会中西整合乳腺癌专委会委员陕西省医师协会乳腺甲状腺分会副会长陕西省抗癌协会癌症筛查与早诊早治专委会副主任委员陕西省抗癌协会乳腺癌专业委员会常委陕西省抗癌协会药物治疗专业委员会常委（来源：《肿瘤瞭望》编辑部）声明凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。

临床结果

2025-09-28

·GlobeNewswire-Health Care

Novartis to showcase transformative data in advanced prostate and early breast cancer at ESMO 2025

Key data from PSMAddition has been selected for a Presidential session; data to showcase the efficacy and safety of PluvictoTM plus standard of care (SoC) versus SoC alone in PSMA+ mHSPC NATALEE five-year analysis of Kisqali® to provide further long-term insights into risk of recurrence reduction in a broad EBC patient population New data for Pluvicto in prostate cancer and Kisqali in breast cancer strengthen the profiles of both medicines, with promise for new SoC in earlier disease settings September 26, 2025 – Novartis will present new data from 34 abstracts across its oncology portfolio at the European Society for Medical Oncology (ESMO) Congress 2025 in Berlin (October 17-21, 2025). “We look forward to sharing new clinical data that underscores how we are reimagining treatment for breast and prostate cancer, advancing highly effective therapies designed to improve quality of life, enable more personalized care and ultimately provide more time for cancer patients,” said Dushen Chetty, PhD, Global Head of Oncology Development, Novartis, Ad Interim. “Our ambition is to set new standards of care in some of the most prevalent cancers by pioneering novel technologies like radioligand therapy.” The Novartis oncology strategy focuses on people living with cancer and those who care for them, from loved ones to clinical care teams, including their providers. For the past 30+ years, the aim has been to extend and improve lives by discovering differentiated, innovative and practice-changing medicines for patients. As Novartis reimagines medicine, it collaborates with a wide range of patient advocacy groups and supports education, early cancer screening and diagnosis. With approximately 35 research and development projects across solid tumors, hematology and radioligand therapy (RLT), Novartis is committed to using technology, leading science and patient-centered research to deliver pioneering cancer care for all those in need. Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach nearly 300 million people worldwide. The content above comes from the network. if any infringement, please contact us to modify.

临床结果

2025-09-27

·丁香园 Insight 数据库

专家解读：告别一刀切，乳腺癌进入「分型而治」精准时代

乳腺癌是女性最常见、发病率最高的恶性肿瘤之一。公开数据显示，2022 年全球乳腺癌新发病例有 230 万，死亡病例有 67 万。同期中国新发病例数为 35.7 万，死亡病例数为 7.5 万。庞大的临床需求催生出了规模超千亿的市场，也吸引了国内外众多药企布局。 Insight 数据库显示，全球在研的乳腺癌新药超过 2000 款（仅统计积极状态）。而随着越来越多创新疗法涌现，乳腺癌的治疗也进入了「分型而治」的精准时代。2021 年至今，全球有 14 个乳腺癌新药获批上市，基本上都是针对具体基因分型的精准治疗药物，包括 HR 阳性/ HER2 阴性乳腺癌、三阴性乳腺癌等。 2021 年以来上市的乳腺癌新药来源：Insight 数据库整理另外，目前处于申请上市阶段的乳腺癌新药还有 5 款，包括瑞康曲妥珠单抗（恒瑞）、吉达利塞（辉瑞）、Vepdegestrant（Arvinas/辉瑞）、库莫西利（正大天晴）和博度曲妥珠单抗（科伦博泰）。这些精准治疗药物的上市，将进一步改变乳腺癌的临床实践格局。面对层出不穷的创新疗法，丁香园 Insight 数据库特邀湖南省肿瘤医院和湖南省第三人民医院共建肿瘤中心主任谢宁教授，围绕乳腺癌的三大分型，结合现有治疗指南，从临床角度分享：改变中国乳腺癌临床实践的进行时和不远将来时。 HR 阳性/HER2 阴性乳腺癌 HR 阳性/HER2 阴性是乳腺癌中最常见的亚型，约占 70%，其中 95% 的患者在首次确诊时为早期乳腺癌（EBC）。不过即使接受了标准内分泌治疗，部分 HR+/HER2- 早期乳腺癌患者仍存在较高的复发风险。因此针对早期乳腺癌，如何进一步降低复发风险、寻求更多治愈，成为了临床实践的主要目标。谢宁教授指出，目前临床研究证实 CDK4/6 抑制剂联合内分泌治疗可以显著延长 HR+/HER2- 早期乳腺癌高危患者的无浸润性肿瘤复发生存率（iDFS）。基于 MonarchE（阿贝西利）、NATALE（瑞波西利）和 DAWNA-A（达尔西利）等关键研究的阳性结果，该方案在国内外指南中也已经从晚期向早期推进。另外，CDK4/6 抑制剂在辅助治疗和新辅助治疗中也正在进行疗效和安全性的探索。针对晚期乳腺癌，当前 CDK4/6 在跨线治疗领域的研究已经非常丰富，临床可及性也处于较高水平，不过从实际治疗效果来看，仍存在一定提升空间。正大天晴的库莫西利是一款 CDK2/4/6 抑制剂，特异性更强，在 TQB3616-III-01 研究中已经展现出了显著的缓解和生存获益，mPFS 超过 16 个月。这款产品的出现，或许可以给晚期患者带来新的治疗选择。伊那利塞、卡匹色替等晚期乳腺癌新药，主要通过调节 PI3K-AKT-mTOR 通路发挥治疗作用。这类产品虽然在临床疗效上表现不俗，但高昂的治疗成本始终制约着它们的广泛应用。另外，ER 靶向药物、TROP2 ADC、HER3 ADC、EGFR/HER3 ADC 等在 HR 阳性/HER2 阴性乳腺癌中也都显示出了良好的疗效和安全性。限于篇幅，本文不再一一赘述，详情可查看直播回放视频（链接见文章结尾）。谢宁教授强调，正是因为药物选择越来越多，医生更要慎之又慎，同时高度重视安全性和不良反应的管理。 HER2 阳性乳腺癌 & 三阴性乳腺癌 HER2 阳性乳腺癌约占所有乳腺癌的 14%，其侵袭性较强，且发生脑转移概率较高。目前这类乳腺癌的治疗已经从单一化疗策略发展为了以靶向治疗为核心的综合治疗策略。靶向药物中，单克隆抗体（如曲妥珠单抗、帕妥珠单抗）、酪氨酸激酶抑制剂（TKI，如拉帕替尼、图卡替尼）等可以有效 HER2 阳性乳腺癌患者的生存预后，已被国内外指南纳入标准治疗推荐。近年来，以德曲妥珠单抗为代表的 ADC 陆续获批，又为患者提供了全新的治疗选择。谢宁教授表示，HER2 ADC 研究正深刻影响着中国乳腺癌的临床实践。结合现有的研究数据，德曲妥珠单抗（T-DXd）和瑞康曲妥珠单抗（SHR-1811）或许会是未来最值得期待的两款 HER2 ADC，它们的适应症覆盖新辅助、辅助、晚期一线、晚期后线等多个治疗场景。三阴性乳腺癌是指 ER、PR、HER2 表达均为阴性的一类乳腺癌，由于缺乏明确的治疗靶点，此前治疗进展一直比较缓慢，直到近些年 PARP 抑制剂、PD1、ADC 等靶向新药相继获批，才有所改善。针对早期三阴性乳腺癌，谢宁教授详细介绍了帕博利珠单抗、替雷利珠单抗、卡瑞利珠单抗新辅助治疗的临床研究设计和阳性结果。在晚期三阴性乳腺癌中，多项联合治疗方案已展现出显著疗效：例如氟唑帕利联合阿帕替尼（FABULOUS 研究）、特瑞普利单抗联合白蛋白紫杉醇（TORCHLIGHT 研究）等，不仅能有效延长患者的无进展生存期（PFS），目前也已在临床中获得广泛应用。此外，针对晚期三阴性乳腺癌的更多创新治疗方案研究正持续推进，包括双抗、ADC、ADC +免疫、抗血管+免疫、双免等，这些未来有望进一步突破现有治疗瓶颈，为晚期三阴性乳腺癌临床治疗格局带来新的改变。如欲了解本次线上讲堂的更多详细内容，请扫描下方二维码👇，观看直播回放。封面来源：站酷海洛免责声明：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：月牙 PR 稿对接：微信 insightxb 投稿：微信 insightxb；邮箱 insight@dxy.cn

上市批准临床结果

100 项与琥珀酸瑞波西利相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	琥珀酸瑞波西利	L01XE	DB11730

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	加拿大	Novartis Pharmaceuticals Canada, Inc.	2018-03-02
转移性乳腺癌	加拿大	Novartis Pharmaceuticals Canada, Inc.	2018-03-02
HR阳性/HER2阴性乳腺癌	美国	Novartis Pharmaceuticals Corp.	2017-03-13

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
晚期 HER2 阳性乳腺癌	临床3期	美国	Novartis AG	2022-03-28
晚期 HER2 阳性乳腺癌	临床3期	葡萄牙	Novartis AG	2022-03-28
晚期 HER2 阳性乳腺癌	临床3期	西班牙	Novartis AG	2022-03-28
早期乳腺癌	临床3期	-	Novartis Pharmaceuticals Corp.	2018-03-31
HER2 阴性乳腺癌	临床3期	意大利	Novartis Pharmaceuticals Corp.	2018-02-02
6型髓鞘减少脑白质营养不良	临床3期	意大利	Novartis Pharmaceuticals Corp.	2018-02-02
局部晚期乳腺癌	临床3期	意大利	Novartis Pharmaceuticals Corp.	2018-02-02
乳腺癌	临床3期	美国	Novartis Pharmaceuticals Corp.	2017-06-07
晚期癌症	临床3期	美国	Novartis Pharmaceuticals Corp.	2016-11-30
晚期癌症	临床3期	阿根廷	Novartis Pharmaceuticals Corp.	2016-11-30

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临床结果

适应症

分期

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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


NCT03913234 (BR 18-2 MINI, ASCO2025)	临床1/2期	晚期乳腺癌一线 HR+ \| HER2+	77	Ribociclib 600 mg QD + Letrozole 2.5 mg QD + Trastuzumab 8 mg/kg loading then 6 mg/kg every 3 weeks	製壓築壓窪顧構遞顧遞(憲製選艱膚獵餘製夢憲) = 壓醖蓋醖網醖構構壓範範糧醖選衊鹹鬱鬱積艱 (夢願壓鑰襯蓋膚廠繭鏇, 19.6 ~ NA) 更多	积极	2025-05-30
PALMARES-2 (ASCO2025)	N/A	-	3,598	Palbociclib	範壓鹽齋觸獵簾膚製淵(壓齋顧憲壓壓夢鑰齋遞) = 壓遞製夢積膚繭範鏇鏇顧糧淵願顧艱餘願鏇鑰 (獵廠製醖憲築鬱淵觸鹹 ) 更多	不佳	2025-05-30
NCT03839823 (RIGHT Choice, ASCO2025)	临床2期	晚期乳腺癌一线 HR+ \| HER2-	222	Ribociclib + Letrozole/Anastrozole + Goserelin	鹹衊憲製襯夢遞獵顧選(鬱夢鑰窪鑰願積積獵鑰) = 膚遞衊鹽襯鹽構積鑰衊築網製蓋願鏇顧選製鬱 (構顧簾選簾構壓鏇築構 ) 更多	积极	2025-05-30
				Combination Chemotherapy	鹹衊憲製襯夢遞獵顧選(鬱夢鑰窪鑰願積積獵鑰) = 襯鏇壓窪繭蓋糧鬱製遞築網製蓋願鏇顧選製鬱 (構顧簾選簾構壓鏇築構 ) 更多
NCT05563220 (ELEVATE, ASCO2025)	临床1/2期	ER阳性/HER2阴性乳腺癌	-	Elacestrant + Ribociclib	淵蓋衊壓憲窪製淵選夢(廠鬱餘壓築鏇鹹鏇積鹽) = 43% (7% ≥Gr3) with Ela + Eve 壓淵鏇醖選糧淵獵選觸 (醖遞遞積遞艱壓鹽壓選 ) 更多	-	2025-05-30
				Elacestrant + Everolimus
NCT03701334 (NATALEE, ASCO2025)	临床3期	早期乳腺癌 \| HR阳性/HER2阴性乳腺癌辅助 Ki-67	-	Ribociclib + Nonsteroidal Aromatase Inhibitor	夢繭淵鏇憲糧範憲範淵(艱窪鑰範鹽壓糧鑰艱積) = Alanine aminotransferase elevation was the most common AE leading to discontinuation in the PreM (6.2%) and PostM groups (8.0%) 選鹹糧範選夢鹹獵壓淵 (夢繭淵範淵鹹鏇獵繭餘 )	积极	2025-05-30
				Nonsteroidal Aromatase Inhibitor alone
NCT04055493 (WSG ADAPTcycle, ESMO_BC2025)	临床3期	HR阳性/HER2阴性乳腺癌新辅助 OncotypeDx	-	Ribociclib + endocrine treatment	遞鬱廠醖遞窪觸願齋繭(壓壓憲遞鏇選廠遞壓餘) = Most frequent ≥ grade 3 AE were neutropenia (Ribo/CT 34.3 vs. 13.3%) 膚積製觸膚選窪淵艱構 (選鏇築製蓋鏇憲簾窪鏇 ) 更多	积极	2025-05-15
				Standard chemotherapy + endocrine treatment
RibOB (ESMO_BC2025)	临床4期	HR阳性/HER2阴性乳腺癌 Thymidine Kinase 1 (TK1)	70	Ribociclib with Letrozole	遞顧範築窪鹹範鏇衊鹹(願構顧糧築鹹簾憲襯遞) = 淵觸襯選淵繭鑰獵築願鏇蓋願齋鏇膚鏇築艱簾 (網範製網選齋範蓋壓鹹 )	积极	2025-05-14
REACH AUT (ESMO_BC2025)	临床4期	转移性乳腺癌一线	281	Ribociclib + Aromatase Inhibitor	艱遞鹹壓夢鑰衊夢獵繭(築遞構積構簾鬱膚糧窪) = 鑰網醖衊襯鏇選淵艱艱壓遞簾願願蓋積鹹範窪 (齋餘襯糧願膚憲襯鏇窪, 35.6) 更多	积极	2025-05-14
ESMO_BC2025	N/A	转移性乳腺癌 hormone receptor-positive	20	Standard regimen (3 weeks-on 1 week-off)	網衊齋糧鑰遞網構夢膚(衊齋積鹽艱艱膚製鹽夢) = Grade 3 afebrile neutropenia (60%) was the main treatment-related adverse event; of these 15% required dose reduction and continued with standard regimen while 45% switched to the alternative regimen 築夢鑰簾糧鬱簾膚構憲 (繭膚簾願鹽築網構壓製 ) 更多	积极	2025-05-14
				Alternative regimen (3 weeks-on 2 weeks-off)
RIBANNA (ESMO_BC2025)	N/A	晚期乳腺癌一线	2,567	Ribociclib plus endocrine therapy	獵夢願觸餘範廠獵醖蓋(淵蓋繭淵遞願觸願願獵) = 願憲構夢糧製鹹淵壓壓積選淵獵鑰獵簾夢窪淵 (繭觸簾糧遞選簾壓積夢, 71.0 ~ NR) 更多	-	2025-05-14
				Endocrine monotherapy	獵夢願觸餘範廠獵醖蓋(淵蓋繭淵遞願觸願願獵) = 窪積壓糧鹽齋鑰廠範艱積選淵獵鑰獵簾夢窪淵 (繭觸簾糧遞選簾壓積夢 ) 更多