Artificial Intelligence Model-Guided Neoadjuvant Anti-HER2 Targeted Therapy: A Randomized, Controlled, Open-Label, Multicenter Phase III Clinical Study

Based on total pathologic complete response (tpCR) after surgery, to evaluate the efficacy of an artificial intelligence model-matched anti-HER2 targeted treatment strategy (investigational arm) versus nab-paclitaxel + carboplatin + trastuzumab + pertuzumab (PCbHP, control arm) as neoadjuvant therapy for patients with early or locally advanced human epidermal growth factor receptor 2 (HER2)-positive breast cancer.

开始日期2026-05-01

申办/合作机构

复旦大学

NCT06495541

/ Not yet recruitingN/AIIT

The Real World Study of Pyrotinib in the Treatment of Advanced Breast Cancer With HER2 Positive

Research object：Planned to receive pyrrolidine for HER2 positive first-line breast cancer patients
Research purpose:
Main research objectives:
To observe the efficacy and safety of pyrrolidine in the treatment of HER2 positive advanced first-line breast cancer.
Secondary research objectives:
1. Evaluate the correlation between patient characteristics in the late stage of treatment and specific treatment plans and clinical outcomes Sex (including safety outcomes)
2. Evaluate whether and how previous anti HER2 therapy affects the efficacy of subsequent pyrrolitinib treatment
3. To observe the efficacy of pyrrolitinib in patients with brain metastasis of HER2 positive breast cancer
Research endpoint:
Main research endpoint:
Progression free survival (rwPFS)
Secondary study endpoint:
Efficacy endpoints: objective response rate (rwORR), disease control rate (rwDCR), until treatment failure Time to Flight (TTF), Total Survival (OS), Security

开始日期2026-04-01

申办/合作机构

天津市肿瘤医院（天津医科大学肿瘤医院）

NCT07417241

/ Not yet recruiting临床2期IIT

Efficacy and Safety of SHR-A1811 Versus Pyrotinib Plus Capecitabine in Patients With Trastuzumab Primary-Resistant HER2-Positive Advanced Breast Cancer：A Prospective, Multicenter, Open-Label, Randomized, Controlled Study

This is a prospective, multicenter, open-label, randomized, controlled Study. The purpose of this study is to evaluate the efficacy and safety of SHR-A1811 versus pyrotinib plus capecitabine in the treatment of trastuzumab primary-resistant HER2-positive advanced breast cancer.

开始日期2026-03-31

申办/合作机构

北京肿瘤医院（北京大学肿瘤医院）

100 项与马来酸吡咯替尼相关的临床结果

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100 项与马来酸吡咯替尼相关的转化医学

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100 项与马来酸吡咯替尼相关的专利（医药）

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380

项与马来酸吡咯替尼相关的文献（医药）

2026-03-01·JOURNAL OF ETHNOPHARMACOLOGY

Shenling Baizhu powder alleviates pyrotinib-induced diarrhea via CFTR-activated chloride secretion

Article

作者: Wang, Jingliang ; Jiang, Fengxian ; Liu, Lei ; Zhao, Jing ; Shu, Yang ; Qi, Fanghua ; Pan, Liying ; Lai, Jingjiang ; Fu, Guobin ; Ran, Pancen ; Xu, Wei ; Yuan, Xiaotian

ETHNOPHARMACOLOGICAL RELEVANCE:

Shenling Baizhu Powder (SBP), a classic traditional Chinese medicine formula documented in Taiping Huimin Heji Jufang, has been widely used in the management of gastrointestinal disorders. Pyrotinib, a tyrosine kinase inhibitor employed in cancer treatment, is frequently associated with chemotherapy-induced diarrhea.

PURPOSE:

This study aimed to investigate the effect of pyrotinib on intestinal chloride secretion and to evaluate the therapeutic potential and underlying mechanism of SBP against pyrotinib-induced diarrhea.

METHODS:

Twenty-four rats were randomly divided into four groups: control, SBP, pyrotinib, and pyrotinib + SBP. Intestinal chloride secretion and channel activity were assessed using the Ussing chamber system. Network pharmacology analysis was performed to predict the signaling pathways involved in SBP-mediated cystic fibrosis transmembrane conductance regulator (CFTR) regulation. A two-sample Mendelian randomization (MR) analysis was further conducted to examine causal relationships between key targets identified through network pharmacology and CFTR, using summary-level genetic data. Western blot analysis was used to validate the predicted signaling pathway.

RESULTS:

SBP administration significantly alleviated diarrhea symptoms and restored electrolyte homeostasis in pyrotinib-treated rats. Ussing chamber experiments using rat ileal tissues and T84 cell models demonstrated that SBP effectively inhibited chloride ion secretion through suppression of the CFTR channel. Analysis based on network pharmacology revealed SBP as a potential regulator of CFTR, acting through Epidermal Growth Factor (EGF)-mediated cyclic adenosine monophosphate (cAMP) signaling. MR analysis provided supporting evidence for a causal effect of EGF on CFTR (p = 0.039). Experimental validation confirmed that SBP downregulated EGF and cAMP expression, consequently attenuating CFTR-mediated chloride secretion.

CONCLUSION:

SBP ameliorates pyrotinib-induced diarrhea by modulating the EGF-cAMP-CFTR signaling axis, thereby inhibiting intestinal chloride secretion and restoring electrolyte balance. In addition to confirming its therapeutic effect, this study reveals a previously unrecognized mechanism whereby SBP downregulates EGFR-dependent CFTR activation, offering a mechanistic explanation for its antidiarrheal properties. These findings not only highlight the mechanistic novelty of SBP in the context of targeted-therapy-associated diarrhea but also provide a scientific foundation supporting its clinical application and future translational development.

2026-03-01·DRUG METABOLISM AND DISPOSITION

In vitro metabolism studies of 5 acrylamide covalent drugs: Comparison with metabolism and disposition in human

Article

作者: Shen, Liang ; Li, Ruixing ; Tao, Yi ; Cao, Weiqun ; Shi, Qingfeng ; Zhu, Mingshe

Targeted covalent inhibitors, such as acrylamide covalent drugs (ACDs), offer advantages in potency, selectivity, and duration of effect compared with traditional small-molecule inhibitors. However, ACDs undergo unique biotransformation pathways in humans, including CYP-mediated metabolism, protein covalent binding, and nonenzymatic glutathione (GSH) adduction, which make standard in vitro metabolism assays for small molecules unsuitable for characterizing ACDs. This study aimed to develop a specialized panel of in vitro metabolism experiments for characterizing ACDs. The approach included metabolism stability assays in human liver microsomes with or without NADPH, covalent binding to human serum albumin with or without GSH, and metabolite profiling in human liver microsomes with or without GSH. In vitro metabolic data were generated for 5 ACDs, abivertinib, afatinib, osimertinib, ibrutinib, and pyrotinib, and compared with reported human metabolism and disposition data. In general, in vitro biotransformation pathways determined in this study are consistent with major metabolic clearance pathways observed in humans. For example, osimertinib showed the highest nonspecific protein covalent binding, a high oxidation-to-GSH adduct ratio, and moderate NADPH-dependent metabolic rates, supporting protein covalent binding as the major metabolic pathway in humans. In contrast, afatinib exhibited minimal CYP-mediated metabolism after accounting for covalent binding to microsomal proteins, low serum protein binding, and a very low oxidation-to-GSH adduct ratio, consistent with GSH adduction being the predominant biotransformation pathway in humans. The results demonstrate that the newly developed in vitro metabolism workflow enables more accurate predictions of CYP-mediated clearance rates and clarifies the relative contributions of CYP metabolism, nonspecific protein covalent binding, and GSH adduction to overall metabolic clearance in humans. SIGNIFICANT STATEMENT: This study established a novel in vitro metabolism approach for characterizing acrylamide covalent drugs. By comparing in vitro metabolic data for abivertinib, afatinib, osimertinib, ibrutinib, and pyrotinib with reported human metabolism and disposition data, we demonstrated that this method improves the accuracy of predicting CYP-mediated metabolic rates. Furthermore, it provides clearer insights into the relative contributions of CYP metabolism, nonspecific protein covalent binding, and glutathione adduction to the overall metabolic clearance of acrylamide covalent drugs in humans.

2026-03-01·Cancer Medicine

Final Efficacy and Safety Results of Pyrotinib Combined With Trastuzumab and Chemotherapy in Pre‐Treated Human Epidermal Growth Factor Receptor 2‐Positive Metastatic Breast Cancer

Article

作者: Lan, Xiaofeng ; Xie, Xiaofeng ; Huang, Jiayi ; Lei, Rongmei ; Huang, Daijia ; Song, Lin ; Bai, Xue ; Du, Caiwen ; Chen, Liping ; Zheng, Wenyu ; Chen, Xuelian

ABSTRACT:

Purpose:

Findings from our previous study showed that the combination of pyrotinib, trastuzumab, and chemotherapy represents a viable treatment strategy with an acceptable safety profile for heavily pre‐treated human epidermal growth factor receptor 2 (HER2)‐positive metastatic breast cancer (MBC). We present here the final efficacy and safety results of our investigation.

Methods:

Patients with HER2‐positive MBC who previously received anti‐HER2 therapies such as trastuzumab, pertuzumab, or lapatinib were treated with a combination of pyrotinib, trastuzumab, and chemotherapy. Progression‐free survival (PFS), predictive factors of PFS, and safety were updated in both the intention‐to‐treat population (ITT) and the subgroup exhibiting brain metastases (Sub‐BM). Overall survival (OS) along with its predictive factors was initially analyzed in both ITT and Sub‐BM.

Results:

Forty patients were eligible for this analysis. After a median follow‐up of 46.6 months, 27 deaths occurred and four patients continued treatment with pyrotinib combined with trastuzumab and chemotherapy. The median PFS was 7.5 [95% confidence interval (CI), 4.5–10.5 months] and 9.1 months (95% CI, 0.0–18.9 months) in the ITT and Sub‐BM, respectively. The median OS was 32.2 (95% CI, 21.8–42.6 months) and 32.2 months (95% CI, 18.4–46.0 months) in the ITT and Sub‐BM, respectively. Cox regression analyses revealed that liver or/and lung metastases were significant adverse predictive factors for PFS ( p = 0.020) in the ITT. No new safety concerns were identified following 28 months of additional follow‐up. Adverse events were similar to those reported at the primary analyses with respect to specificity, incidence, and severity.

Conclusion:

Updated analyses pertaining to PFS and safety were generally aligned with data obtained from initial assessments. The OS outcomes further substantiated that the combination of pyrotinib, trastuzumab, and chemotherapy is an alternative therapeutic regimen for managing HER2‐positive MBC with heavy pre‐treatment in certain situations, particularly among those with non‐visceral metastases.

970

项与马来酸吡咯替尼相关的新闻（医药）

2026-04-30

·ioncology

瞭望前瞻丨2026 ESMO BC盛幕将启，一文汇总重磅研究进展

编者按：2026年欧洲肿瘤内科学会乳腺癌年会（ESMO BC）将于当地时间5月6日至8日在德国柏林举行。本次大会内容丰富、亮点纷呈，全面覆盖乳腺癌的靶向治疗、内分泌治疗以及免疫治疗等领域，届时将有多项极具影响力的研究成果公布。《肿瘤瞭望-乳腺时讯》特别对会议即将披露的重要研究内容进行了系统汇总，以飨读者。 Proffered Paper session 1 时间：5月6日16:00 - 17:30 地点：Berlin Hall 主席：Sara M. Tolaney (Boston, MA, United States of America) Masakazu Toi (Bunkyo-ku, Japan) LBA1-Residual cancer burden (RCB) following neoadjuvant treatment (NAT) with trastuzumab deruxtecan (T-DXd) followed by paclitaxel + trastuzumab + pertuzumab (THP) vs dose-dense doxorubicin + cyclophosphamide followed by THP (ddAC-THP) in high-risk HER2+ early-stage breast cancer (eBC) 高危HER2+早期乳腺癌（eBC）新辅助治疗（NAT）后T-DXd序贯紫杉醇+曲妥珠单抗+帕妥珠单抗（THP）与剂量密集多柔比星+环磷酰胺序贯THP（ddAC-THP）的残余肿瘤负荷（RCB）比较报告时间：16:00 - 16:10 讲者：Lajos Pusztai (New Haven, CT, United States of America) 214O - Chemotherapy-free, pathological complete response (pCR)-guided strategy with trastuzumab-pertuzumab (HP) and T-DM1 in HER2+ early breast cancer (EBC): PHERGain-2 曲妥珠单抗-帕妥珠单抗（HP）和T-DM1治疗HER2+早期乳腺癌（EBC）的无化疗、病理完全缓解（pCR）指导策略：PHERGain-2 报告时间：16:10 - 16:20 讲者：Antonio LLOMBART CUSSAC (Valencia, Spain) 215O - Randomized, phase II trial to evaluate the efficacy and safety of atezolizumab plus capecitabine adjuvant therapy compared to capecitabine for triple-negative breast cancer (TNBC) with residual invasive cancer after neoadjuvant chemotherapy (MIRINAE trial, KCSG-BR18-21) 一项随机 II 期试验，旨在评估阿替利珠单抗联合卡培他滨辅助治疗对比卡培他滨单药治疗新辅助化疗后残留浸润性癌的三阴性乳腺癌 (TNBC) 的疗效和安全性（MIRINAE 试验，KCSG-BR18-21）报告时间：16:20 - 16:30 讲者：In Hae Park (Seoul, Republic of Korea) 1O - ctDNA detection rates during surveillance in high-risk HR+/HER2 negative breast cancer from the TRAK-ER study TRAK-ER研究中高危HR+/HER2阴性乳腺癌监测期间ctDNA的检出率报告时间：16:52 - 17:02 讲者：Niamh Cunningham (London, United Kingdom) LBA2 - A window-of-opportunity (WOO) trial of giredestrant +/- LHRH analogue vs anastrozole + LHRHa in premenopausal patients with ER+/HER2- early breast cancer: PREcoopERA 一项在ER+/HER2-早期乳腺癌绝经前患者中评估giredestrant±LHRH类似物对比阿那曲唑+LHRH类似物的机会窗（WOO）试验：PREcoopERA 报告时间：17:02 - 17:12 讲者：Elisabetta Munzone (Milan, Italy) Rapid Oral session 1 时间：5月7日08:30 - 10:00 地点：Berlin Hall 主席：Sonia Pernas (Hospitalet de Llobregat, Spain) Peter Dubsky (Luzern, Switzerland) 216RO - 5-year invasive disease-free survival (iDFS) of the strategy-based, randomized phase II PHERGain trial evaluating chemotherapy (CT) de-escalation in HER2[+] early breast cancer (EBC) patients (pts) 基于策略的随机Ⅱ期PHERGain试验评估 HER2+早期乳腺癌（EBC）患者化疗（CT）降阶治疗的5年无侵袭性疾病生存期（iDFS）报告时间：08:30 - 08:35 讲者：Javier C. Cortés (Barcelona, Spain) 217RO - Neoadjuvant trastuzumab, pertuzumab and tucatinib without chemotherapy in HER2+ early breast cancer: The TRAIN-4 study 新辅助曲妥珠单抗、帕妥珠单抗联合图卡替尼治疗HER2阳性早期乳腺癌，无需化疗：TRAIN-4研究报告时间：08:35 - 08:40 讲者：Fleur M. Louis (Amsterdam, Netherlands) 2RO - Tumor-informed ctDNA dynamics and efficacy of sequential pyrotinib–pertuzumab neoadjuvant therapy in HER2-positive breast cancer: A randomized, open-label, phase II trial 肿瘤相关ctDNA动态变化及序贯吡咯替尼-帕妥珠单抗新辅助治疗在HER2阳性乳腺癌中的疗效：一项随机、开放标签的II期试验报告时间：08:40 - 08:45 讲者：Haoyu Wang (上海交通大学医学院附属瑞金医院) 3RO - Improved identification of high-risk node-negative breast cancer using a multimodal clinical, pathologic, and genomic model in the TAILORx Trial 在TAILORx试验中，利用多模态临床、病理和基因组模型改进了高危淋巴结阴性乳腺癌的识别报告时间：09:00 - 09:05 讲者：Frederick M. Howard (Chicago, IL, United States of America) 218RO - Revisiting estrogen receptor positivity in breast cancer: Long-term outcomes and endocrine therapy benefit across ER expression levels 重新审视乳腺癌中雌激素受体阳性亚型：不同雌激素受体表达水平下的长期预后和内分泌治疗获益报告时间：09:05 - 09:10 讲者：Flora Nguyen Van Long (Quebec, QC, Canada) 187RO - Lymph node surgery and CDK4/6 inhibitors in early breast cancer: A cost-consequence analysis from 5 randomized trials 早期乳腺癌淋巴结手术和CDK4/6抑制剂：来自5项随机试验的成本效益分析报告时间：09:10 - 09:15 讲者：Andre Pfob (Heidelberg, Germany) 4RO - A comparative analysis between tissue-free ctDNA detection and a multivariant tumour-informed assay in early triple-negative breast cancer 早期三阴性乳腺癌中无组织ctDNA检测与多变量肿瘤信息检测的比较分析报告时间：09:15 - 09:20 讲者：Niamh Cunningham (London, United Kingdom) LBA3 - The UK retrospective genetic testing programme: Utilising linkage of nationally collected data to identify and offer germline genetic testing to patients with historic diagnoses of breast or ovarian cancer 英国回顾性基因检测计划：利用国家收集的数据的链接来确定和提供生殖细胞系基因检测给有乳腺癌或卵巢癌病史的患者报告时间：09:44 - 09:49 讲者：Clare A. Turnbull (London, United Kingdom) LBA5 - Efficacy of an mHealth intervention to address informational needs in adolescent and young adult (AYA) breast cancer survivors (BCS): A secondary outcome from the YES trial 移动医疗干预对满足青少年和年轻成人（AYA）乳腺癌幸存者（BCS）信息需求的效果：YES试验的次要结局报告时间：09:54 - 09:59 讲者：Shoshana M. Rosenberg (New York, NY, United States of America) Proffered Paper session 2 时间：5月7日14:15 - 15:45 地点：Berlin Hall 主席：Nicholas C. Turner (London, United Kingdom) 418O - Safety and patient (pt)-reported outcomes (PROs) from evERA breast cancer (BC): A phase III trial of giredestrant (GIRE) + everolimus (E) in pts with oestrogen receptor-positive, HER2-negative advanced BC (ER+, HER2– aBC) previously treated with a CDK4/6 inhibitor (i) evERA BC研究的安全性和患者报告结局（PRO）：一项III期试验，评估giredestrant+依维莫司在既往接受过CDK4/6抑制剂治疗的雌激素受体阳性、HER2 阴性晚期乳腺癌（ER+, HER2– aBC）) 患者中的疗效报告时间：14:15 - 14:25 讲者：Miguel Martin (Madrid, Spain) 415O - First-line (1L) datopotamab deruxtecan (Dato-DXd) vs chemotherapy (CT) in patients (pts) with locally recurrent inoperable or metastatic triple-negative breast cancer (mTNBC) for whom immunotherapy was not an option: Patient-reported outcomes (PROs) from TROPION-Breast02 在不能接受免疫治疗的局部复发、不可手术或转移性三阴性乳腺癌（mTNBC）患者（pts）中，一线（1L）datopotamab deruxtecan（Dato-DXd）与化疗（CT）的比较：TROPION-Breast02研究的患者报告结局（PRO）报告时间：14:25 - 14:35 讲者：Peter Schmid (London, United Kingdom) 416O - SMART: On-treatment ctDNA dynamics predicts response and progression in metastatic breast cancer SMART：治疗期间ctDNA动态变化可预测转移性乳腺癌的疗效和进展报告时间：14:53 - 15:03 讲者：Pedram Razavi (New York, NY, United States of America) 417O - Capivasertib (C) and fulvestrant (F) for patients (pts) with HR+/HER2− advanced breast cancer (ABC): Final overall survival (OS) results from the phase III CAPItello-291 trial 卡匹色替联合氟维司群用于HR+/HER2-晚期乳腺癌（ABC）患者：III期CAPItello-291试验的最终总生存期（OS）结果报告时间：15:03 - 15:13 讲者：Hope S. Rugo (Los Angeles, CA, United States of America) Rapid Oral session 2 时间：5月8日08:30 - 10:00 地点：Berlin Hall 419RO - Emergence of ESR1 mutations (ESR1m) in ctDNA during first-line (1L) endocrine-based therapy in HR+/HER2- advanced breast cancer: Findings from the SERENA-6 trial 在HR+/HER2-晚期乳腺癌一线内分泌治疗期间，ctDNA中ESR1突变（ESR1m）的出现情况：SERENA-6试验的结果报告时间：08:30 - 08:35 讲者：François Clément Bidard (Paris, France) 420RO - Efficacy of inavolisib (INAVO) + palbociclib (PALBO) + fulvestrant (FULV) in patients (pts) with PIK3CA-mutated, hormone receptor-positive, HER2-negative (HER2–), endocrine-resistant advanced breast cancer (aBC) with and without hyperglycaemia (HG) in the phase III INAVO120 trial 在III期INAVO120试验中，评估伊利那塞+哌柏西利+氟维司群联合治疗PIK3CA突变、激素受体阳性、HER2阴性、内分泌耐药的晚期乳腺癌（aBC）患者（伴或不伴高血糖）的疗效报告时间：08:35 - 08:40 讲者：Sibylle Loibl (Neu-Isenburg, Germany) 421RO - Dose optimization of BTX-9341, a first-in-class CDK4/6 bifunctional degrader, in CDK4/6 inhibitor-pretreated HR+/HER2− advanced/metastatic breast cancer 在接受过CDK4/6抑制剂治疗的HR+/HER2-晚期/转移性乳腺癌患者中，BTX-9341（一种首创的CDK4/6双功能降解剂）的剂量优化报告时间：08:40 - 08:45 讲者：Matthew P. Goetz (Rochester, NY, United States of America) 422RO - A phase II study of patritumab deruxtecan (HER3-DXd) in patients (pts) with metastatic breast cancer (MBC) Patritumab Deruxtecan（HER3-DXd）治疗转移性乳腺癌（MBC）患者的II期研究报告时间：09:00 - 09:05 讲者：Erika P. Hamilton (Nashville, TN, United States of America) LBA4 - Efficacy and safety of sacituzumab govitecan (SG) plus trastuzumab in patients with HER2+ metastatic breast cancer after prior trastuzumab deruxtecan (T-DXd): Results from the phase II SATEEN trial sacituzumab govitecan（SG）联合曲妥珠单抗治疗既往接受过T-DXd治疗的HER2+转移性乳腺癌患者的疗效和安全性：2期SATEEN试验的结果报告时间：09:10 - 09:15 讲者：Paolo Tarantino (Boston, MA, United States of America) 423RO - Addition of tucatinib to trastuzumab emtansine (T-DM1) in patients with previously treated HER2+ locally advanced/metastatic breast cancer (LA/MBC): Updated efficacy analysis from the HER2CLIMB-02 trial 在既往接受过治疗的HER2阳性局部晚期/转移性乳腺癌 (LA/MBC) 患者中，T-DM1联合图卡替尼治疗方案的疗效：HER2CLIMB-02 试验的最新疗效分析报告时间：09:15 - 09:20 讲者：Giuseppe Curigliano (Milan, Italy) 424RO - SACI-IO HR+: Final results from a randomized phase II trial of sacituzumab govitecan with or without pembrolizumab in hormone receptor-positive/HER2-negative (HR+/HER2-) metastatic breast cancer (MBC) SACI-IO HR+：一项随机 II 期试验的最终结果，该试验评估了戈沙妥珠单抗联合或不联合帕博利珠单抗治疗激素受体阳性/HER2阴性 (HR+/HER2-) 转移性乳腺癌 (MBC)的疗效报告时间：09:35 - 09:40 讲者：Ana C. Garrido-Castro (Boston, MA, United States of America) 425RO - A randomized phase II study of pembrolizumab plus carboplatin vs. carboplatin alone in unresectable advanced breast cancer (ABC) with chest wall disease (CWD) [ICI-CHEST, TBCRC 44] 一项随机II期研究比较了帕博利珠单抗联合卡铂与单用卡铂治疗不可切除的晚期乳腺癌（ABC）伴胸壁疾病（CWD）的疗效 [ICI-CHEST, TBCRC 44] 报告时间：09:40 - 09:45 讲者：Neelima Vidula (Boston, MA, United States of America) 426RO - Pumitamig in combination with DB-1305/BNT325 as first-line (1L) treatment for patients with advanced or metastatic triple-negative breast cancer (a/mTNBC): Efficacy and safety from a multicenter, open-label, phase I/II trial Pumitamig联合DB-1305/BNT325作为一线（1L）治疗晚期或转移性三阴性乳腺癌（a/mTNBC）患者的疗效和安全性：一项多中心、开放标签的1/2期试验报告时间：09:45 - 09:50 讲者：张剑（复旦大学附属肿瘤医院）（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。

临床结果临床2期免疫疗法

2026-04-29

·医脉通乳腺肿瘤

春聚冰城，大咖论道！殷咏梅教授：2026版CSCO BC指南更新！创新力量引领治疗新范式！

冰城四月，春意正浓。2026中国临床肿瘤学会（CSCO）指南大会于哈尔滨盛大召开。本次会议汇聚国内外肿瘤领域顶级专家，重点解读《中国临床肿瘤学会（CSCO）乳腺癌诊疗指南2026》[1]（以下简称“2026版CSCO BC指南”）最新内容。新版指南以精准分层、优化治疗、扩大患者获益为核心导向，立足国际前沿进展，兼顾国内临床可及性，在晚期乳腺癌化疗策略、人表皮生长因子受体2（HER2）阳性乳腺癌靶向治疗等多个领域进行了重要更新，引发临床广泛关注。据此，医脉通特邀CSCO乳腺癌专家委员会主任委员，江苏省人民医院殷咏梅教授，围绕2026版CSCO BC指南的核心更新要点与创新药物的临床价值进行深度访谈。医脉通：化疗作为晚期乳腺癌综合治疗的基石，其方案优化与给药模式创新是CSCO BC指南历年更新的核心内容之一。作为CSCO BC主任委员，您深度参与并推动了2026版CSCO BC指南更新。请您分享新版指南在晚期乳腺癌患者的化疗策略方面，有哪些新的思路与趋势？殷咏梅教授江苏省人民医院 2026版CSCO BC指南以精准分层、优化治疗、进一步扩大患者获益为核心纲领，在晚期乳腺癌化疗领域实现了多重突破，充分彰显了指南对临床实践的引领性以及对患者的人文关怀。具体体现在以下三个方面：其一，化疗在晚期乳腺癌综合治疗中的地位不可或缺。在靶向治疗、免疫治疗蓬勃发展的当下，化疗在晚期乳腺癌治疗中仍然占据重要地位。对于无明确靶向或免疫治疗指征的紫杉类敏感患者，以紫杉类药物为基础的化疗仍是标准治疗选择；对于内分泌治疗耐药的激素受体（HR）阳性/HER2阴性患者，化疗仍然是延长生存的关键手段。其二，化疗通过联合其他治疗手段构建多元化治疗体系。新版指南进一步强化了化疗联合应用的价值，通过“化疗+”协同模式提升患者获益。例如，在三阴性乳腺癌中，化疗联合免疫检查点抑制剂已成为一线标准治疗；在HER2阳性乳腺癌中，化疗仍与抗HER2靶向药物，尤其是单克隆抗体、小分子酪氨酸激酶抑制剂（TKI）类药物构成联合方案；而在细胞周期蛋白依赖性激酶4/6（CDK4/6）抑制剂联合内分泌治疗进展后的HR阳性/HER2阴性转移性乳腺癌中，化疗同样是重要的治疗选择之一。其三，鼓励探索“去输液化”的创新化疗模式，迈向以患者为中心的慢病管理。随着诊疗理念的进步，晚期乳腺癌治疗已从单纯追求疗效转向疗效与生活质量并重。指南首次将紫杉醇口服溶液纳入注释，标志着化疗从院内输液向居家口服、去输液化的进一步跨越。这不仅是在给药方式方面的革新，更是践行“提升患者生活质量、实现长期慢病管理”理念的关键途径。图1 2026版CSCO BC指南[1]首次将口服紫杉醇纳入注释医脉通：晚期乳腺癌化疗策略已在宏观层面发生了重要方向性转变，新型化疗模式的探索也取得了重要进展。此次更新也首次新增了紫杉醇口服溶液的相关注释。您深度参与了紫杉醇口服溶液的乳腺癌全球多中心Ⅲ期临床OPTIMAL研究，结合研究结果，您如何评价紫杉醇口服溶液的临床价值？殷咏梅教授江苏省人民医院 OPTIMAL研究[2]证实了紫杉醇口服溶液非劣于静脉紫杉醇，填补了这一创新药物在乳腺癌领域的证据空白。该研究是一项全球多中心、随机对照、开放标签的Ⅲ期临床研究，共纳入549例HER2阴性复发或转移性乳腺癌患者，一组给予口服紫杉醇溶液，另一组给予静脉紫杉醇。研究结果显示，中位随访约39个月时，紫杉醇口服组的中位无进展生存期（PFS）为10.0个月，静脉组为8.5个月（HR=0.869，95%CI 0.707~1.068），达到非劣效标准；而在PFS亚组分析中，中国人群显示出更优的获益趋势（HR=0.754，95%CI 0.575~0.990）。两组中位总生存期（OS）相当，分别为32.6个月和31.8个月（HR=0.967，95%CI 0.762~1.227）。在肿瘤缓解方面，紫杉醇口服组的客观缓解率（ORR）为43.3%，在数值上高于对照组的38.8%，达到非劣效结果。在安全性方面，紫杉醇口服溶液外周神经毒性发生率（37.9% vs 48.3%）和超敏反应发生率（0.7% vs 2.7%）均低于静脉组。目前来说，这一研究奠定了紫杉醇口服溶液在晚期乳腺癌化疗中的适应症，意义非凡。图2 OPTIMAL研究[2]的PFS与OS结果图3 OPTIMAL研究[2]的PFS亚组分析结果紫杉醇口服溶液不仅优化了给药路径，也革新了化疗生态。紫杉醇口服溶液无需预处理、无需中心静脉置管，患者可居家自行服药，将化疗给药模式从医院集中治疗转向居家自主用药，大幅减少了患者往返医院的时间成本和经济负担，同时在心理层面也有诸多优化。这一改变充分彰显了以患者为中心的核心理念，进一步推动了乳腺癌治疗新生态的构建。医脉通：目前，紫杉醇口服溶液已在国内获批胃癌适应症，其乳腺癌晚期一线适应症也获批在即。展望未来，您认为其适应症获批后，将如何影响中国晚期乳腺癌患者的治疗格局？在更广泛的可及性之下，我们离真正的“居家化疗”时代还有多远？殷咏梅教授江苏省人民医院紫杉醇口服溶液的获批将进一步拓宽一线化疗选择，实现精准分层下的个体化治疗。在临床决策中，医生不仅要考虑肿瘤的分子分型，还需兼顾患者的体能状态、生活自理能力、就医条件和个人偏好等个体化因素。对于体能良好、生活自理能力强、就医不便或倾向于减少院内停留的患者，紫杉醇口服溶液可作为其优先考虑的化疗方案。紫杉醇口服溶液的获批能够推动治疗模式从“以医院为中心”向“以患者为中心”转变。这一转变与指南中“优化治疗、扩大患者获益”的核心导向高度契合。适应症获批后，这一模式可从指南推荐走向临床普及，有效改变晚期乳腺癌的治疗场景。从更长远视角看，紫杉醇口服溶液的获批还有望加速居家化疗体系的构建。口服化疗药物有望与皮下制剂组成全口服、去输液的联合方案，进一步提升患者生活质量。让患者在保证治疗疗效的同时提升生活质量，兼顾长期生存和高质量生活的终极目标，推动乳腺癌治疗向慢病化管理模式演进。医脉通：基于您的分享，我们看到化疗模式正在不断创新，为HER2阴性晚期乳腺癌带来了重要变革。而在HER2阳性乳腺癌领域，抗HER2靶向治疗的革新也正在改写其治疗格局。您认为新版指南在HER2阳性晚期乳腺癌领域有哪些值得关注的更新？殷咏梅教授江苏省人民医院 2026版CSCO BC指南在HER2阳性晚期乳腺癌领域，延续了“曲妥珠单抗治疗敏感”和“曲妥珠单抗治疗失败/TKI治疗失败”的分层决策路径，并以抗体药物偶联物（ADC）药物重塑治疗格局，同步强化中国原研治疗方案的价值，实现了HER2阳性晚期乳腺癌全程诊疗策略的精细化升级。一线治疗方面，以THP双靶方案为核心，抗HER2单抗选择日趋丰富。对于曲妥珠单抗敏感患者，THP双靶方案仍占据核心地位。伊尼妥单抗作为我国自主研发的改良型抗HER2单克隆抗体，其Fab段与曲妥珠单抗相同，但Fc段经两个氨基酸位点修饰后增强了抗体依赖细胞介导的细胞毒作用（ADCC）效应，其关键性Ⅲ期HOPES研究[3]中，伊尼妥单抗联合长春瑞滨对比单纯化疗显著延长了中位PFS（39.6周 vs 14.0周，HR=0.24；95%CI 0.16~0.36；P<0.0001）。目前该药物被纳入抗HER2单抗基础用药的选择范畴，与曲妥珠单抗、帕妥珠单抗等药物共同丰富了靶向用药矩阵。同时，由PHILA研究验证的吡咯替尼联合曲妥珠单抗和多西他赛（PyroHT）方案地位进一步巩固，该Ⅲ期研究由徐兵河院士牵头，其近日更新的长期随访数据再次发表于《英国医学杂志》（BMJ）[4]。此外，Ⅱ级推荐新增了德曲妥珠单抗（T-DXd）联合帕妥珠单抗（T-DXd+P）方案，其依据为Ⅲ期DESTINY-Breast09研究[5]，该研究在2025年ASCO年会上公布的结果显示，T-DXd+P一线治疗HER2阳性转移性乳腺癌的中位PFS达40.7个月，较THP方案的26.9个月显著延长（HR=0.56），疾病进展或死亡风险降低44%。图4 伊尼妥单抗被纳入2026版CSCO BC指南[1]注释二线治疗方面，以ADC药物为核心，治疗格局迎来了深刻改变。T-DXd被列为曲妥珠单抗和/或TKI治疗失败人群唯一*的Ⅰ级推荐，其依据为DESTINY-Breast03[6]研究。Ⅱ级推荐中新增了瑞康曲妥珠单抗（SHR-A1811）、博度曲妥珠单抗及维迪西妥单抗（肝转移）等多个中国原研新药方案。此外，卡培他滨联合吡咯替尼依然是极具竞争力的可选方案。总体而言，从一线到二线及后线，从维持治疗策略到脑转移的系统性管理，新版指南体现了对HER2阳性晚期乳腺癌患者长生存与高质量生活兼顾的全程管理理念。 *截至2026年4月26日，T-DXd为2026版CSCO BC指南HER2阳性复发转移乳腺癌治疗列表中曲妥珠单抗和/或TKI治疗失败人群的唯一Ⅰ级推荐。专家简介殷咏梅教授江苏省人民医院二级教授，主任医师，博导江苏省人民医院（南京医科大学第一附属医院、江苏省妇幼保健院）副院长中国临床肿瘤学会（CSCO）副理事长北京市希思科临床肿瘤学研究基金会副理事长第19届St. Gallen国际乳腺癌大会专家团成员 CSCO乳腺癌专家委员会主任委员中国医药创新促进会抗肿瘤药物临床研究专业委员会副主任委员中国抗癌协会乳腺癌专业委员会常委 CSCO BC指南执笔专家参考文献 [1]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2026. 北京: 人民卫生出版社. 2026. [2]Xu B, Jeong H, Sun T, Sohn J, Zhang Q, Kostic S, et al. OPTIMAL: A Multinational Phase Ⅲ Study of Oral Paclitaxel (DHP107) versus Intravenous Weekly Paclitaxel in HER2-Negative Recurrent or Metastatic Breast Cancer. Ann Oncol. 2026. doi: 10.1016/j.annonc.2026.03.002. [3]Wang T,Zhang P,Di L,et.al..Efficacy and safety of inetetamab in combination with chemotherapy as first-line treatment of HER2-positive metastatic breast cancer: a subgroup analysis in the HOPES study.Transl Breast Cancer Res 2022;3:15，DOI: 10.21037/tbcr-21-42. [4]Fei Ma, et al. British Medical Journal. 2026;392:e087259 [5]Sara M. Tolaney, et al. Trastuzumab deruxtecan (T-DXd) + pertuzumab (P) vs taxane + trastuzumab + pertuzumab (THP) for first-line (1L) treatment of patients (pts) with human epidermal growth factor receptor 2–positive (HER2+) advanced/metastatic breast cancer (a/mBC): Interim results from DESTINY-Breast09. 2025 ASCO LBA 1008. [6]Cortés J, Hurvitz SA, Im SA, et al. Trastuzumab deruxtecan versus trastuzumab emtansine in HER2-positive metastatic breast cancer: long-term survival analysis of the DESTINY-Breast03 trial. Nat Med. 2024;30(8):2208-2215. 编辑：Andy 审校：Elan 排版：Seren 执行：Ocean 本平台旨在为医疗卫生专业人士传递更多医学信息。本平台发布的内容，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。如该等信息被用于了解医学信息以外的目的，本平台不承担相关责任。本平台对发布的内容，并不代表同意其描述和观点。若涉及版权问题，烦请权利人与我们联系，我们将尽快处理。

2026-04-29

·科学网

文献清单：“生物标志物”方向 | MDPI JPM

期刊名：Journal of Personalized Medicine 期刊主页：https://www.mdpi.com/journal/jpm 本期精选文章聚焦生物标志物，通过探讨其在神经退行性疾病、癌症、哮喘等多种疾病诊疗中的应用，展示了疾病精准防治的个体化路径。希望能为相关领域学者提供新思路，欢迎阅读与交流。 1.Redefining Non-Motor Symptoms in Parkinson’s Disease 重新定义帕金森病的非运动症状 by Laura Peña-Zelayeta, Karen M. Delgado-Minjares, Marcos M. Villegas-Rojas, Karen León-Arcia, Alberto Santiago-Balmaseda, Jesús Andrade-Guerrero, Isaac Pérez-Segura, Emmanuel Ortega-Robles, Luis O. Soto-Rojas, Oscar Arias-Carrión https://www.mdpi.com/2075-4426/15/5/172 2. Anti-Amyloid Monoclonal Antibodies for Alzheimer’s Disease: Evidence, ARIA Risk, and Precision Patient Selection 阿尔茨海默病的抗淀粉样蛋白单克隆抗体：证据、ARIA 风险与精准患者筛选 by Amer E. Alkhalifa, Abdulrahman Al Mokhlf, Hande Ali, Nour F. Al-Ghraiybah, Vasiliki Syropoulou https://www.mdpi.com/2075-4426/15/9/437 3. Targeting Metabolic Vulnerabilities to Combat Drug Resistance in Cancer Therapy 靶向代谢脆弱性以对抗癌症治疗中的耐药性 by Taranatee Khan, Manojavan Nagarajan, Irene Kang, Chunjing Wu, Medhi Wangpaichitr https://www.mdpi.com/2075-4426/15/2/50 4. Expression of Tissue Remodeling- and Inflammation-Related Factors During the Wound-Healing Process in Humans 人体伤口愈合过程中组织重塑及炎症相关因子的表达 by Dimitrios Vardakostas, Athanasios Moustogiannis, Zoe Garoufalia, Elli Karatza, Anastassios Philippou, Gregory Kouraklis, Michael Koutsilieris, Dimitrios Mantas https://www.mdpi.com/2075-4426/15/1/14 5. Cardiac Autonomic Measures Predict Clinician-Rated Anxiety and Behavioral Response to Propranolol in Autistic Children and Young Adults 心脏自主神经指标可预测自闭症儿童及青少年对普萘洛尔的临床医生评定焦虑与行为反应 by Carrina Appling, Nanan Nuraini, Ryan Holem, Samantha Hunter, Kathy Hirst, Nicole Takahashi, Micah O. Mazurek, Stephen M. Kanne, Bradley Ferguson, David Q. Beversdorf https://www.mdpi.com/2075-4426/15/7/286 6. Oxidative Stress Biomarkers as Preclinical Markers of Mild Cognitive Impairment: The Impact of Age and Sex 氧化应激生物标志物：轻度认知障碍的临床前预测指标 —— 年龄与性别的影响 by Stavroula Ioannidou, Magda Tsolaki, Argyrios Ginoudis, Androniki Tamvakis, Anthoula Tsolaki, Kali Makedou, Evgenia Lymperaki https://www.mdpi.com/2075-4426/15/5/171 7. AI-Guided Chemotherapy Optimization in Lung Cancer Using Genomic and Survival Data 基于基因组与生存数据的人工智能引导肺癌化疗优化方案 by Hojin Moon, Phan N. Nguyen, Jaehee Park, Minho Lee, Sohyul Ahn https://www.mdpi.com/2075-4426/15/6/218 8. Established and Emerging Asthma Biomarkers with a Focus on Biologic Trials: A Narrative Review 以生物制剂临床试验为重点的经典与新型哮喘生物标志物 —— 一篇叙述性综述 by Philip F. Lavere、Kaitlin M. Phillips、Nicola A. Hanania、Muhammad Adrish https://www.mdpi.com/2075-4426/15/8/370 期刊介绍：主编：Prof. Dr. Kenneth P.H. Pritzker, University of Toronto, Canada JPM期刊致力于整合个性化医学的各个方面，推动该领域的研究与实践。期刊涵盖创新的临床前与转化科学研究、技术进展及临床应用，发表研究论文、综述、评论和通讯等多种类型文章，强调详实的实验与理论成果，注重研究可重复性。旨在搭建一个跨学科交流平台，汇聚学术研究者、临床医生、生物技术与制药企业、诊断专家、医疗从业者、伦理与监管机构以及政府部门，共同促进个性化医学的发展。特别声明：本文转载仅仅是出于传播信息的需要，并不意味着代表本网站观点或证实其内容的真实性；如其他媒体、网站或个人从本网站转载使用，须保留本网站注明的“来源”，并自负版权等法律责任；作者如果不希望被转载或者联系转载稿费等事宜，请与我们接洽。

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KEGG	Wiki	ATC	Drug Bank
-	-	L01XE	DB14993

研发状态

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适应症	国家/地区	公司	日期
晚期 HER2 阳性乳腺癌	中国	江苏恒瑞医药股份有限公司	2023-04-17
HER2阳性乳腺癌	中国	江苏恒瑞医药股份有限公司	2018-08-12

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适应症	最高研发状态	国家/地区	公司	日期
HER2低表达乳腺癌	临床3期	中国	江苏恒瑞医药股份有限公司	2024-01-17
HR阳性乳腺癌	临床3期	中国	江苏恒瑞医药股份有限公司	2024-01-17
HR阳性/HER2低表达乳腺癌	临床3期	中国	江苏恒瑞医药股份有限公司	2024-01-17
浸润性乳腺癌	临床3期	中国	江苏恒瑞医药股份有限公司	2024-01-17
晚期非小细胞肺癌	临床3期	美国	江苏恒瑞医药股份有限公司	2020-09-11
晚期非小细胞肺癌	临床3期	中国	江苏恒瑞医药股份有限公司	2020-09-11
晚期非小细胞肺癌	临床3期	澳大利亚	江苏恒瑞医药股份有限公司	2020-09-11
晚期非小细胞肺癌	临床3期	比利时	江苏恒瑞医药股份有限公司	2020-09-11
晚期非小细胞肺癌	临床3期	法国	江苏恒瑞医药股份有限公司	2020-09-11
晚期非小细胞肺癌	临床3期	德国	江苏恒瑞医药股份有限公司	2020-09-11

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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


NCT03863223 (PHILA, Pubmed) 人工标引	临床3期	HER2阳性转移性乳腺癌 HER2 Positive	590	Pyrotinib + Trastuzumab + Docetaxel	範蓋鏇鹹繭願餘餘觸鹹(憲遞遞窪網壓簾鹹範憲) = 鏇醖獵糧構鹹願餘鑰餘餘齋蓋齋積鬱遞夢繭構 (艱憲鬱鏇鑰鑰觸夢鑰廠, 19.3 ~ 27.8) 更多	优效	2026-03-16
				Placebo + Trastuzumab + Docetaxel	範蓋鏇鹹繭願餘餘觸鹹(憲遞遞窪網壓簾鹹範憲) = 廠築網餘窪鏇顧憲鬱顧餘齋蓋齋積鬱遞夢繭構 (艱憲鬱鏇鑰鑰觸夢鑰廠, 9.5 ~ 12.4) 更多
NCT03863223 (PHILA, Pubmed \| BMJ)	临床3期	HER2阳性转移性乳腺癌一线	590	Pyrotinib + Trastuzumab + Docetaxel	壓鏇製觸憲範窪鬱壓窪(願網廠廠遞壓鹹範衊顧) = 選夢鬱壓壓衊願糧鬱築簾壓廠顧願鹹淵壓襯鬱 (遞範窪憲餘觸網築選願, 19.3 ~ 27.8) 更多	优效	2026-03-16
				Placebo + Trastuzumab + Docetaxel	壓鏇製觸憲範窪鬱壓窪(願網廠廠遞壓鹹範衊顧) = 鑰簾膚遞築膚構鬱鑰願簾壓廠顧願鹹淵壓襯鬱 (遞範窪憲餘觸網築選願, 9.5 ~ 12.4) 更多
NCT03863223 (PHILA, SABCS2025) 人工标引	临床3期	HER2阳性转移性乳腺癌一线 HER2 Positive	590	Pyrotinib + Trastuzumab + Docetaxel	鏇繭網糧獵蓋壓築艱鬱(鑰顧獵顧鏇製鏇糧膚膚) = 獵遞鹹選糧選選窪膚襯襯獵壓艱醖齋製築鏇選 (繭積觸淵遞鏇襯鹽鹽鑰, 19.2 ~ NE) 更多	积极	2025-12-12
				Placebo + Trastuzumab + Docetaxel	鏇繭網糧獵蓋壓築艱鬱(鑰顧獵顧鏇製鏇糧膚膚) = 簾顧選襯鏇積顧夢範衊襯獵壓艱醖齋製築鏇選 (繭積觸淵遞鏇襯鹽鹽鑰, 6.4 ~ 13.2) 更多
NCT07014410 (SYSUCC-002, SABCS2025)	临床2期	HER2阳性转移性乳腺癌一线 HER2-Positive \| Estrogen Receptor-Positive	16	PyrotinibDalpiciclibLetrozoleib + PyrotinibDalpiciclibLetrozole + PyrotinibDalpiciclibLetrozole (Estrogen Receptor-Positive and HER2-Positive Metastatic Breast Cancer)	鹽壓艱顧艱願淵夢願顧(選觸網鹽糧憲選廠醖襯) = 壓淵簾網鑰選獵鹽簾選觸廠願製築網範廠鹹網 (壓糧簾構積簾襯窪遞鬱, 41 ~ 88)	积极	2025-12-12
SABCS2025	N/A	HER2阳性乳腺癌巩固 HER2-Positive	104	Pyrotinib 400 mg/day	膚鑰製夢願鏇獵範繭廠(廠淵選獵範製積糧鬱鑰) = 構築襯憲簾鏇艱鏇製鬱夢夢鬱糧衊膚積憲膚齋 (選餘廠蓋窪壓壓齋積願 ) 更多	积极	2025-12-11
SABCS2025	N/A	HER2阳性乳腺癌新辅助 HR+ \| HER2-positive	104	Pyrotinib-containing regimen	鏇構鑰顧積網窪選鹹製(製糧願壓糧憲糧構夢鬱) = 襯衊憲餘淵淵鏇觸壓鏇鏇築淵鬱憲憲鑰衊繭築 (壓獵蓋憲淵鑰選蓋簾顧 ) 更多	积极	2025-12-11
NCT05292742 (KATHERINE, SABCS2025)	临床2期	HER2阳性乳腺癌辅助 HER2-positive	102	CapecitabinePyrotinibTrastuzumab + CapecitabinePyrotinibTrastuzumab + CapecitabinePyrotinibTrastuzumabe (HER2-positive early breast cancer + Non-pCR)	構願膚醖艱鑰餘製餘艱(獵築蓋觸淵膚壓獵遞觸) = 願蓋構鹹願醖鹽憲簾鑰糧獵網夢構蓋鬱衊鹹襯 (範鬱膚蓋顧顧壓蓋糧壓, 83.3 ~ 95.6) 更多	积极	2025-12-11
ESMO_ASIA2025	N/A	HER2阳性转移性乳腺癌 HER2-positive	337	Pyrotinib	壓夢鹽製願壓壓網願壓(製糧夢齋膚鏇鹹簾窪構) = 艱鬱鬱艱淵範糧願鹹選窪獵築構齋壓壓網鏇願 (廠鹽選廠觸構衊襯襯獵, 12.9 ~ 17.6) 更多	积极	2025-12-05
				Pyrotinib (First-line treatment)	壓夢鹽製願壓壓網願壓(製糧夢齋膚鏇鹹簾窪構) = 鹹淵獵窪鏇齋鏇壓積觸窪獵築構齋壓壓網鏇願 (廠鹽選廠觸構衊襯襯獵, 10.1 ~ 32.6) 更多
ESMO_ASIA2025	N/A	HER2阳性转移性乳腺癌一线 HER2-positive	411	Docetaxel+Trastuzumab+Pyrotinib	鑰廠鹹積繭鹽齋醖衊觸(艱糧鹽鹹憲鹹範衊夢遞) = 廠鏇艱選鹽鑰鏇範網願鹹淵壓鑰網獵積鑰鬱獵 (艱艱餘蓋範選膚窪選簾, 21.2 ~ 30.4) 更多	积极	2025-12-05
				Taxane+Trastuzumab+Pertuzumab	鑰廠鹹積繭鹽齋醖衊觸(艱糧鹽鹹憲鹹範衊夢遞) = 醖鹹構積夢齋鑰餘膚觸鹹淵壓鑰網獵積鑰鬱獵 (艱艱餘蓋範選膚窪選簾, 13.2 ~ 23.3) 更多
NCT04486911 (MUKDEN 01, ESMO2025)	临床2期	ER阳性/PR阳性/HER2阳性乳腺癌一线 \| 新辅助 ER Positive \| PR Positive \| HER2 Positive	81	Pyrotinib+Letrozole+Dalpiciclib	憲鬱繭鹽襯糧壓窪觸餘(觸憲遞糧鬱壓鑰窪鏇夢) = 膚觸簾鹽構遞窪夢遞構鬱選觸糧觸製醖廠簾築 (範範構壓夢觸築壓醖構, 88.6 ~ 99.1) 更多	积极	2025-10-17