Doctors leading this study would like to learn about providing cancer treatment/therapies to Nigerian women with breast cancer based on their human epidermal growth factor receptor 2 (HER2) status. This study will focus on the efficacy and safety of anti-HER2 cancer treatment before and after surgery.

开始日期2026-01-01

申办/合作机构

The University of Chicago

NCT04419181

/ Suspended临床2期IIT

A Feasibility Study of De-escalation of Chemotherapy in Patients with Early-Stage HER2 Positive Breast Cancer

The main purpose of this research study is to find out if de-escalation of chemotherapy before surgery followed by a selective escalation of adjuvant targeted therapies are efficacious and tolerable in early-stage HER2 positive breast cancer.

开始日期2025-08-11

申办/合作机构

University of Rochester

CTRI/2025/04/085328

/ Not yet recruiting临床1期

A randomized, double-blind, three-arm, balanced, single-dose, parallel-group study comparing pharmacokinetics of Pertuzumab (420 mg solution for Infusion) of Intas Pharmaceuticals Limited, India with Perjeta of Genentech Inc, A member of Roche Group, USA and Perjeta of Roche Pharma AG, Germany in normal, healthy, adult, human male subjects - NIL

开始日期2025-04-27

申办/合作机构

Intas Pharmaceuticals Ltd.

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100 项与帕妥珠单抗相关的专利（医药）

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项与帕妥珠单抗相关的文献（医药）

2025-08-01·MODERN PATHOLOGY

Impact of Hormone Receptor Status and HER2 Expression on Neoadjuvant Targeted Therapy Response in HER2-Positive Breast Cancer: A Multicenter Retrospective Study

Article

作者: Dai, Hao ; Zhao, Yajie ; Jiao, Dechuang ; Fei, Junchao ; Wang, Dandan ; Zhang, Jiao ; Wang, Jia ; Liu, Zhenzhen ; Zhang, Jingyang ; Guo, Xuhui

Previous studies indicate that HER2 protein expression and hormone receptor (HoR) status affect the sensitivity of HER2-positive breast cancer to neoadjuvant therapy, but it is unclear if sensitivity varies among subgroups defined by HER2 and HoR status. We examined 2 cohorts of patients, aged 18 to 80 years, with HER2-positive early breast cancer who underwent neoadjuvant therapy followed by surgery between January 1, 2009, and December 31, 2022: cohort 1 included 2648 patients, and cohort 2 had 141 patients with RNA expression data. Patients were divided into 4 groups based on immunohistochemical HER2 and HoR status: HER2(3+)/HoR-, HER2(3+)/HoR+, HER2(2+)/HoR-, and HER2(2+)/HoR+. We evaluated total pathological complete response (TpCR, defined as ypT0/is ypN0) rates, disease-free survival (DFS), and variations in PAM50 intrinsic subtypes across different subgroups. In cohort 1, HER2(3+)/HoR- had a higher TpCR rate (44.5%) than HER2(3+)/HoR+ (33.8%) (P < .001), HER2(2+)/HoR- (31.7%) (P = .013), and HER2(2+)/HoR+ (13.8%) (P < .001). DFS was similar across groups (P = .445). Trastuzumab or trastuzumab plus pertuzumab significantly improved TpCR rates and DFS in HER2(3+)/HoR- and HER2(3+)/HoR+ but not in HER2(2+)/HoR- and HER2(2+)/HoR+. Cohort 2 showed significant PAM50 subtype differences across these groups (P < .001). In conclusion, the responsiveness of HER2-positive breast cancer to neoadjuvant targeted therapy is significantly influenced by HER2 expression levels and HoR status, emphasizing the necessity of precision medicine approaches to tailor therapeutic strategies for improved clinical outcomes.

2025-07-01·BREAST CANCER RESEARCH AND TREATMENT

Association of statin use on survival outcomes of patients with early-stage HER2-positive breast cancer in the APHINITY trial

Article

作者: Dent, Susan ; Gelber, Richard D ; De Angelis, Carmine ; Poggio, Francesca ; Martel, Samuel ; Maurer, Christian ; Piccart, Martine ; Ferreira, Arlindo ; Thomssen, Christoph ; Agostinetto, Elisa ; Lambertini, Matteo ; Schiff, Rachel ; de Azambuja, Evandro ; Brandão, Mariana ; Ponde, Noam ; Ameye, Lieveke

Abstract:

Purpose:

There is evidence that statins might improve the outcome of patients with breast cancer. The role of statins in patients with early HER2-positive breast cancer is unknown. Therefore, we explored the association between statin use and survival outcomes in early HER2-positive breast cancer patients in the phase III APHINITY trial (adjuvant pertuzumab/trastuzumab).

Methods:

All patients (intent-to-treat population, n = 4804) were included (6.2 years median follow-up database). The primary objective was to investigate the association of statin use on invasive disease-free survival (IDFS), distant relapse-free interval (DRFI), and overall survival (OS). Patients who received statins at baseline, or started statins within 1 year from randomization were considered statin users. Survival curves were estimated using the Kaplan–Meier method. We used a Cox proportional hazards model for multivariate analysis.

Results:

Overall, 423 (8.8%) patients were classified as statin users. They were older, more often postmenopausal, had a higher body mass index, more often diabetes, hypertension, coronary heart disease and hyperlipidemia, had smaller sized tumors, were treated more often with breast conserving surgery, and less often with anthracycline-containing regimens. Overall, 508 IDFS events (12.8% among statin users and 10.4% among non-statin users) and 272 deaths (8.5% and 5.4%, respectively) occurred. In multivariate analysis, statin use was not associated with IDFS (HR, 1.11; 95% CI, 0.80–1.52), DRFI (HR, 1.21; 95% CI, 0.81–1.81) nor OS (HR, 1.16; 95% CI, 0.78–1.73).

Conclusion:

In APHINITY, statin use was not associated with improved survival outcomes. These results must be interpreted with caution due to the exploratory nature of the analysis and the associated limitations.

2025-06-01·Journal of Cancer Policy

Availability, affordability and health insurance coverage of breast cancer services in Iran - An analysis based on the Universal Health Coverage-Service Planning Delivery and Implementation tool

Article

作者: Bijlmakers, Leon ; Heydari, Majid ; Nouhi, Mojtaba ; Goudarzi, Zahra

BACKGROUND:

As part of efforts to achieve Universal Health Coverage for priority conditions in Iran, it is crucial to evaluate the breast cancer service package and identify aspects that may require adjustment. This study analyzes the current state of breast cancer service supply, service delivery platforms, health insurance coverage, and patient co-payment levels.

METHODS:

The Universal Health Coverage Compendium (UHCC) developed by WHO served to list and distinguish various types of breast cancer services. Information from health insurance agencies in Iran was obtained on actual service provision in the country. The Universal Health Coverage Service Planning Delivery and Implementation (UHC-SPDI) tool was used to assess the scope of breast cancer service delivery in Iran and human workforce levels, and to identify possible gaps in service coverage.

RESULTS:

All 73 actions listed as breast cancer services in the UHC-SPDI are provided in the Iranian healthcare system, with a strong reliance on out-patient centers and hospitals rather than primary health care facilities as service delivery platforms, reflecting suboptimal integration of service delivery. Eighty-seven percent of the services are recognized and accepted by health insurance agencies, with cost coverage levels ranging from 20% for magnetic resonance imaging to 100% for intravenous targeted therapy for metastasis. Genomic tests and four medicines (Pembrolizumab, Pertuzumab, Anastrozole, and Fluorouracil) are not covered by health insurance.

CONCLUSION:

The UHC-SPDI has offered an instrumental framework for a comprehensive assessment of Iran's national breast cancer service package composition by connecting it to the service delivery system and human resources competencies. There is room for improvement of the breast cancer service package in Iran, not only in terms of their health insurance coverage, but also in terms of their actual delivery.

562

项与帕妥珠单抗相关的新闻（医药）

2025-05-27

·新药前沿

ASCO 2025 亮点聚焦：肿瘤学关键进展与中国崛起的全球影响力

2025年美国临床肿瘤学会（ASCO）年会于芝加哥拉开帷幕，会议将围绕乳腺癌与血液癌突破性进展、创新治疗模式及中国在肿瘤研发中的崛起展开。以下是核心亮点梳理：乳腺癌与血液癌：改变临床实践的数据乳腺癌领域SERENA-6试验（阿斯利康）：III期研究评估口服选择性雌激素受体降解剂（SERD）camizestrant联合CDK4/6抑制剂治疗HR阳性/HER2阴性晚期乳腺癌合并ESR1突变患者。该试验首次证明无需影像学进展即可显著延长无进展生存期（PFS），被MD Anderson专家称为“内分泌耐药管理的范式转变”。DESTINY-Breast09（阿斯利康/第一三共）：抗体偶联药物（ADC）Enhertu联合或不联合罗氏Perjeta作为HER2阳性转移性乳腺癌一线治疗的III期数据公布，为患者提供“去化疗化”高效选择。血液癌突破Rusfertide（武田/Protagonist）：治疗真性红细胞增多症的拟铁调素类似物在III期VERIFY试验中展现显著疗效——77%患者达主要终点（安慰剂组33%），减少放血需求并改善生活质量，获全体大会报告席位。微小残留病（MRD）检测：多发性骨髓瘤MRD动态监测技术或成新药开发“加速器”，推动临床策略革新。创新治疗模式：双/三特异性抗体与放射性药物双特异性抗体：针对“冷肿瘤”（如前列腺癌、胆囊癌）的VEGF/免疫双靶点抗体崭露头角，通过抑制血管生成同时激活免疫应答破解治疗困境。三特异性抗体：强生JNJ-5322与Ichnos GlenmarkISB-2001针对复发/难治多发性骨髓瘤的早期临床数据首次披露，开启靶向治疗新维度。放射性药物：新型同位素与生物标志物发现推动领域爆发，MD Anderson专家称“放射药物正从诊断工具向精准治疗武器进化”。中国力量：从“快速跟随”到全球创新引领者研发占比跃升：Truist证券报告指出，ASCO 2025近1/3报告涉及中国公司研发管线，印证中国从“仿制跟随”向“首创新药（FIC）”的战略转型。案例聚焦：康方生物/Summit的PD-1/VEGF双抗ivonescimab：临床数据或撼动Keytruda在免疫治疗霸主地位，引发默沙东、辉瑞等巨头争相布局同类管线。行业影响：专家指出，中美创新竞争将催生“激发彼此潜力”效应——倒逼药企聚焦差异化管线设计与生物学机制深度挖掘，最终惠及全球患者。ASCO 2025不仅是肿瘤治疗前沿的展示窗口，更成为全球研发格局变迁的缩影。从耐药破解到冷肿瘤攻坚，从中国创新崛起到治疗模式革新，这场盛会或将重塑未来十年癌症治疗版图。本文由「新药前沿」微信公众号根据公开资料整理编辑，欢迎个人转发至朋友圈。媒体或机构转载授权请在「新药前沿」微信公众号留言公众号名称，审核通过后开通白名单获取转载授权，转载请标识来源。免责声明：本文仅作信息交流之目的，非投资建议或者治疗方案推荐，「新药前沿」微信公众号不对任何主体因使用本文内容而导致的任何损失承担责任。限于作者水平和专业知识所限，如有谬误，欢迎指正！

ASCO会议抗体药物偶联物临床3期临床结果

2025-05-27

·Business Wire

ASCO 2025: REVEAL GENOMICS Unveils New HER2DX Data From 800+ Patients

BARCELONA, Spain--(BUSINESS WIRE)--REVEAL GENOMICS, S.L., a biotechnology company advancing precision oncology through biomarker innovation, today announced the presentation of four independent studies at the 2025 ASCO Annual Meeting. The studies, involving more than 800 patients, evaluated the clinical utility of its flagship test, HER2DX, in early-stage HER2-positive (HER2+) breast cancer. The studies presented at the 2025 ASCO Annual Meeting, involving more than 800 patients, evaluated the clinical utility of HER2DX, in early-stage HER2-positive (HER2+) breast cancer. The four studies, CompassHER2 pCR, BionHER, RESPECT and DFCI, validate HER2DX as a powerful genomic tool for predicting response to therapy and long-term prognosis, addressing critical questions. The findings, which provide valuable insights for optimizing treatment strategies in early-stage HER2+ breast cancer and metastatic breast cancer, will be shared in oral and poster sessions led by academic investigators from the U.S., Europe, and Japan. CompassHER2 pCR or EA1181 (U.S.): HER2DX determining response to THP-based de-escalated therapy This study is led by the ECOG-ACRIN Cancer Research Group (ECOG-ACRIN), a scientific organization that designs and conducts cancer research involving adults who have or are at risk of developing cancer, comprising nearly 1,400 member institutions in the U.S. and around the world. HER2DX was evaluated as a secondary aim as part of a pre-specified, prospectively planned analysis embedded in the CompassHER2 pCR trial, also known as EA1181 (NCT04266249). This large, prospective multicenter phase II trial is assessing neoadjuvant taxane, trastuzumab, and pertuzumab (THP) in more than 2,000 patients with stage II–III HER2+ breast cancer, without the use of anthracyclines, cyclophosphamide, and carboplatin. The HER2DX assay was defined as a key secondary endpoint, with profiling of all available baseline samples planned. Among 569 patients assessed to date for the HER2DX pathologic complete response (pCR) score, those with higher scores achieved significantly greater pCR rates, independent of estrogen receptor (ER) status. These findings confirm the ability of HER2DX to identify tumors more likely to respond to THP. Importantly, additional results are expected from this trial, as patients continue to be followed for the primary endpoints of 3-year survival outcomes, and the study team plans to profile many more baseline samples. “The ability to predict response to THP is extremely valuable,” said Dr. Nadine Tung, Director of Breast Medical Oncology at Beth Israel Deaconess Medical Center, Professor of Medicine at Harvard Medical School, and Principal Investigator of the CompassHER2 pCR (EA1181) trial. “HER2DX provides a biology-driven tool that contributes to the selection of patients who can safely reduce chemotherapy, something we’ve long needed in HER2-positive early breast cancer.” “It is encouraging to see the assay’s performance in both ER-positive and ER-negative subgroups,” added Dr. Tung. “The plan is to profile all available samples from the trial, and these early data already provide valuable insights for guiding treatment selection.” BionHER trial (Spain): Validation of HER2DX-guided de-escalation strategy The BionHER phase II trial (NCT05912062) evaluated HER2DX in 83 patients with stage I–III HER2+ breast cancer treated with neoadjuvant THP for up to 15 weeks at the Catalan Institute of Oncology (ICO L’Hospitalet, Barcelona, Spain). HER2DX was successfully performed in all baseline FFPE tumor samples. The HER2DX pCR score was significantly associated with pCR with a performance AUC of 0.835. Patients classified by HER2DX pCR score into low, medium, and high groups had increasing pCR rates of 13.3%, 51.6%, and 81.8%, respectively. HER2DX outperformed traditional biomarkers, such as ER, Ki-67, and tumor-infiltrating lymphocytes, in predicting pCR. “HER2DX is transforming the way we approach treatment selection in HER2-positive disease,” said Dr. Sònia Pernas, head of the breast cancer unit at ICO L’Hospitalet, and Principal Investigator of the BionHER study. “By identifying tumors more likely to respond to dual HER2 blockade with a single taxane, we are increasingly able to personalize treatment intensity without compromising efficacy.” RESPECT trial (Japan): a response for an unrepresented population Trans-RESPECT is a prespecified translational analysis within the Japanese RESPECT non-inferiority trial (NCT01104935), in which 266 patients aged 70–80 years with stage I-III HER2+ breast cancer were randomized to receive adjuvant trastuzumab with or without chemotherapy (Sawaki et al. J Clin Oncol 2020). HER2DX was assessed in 154 of these patients, with a median follow-up of 9.1 years. The HER2DX risk score effectively stratified patients by 10-year relapse-free survival (86.6% in the low-risk group vs. 68.4% in the high-risk group) and overall survival (94.5% vs.72.5%). Notably, chemotherapy conferred an overall survival benefit only in tumors classified as pCR-high by HER2DX, with a significant interaction p-value of 0.045. “HER2DX provided clear long-term prognostic information in this elderly population,” said Dr. Kazuki Nozawa, Lead Investigator of Trans-RESPECT, from the Department of Advanced Clinical Research and Development and the Department of Breast Surgery at Nagoya City University Graduate School of Medical Sciences. “Importantly, its ability to help identify which patients may benefit from adjuvant chemotherapy is highly relevant to clinical decision-making. Older patients with HER2DX low-risk scores, particularly those classified as pCR-low or -medium, appear to be ideal candidates for trastuzumab alone, without chemotherapy.” DFCI T-DXd study (U.S.): predicting survival outcome to T-DXd Dana-Farber Cancer Institute (DFCI) conducted a retrospective analysis of 41 patients with metastatic breast cancer (25 HER2-positive, 16 HER2-negative) treated with trastuzumab deruxtecan (T-DXd) monotherapy between 2017 and 2023. The HER2DX HER2 signature score was significantly associated with time to next treatment (p=0.001). When stratified into tertiles, patients in the highest tertile had a median time to next treatment of 12.03 months compared to 4.7 months in the lowest tertile (p=0.02). “Quantitative measurement of HER2 amplicon expression by HER2DX is a key determinant of T-DXd activity in metastatic breast cancer,” said Dr. Sara M. Tolaney, Chief of the Division of Breast Oncology at Dana-Farber Cancer Institute. She added, “Further evaluation of this genomic test in ongoing T-DXd trials is warranted.” HER2DX makes a significant impact at ASCO 2025 “ASCO 2025 marks a pivotal milestone for HER2DX,” said Dr. Aleix Prat, Chief Scientific Officer and co-founder of REVEAL GENOMICS. “This test is demonstrating clinical value in real-world practice across continents and care settings, assisting in the tailoring of chemotherapy intensity in the neoadjuvant setting and supporting chemotherapy-free decisions in the adjuvant setting.” Patricia Villagrasa, CEO and co-founder, added, “HER2DX was developed with HER2+ disease at its core, and these four high-quality, independent studies reinforce its clinical value. As we continue to grow globally, this is a clear example of how REVEAL GENOMICS is turning cutting-edge science into meaningful solutions that advance personalized cancer care worldwide.” About HER2DX HER2DX is the world’s first diagnostic test formulated specifically for HER2+ breast cancer. Marketed by REVEAL GENOMICS since January 2022, the HER2DX is a standardized 27-gene expression test for patients with early-stage HER2+ breast cancer. HER2DX is a prognostic and predictive assay based on clinical and genomic data. The test integrates clinical information (i.e., tumor size and nodal status) with biological information tracking immune response, luminal differentiation, tumor cell proliferation, and expression of the HER2 17q12-21 chromosomal amplicon, including the ERBB2 gene. HER2DX®️predicts: Risk of relapse score (high vs. low): the risk of recurrence in patients with newly diagnosed HER2+ breast cancer. pCR likelihood score (high vs. medium vs. low): the likelihood of a patient responding to anti-HER2-based treatment before surgery. ERBB2 score (high vs. medium vs. low): the quantitative expression of ERBB2 mRNA across HER2-negative, HER2-low and HER2+ breast cancer. About REVEAL GENOMICS REVEAL GENOMICS, S.L., together with its U.S. subsidiary REVEAL GENOMICS, Inc., is a biotechnology company dedicated to redefining the role of biomarkers in oncology. The company focuses on developing innovative diagnostic tools that optimize therapeutic decision-making for individuals with cancer. By leveraging advanced genomic technologies, sophisticated computational algorithms, and machine learning, REVEAL GENOMICS generates novel insights into cancer biology and treatment response. academic and clinical institutions to advance precision oncology. REVEAL GENOMICS, S.L. is a spin-off company of Hospital Clínic of Barcelona, IDIBAPS, the University of Barcelona (U.B.), and the Vall d’Hebron Institute of Oncology (VHIO). REVEAL GENOMICS® and HER2DX® are registered trademarks of REVEAL GENOMICS, S.L. For further information visit: http://www.reveal-genomics.com

临床结果临床2期ASCO会议

2025-05-27

·肿瘤界

2025 ASCO丨乳腺肿瘤领域中国研究口头报告/壁报摘要标题来袭

点击蓝字关注我们前言2025年美国临床肿瘤学会（ASCO）年会将于当地时间5月30日-6月3日在美国芝加哥盛大召开。ASCO年会作为全球肿瘤学领域的顶级盛会，汇聚了来自世界各地的肿瘤学专家、医生和研究人员，旨在分享最新的研究成果、探讨最前沿的诊疗技术，推动肿瘤学领域的不断进步。日前，ASCO在线公布了本届大会入选的摘要标题，其中有超70项来自中国的研究入选口头报告。本文特别整理了乳腺肿瘤领域的中国研究，包括口头报告（Oral/Rapid Oral Abstract Session）及壁报环节（Poster Session）的摘要标题，邀您一同抢先了解！口头报告Oral Abstract Session报告地点：Hall B1摘要号：LBA500De-escalated neoadjuvant taxane plus trastuzumab and pertuzumab with or without carboplatin in HER2-positive early breast cancer (neoCARHP): A multicentre, open-label, randomised, phase 3 trial. 多中心、开放标签、随机、III期neoCARHP研究：紫杉类联合曲妥珠单抗和帕妥珠单抗联合或不联合卡铂降阶梯治疗HER2阳性早期乳腺癌讲者：王坤广东省人民医院当地时间：6月2日 15:00北京时间：6月3日 04:00快速口头报告Rapid Oral Abstract Session报告地点：Hall B1摘要号：515Dalpiciclib (Dalp) plus endocrine therapy (ET) as adjuvant treatment for HR+/HER2– early breast cancer (BC): The randomized, phase 3, DAWNA-A trial. 随机、III期DAWNA-A研究：达尔西利（Dalp）联合内分泌治疗（ET）辅助治疗HR+/HER2-早期乳腺癌（BC）讲者：邵志敏复旦大学附属肿瘤医院当地时间：6月1日 09:00北京时间：6月1日 22:00报告地点：Hall D2摘要号：1017HER2-ADC trastuzumab rezetecan (SHR-A1811) in HER2-positive breast cancer with brain metastases: Update results from REIN trial. REIN研究最新结果：HER2-ADC瑞康曲妥珠单抗（SHR-A1811）治疗伴脑转移的HER2阳性乳腺癌讲者：闫敏河南省肿瘤医院当地时间：5月30日 15:21北京时间：5月31日 04:21摘要号：1018A phase II clinical study of adebrelimab and bevacizumab combined with cisplatin/carboplatin in triple-negative breast cancer patients with brain metastases.阿得贝利单抗和贝伐珠单抗联合顺铂/卡铂治疗三阴性乳腺癌脑转移患者的II期临床研究讲者：李婷复旦大学附属肿瘤医院当地时间：5月30日 15:27北京时间：5月31日 04:27摘要号：1019Sacituzumab tirumotecan (sac-TMT) as first-line treatment for unresectable locally advanced/metastatic triple-negative breast cancer (a/mTNBC): Initial results from the phase II OptiTROP-Breast05 study.II期OptiTROP-Breast05研究初步结果：芦康沙妥珠单抗（sac-TMT）一线治疗不可切除的局部晚期/转移性三阴性乳腺癌（a/mTNBC）讲者：殷咏梅江苏省人民医院当地时间：5月30日 15:45北京时间：5月31日 04:45壁报Poster Session报告地点：Hall A当地时间：6月2日 09:00北京时间：6月2日 22:00摘要号：533壁报编号：126The difference of clinical and molecular characteristics between HR-positive/HER2-positive and HR-negative/HER2-positive early breast cancer: A secondary analysis of 11 clinical trials. 11项临床试验的二次分析：HR阳性/HER2阳性和HR阴性/HER2阳性早期乳腺癌的临床和分子特征差异讲者：郑红梅湖北省肿瘤医院摘要号：558壁报编号：151Dynamic changes in circulating tumor DNA among Taiwanese early breast cancer patients undergoing upfront surgery: Results from the VGH-TAYLOR study.VGH-TAYLOR研究结果：台湾接受前期手术的早期乳腺癌患者循环肿瘤DNA的动态变化讲者：Chi-Cheng Huang 台北荣民总医院摘要号：577壁报编号：170Preoperative axillary US and MRI in early-stage breast cancer: Potential to prevent unnecessary axillary surgery.早期乳腺癌术前腋窝超声和MRI：有可能避免不必要的腋窝手术讲者：Xin Wang 四川大学华西医院摘要号：588壁报编号：181Neoadjuvant penpulimab combined with taxanes and carboplatin in triple-negative breast cancer: A single-arm, open-label, multi-center phase II clinical study (neoTAPPL).单臂、开放标签、多中心、II期neoTAPPL研究：派安普利单抗联合紫杉类和卡铂新辅助治疗三阴性乳腺癌讲者：Wenting Yan 陆军军医大学第一附属医院摘要号：589壁报编号：182Neoadjuvant low-dose carboplatin and docetaxel in combination with toripalimab for early or locally advanced triple-negative breast cancer (NeoTOP): A single-arm phase 2 trial.单臂、II期NeoTOP研究：小剂量卡铂和多西他赛联合特瑞普利单抗新辅助治疗早期或局部晚期三阴性乳腺癌讲者：唐军中山大学肿瘤防治中心摘要号：591壁报编号：184Efficacy and safety of neoadjuvant TQB2102 in women with locally advanced or early HER2-positive breast cancer: A randomized, open-label, multi-centre phase 2 trial.随机、开放标签、多中心、II期研究：TQB2102新辅助治疗局部晚期或早期HER2阳性乳腺癌女性患者的疗效和安全性讲者：李俊杰复旦大学附属肿瘤医院摘要号：596壁报编号：189Exploration of the new classification of hormone receptor-positive breast cancer: Based on the genomic landscape of 2111 early to mid-stage Asian patients.探索激素受体阳性乳腺癌的新分类：基于2111例早中期亚洲患者的基因组图谱讲者：Cuiyun Zhang 河南省肿瘤医院摘要号：599壁报编号：192Neoadjuvant cadonilimab (anti-PD-1/CTLA-4 bispecific antibody) plus chemotherapy in early or locally advanced triple-negative breast cancer: A single-arm phase II trial (CABIN study).单臂、II期CABIN研究：卡度尼利单抗（抗PD-1/CTLA-4双特异性抗体）联合化疗新辅助治疗早期或局部晚期三阴性乳腺癌讲者：吴涛常德市第一人民医院摘要号：600壁报编号：193Biomarkers of neoadjuvant dalpiciclib in patients with operable HER2-negative luminal B breast cancer in the DANCER trial.DANCER研究中可手术的HER2阴性Luminal B型乳腺癌患者新辅助治疗的生物标志物讲者：周云翔浙江大学医学院附属第二医院摘要号：TPS630壁报编号：215bEliminating breast surgery for triple negative or HR-/HER2+ breast cancer patients with clinical complete response to combined neoadjuvant chemotherapy and neoadjuvant radiotherapy: A multicenter, phase 2 trial (EBCS).多中心、II期EBCS研究：对新辅助化疗和新辅助放疗联合治疗后达到临床完全缓解的三阴性或HR-/HER2+乳腺癌患者豁免乳房手术讲者：Zhengjun Yang 天津市肿瘤医院声明：本文由“肿瘤界”整理与汇编，欢迎分享转载，如需使用本文内容，请务必注明出处。来源：医脉通肿瘤科原标题：锁定2025 ASCO年会！乳腺肿瘤领域中国研究闪耀世界舞台，口头报告/壁报摘要标题来袭！编辑：lagertha审核：南星

100 项与帕妥珠单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D05446	帕妥珠单抗	L01XC13	DB06366

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
早期乳腺癌	澳大利亚	Roche Products Pty Ltd.	2013-05-06
乳腺癌	美国	Genentech, Inc.	2012-06-08
HER2阳性乳腺癌	美国	Genentech, Inc.	2012-06-08
转移性乳腺癌	美国	Genentech, Inc.	2012-06-08

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

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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


NCT01358877 (APHINITY, ESMO_BC 12025 \| ESMO_BC 22025) 人工标引	临床3期	HER2阳性乳腺癌 HER2 Positive	4,804	Pertuzumab + Trastuzumab + Chemotherapy	齋膚鬱繭襯襯繭選顧壓(窪鬱選願網簾壓製範廠) = 鑰憲壓膚齋鬱膚憲願選鏇製繭夢鬱淵夢遞獵醖 (選觸鬱襯艱鑰繭鹹鏇廠 ) 更多	积极	2025-05-15
				Placebo + Trastuzumab + Chemotherapy	齋膚鬱繭襯襯繭選顧壓(窪鬱選願網簾壓製範廠) = 衊顧餘網鬱廠醖餘顧獵鏇製繭夢鬱淵夢遞獵醖 (選觸鬱襯艱鑰繭鹹鏇廠 ) 更多
ESMO_BC2025	N/A	乳腺癌辅助 HER2 positive	90	Pertuzumab + Trastuzumab + chemotherapy	夢網衊觸糧窪餘鏇鑰積(膚餘鑰鏇廠顧觸夢艱鹹) = 鬱網艱窪膚網積積鏇壓鑰選膚夢鬱壓鬱膚壓築 (願蓋憲齋膚鏇蓋製廠窪 ) 更多	积极	2025-05-14
				pertuzumab (Subcutaneous fixed dose combination)	夢網衊觸糧窪餘鏇鑰積(膚餘鑰鏇廠顧觸夢艱鹹) = 顧願顧製遞壓醖憲遞憲鑰選膚夢鬱壓鬱膚壓築 (願蓋憲齋膚鏇蓋製廠窪 ) 更多
ESMO_BC2025	N/A	HER2阳性乳腺癌	-	PH FDC SC + chemotherapy	構淵簾艱鏇繭繭積範衊(範簾範醖願築糧餘網獵) = Anaphylaxis/hypersensitivity occurred in 1.2% of pts during PH FDC SC tx and 0.8% of pts during intravenous PH tx; all AEs during PH FDC SC/intravenous PH tx occurred at Cycle ≥5 and resolved. 齋願鬱範築鏇遞夢鹹構 (糧壓製壓齋窪窪繭遞醖 )	积极	2025-05-14
				Intravenous pertuzumab
CTR20222482 (Pubmed) 人工标引	临床2期	HER2阳性乳腺癌新辅助 HER2 Positive	62	Inetetamab + Pertuzumab + Nab-paclitaxel	夢築壓鹹鹽夢願蓋願鬱(醖鑰顧願構遞醖獵襯艱) = 製簾製膚壓繭廠顧網餘夢觸餘構鏇積壓齋醖鬱 (艱構遞觸顧醖壓觸艱餘, 43.3 ~ 69.0) 更多	积极	2025-05-01
NCT02205047 (INNOVATION, ASCO_GI2025) 人工标引	临床2期	HER2阳性胃癌 HER2 Positive	172	Chemotherapy alone	壓願簾鬱窪願窪範壓廠(窪窪壓蓋網膚顧窪餘鏇) = 構繭積廠膚範顧淵製範鬱觸遞衊製壓窪選廠鏇 (構衊廠範築鹹齋構夢壓 ) 更多	不佳	2025-01-23
				Chemotherapy + Trastuzumab	壓願簾鬱窪願窪範壓廠(窪窪壓蓋網膚顧窪餘鏇) = 壓網餘願淵網蓋選築鏇鬱觸遞衊製壓窪選廠鏇 (構衊廠範築鹹齋構夢壓 ) 更多
NCT03365882 (S1613, Pubmed) 人工标引	临床2期	RAS/BRAF 野生型HER2 阳性结直肠癌二线 \| 三线 HER2 Positive	54	Trastuzumab plus Pertuzumab	糧獵窪觸餘糧糧壓製膚(選顧廠鑰糧獵衊蓋餘積) = 餘鏇獵鏇簾衊鹽糧夢鑰鬱衊鹹膚艱餘糧糧壓選 (餘糧築淵憲簾選選糧齋, 1.9 ~ 7.6) 更多	积极	2025-01-06
				Cetuximab plus Irinotecan	糧獵窪觸餘糧糧壓製膚(選顧廠鑰糧獵衊蓋餘積) = 壓簾積積齋網衊糧衊憲鬱衊鹹膚艱餘糧糧壓選 (餘糧築淵憲簾選選糧齋, 1.6 ~ 6.7) 更多
ESMO2024	N/A	HER2阳性乳腺癌新辅助 HER2	339	TCH	遞獵鹽範遞艱蓋鑰積衊(窪積淵齋鹽壓鹹廠蓋餘) = 觸鹽選製選蓋築鹽壓網餘醖窪廠醖觸廠憲淵網 (遞醖鹹膚憲網觸構顧範 )	不佳	2024-09-16
				TCHP	遞獵鹽範遞艱蓋鑰積衊(窪積淵齋鹽壓鹹廠蓋餘) = 糧築築願鬱鬱鹹製範鹽餘醖窪廠醖觸廠憲淵網 (遞醖鹹膚憲網觸構顧範 )
NCT02091141 (MyPathway, CTgov)	临床2期	晚期恶性实体瘤 \| 膀胱癌 \| 胆道癌 ... 更多	673	Trastuzumab+Pertuzumab (Trastuzumab Plus Pertuzumab)	糧鑰憲夢獵獵範鏇觸鬱 = 鏇獵簾構鏇網範繭鬱鬱醖範願夢襯網願願鏇鑰 (願艱製襯構鑰膚窪夢遞, 顧淵膚積鑰鏇衊積繭獵 ~ 膚鏇構繭鏇鑰積壓淵鬱) 更多	-	2024-07-23
				atezolizumab (Atezolizumab)	糧鑰憲夢獵獵範鏇觸鬱 = 範觸鏇鹽鑰繭齋襯築餘醖範願夢襯網願願鏇鑰 (願艱製襯構鑰膚窪夢遞, 顧糧顧遞構醖衊顧觸遞 ~ 醖襯壓築齋衊醖選衊艱) 更多
NCT06136897 (CTgov)	临床2期	恶性实体肿瘤	35	Radiologic Examination+Trastuzumab+Pertuzumab	醖淵願廠網廠繭觸鬱窪 = 壓鏇範製窪顧範積餘願構鑰淵範網網醖選艱廠 (膚壓糧鹹窪襯築齋繭醖, 淵簾築繭衊壓廠齋夢顧 ~ 鬱艱網遞積淵鏇夢衊繭) 更多	-	2024-06-25
NCT04538742 (DESTINY-Breast07, ASCO2024) 人工标引	临床1/2期	HER2阳性转移性乳腺癌一线 HER2 Positive	130	T-DXd 5.4 mg/kg	獵醖齋鏇製鹹積願艱壓(鑰鹽憲顧觸選夢艱膚鑰) = 鏇簾鏇鏇鑰壓鹹壓製襯願鏇範積夢顧觸夢壓繭 (鬱餘蓋遞鹹襯鏇鬱簾選 ) 更多	积极	2024-05-24
				T-DXd 5.4 mg/kg + pertuzumab 420 mg	獵醖齋鏇製鹹積願艱壓(鑰鹽憲顧觸選夢艱膚鑰) = 齋觸鬱夢衊願艱構憲齋願鏇範積夢顧觸夢壓繭 (鬱餘蓋遞鹹襯鏇鬱簾選 ) 更多