预约演示

更新于：2026-10-23

Trastuzumab

曲妥珠单抗

更新于：2026-10-23

概要

基本信息

药物类型

单克隆抗体

别名

Anti-HER2/neu-MAb、Nanotrastuzumab、trastuzumab

+ [18]

靶点

HER2

作用方式

拮抗剂

作用机制

HER2拮抗剂(受体蛋白酪氨酸激酶 erbB-2拮抗剂)、ADCC(抗体依赖的细胞毒作用)

治疗领域

肿瘤消化系统疾病口颌疾病+ [7]

在研适应症

HER2阳性结直肠癌HER2阳性唾液腺癌HER2阳性胃癌+ [41]

非在研适应症

腺癌晚期乳腺癌进展期胃腺癌+ [41]

原研机构

Genentech, Inc.

在研机构

F. Hoffmann-La Roche Ltd.

上海罗氏制药有限公司Roche Pharma (Schweiz) AG

+ [8]

非在研机构

Novartis Pharmaceuticals Corp.

Sanofi

Eisai, Inc.

+ [14]

权益机构-

最高研发阶段批准上市

首次获批日期

美国 (1998-09-25),

转移性乳腺癌

最高研发阶段(中国)批准上市

特殊审评加速批准 (美国)、孤儿药 (美国)、孤儿药 (日本)、优先审评 (美国)

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结构/序列

Sequence Code 18481L

来源: *****

Sequence Code 44772H

来源: *****

关联

1,271

项与曲妥珠单抗相关的临床试验

NCT07578116

/ Recruiting临床3期IIT

Randomized Phase III Trial of Multimodality Therapy Versus Standard of Care Systemic Therapy in HER2 Positive (HER2+) De Novo (AJCC Stage IV) Oligometastatic Breast Cancer With Response to Initial Chemotherapy

This phase III trial evaluates the effect of adding locoregional therapy (surgery and radiation) and metastasis-directed stereotactic body radiation therapy (SBRT) to standard systemic therapy following standard HER2-targeted systemic therapy, compared to standard systemic therapy alone, in treating patients with HER2-positive stage IV breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic) or to a limited number of sites (oligometastatic). The usual approach for patients with (oligo)metastatic HER2-positive breast cancer is systemic drug treatment, which means medicines that travel through the whole body to treat both the breast and any areas where the cancer has spread. There are a number of approved HER2-targeted systemic therapy regimens available to patients. These typically include immunotherapy and/or chemotherapy. Immunotherapy drugs may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Unlike systemic therapy, locoregional therapies like surgery and radiation are focused treatments at the site of disease, delivered with the intent of sparing healthy tissues. Breast surgeries such as breast conserving therapy or total mastectomy are procedures in which the cancerous breast tissue (and healthy breast tissue in the case of total mastectomy) are surgically removed from the body. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. SBRT is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. Adding locoregional therapy, as well as metastasis-directed SBRT, to standard systemic therapy may help patients with (oligo)metastatic, HER2-positive stage IV breast cancer live longer overall or before their cancer progresses, and may help more patients achieve no evidence of disease, when compared to standard systemic therapy alone.

开始日期2027-03-09

申办/合作机构

SWOG

[+1]

NCT07772245

/ Not yet recruiting临床2期IIT

Phase II Trial of Retifanlimab With Trastuzumab and Pertuzumab Combination in HER2-Addicted Breast Cancer

The goal of this Clinical Trial is to find out how well 3 medicines (retifanlimab, trastuzumab and pertuzumab) work at treating HER2-positive breast cancer in Male and female patients, 18 or older. The main question aims to determine the pathologic response rate [residual cancer burden (RCB)- 0] in the breast and lymph nodes after 6 cycles of retifanlimab, trastuzumab and pertuzumab in patients with HER2-addicted breast cancer. Participants will will have at least 6 cycles of the study drug, assuming the participant is responding to and tolerating the treatment well. Every cycle will last about 21 days.

开始日期2026-12-31

申办/合作机构

The Methodist Hospital Research Institute

NCT07679269

/ Not yet recruiting临床2期

An Open Label, Multi-center Alpelisib Roll-over Study to Assess Long-term Safety in Participants Who Have Completed a Novartis Sponsored Alpelisib (BYL719) Study and Are Judged by the Investigator to Benefit From Continued Treatment With Alpelisib.

The purpose of this study is to provide post-trial access to alpelisib and to assess its long-term safety when administered as a single agent or in combination with other drugs. This study is intended for participants who are currently receiving alpelisib in a Novartis-sponsored clinical trial (parent study) and, in the Investigator's judgment, would benefit from continued treatment with alpelisib.

开始日期2026-12-15

申办/合作机构

Novartis Pharmaceuticals Australia Pty Ltd.

100 项与曲妥珠单抗相关的临床结果

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100 项与曲妥珠单抗相关的转化医学

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100 项与曲妥珠单抗相关的专利（医药）

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11,597

项与曲妥珠单抗相关的文献（医药）

2027-02-01·BIOELECTROCHEMISTRY

Super-antifouling electrochemical biosensor based on a biomimetic gemini zwitterionic interface for sensitive detection of therapeutic antibodies

Article

作者: Qu, Jia-Huan ; Zhao, Zheng ; Han, Hai ; Yu, Wanqing ; Li, Haidong ; Chen, Zhiwei ; Jiang, Zhengjin ; Hai, MingFang ; Wang, Qiqin

Biofouling, arising from the nonspecific adsorption of proteins, cells, and other biomolecules, remains a major challenge that compromises the stability and reliability of diagnostic and therapeutic platforms. To address this issue, a super-antifouling electrochemical aptasensor was developed by integrating a biomimetic "gemini" zwitterionic monomer (BSMMP) with polydopamine (PDA). The covalent assembly of BSMMP and PDA forms a multi-site anchoring layer that enables the stable functionalization of the affinity aptamer GC20. Owing to its dense hydration shell, the PDA-BSMMP hybrid interface acts as a physical barrier against nonspecific adsorption, maintaining electron-transfer stability in undiluted human serum. Differential pulse voltammetry confirmed that this interface markedly reduced biofouling-induced signal loss, limiting attenuation to less than 15%, nearly fourfold lower than that of the unmodified surface. The platform achieved a low limit of detection of 0.97 ng/mL, a broad linear range from 1 ng/mL to 100 μg/mL, and high selectivity for trastuzumab in a label-free format without secondary antibodies or additional signal amplification. Finally, this platform successfully quantified trastuzumab in serum from breast cancer patients, with results consistent with commercial ELISA kits. Overall, this super-antifouling aptasensor offers great potential for therapeutic drug monitoring, advancing zwitterionic interface-based biosensing strategies for point-of-care diagnostics.

2027-01-01·JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Development and application of antibody framework region-targeted cross-linking mass spectrometry for epitope screening within patient-derived immune complexes

Article

作者: Nakamura, Minoru ; Ohyama, Kaname ; Aibara, Nozomi ; Matsugi, Yuya ; Kutsuna, Yuki Jimbayashi ; Kawakami, Atsushi ; Hamasaki, Maya ; Yamazawa, Ryuji ; Nakashima, Mikiro

Identification of antibody-binding epitopes on antigens is essential for understanding the pathogenic roles of immune complexes (ICs) in autoimmune diseases and for the development of diagnostics and therapeutics. However, methods for direct epitope characterization of IC-antigens formed in vivo remain limited. Here, we investigated antibody framework region (FR)-targeted cross-linking mass spectrometry (XL-MS) as an approach to identify epitopes in patient-derived ICs. Four IC models with known epitopes (tumor necrosis factor alpha-adalimumab, tumor necrosis factor alpha-infliximab, human epidermal growth factor receptor 2-pertuzumab, and human epidermal growth factor receptor 2-trastuzumab) were analyzed using three cross-linkers of different lengths: bis(sulfosuccinimidyl) suberate (BS3), bis(sulfosuccinimidyl) glutarate (BS2G), and 1,1'-carbonyldiimidazole (CDI). BS3 preferentially generated antigen-FR cross-links, whereas CDI predominantly produced antigen-complementarity-determining region cross-links. Several cross-linked peptides contained antigen sequences overlapping previously reported epitopes, supporting the validity of this approach for epitope mapping. As a proof-of-concept clinical application, serum samples from patients with primary biliary cholangitis were analyzed using a targeted database containing four disease-associated autoantigens (PDC-E2, BCOADC-E2, OGDC-E2, and E3BP). Two candidate epitope peptides were identified. One corresponded to a known immunodominant epitope, whereas the other represented a novel candidate site supported by computational epitope prediction analysis. These findings demonstrate that FR-targeted XL-MS provides a strategy for identifying epitopes within patient-derived IC-antigens through the use of conserved antibody FRs. This approach may contribute to understanding antigen recognition mechanisms in autoimmune diseases and support the discovery of disease-relevant therapeutic targets.

2026-12-31·mAbs

Self-interaction nanoparticle spectroscopy predicts high-concentration viscosity of therapeutic IgG1 antibodies

Article

作者: Andersen, Nisana ; Luu, Steven ; Stephens, Nicole ; Mehta, Shrenik ; Bol, Karenna ; Heisler, Joel ; Swartz, Trevor ; Kovner, Daniel ; Rude, Erina ; Makowski, Emily ; Ibrahim, Julissa ; Zarzar, Jonathan ; Carter, Paul J. ; Stepurska, Kateryna ; Baginski, Tomasz ; Izadi, Saeed ; Paidi, Santosh Kumar ; O’Connor, Kelly

Predicting high-concentration viscosity of monoclonal antibodies is crucial for their development as therapeutics for subcutaneous delivery, but traditional experimental rheometry methods for assessing viscosity are low-throughput, which limits their utility. This study evaluates self-interaction nanoparticle spectroscopy (SINS) assays - specifically charge-stabilized SINS (CS-SINS) and PEG-stabilized SINS (PS-SINS) - for high-throughput viscosity prediction. We characterized 96 IgG₁ antibodies, assessing SINS against in silico descriptors and dynamic light scattering (DLS) data. CS-SINS showed strong correlation with charge, offering limited additional utility. In contrast, PS-SINS provided orthogonal information; integrating it with in silico data and DLS significantly improved random forest model accuracy for binary viscosity classification. PS-SINS measurements in multiple buffers captured complementary information, achieving comparable accuracy without DLS. Importantly, PS-SINS scores exhibited a strong logarithmic relationship with high-concentration viscosity in Fc variants of clinical antibodies (r = 0.72 and r = 0.85 for trastuzumab and omalizumab variants, respectively), suggesting a direct mechanistic link. Furthermore, PS-SINS performed reliably with one column-purified (protein A) samples, supporting its early-stage application. These findings establish PS-SINS as a high-throughput tool to accelerate the developability assessment of antibody candidates.

4,574

项与曲妥珠单抗相关的新闻（医药）

2026-10-23

·细胞基因治疗前沿

罗氏！2026Q3业绩超预期，砍掉一款CAR-T

▲11月19-20日大湾区创新药产业生态大会免费扫码报名机会注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需得到授权。 10月22日，罗氏发布2026年前三季度财报。集团销售额464.93亿瑞郎（约合563亿美元），按固定汇率（CER）增长6%，但按瑞郎口径仅增长1%——瑞郎对美元等主要货币的升值吃掉了大部分增幅。第三季度情况有所反转，单季销售额161.3亿瑞郎（约合195亿美元），CER增长7%、瑞郎口径增长8%，增速较上半年明显加快。制药部门前三季度收入362.12亿瑞郎，CER增长7%；诊断部门102.81亿瑞郎，增长4%。公司确认全年指引不变。从治疗领域看，血液板块前三季度71亿瑞郎、增长17%，是增速最高的板块；神经板块76亿瑞郎、增长10%。 Hemlibra（血友病A）37亿瑞郎、增长12%，继续扩大预防治疗的渗透； Polivy 13亿瑞郎、增长24%，一线弥漫大B细胞淋巴瘤适应症放量明显； Lunsumio（莫妥珠单抗）2.06亿瑞郎、增长187%，基数虽小但曲线陡峭； Gazyva也有7.51亿瑞郎、增长7%。罗氏四款双抗产品——Hemlibra、Vabysmo、Columvi、Lunsumio——前三季度合计74.79亿瑞郎，已经成为制药业务里体量最大的产品集群。神经领域的主力仍是Ocrevus，53亿瑞郎、增长7%。这罗氏10月还拿到fenebrutinib在复发型和原发进展型多发性硬化上的FDA优先审评资格，如果获批，神经板块将再添一个口服选项。眼科板块33亿瑞郎、增长9%，几乎全部由Vabysmo贡献——这款双抗前三季度32亿瑞郎、增长10%，在全球眼底病市场持续抢份额。肿瘤板块112亿瑞郎、增长1%，是五大板块里最弱的一环。Herceptin下滑12%至6.95亿瑞郎、Avastin下滑12%至6.39亿瑞郎、Kadcyla下滑9%至13亿瑞郎，三款老产品合计拖累明显。撑住场面的是Tecentriq（26亿瑞郎、+5%）和Alecensa（12亿瑞郎、+6%）。罗氏两款ADC——Kadcyla和Polivy——前三季度合计26.41亿瑞郎，规模上已经被双抗阵营远远甩开。免疫板块50亿瑞郎、增长4%，增速被Actemra的生物类似药竞争压住——这款IL-6R单抗前三季度16亿瑞郎、下滑10%，欧洲市场是重灾区。罗氏在罕见病领域的布局值得单独看。Evrysdi（SMA）前三季度15亿瑞郎、增长18%，这款口服剪接修饰剂已经在与基因疗法和鞘内注射药物的竞争中站稳位置。与财报同步，罗氏做了一次幅度不小的管线梳理：推进13个项目（含3项注册申请），同时剔除13个项目。这13款被剔除的管线中，有一款CD19×CD20异体（allogeneic）CAR-T（RG6540），原本瞄准血液肿瘤。RG6540正是2024年那笔15亿美元Poseida收购案中，被专门点名的两款临床阶段疗法之一。虽然被剔除，但罗氏CEO Thomas Schinecker称没有改变对那笔收购的看法。一边砍掉当初最被看好的资产，一边坚称战略没变。这个矛盾，恰好是罗氏在细胞基因治疗（CGT）上处境的缩影。这家靠小分子和抗体起家的巨头，在CGT上砸了两笔大钱，却始终没能复制它在肿瘤和免疫领域的统治力。罗氏砍掉RG6540，但保留了同平台的RG6538（多发性骨髓瘤），也在继续推进自免方向的细胞治疗。今年上半年，罗氏还砍掉了CD19×CD3双抗RG6382（SLE I期）和亨廷顿病项目tominersen，但制药CEO Teresa Graham当时就明确表态"继续开发自免细胞治疗"。砍的是具体分子，不是整条技术路线。换句话说，罗氏做的是"减法"——把资源从确定性不高的资产里抽出来，集中到少数方向。这符合它今年反复强调的"管线瘦身"逻辑。资料来源：公司官网扫码进群掌握CAR-T疗法、干细胞疗法、基因疗法、溶瘤病毒、核酸药物全方位信息

财报免疫疗法抗体药物偶联物细胞疗法生物类似药

2026-10-23

·BioSpace

Puma Biotechnology to Host Conference Call to Discuss Third Quarter 2026 Financial Results

LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, will host a conference call at 1:30 p.m. PT/4:30 p.m. ET on Thursday, November 5, 2026, following the release of its third quarter 2026 financial results. The call may be accessed by dialing 1-877-709-8150 (domestic) or 1-201-689-8354 (international). Please dial in at least 10 minutes in advance and inform the operator that you would like to join the “Puma Biotechnology Conference Call.” A live webcast of the conference call and presentation slides may be accessed on the Investors section of the Puma Biotechnology website at . A replay of the call will be available shortly after completion of the call and will be archived on Puma’s website for 90 days. About Puma Biotechnology Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. Puma in-licensed the global development and commercialization rights to PB272 (neratinib, oral) in 2011. Neratinib, oral was approved by the U.S. Food and Drug Administration in 2017 for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX ® (neratinib) tablets. In February 2020, NERLYNX ® was also approved by the FDA in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. NERLYNX ® was granted marketing authorization by the European Commission in 2018 for the extended adjuvant treatment of adult patients with early stage hormone receptor-positive HER2-overexpressed/amplified breast cancer and who are less than one year from completion of prior adjuvant trastuzumab-based therapy. NERLYNX ® is a registered trademark of Puma Biotechnology, Inc. In September 2022, Puma entered into an exclusive license agreement for the development and commercialization of the anti-cancer drug alisertib, a selective, small molecule, orally administered inhibitor of aurora kinase A. Initially, Puma intends to focus the development of alisertib on the treatment of small cell lung cancer and breast cancer. In February 2024, Puma initiated ALISCA ® -Lung1, a Phase II clinical trial of alisertib monotherapy for the treatment of patients with extensive-stage small cell lung cancer. In November 2024, Puma initiated ALISCA ® -Breast1, a Phase II clinical trial of alisertib in combination with endocrine therapy for the treatment of patients with HER2-negative, HR-positive metastatic breast cancer. In September 2026, Puma initiated ALISCA ® -Lung2, a Phase II clinical trial of alisertib in combination with paclitaxel for the treatment of patients with advanced small cell lung cancer. ALISCA ® is a registered trademark of Puma Biotechnology, Inc. Further information about Puma Biotechnology may be found at . Contacts Alan H. Auerbach or Mariann Ohanesian, Puma Biotechnology, Inc., +1 424 248 6500 info@pumabiotechnology.com ir@pumabiotechnology.com David Schull, Russo Partners, +1 212 845 4200 david.schull@russopartnersllc.com

上市批准引进/卖出临床2期临床1期财报

2026-10-22

·ioncology

ESMO瞭望前瞻丨众专家Pick“最期待研究”盲盒：乳腺癌领域18项重磅研究，哪一项将改写临床格局？

编者按 2026年ESMO年会即将于10月23日至27日在西班牙马德里召开在即，本次会议汇聚全球顶尖肿瘤学专家学者，聚焦前沿热点，将发布多项突破性临床研究成果。肿瘤瞭望精心甄选了乳腺癌领域18项备受关注的研究，并已邀请部分国内专家分享他们的期待与见解。18项重磅研究“盲盒”待您亲启——是HER2低表达领域ADC药物最新进展更受您的青睐，还是OptiTROP-Breast01研究最终OS分析、DESTINY-Breast09研究脑转移患者分析、TROPION-Breast02研究脑转移患者探索性分析更吸引您的目光？赶快来挑出你“中意”的它吧，后续我们将邀请相关研究作者及国内外权威专家，带来深入、生动且权威的解读。敬请持续关注肿瘤瞭望，一起追踪肿瘤领域的前沿脉搏！ LBA15 Anbenitamab plus albumin-bound docetaxel in patients (pts) with HER2-positive advanced breast cancer (BC): A randomized phase III study 安尼妥单抗（Anbenitamab）联合白蛋白结合型多西他赛用于HER2阳性晚期乳腺癌（BC）患者（pts）：一项随机III期研究徐兵河院士 HEALER研究将由我作大会报告，该研究评估了Anbenitamab联合HB1801对比THP方案一线治疗HER2阳性晚期乳腺癌的疗效和安全性，这是全球首个证实抗HER2双抗联合化疗优于标准THP方案的III期临床试验，该试验结果有望改变HER2阳性晚期乳腺癌一线治疗临床实践，并回应对此类患者一线治疗优化的关注。甘露教授目前HER2阳性晚期乳腺癌一线以THP方案和T-DXd+帕妥珠单抗为治疗选择的背景下，我非常期待Anbenitamab联合HB1801的疗效能够优于现有的THP方案，同时，我也参与了这项研究，该研究中患者的不良反应较轻，为患者了带来更好的生活质量。此外，这也是我国自主研发的双抗产品，其研究数据非常值得期待。赵兵教授该研究是安尼妥单抗（Anbenitamab，KN026）联合白蛋白结合型多西他赛±卡铂用于HER2阳性早期或局部晚期乳腺癌新辅助治疗的随机III期研究，其头对头对比了安尼妥单抗联合方案与THP±卡铂标准方案，结果显示，安尼妥单抗联合方案显著提高tpCR率，安全性可控。期待长期随访数据进一步验证远期生存获益，为HER2阳性乳腺癌新辅助提供国产双抗新方案，拓宽临床治疗选择。 LBA13 Trastuzumab rezetecan (SHR-A1811) in HER2-low advanced breast cancer (BC): a randomized, phase 3 study (HORIZON-Breast06) 瑞康曲妥珠单抗（SHR-A1811）用于HER2低表达晚期乳腺癌（BC）：一项随机III期研究（HORIZON-Breast06）徐兵河院士 HORIZON-Breast06研究对比了trastuzumab rezetecan（SHR-A1811）与研究者选择化疗，在转移阶段既往接受≤1线化疗的HER2低表达复发/转移性乳腺癌人群中的疗效，研究已达到预设主要终点。这是SHR-A1811在HER2低表达晚期乳腺癌中首次取得成功的III期临床试验，期待完整数据的公布，进一步明确不同亚组的疗效与安全性差异，为HER2低表达人群的ADC治疗选择提供依据。赵兵教授 HORIZON-Breast06（SHR-A1811-III-306）是HER2低表达晚期乳腺癌领域重要的随机III期研究，头对头对比瑞康曲妥珠单抗（SHR-A1811）与研究者选择化疗方案在转移阶段既往接受≤1线化疗的HER2低表达复发/转移性乳腺癌人群中的疗效，研究已达到预设主要终点，可显著延长PFS、降低疾病进展或死亡风险。期待完整数据的公布，进一步明确不同亚组的疗效与安全性差异，回应临床关注的HER2低表达人群ADC治疗选择问题，夯实国产HER2 ADC的循证证据，为该人群开辟新的治疗格局。王丽教授 HORIZON-Breast06研究是国产HER2 ADC瑞康曲妥珠单抗（SHR-A1811）在HER2低表达晚期乳腺癌领域的重磅III期临床试验。该研究头对头比较了SHR-A1811与研究者选择化疗方案，入组人群为转移阶段既往接受≤1线化疗的HER2低表达复发/转移性乳腺癌患者，目前研究已经成功达到预设主要终点。研究结果显示，瑞康曲妥珠单抗可显著延长患者无进展生存期，有效降低疾病进展或死亡风险。这是SHR-A1811在HER2低表达晚期乳腺癌中首次取得阳性III期结果，是我国自主研发HER2 ADC药物的重要里程碑。我十分期待完整研究数据的发布，后续亚组分析、安全性数据将进一步厘清不同人群的获益差异。该研究将夯实国产HER2 ADC的循证医学证据，为HER2低表达乳腺癌患者提供新的治疗选项，推动国内乳腺癌诊疗格局的革新。 LBA50 PANKU-Breast01: Randomized Phase III Study of Izalontamab Brengitecan (iza-bren) in Previously Treated Unresectable Locally Advanced or Metastatic (LA/M) Hormone Receptor-Positive/HER2-negative (HR+/HER2-) Breast Cancer (BC) PANKU-Breast01：Izalontamab Brengitecan（iza- bren）用于既往经治的不可切除的局部晚期或转移性（LA/M）激素受体阳性/HER2阴性（HR+/HER2-）乳腺癌（BC）的随机III期研究徐兵河院士 Iza-bren是全球首个EGFR/HER3双抗ADC，在PANKU-Breast01研究中，其对比了研究者选择的化疗在既往经治的不可切除局部晚期或转移性HR+/HER2-乳腺癌中的疗效和安全性。据我所知，这应是全球首个EGFR/HER3双抗ADC在此类乳腺癌患者中取得成功的临床试验，有望为该人群开辟全新的治疗路径。赵艳霞教授 PANKU-Breast01备受关注的原因在于它跳出了当前HR+/HER2-后线ADC扎堆TROP2、HER2低表达的赛道。该药物依靠EGFR和HER3双靶结合扩大肿瘤抗原覆盖、降低单抗原丢失耐药风险，搭配新型TOP I抑制剂载荷Ed-04，有望为TROP2阴性人群提供全新ADC选择，解决内分泌联合CDK4/6抑制剂耐药后部分患者缺少有效ADC方案的临床痛点；加之同平台TNBC队列PANKU-Breast02已于2026 ASCO公布PFS、OS双终点阳性的亮眼结果，大家都高度期待Breast01能否在HR+/HER2-人群中复制该疗效信号，使其成为同时覆盖两大HER2阴性亚型的广谱ADC。该研究的另一重价值体现在证据质量、安全性与行业格局层面，后续可重点关注入组是否无需预设EGFR/HER3阳性、不同亚组获益差异，以及血液学毒性、ILD、EGFR相关皮肤胃肠道不良反应的发生情况，用以判断其治疗窗口。作为国产first-in-class ADC，若Breast01取得阳性结果，将重塑HER2阴性乳腺癌ADC格局，也为向前线联合内分泌、SERD或免疫治疗的探索奠定基础；当然也需客观看待潜在阴性风险，最终疗效与安全性数据仍待正式公布。 LBA49 A DESTINY-Breast09 (DB-)09 analysis of trastuzumab deruxtecan (T-DXd) + pertuzumab (P) vs taxane + trastuzumab + pertuzumab (THP) for patients (pts) with HER2+ advanced/metastatic breast cancer (a/mBC) and baseline (BL) brain metastases (BMs) DESTINY-Breast09（DB-09）分析：德曲妥珠单抗（T-DXd）联合帕妥珠单抗（P）对比紫杉类+曲妥珠单抗+帕妥珠单抗（THP）用于HER2阳性晚期/转移性乳腺癌（a/mBC）且基线（BL）存在脑转移（BMs）的患者（pts）耿翠芝教授 LBA49是关于DB-09研究中CNS-ORR、CNS- PFS的数据，值得期待的关注点：1、颅内客观缓解率（ORR）——DB-09研究之前只公布了整体PFS，未专门报告CNS疗效。2、脑转移进展时间/ CNS-PFS。此外，同场还有TROPION-Breast02研究的三阴性脑转移亚组可以一起看——ADC在颅内的证据正在从HER2+乳腺癌患者扩展到TNBC患者。陈占红教授 HER2阳性乳腺癌脑转移是临床棘手难题，血脑屏障导致很多大分子药物颅内活性有限。既往DESTINY-Breast03证实T-DXd在后线脑转移人群展现突出颅内抗肿瘤活性，但一线初治脑转移患者尚缺少III级循证证据。如果本亚组证实T-DXd联合帕妥珠单抗可带来颅内病灶缓解、延长生存，将直接改写一线伴脑转移HER2阳性晚期乳腺癌治疗格局，有望把T-DXd联合帕妥珠确立为该高危人群优选一线方案，减少对局部放疗的单纯依赖；同时需要高度关注间质性肺病（ILD）在脑转移人群中的安全风险。若阳性，具备很强改变临床实践潜力。 LBA51 Results From KEYNOTE-B49: A Phase 3, Randomized, Double-Blind Study of Pembrolizumab (Pembro) vs Placebo (Pbo) Plus Chemotherapy (CT) in Participants (Pts) With HR+/HER2− Advanced Breast Cancer (ABC) KEYNOTE-B49研究结果：一项在HR+/HER2-晚期乳腺癌（ABC）受试者（Pts）中比较帕博利珠单抗（Pembro）与安慰剂（Pbo）联合化疗（CT）的3期、随机、双盲研究耿翠芝教授 KEYNOTE-B49是首次关于免疫制剂帕博利珠单抗与医生选择的化疗对比，针对HR+/HER2-局部复发不可手术或转移性乳腺癌的二线治疗，期待看点：1）如果是阳性结果，该研究是第一次在HR+/HER2-晚期乳腺癌中证明免疫治疗有效，会直接改写这类患者的治疗路径；2）纳入了CPS 1–9 vs ≥10的患者，这两组数据的对比将改变CPS的标准。陈占红教授 HR+/HER2-乳腺癌整体为免疫“冷肿瘤”，既往多项免疫联合研究大多以失败告终，免疫治疗在该亚型始终没有确立地位，仅极少数高TMB、MSI-H人群可选用免疫。KEYNOTE-B49研究是备受关注的“破冰”研究，探索化疗联合PD-1能否突破HR+/HER2-晚期乳腺癌免疫治疗困局。如果 PFS、OS 双终点阳性，将彻底改变HR+/HER2-晚期乳腺癌的治疗版图，把免疫治疗正式纳入该亚型治疗策略；反之如果为阴性，则进一步确认：未经筛选的HR+/HER2-晚期乳腺癌，常规加用PD-1无获益，未来需要聚焦生物标志物筛选获益人群。无论阳性阴性，均会深刻影响临床认知与实践。 LBA23 Final results of TALENT: A neoadjuvant trial of T-DXd with or without anastrozole, or in sequence with chemotherapy for HER2-low, HR+ early-stage breast cancer TALENT研究最终结果：T-DXd联合或不联合阿那曲唑，或与化疗序贯用于HR+/HER2低表达早期乳腺癌新辅助治疗张剑教授这是T-DXd在HER2低表达领域从晚期向早期前移的关键一步。此前TRIO-US B-12的初步数据显示，T-DXd单药在新辅助阶段的影像学客观缓解率约68%，联合阿那曲唑组约58%。本次最终结果需要回答的核心问题是：在HER2-low、HR+这一生物学上更“温和”的亚群中，ADC单药或联合内分泌治疗能否在保乳率和长期结局上真正替代或补充传统化疗。如果最终分析能在手术降期之外显示出可接受的长期安全性，HER2-low早期乳腺癌的新辅助治疗范式将出现实质性松动。看点不在于“有效”，而在于“是否足以改变临床路径”。陈占红教授目前T-DXd全部获批适应症均在晚期阶段，HR+/HER2低表达早期乳腺癌新辅助尚无III级证据。HR+/HER2低表达早期乳腺癌传统新辅助化疗pCR率偏低，很多患者要承受化疗毒性却获益有限。TALENT探索去化疗/减化疗的新辅助策略：如果T-DXd±内分泌能够获得可观pCR，提示部分HR+/HER2低表达早期乳腺癌有望豁免或者减少化疗，实现降毒增效；若序贯化疗组pCR进一步提升，也将为高危HR+/HER2低表达早期乳腺癌新辅助提供新方案。本研究若获得阳性关键终点，将推动ADC向早期HER2低表达乳腺癌拓展，开启新辅助“去化疗”的探索浪潮，对早期乳腺癌治疗范式有潜在变革意义。 LBA27 APEX-Breast01: TQB2102 versus chemotherapy in HER2-low recurrent or metastatic breast cancer (r/m BC) : Results from a randomized phase 3 study 随机3期研究（APEX-Breast01）的结果：TQB2102对比化疗治疗HER2低表达复发或转移性乳腺癌（r/m BC）患者 LBA25 Adjuvant ribociclib (RIB) + nonsteroidal aromatase inhibitor (NSAI) in patients (pts) with HR+/HER2− early breast cancer (EBC): NATALEE 6-y overall survival (OS) and efficacy outcomes 瑞波西利（RIB）+非甾体芳香化酶抑制剂（NSAI）辅助治疗HR+/HER2 -早期乳腺癌（EBC）患者：NATALEE 6年总生存率（OS）和疗效结局葛睿教授经过6年（66.3个月）随访，瑞波西利联合NSAI已在广泛的II-III期 HR+/HER2-EBC人群中显示出明确的具有临床意义的OS获益，而且OS获益持续扩大，HR值持续稳定。同时还观察到瑞波西利6年iDFS获益持续扩大，长期获益在持续累积。杨犇龙教授众所周知，在HR+/HER2−乳腺癌治疗领域，CDK4/6抑制剂的辅助强化治疗目前已形成"三雄争霸"的格局。随着monarchE研究、NATALEE研究等阳性结果的报告，以及相应CDK4/6抑制剂辅助强化适应症的获批，我们更加期待这些CDK4/6抑制剂的短期获益能否转化为长久的生存获益。令人欣喜的是，我们此前已经看到了monarchE研究的阳性结果。因此，我个人更加关注NATALEE研究的OS结果，因为NATALEE研究纳入了更广泛的人群，其中还包括一部分淋巴结阴性患者。我期待本次ESMO会议上相应结果的报告，相信它也将改变临床应用的格局。 539RO Patient-Reported Outcomes (PROs) From DESTINY-Breast05: Health-Related Quality of Life (HRQoL) With Trastuzumab Deruxtecan (T-DXd) Versus Trastuzumab Emtansine (T-DM1) in Patients (Pts) With High-Risk HER2-Positive Early Breast Cancer (eBC) DESTINY-Breast05研究患者报告结局：T-DXd对比T-DM1用于高危HER2阳性早期乳腺癌的健康相关生活质量 543RO DESTINY-Breast11: MRI-assessed objective responses during 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 HER2+ early breast cancer (eBC) DESTINY-Breast11研究：HER2阳性早期乳腺癌新辅助治疗中T-DXd序贯THP对比剂量密集ddAC-THP方案，通过MRI评估客观缓解情况 LBA14 A Double-Blind Placebo Controlled Randomized Phase III Trial of Fulvestrant and Ipatasertib as Treatment for HER-2 Negative and Estrogen Receptor Positive (ER+) Metastatic Breast Cancer (MBC): Overall Survival Results of the CCTG/BCT MA.40/FINER Study (NCT04650581) 一项双盲、安慰剂对照、随机III期试验：氟维司群联合Ipatasertib治疗ER+/HER2-晚期乳腺癌（MBC）——CCTG/BCT MA.40/FINER研究（NCT04650581）的总生存结果 LBA96 First-line (1L) datopotamab deruxtecan (Dato-DXd) vs chemotherapy in patients (pts) with locally recurrent inoperable or metastatic triple-negative breast cancer (mTNBC) for whom immunotherapy was not an option: Exploratory analysis of pts with brain metastases in TROPION-Breast02 TROPION-Breast02研究中脑转移患者的探索性分析：一线Dato-DXd对比化疗治疗不适合免疫治疗的局部复发不可手术或转移性三阴性乳腺癌患者陈文艳教授 TROPION-Breast02研究是一项随机对照、开放、全球多中心的III期临床研究，探索了Dato-DXd在不适合接受 PD-1/PD-L1抑制剂治疗的转移性TNBC患者一线治疗中的疗效及安全性，该研究纳入了10%存在稳定脑转移的患者。众所周知，超过30%的晚期三阴乳腺癌会发生脑转移，血脑屏障的存在，很多药物无法发挥控制脑转移病灶的疗效。非常期待TROPION-Breast02研究中脑转移患者的探索性分析能给我们怎样的惊喜，是否能成为这一临床巨大未被满足需求的突破性的好消息呢？我们拭目以待。 LBA16 VIKTORIA-1: Updated results of a randomized, open-label, phase 3 study of gedatolisib (geda) + fulvestrant (fulv)±palbociclib (palbo) vs standard of care in patients (pts) with HR+/HER2- advanced breast cancer (ABC) (Study 2) VIKTORIA-1：gedatolisib（geda）+氟维司群（fulv）±哌柏西利（palbo）对比标准治疗用于HR+/HER2-晚期乳腺癌（ABC）患者（pts）的随机、开放标签、3期研究的更新结果（Study 2） LBA17 HER2-PET imaging to predict trastuzumab deruxtecan (T-DXd) efficacy in advanced breast cancer: The phase II PREDICT-HER trial HER2-PET显像预测T-DXd在晚期乳腺癌中的疗效：II期PREDICT-HER研究 4639RO Final OS analysis of sacituzumab tirumotecan versus chemotherapy in previously treated locally recurrent or metastatic triple-negative breast cancer: Phase III OptiTROP-Breast01 芦康沙妥珠单抗对比化疗用于既往经治局部复发或转移性三阴性乳腺癌的III期OptiTROP-Breast01研究最终OS分析李曼教授 OS一直是评估临床获益的金标准。此次OptiTROP-Breast01研究公布的最终OS结果，对于经治晚期TNBC的治疗具有非常重要的临床意义。中位随访29.4个月时，芦康沙妥珠单抗组的中位OS达到14.7个月，而化疗组为9.9个月，延长了4.8个月，死亡风险降低40%。长期生存数据同样令人鼓舞，芦康沙妥珠单抗组的24个月OS率达到33.8%，30个月OS率仍有26.8%，均明显高于化疗组。对于既往接受过多线治疗的晚期TNBC患者而言，能够看到更多患者实现两年甚至更长时间的生存，具有非常重要的临床价值。总体来看，我认为此次最终OS分析进一步证实了芦康沙妥珠单抗的临床价值，达到了持续、明确的总生存获益，也进一步增强了我们在晚期TNBC患者中应用该药物的信心。 4RO Target switching with conserved-payload novel ADCs in patients with metastatic breast cancer following prior ADC therapy (SWITCH): a prospective, open-label, phase 2 platform trial 转移性乳腺癌ADC经治后采用同载荷异载荷新型ADC的靶点转换研究：一项前瞻性、开放标签的 II 期平台试验（SWITCH） 5RO Safety and efficacy of SYS6043, a Novel B7-H3–Targeting Antibody-Drug Conjugate, in Patients with Advanced breast cancer 新型靶向B7-H3 ADC SYS6043治疗晚期乳腺癌的安全性与有效性 4640RO Bulumtatug Fuvedotin (BFv, 9MW2821), a Nectin-4–Directed Antibody-Drug Conjugate (ADC), in Patients with Locally Advanced or Metastatic Triple Negative Breast Cancer (la/mTNBC) Previously Treated with Topoisomerase I Inhibitor (TopI)-Based ADCs: Results from a Phase 2 Study 新型靶向Nectin-4 ADC bulumtatug Fuvedotin（BFv，9MW2821）在既往接受过拓扑异构酶I抑制剂为基础的ADC治疗的局部晚期或转移性三阴性乳腺癌（la/mTNBC）患者中显示出显著疗效：一项II期临床研究的结果张剑教授这项II期口头报告专门入组既往全部接受过TopI类ADC的la/mTNBC患者，切中了ADC后线序贯这一当前乳腺癌最迫切的临床问题。60例可评估患者中ORR 30.0%、DCR 80.0%、mPFS 3.7个月、mDOR约8.7个月、12个月OS率63.5%，说明重度经治人群中仍有一部分患者能获得较持久的疾病控制。安全性总体可控。这项研究最重要的互文是同届SWITCH试验——TopI-ADC经治后仅换靶点不换载荷的确认ORR仅0–8.3%，而BFv同时更换Nectin-4靶点和MMAE载荷后仍有30%的ORR，支持“载荷多样性可能恢复敏感性”这一假说，也提示BFv目前仍是有前景的II期后线候选，我们也期待正在进行的关键性III期能否复制疗效并转化为PFS/OS获益。在ESMO大会期间，我们将陆续邀请这些研究的作者以及中外权威专家，带来深入、生动且权威的解读。敬请持续关注肿瘤瞭望，一起追踪肿瘤领域的前沿脉搏！声明：以上仅为部分专家观点，若本文中您心仪的研究未出现，欢迎在评论区告诉我们！（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。

100 项与曲妥珠单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D03257	曲妥珠单抗	L01FD01	DB00072

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
HER2阳性结直肠癌	日本	Chugai Pharmaceutical Co., Ltd.	2022-03-28
HER2阳性唾液腺癌	日本	Chugai Pharmaceutical Co., Ltd.	2021-11-25
HER2阳性胃癌	日本	Chugai Pharmaceutical Co., Ltd.	2011-03-10
胃癌	美国	Genentech, Inc.	2010-10-20
乳腺癌	日本	Chugai Pharmaceutical Co., Ltd.	2001-04-04
早期乳腺癌	欧盟	Roche Registration GmbH	2000-08-28
早期乳腺癌	冰岛	Roche Registration GmbH	2000-08-28
早期乳腺癌	列支敦士登	Roche Registration GmbH	2000-08-28
早期乳腺癌	挪威	Roche Registration GmbH	2000-08-28
HER2阳性乳腺癌	欧盟	Roche Registration GmbH	2000-08-28
HER2阳性乳腺癌	冰岛	Roche Registration GmbH	2000-08-28
HER2阳性乳腺癌	列支敦士登	Roche Registration GmbH	2000-08-28
HER2阳性乳腺癌	挪威	Roche Registration GmbH	2000-08-28
HER2阳性胃食管结合部腺癌	欧盟	Roche Registration GmbH	2000-08-28
HER2阳性胃食管结合部腺癌	冰岛	Roche Registration GmbH	2000-08-28
HER2阳性胃食管结合部腺癌	列支敦士登	Roche Registration GmbH	2000-08-28
HER2阳性胃食管结合部腺癌	挪威	Roche Registration GmbH	2000-08-28
HR阳性乳腺癌	欧盟	Roche Registration GmbH	2000-08-28
HR阳性乳腺癌	冰岛	Roche Registration GmbH	2000-08-28
HR阳性乳腺癌	列支敦士登	Roche Registration GmbH	2000-08-28

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
膀胱癌	临床3期	英国	-	2023-03-07
结直肠癌	临床3期	英国	-	2023-03-07
胆囊肿瘤	临床3期	英国	-	2023-03-07
血液肿瘤	临床3期	英国	-	2023-03-07
肺癌	临床3期	英国	-	2023-03-07
卵巢癌	临床3期	英国	-	2023-03-07
胰腺癌	临床3期	英国	-	2023-03-07
前列腺癌	临床3期	英国	-	2023-03-07
唾液腺肿瘤	临床3期	英国	-	2023-03-07
皮肤肿瘤	临床3期	英国	-	2023-03-07

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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


NCT05885776 (PHEDRA, ESMO2026)	临床2期	HER2阳性乳腺癌新辅助 HER2 positive \| HR positive	48	Pyrotinib + Trastuzumab + AI	顧獵壓繭憲構築觸範壓(網遞艱積蓋築獵網觸餘) = 齋網鹽膚鬱觸鏇繭範膚範願顧廠築鹽製築憲齋 (選簾艱窪壓壓壓顧遞蓋 ) 更多	积极	2026-10-23
ESMO2026	N/A	HER2 阴性乳腺癌 HER2 overexpression	195	Trastuzumab	鏇夢襯壓鹹廠齋鏇構繭(膚夢選醖淵廠襯鏇築選) = 範廠獵鏇艱齋窪鬱鹹衊繭齋夢築構糧餘鏇夢願 (蓋願夢鬱醖簾壓餘襯艱 ) 更多	积极	2026-10-23
NCT06832904 (NEOTORCH-BREAST05, ESMO2026)	临床2期	HER2阳性乳腺癌新辅助 HER2-positive	38	Neoadjuvant chemotherapy + Pyrotinib + trastuzumab	遞繭齋繭蓋壓願積鹽蓋(鹽蓋遞遞膚築夢築鹽鏇) = diarrhea (29, 76.3%) 積製襯積餘網簾鏇網簾 (襯鏇積鏇膚衊範淵夢鏇 ) 更多	积极	2026-10-23
ESMO2026	N/A	HER2阳性乳腺癌新辅助 HER2 positive	178	Anthracycline-taxane based chemotherapy with pertuzumab/trastuzumab	齋簾遞襯憲艱顧鏇繭製(糧鹽衊構衊觸窪衊醖鹹) = 鹹衊簾製簾鹽願積餘願製壓夢鏇顧壓鹽願鏇壓 (鹽憲鬱襯衊廠鬱夢簾廠, 3.89 ~ 12.0) 更多	积极	2026-10-23
ESMO2026	N/A	胃食管交界处癌 HER2 \| MSI-H/dMMR \| PD-L1	345	Trastuzumab	鬱壓觸廠壓鹽鹹積糧蓋(築鏇顧鏇選願夢範壓糧) = 壓構選鹹艱鑰糧蓋鏇構衊夢夢簾夢蓋艱蓋願繭 (鬱鏇窪膚積艱艱窪積鑰 ) 更多	积极	2026-10-23
ESMO2026	N/A	胃食管交界处癌 HER2 \| MSI-H/dMMR \| PD-L1	345	Immune checkpoint inhibitors (ICIs)	鬱壓觸廠壓鹽鹹積糧蓋(築鏇顧鏇選願夢範壓糧) = 築顧觸鏇蓋淵夢築壓鬱衊夢夢簾夢蓋艱蓋願繭 (鬱鏇窪膚積艱艱窪積鑰 ) 更多	积极	2026-10-23
ESMO2026	N/A	早期乳腺癌 HR+ \| HER2+ \| HR− ... 更多	15,673	Chemotherapy	窪簾鏇製鏇鏇構願築壓(壓襯襯觸範糧壓壓窪鏇) = 窪願齋製膚鹹網齋簾遞窪醖艱積壓齋膚糧鑰廠 (鹹鏇網顧繭顧蓋選壓積 ) 更多	积极	2026-10-23
ESMO2026	N/A	早期乳腺癌 HR+ \| HER2+ \| HR− ... 更多	15,673	Targeted therapy + Extended endocrine therapy	窪簾鏇製鏇鏇構願築壓(壓襯襯觸範糧壓壓窪鏇) = 簾壓簾鑰構壓鏇襯夢構窪醖艱積壓齋膚糧鑰廠 (鹹鏇網顧繭顧蓋選壓積 ) 更多	积极	2026-10-23
ESMO2026	N/A	HER2阳性转移性乳腺癌一线 HER2-positive	697	Trastuzumab and taxane	淵襯願獵壓鹹糧醖鬱鏇(醖艱遞網構選壓構餘糧) = 繭遞範選壓顧鹽蓋膚壓遞觸鬱齋夢膚鬱廠壓衊 (範窪顧襯遞鑰膚範廠夢 ) 更多	积极	2026-10-23
ESMO2026	N/A	HER2阳性转移性乳腺癌一线 HER2-positive	697	Trastuzumab, taxane, and pertuzumab (THP)	淵襯願獵壓鹹糧醖鬱鏇(醖艱遞網構選壓構餘糧) = 廠製餘構齋膚蓋鏇鏇鑰遞觸鬱齋夢膚鬱廠壓衊 (範窪顧襯遞鑰膚範廠夢 ) 更多	积极	2026-10-23
ESMO2026	N/A	HER2阳性乳腺癌新辅助 HER2-positive	160	Trastuzumab plus pertuzumab	憲夢衊網鬱夢艱繭顧顧(鏇夢蓋憲構構顧築艱夢) = 願鏇齋膚艱簾窪築願蓋範夢獵夢齋網築憲鑰獵 (糧鏇願鏇鏇遞鹹憲範齋 ) 更多	积极	2026-10-23
ESMO2026	N/A	HER2阳性乳腺癌新辅助 HER2-positive	160	Trastuzumab alone	鹹積廠顧選範簾願艱簾(鏇觸壓觸製衊膚範網廠) = 製願廠網窪蓋築構鏇憲艱築繭襯製觸夢醖鹽餘 (簾構餘鏇繭齋鏇窪鏇鹹 ) 更多	积极	2026-10-23
NCT01973660 (PAMELA, ESMO2026)	临床2期	HER2阳性乳腺癌新辅助 HER2-positive	72	trastuzumab/lapatinib	醖顧窪憲鏇繭糧簾廠構(獵憲餘壓鑰夢鑰衊網艱) = 餘鏇獵獵淵獵蓋壓齋膚糧鹹鹹醖蓋鑰遞鑰鬱襯 (鏇願網鏇壓餘築網餘選 ) 更多	积极	2026-10-23
NCT02925234 (ESMO2026)	临床2期	转移性结直肠癌 HER2 overexpression/ERBB2 amplification	48	Trastuzumab and pertuzumab	憲簾鹹憲壓鏇鹽顧蓋淵(繭糧鹹衊淵繭齋構淵鹽) = 憲繭選鹹願鏇衊餘網窪窪遞選獵網築醖齋遞願 (窪齋壓顧鏇築糧膚夢鑰, 0.38 ~ 0.64) 更多	积极	2026-10-23