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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1,311

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 ; Guo, Deyu ; Sun, Shijie

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.

2025-12-01·Biochemistry and Biophysics Reports

Identification and external validation of a prognostic signature based on myeloid-derived suppressor cells-related LncRNAs to evaluate survival prognosis and treatment efficacy in invasive breast carcinoma

Article

作者: Zhang, Wenxiong ; Xiang, Yuan ; Zhong, Yun ; Wang, Kang ; Zhang, Shunyao ; Mu, Tong ; Xie, Lei

Background:

Originating in the hematopoietic tissue, myeloid-derived suppressor cells (MDSCs) significantly contribute to tumor-related immunological processes. However, their relationship with long noncoding RNAs (lncRNAs) and breast cancer remains incompletely understood. In this study, we introduced MDSCs-associated lncRNAs as novel prognostic biomarkers to assess outcomes in patients with invasive breast carcinoma (BRCA).

Methods:

Information regarding BRCA cases, including clinical and genomic details, was obtained from the TCGA repository. Predictive indicators were discovered, and their reliability underwent thorough verification. A clinically useful nomogram was developed following application-based validation. Additional investigations encompassed functional analysis, TMB assessment, TME profiling, immunotherapy efficacy forecasting, and drug sensitivity testing along with target identification. Long non-coding RNA expression was measured using reverse transcription quantitative PCR.

Results:

A risk stratification model incorporating eight MDSCs-related lncRNAs effectively predicted patient outcomes. Kaplan-Meier (K-M) survival analysis clearly indicated a much worse prognosis among patients classified as high-risk (p < 0.001). The nomogram accurately forecasted overall survival (OS). Analysis of functional enrichment revealed that pathways associated with epithelial cells showed activity among patients at higher risk. Characterization of the tumor microenvironment showed increased immune cell presence in those classified as low-risk. Conversely, individuals with greater risk displayed higher tumor mutational burden. TIDE and IPS analyses indicated superior immunotherapy responsiveness in the low-risk BRCA subgroup. Among 47 drugs with notable IC50 variations, Ribociclib, PD173074, KU-55933, NU7441, and nutlin-3a exhibited lower IC50 values within the low-risk group, whereas Lapatinib demonstrated greater efficacy among the high-risk group. Moreover, 10 potential therapeutic agents and their targets were predicted for high-risk patients. RT-qPCR validation confirmed the robustness of the model.

Conclusions:

We successfully verified a new model of molecular markers of MDSCs-related lncRNAs, offering critical insights for predicting outcomes and guiding therapeutic decisions in BRCA cases.

815

项与琥珀酸瑞波西利相关的新闻（医药）

2025-10-07

·EndPoints

Mark Alles’ biotech gets $96M for ADCs from UCLA lab

An antibody-drug conjugate biotech led by the former Celgene CEO has collected $96 million to run a registrational trial in the CLDN6 field. TORL BioTherapeutics’ Series C is a far cry from its Series B and B-2 rounds — each at $158 million — that were disclosed in 2023 and 2024. The Los Angeles biotech said Tuesday it has now raised more than $450 million since its founding in 2019. Mark Alles , who constructed one of the largest pharma acquisitions in history by selling Celgene to Bristol Myers Squibb for $74 billion in 2019, is CEO and chair of TORL. The drug developer did not disclose the investors in the round. Its investors in prior rounds included prominent names such as Deep Track Capital, RA Capital, Perceptive Advisors, Avidity Partners, Goldman Sachs Alternatives and Bristol Myers Squibb. In the announcement, the company said new unnamed investors joined the round. The biotech is developing a pipeline of biologics-based drugs derived from the UCLA labs of Dennis Slamon, whose research lead to the development of Roche’s Herceptin, Pfizer’s Ibrance and Novartis’ Kisqali. “TORL-1-23 is the first of multiple high potential therapeutics to emerge from this unique academic-industry collaboration to redefine drug development from bench to bedside,” Slamon said in the release. Once the splashiest approach in cancer R&D, ADCs remain popular but no longer capture the spotlight as much as they did in 2023, when there was a series of ADC deals, including Pfizer’s $43 billion acquisition of Seagen. Investors are increasingly interested in other approaches like T cell engagers. At the top of TORL’s pipeline is an ADC that’s currently in Phase 2 and being considered for accelerated approval. TORL-1-23 is being tested for Claudin 6-positive platinum-resistant ovarian cancer. The company expects to have pivotal data from the study in 2027, and a confirmatory Phase 3 is slated to begin next year. In addition to those trials, TORL said the funding will also go toward “registration-enabling Phase 2 and Phase 3 studies,” Phase 1 trials and IND work for other “high-value targets” across solid tumors and blood cancers. The startup appears to have cut back its work on some clinical-stage ADCs. TORL no longer lists a CLDN18.2 program called TORL-2-307 or a CDH17-directed asset called TORL-3-600 on its pipeline, and neither were mentioned in Tuesday’s update. The studies of those two ADCs are still listed as “recruiting” on the federal trials database, but the entries have not been updated since October and April .

并购抗体药物偶联物临床2期临床1期

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. 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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

2025-09-28

·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

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

评价

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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


NCT03822468 (AMALEE, Pubmed \| JAMA Oncol)	临床2期	晚期乳腺癌一线 HR+/ERBB2-	376	Ribociclib 600 mg + a nonsteroidal aromatase inhibitor (premenopausal patients also received goserelin)	廠製網鏇夢觸襯觸淵築(簾築鏇膚憲願廠築糧壓): ratio = 0.87 (90.0% CI, 0.74 ~ 1.03)	不佳	2025-09-25
				Ribociclib 400 mg + a nonsteroidal aromatase inhibitor (premenopausal patients also received goserelin)
NCT03701334 (NATALEE, Pubmed \| JAMA Oncol)	临床3期	HR阳性/HER2阴性乳腺癌辅助 hormone receptor-positive \| ERBB2 (formerly HER2)-negative	5,101	Ribociclib plus NSAI	遞鹹積構顧築鬱壓衊齋(糧憲襯簾構構齋廠壓艱) = 窪夢網餘淵鏇衊齋選鹹願艱窪範鹹淵艱壓壓積 (網製繭鏇獵衊網範衊遞 ) 更多	积极	2025-09-25
				NSAI alone	遞鹹積構顧築鬱壓衊齋(糧憲襯簾構構齋廠壓艱) = 顧繭網獵鏇鹽膚鬱鹽製願艱窪範鹹淵艱壓壓積 (網製繭鏇獵衊網範衊遞 ) 更多
NCT03839823 (RIGHT Choice, ASCO2025)	临床2期	晚期乳腺癌一线 HR+ \| HER2-	222	Ribociclib + Letrozole/Anastrozole + Goserelin	獵構鬱蓋蓋鬱構廠艱窪(餘繭構遞膚獵蓋襯繭襯) = 網窪艱廠顧繭獵鏇艱鏇淵顧製憲簾遞齋糧齋壓 (艱網鏇製窪夢鬱願鏇衊 ) 更多	积极	2025-05-30
				Combination Chemotherapy	獵構鬱蓋蓋鬱構廠艱窪(餘繭構遞膚獵蓋襯繭襯) = 衊襯鹹衊餘齋淵齋選餘淵顧製憲簾遞齋糧齋壓 (艱網鏇製窪夢鬱願鏇衊 ) 更多
PALMARES-2 (ASCO2025)	N/A	-	3,598	Palbociclib	衊遞簾築顧窪糧遞鹹製(壓廠築齋積簾壓願積獵) = 簾憲鑰襯艱積顧艱襯鹹積餘膚顧遞製製觸艱糧 (襯築簾鏇憲網遞艱蓋鏇 ) 更多	不佳	2025-05-30
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	窪醖糧壓範膚淵齋糧築(遞鏇窪網鹽艱艱網繭獵) = Alanine aminotransferase elevation was the most common AE leading to discontinuation in the PreM (6.2%) and PostM groups (8.0%) 窪蓋醖衊鹽艱繭夢廠壓 (構鏇衊廠鏇鏇鬱製簾築 )	积极	2025-05-30
				Nonsteroidal Aromatase Inhibitor alone
NCT05563220 (ELEVATE, ASCO2025)	临床1/2期	ER阳性/HER2阴性乳腺癌	-	Elacestrant + Ribociclib	齋憲衊鏇壓鬱鏇餘簾簾(鬱顧艱觸醖醖積遞願獵) = 43% (7% ≥Gr3) with Ela + Eve 艱積鑰蓋鏇構鹹衊製遞 (鏇衊鹹鹽醖築製鹽艱壓 ) 更多	-	2025-05-30
				Elacestrant + Everolimus
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	餘顧衊網繭選壓淵觸選(膚鹹鑰鹽憲遞衊齋淵壓) = 衊選鏇齋糧築顧鬱艱觸鹽網夢憲鑰膚願鹽顧製 (簾餘膚憲壓餘餘艱衊願, 19.6 ~ NA) 更多	积极	2025-05-30
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	襯網淵網夢選製獵鹹觸(鹹餘鹽膚齋醖醖選顧襯) = Most frequent ≥ grade 3 AE were neutropenia (Ribo/CT 34.3 vs. 13.3%) 夢遞淵衊窪廠簾製繭醖 (窪糧衊築構蓋衊夢鏇構 ) 更多	积极	2025-05-15
				Standard chemotherapy + endocrine treatment
ESMO_BC2025	N/A	转移性乳腺癌 hormone receptor-positive	20	Standard regimen (3 weeks-on 1 week-off)	觸憲願醖餘淵築糧遞繭(選窪襯衊壓襯製膚淵衊) = 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 衊糧淵餘艱齋繭鬱糧製 (夢衊構淵鹽網衊餘衊鹽 ) 更多	积极	2025-05-14
				Alternative regimen (3 weeks-on 2 weeks-off)
RibOB study (ESMO_BC2025)	临床4期	HR阳性/HER2阴性乳腺癌一线 G8 score \| Leukocyte telomere length (LTL) \| plasma inflammatory cytokines ... 更多	70	Ribociclib 600 mg	膚膚夢糧艱蓋糧鹽獵鬱(構廠顧鬱顧顧遞壓廠衊) = 憲壓築顧壓構鏇範膚壓繭繭壓鹹鹹餘夢簾遞積 (鑰鑰範膚鹹製鏇積顧積, 24 ~ NE) 更多	积极	2025-05-14