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]

NCT07126561

/ Not yet recruiting临床2期IIT

Phase II Open Label Trial of Trastuzumab Deruxtecan (Enhertu, DS-8210) in HER2 Positive Newly Diagnosed Metastatic Esophageal, Gastric, GEJ Cancer Patients With an ECOG Performance Status of 2

Purpose: This clinical trial is designed to evaluate the safety and effectiveness of Trastuzumab Deruxtecan for patients with HER2 Positive Newly Diagnosed Metastatic Esophageal, Gastric, GEJ Cancer. The goal is to determine how well this treatment works and to identify any potential side effects.
Who Can Participate: We are looking for Participants with histologically confirmed HER2 positive locally advanced unresectable and/or metastatic esophageal, gastric or GEJ adenocarcinoma with an ECOG PS of 2 and measurable disease according to RECIST 1.1 within 42 days prior to registration. Participants will be carefully screened to ensure they meet the study requirements.
What to Expect: Participants will undergo 6.4mg/kg, IV infusion of Trastuzumab deruxtucan over the course of the study. They will receive detailed information about the study and will have the opportunity to ask questions before deciding to participate. Informed consent will be obtained to ensure that participants understand the study's purpose, procedures, risks, and benefits.
Safety Monitoring: The health and safety of participants are our top priority. An Independent Data and Safety Monitoring Committee (DSMC) will regularly review the study data to ensure participant safety and to monitor for any adverse events. Any serious side effects will be reported and addressed promptly.
Benefits and Risks: While the study aims to provide potential benefits, such as improved treatment options for HER2 Positive Newly Diagnosed Metastatic Esophageal, Gastric, GEJ Cancer there may also be risks involved. Participants will be informed of all possible risks before enrolling in the study.
Confidentiality: All personal information will be kept confidential, and data will be used only for research purposes.
Contact Information: For more information about this study, please contact PhaseIICRA@medicine.bsd.uchicago.edu

开始日期2026-11-01

申办/合作机构

The University of Chicago

NCT07137416

/ Recruiting临床1期IIT

Phase 1b Study of Pidnarulex and Trastuzumab Deruxtecan in Patients With HER2 Expressing Solid Tumors

This phase I trial tests the safety, side effects, and best dose of pidnarulex in combination with trastuzumab deruxtecan in treating patients with breast cancer and other solid tumors that express varying levels of a protein called HER2 and that has spread from where it first started (primary site) to other places in the body (metastatic), that cannot be removed by surgery (unresectable), or that has spread to nearby tissue or lymph nodes (locally advanced). Pidnarulex is an enzyme inhibitor that causes cell death and prevents tumor cell growth. Trastuzumab deruxtecan is in a class of medications called antibody-drug conjugates. It is composed of a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called deruxtecan. Trastuzumab attaches to HER2 positive tumor cells in a targeted way and delivers deruxtecan to kill them. Giving pidnarulex in combination with trastuzumab deruxtecan may be safe, tolerable and/or effective in treating patients with metastatic, unresectable, or locally advanced HER2-expressing breast cancer or other solid tumors.

开始日期2026-10-05

申办/合作机构

National Cancer Institute

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1,071

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2026-07-01·Value in Health Regional Issues

Budget Impact Analysis of Fam-Trastuzumab-Deruxtecan as a Second Line in Patients With HER2-Positive Metastatic Breast Cancer in Oman

Article

作者: Aljaber, Rana ; Al Froukh, Rawan F ; Al Hashar, Amna

OBJECTIVES:

Despite advancements, breast cancer remains a major global health and financial challenge. Trastuzumab-based therapies, particularly Fam-Trastuzumab-Deruxtecan (T-DXd), have shown superior outcomes, leading to its recommendation as a preferred second-line treatment. However, its high cost necessitates a budget impact analysis (BIA) to evaluate financial feasibility. This study assesses the 1-year budget impact of replacing Trastuzumab Emtansine (TDM1) with T-DXd for HER2+ metastatic breast cancer in an Omani cancer center.

METHODS:

A static BIA model was built based on National Institute for Health and Care Excellence template with adaptation as required. The model time horizon was 1 year then projected over another 2 years, using 2022 as the baseline year, adopting Omani healthcare-payer perspective. The analysis considered 2 scenarios: (1) TDM1 as the current formulary drug and (2) T-DXd is introduced instead of TDM1, assuming that treatment share would be 100%. One-way sensitivity analysis is performed to assess the model's robustness.

RESULTS:

The BIA demonstrated that replacing TDM1 with T-DXd for the eligible patients would lead to increase in the budget expenditure. Over a 3-year period, considering the provided assumptions and input data, the cumulative excess amount to €5 909 481.67. The primary contributing factors are the drug acquisition cost and the median treatment duration. The sensitivity analysis results suggest the model is robust to changes in adverse drug reaction costs, unlike changes in treatment duration and drug cost.

CONCLUSIONS:

Although T-DXd improves clinical outcomes, its adoption as a second-line treatment in Oman poses a substantial financial burden, necessitating careful budget planning to ensure long-term affordability.

2026-06-01·BREAST

Antibody–drug conjugate sequencing in HER2-positive metastatic breast cancer: Real-world outcomes of trastuzumab deruxtecan with and without prior T-DM1 exposure

Article

作者: Bayram, Ertuğrul ; Deliktaş Onur, İlknur ; Yeşil Çınkır, Havva ; Majidova, Nargiz ; Gündüz, Şeyda ; Erdem, Dilek ; Karadurmuş, Nuri ; Er, Özlem ; Selçukbiricik, Fatih ; Başaran, Gül ; Güney, Bünyamin ; Kalem, Ali ; Gürsu, Rıza Umar ; Oruç, Ahmet ; Seyyar, Mustafa ; Tünbekici, Salih ; Güren, Ali Kaan ; Ateş, Öztürk ; Köylü, Bahadır ; Yazıcı, Melike ; Güney, Gizem ; Akdoğan, Orhun ; Türker, Sema ; Araz, Murat ; Göker, Erdem ; Kaban, Kerim ; Yılmaz, Mesut ; Aykan, Musa Barış ; Demir, Nazan ; Yıldız, İbrahim ; Molinas Mandel, Nil ; Kıkılı, Cevat İlteriş ; Biter, Sedat ; Korkmaz, Taner ; Tunalı, Didem ; Çabuk, Devrim ; Laçin, Şahin ; Bilici, Ahmet ; Sezer, Ahmet ; Altunok, Oğuz ; Şahin, Taha Koray ; Çelik, Emir ; Bayoğlu, İbrahim Vedat ; Aksoy, Sercan ; Açıkel Yüksel, Sakine Damla ; Ekinci, Ömer Burak ; Kemik, Fatih ; Özçelik, Hakan ; Güven, Deniz Can ; Yazıcı, Ozan ; Tural, Deniz

BACKGROUND:

Optimal sequencing of trastuzumab emtansine (T-DM1) and trastuzumab deruxtecan (T-DXd) in HER2 positive metastatic breast cancer (mBC) remains uncertain, and real-world evidence on the impact of prior T-DM1 exposure on subsequent T-DXd outcomes is limited.

METHODS:

We conducted a multicenter, retrospective cohort study across 21 oncology centers in Türkiye including consecutive adults with HER2 positive mBC who received at least one cycle of T-DXd between 2020 and 2025. Patients were classified as T-DM1 pretreated or T-DM1 naive at T-DXd initiation. The primary endpoint was progression free survival (PFS); secondary endpoints included objective response rate (ORR), duration of response (DOR), and overall survival (OS). To address confounding by indication, we applied stabilized inverse probability of treatment weighting (IPTW) based on prespecified clinical covariates and assessed covariate balance using standardized mean differences.

RESULTS:

Among 218 patients treated with T-DXd, 137 (62.8%) had received prior T-DM1 and 81 (37.2%) were T-DM1 naive. The ORR was 71.9%, including 15.2% complete and 56.7% partial responses. Median DOR in the overall cohort was 20.96 months (95% CI, 15.71-26.22). In the IPTW-weighted analysis, prior T-DM1 exposure was associated with significantly shorter PFS: 12.1 months (95% CI, 10.3-20.5) versus 26.0 months (95% CI, 18.9 - not reached) in T-DM1 naive patients (IPTW-weighted log-rank p = 0.006). Prior T-DM1 remained independently associated with higher progression risk (HR 1.99, 95% CI 1.09 - 3.62; p = 0.02). Median OS was 18.9 months (95% CI, 17.2-not reached) in T-DM1 pretreated patients and not reached in T-DM1 naive patients; the IPTW-weighted OS hazard ratio did not reach statistical significance (HR 1.80, 95% CI 0.86-3.79; p = 0.12).

CONCLUSIONS:

Trastuzumab deruxtecan demonstrated substantial real-world activity after prior T-DM1 exposure, but PFS was significantly shorter compared with T-DM1 naive patients, even after rigorous adjustment for measured confounding. These findings highlight the clinical relevance of antibody drug conjugate sequencing and support prospective studies to define the optimal positioning of T-DXd in HER2 positive mBC treatment algorithms.

2026-06-01·DRUGS

Sequential Use of Trastuzumab Deruxtecan and Sacituzumab Govitecan in Patients with Breast Cancer: A Pharmacological Approach to Support the Clinical Rationale

Review

作者: Mathijssen, Ron H J ; Bria, Emilio ; Curigliano, Giuseppe ; Danesi, Romano ; Inglese, Elvira ; Del Re, Marzia ; Blok, Erik J

Antibody-drug conjugates (ADCs) represent a major advance in breast cancer therapy, with trastuzumab deruxtecan and sacituzumab govitecan emerging as leading agents targeting distinct tumor antigens and employing different linker-payload designs. Trastuzumab deruxtecan is a second-generation HER2-directed ADC composed of trastuzumab linked via a cleavable tetrapeptide linker to the camptothecin derivative exatecan, a highly potent topoisomerase I inhibitor. Its high drug-to-antibody ratio (DAR 8:1), membrane-permeable payload, and efficient lysosomal release confer strong antitumor activity, including a robust bystander effect in HER2-low tumors. By contrast, sacituzumab govitecan is a TROP-2-targeted ADC conjugated through a hydrolysable CL2A linker to SN-38, the active metabolite of irinotecan. Sacituzumab govitecan features a high DAR (7.6:1) and allows extracellular as well as intracellular release of SN-38, enhancing bystander killing in tumors with heterogeneous TROP-2 expression, while maintaining a favorable toxicity profile due to the lower intrinsic potency of SN-38 relative to exatecan. Since both these ADCs are conjugated to topoisomerase I inhibitors, concerns about potential cross-resistance regarding their sequencing in clinical practice are being raised, and currently there is a lack of predictive biomarkers providing a rational basis for their sequential administration. Resistance mechanisms exhibit significant heterogeneity: resistance to trastuzumab deruxtecan has been associated with mutations in TOPO I and SLX4, impaired lysosomal function, and efflux via ABC transporters. In contrast, resistance to sacituzumab govitecan is linked to overexpression of multidrug resistance proteins, particularly BCRP-mediated efflux. Clinically, trastuzumab deruxtecan has shown substantial efficacy in both HER2-positive and HER2-low breast cancer, whereas sacituzumab govitecan has demonstrated efficacy across triple-negative and hormone receptor-positive/HER2-negative breast cancers. Collectively, these agents highlight how variations in target antigen, linker chemistry, and payload potency impact ADC activity, therapeutic index, and potential strategies for sequential treatment in advanced breast cancer.

6,159

项与德曲妥珠单抗相关的新闻（医药）

12 小时之前

·PRNewswire

Paradigm Health Implements New Clinical Trial Solution to Support Observational Study Presented at ASCO

Paradigm Health's Scalable Platform for Integrated Research and Evidence (SPIRE) helps trial sponsors generate high-quality clinical trial data across community healthcare practices Columbus, Ohio and CHICAGO, June 1, 2026 /PRNewswire/ -- Paradigm Health today announced its role in the execution of a multicenter, hybrid, observational post-marketing commitment study in the United States evaluating an FDA-approved therapy in patients with human epidermal growth factor receptor 2 (HER2) immunohistochemistry (IHC) 3+ solid tumors. The trial uses Paradigm Health's SPIRE model as the technology-enabled infrastructure to accelerate end-to-end trial operations, from trial design, site selection, patient identification, and data collection, to efficient evidence generation. A principal investigator from Florida Cancer Specialists & Research Institute (FCS) presented a poster on the trial design and operations at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting on June 1. The abstract (TPS11202) is titled A pragmatic, hybrid observational study evaluating the effectiveness of trastuzumab deruxtecan (T-DXd) in patients with human epidermal growth factor receptor 2 (HER2) immunohistochemistry (IHC) 3+ solid tumors: DESTINY-PanTumor04. Study authors also include researchers from Paradigm Health, AstraZeneca (trial sponsor), and Daiichi Sankyo. The SPIRE infrastructure uses the same data collection technology that underpins the proof-of-concept currently underway with the U.S. Food & Drug Administration (FDA) to evaluate the implementation of Real-Time Clinical Trials. The trial was designed to track approximately 100 patients at up to 30 U.S. locations, from community practices to academic medical centers. The SPIRE model provides the end-to-end infrastructure that can help sponsors design pragmatic trials and embed into study sites to automate data collection, identify eligible patients faster, and expedite transmission of analysis-ready data to sponsors. By streamlining these labor-intensive steps, SPIRE enables researchers across community settings, hospitals, and academic medical centers to participate in the same late-phase clinical trials. "This research shows how SPIRE can be used in a broad range of healthcare settings. Already, 13 community oncology centers are participating in this study," said Kent Thoelke, Founder and CEO of Paradigm Health. "By connecting fragmented clinical databases and other data sources, we can lower the operational burden for research staff while maintaining the completeness and accuracy needed by trial sponsors. This helps make clinical research feasible for more study sites, ultimately, opening research up to more patients." The poster highlights the study's pragmatic trial elements achieved through the SPIRE model, including broad eligibility criteria, routine clinical practice settings, integration of primary and secondary sources into study data collection, and pragmatic endpoints. Paradigm Health's SPIRE model optimizes the trial design, site selection, and simplification of patient identification and enrollment, improving data accuracy and completeness, all aimed at making clinical trial workflows feasible for more sites. SPIRE-enabled pragmatic prospective studies are uniquely positioned to evaluate effectiveness in routine care and enroll patient populations that are reflective of real-world healthcare settings. "Observational and late-phase studies require the technological infrastructure to operate within clinical care delivery, and my team at FCS is at the forefront of this technological modernization," said Lucio Gordan, President and Managing Physician at FCS. "Paradigm Health's SPIRE was designed to help trial sites align clinical workflows with research operations, expediting analysis-ready data capture without increasing burden on providers or site staff." About Paradigm Health Paradigm Health has engineered an AI-powered platform to make clinical trials more accessible and efficient, so that patients, researchers, and study sponsors can maximize the impact of clinical research. Incubated by ARCH Venture Partners and backed by leading healthcare and life sciences investors, Paradigm Health aims to break down barriers across the trial ecosystem through one seamless infrastructure implemented at healthcare provider organizations, bringing potentially life-saving therapies to patients faster. For more information, visit . About SPIRE Scalable Platform for Integrated Research and Evidence (SPIRE) is an end-to-end, technology-enabled alternative to traditional CRO-led approaches for prospective, pragmatic studies, particularly for approved products and products nearing approval with established safety profiles. The solution combines: EHR-integrated technology embedded directly into patient visits, in community, rural, and academic settings across 46 of 50 states Data-driven study design and site selection informed by care patterns and site capabilities Full-service study conduct support across site selection, startup, enrollment, data management, safety, and closeout SPIRE Intended Use Cases SPIRE is intended for prospective, pragmatic U.S. studies for assets that are approved of nearing approval, including: Post-marketing requirements and commitments with observational designs Phase IV safety and/or effectiveness Label expansion Comparative effectiveness Prospective registries and external control arms Hybrid studies incorporating randomized and pragmatic elements About Paradigm Health's Collaboration with FDA on Real-Time Clinical Trials In April 2026, Paradigm Health announced a landmark research collaboration with the FDA focused on advancing a new model to accelerate clinical trial execution and regulatory review. The model uses Paradigm Health's technology-enabled Study Conduct platform to allow real-time review by the FDA, by automating data collection and analysis, and streamlining the reporting of key safety and efficacy signals to trial sponsors and the FDA. SOURCE Paradigm Health, Inc. 21% more press release views with Request a Demo

临床研究免疫疗法ASCO会议

12 小时之前

·ioncology

ASCO中国标尺丨梁斐教授：“看穿”数据——统计学视角下的DESTINY-Breast系列研究解读

编者按：近年来，DESTINY-Breast（DB）系列研究不断刷新HER2阳性乳腺癌的治疗格局。从DB-03到DB-09，再到DB-05和DB-11，T-DXd在晚期、早期、新辅助等多个治疗场景中均展现出令人瞩目的疗效。然而，临床研究的设计与解读并不仅仅是看一个P值或风险比。作为统计学者，我们更需要关注：研究终点选择的合理性、α分配策略、期中分析的设计与解读、亚组分析的正确方法，以及样本量调整背后的考量。本文邀请到复旦附属中山医院生物统计室统计师梁斐教授，他从统计学角度出发，解析DB-09和DB-11这两项早期新辅助和晚期一线治疗具有里程碑意义的研究，并结合2026年ASCO大会公布的最新DB-09探索性分析结果，与读者共同探讨如何科学地解读这些关键证据。 DB-09研究主要终点PFS的“定期考核” DB-09研究是一项针对HER2阳性晚期或转移性乳腺癌一线治疗的三臂随机对照研究，包含T-DXd单药、T-DXd联合帕妥珠单抗以及THP对照组。任何一个试验组与对照组相比达到统计学显著性，均可宣布研究成功；两个试验组之间没有预设的直接比较，因此不应对T-DXd单药与联合方案进行头对头比较。 DB-09研究T-DXd联合组已达到主要终点，T-DXd联合帕妥珠单抗组对比THP组的PFS显著优于THP组（BICR评估：40.7 vs 26.9个月，HR 0.56，P＜0.00001）[4]。基于此，该联合方案的相关晚期一线治疗适应症已经于2025年12月获得美国FDA批准[5]。期中分析是DB-09研究设计中的关键环节，主要分为两类。第一类是无效性期中分析，其目的是基于期中数据判断试验是否可能失败，从而提前终止研究，减少受试者不必要的暴露。终止标准通常基于HR或P值以及安全性因素，且需要事先在方案中规定。DB-09研究的第一次期中分析即为无效性分析，计划在研究进行24个月、累计事件数228例时进行。第二类是有效性期中分析，其目的是基于期中数据提前宣布研究成功，加速药物上市。在这种分析中，传统的P=0.05标准不再适用，需基于α消耗函数确定界值。具体到DB-09研究，T-DXd单药组在PFS信息量达到70%时进行一次有效性期中分析，采用Haybittle-Peto停止界值，消耗双侧α为0.000430，最终PFS分析时累计双侧α为2%。T-DXd联合帕妥珠单抗组在相同信息量比例下进行有效性期中分析，同样消耗双侧α为0.000430，最终PFS分析时累计双侧α为3%。这种严格的α消耗策略，确保了期中分析的统计学严谨性，避免因多次检验而膨胀I类错误。目前，T-DXd联合组已通过无效性期中分析和第一次有效性期中分析，并获得积极结果。T-DXd单药组目前仍在继续随访，表明其已通过第一次无效性测试，相对于对照组有效，期待具体的有效性分析结果公布。 DB-09研究最佳缓解持续时间和临床结局总生存期（OS）仍被大多数临床医生认为是检验临床获益的“金标准”。在DB-09研究中，OS作为关键次要终点，当T-DXd单药组和联合组PFS的ITT检验均被拒绝后，才能将全部5%的α传递给后续的OS检验。目前，T-DXd联合帕妥珠单抗组的OS尚未成熟，已显示出PFS2获益（NC vs 36.5个月，HR 0.60，95%CI：0.45-0.79，P=0.00038）[6]。既往报道的DB-01/02/03研究汇总分析[7]显示，达到CR患者的预后大幅优于仅达到部分缓解（PR）或未达到缓解的患者，其2年PFS率达77.8%，3年OS率达88.6%，均较PR患者提高30%以上，表明肿瘤深度缓解可能是生存获益的潜在预测指标。 2026年ASCO大会报道了DB-09研究的一项探索性分析[8]，研究人员根据 RECIST V1.1将肿瘤缓解分为四类：完全缓解（CR）、深度 PR（靶病灶总径缩小≥80% 至＜100%）、非深度PR（靶病灶总径缩小≥30% 至＜80%）、疾病稳定/进展（SD/PD），以分析不同缓解深度与患者预后的相关性。研究结果显示T-DXd＋P组有超过一半（~53%）的患者达到CR或深度PR，其中15.4%达到CR，33.7%达到PR（＜80%）、37.4%达到深度PR。在生存结局方面，CR与深度PR患者的2年PFS率获益相当（分别为 85.1%、80.0%），均显著优于非深度PR（64.3%）及SD/PD（35.5%）患者；其中深度PR患者较非深度PR患者的2年PFS率提升15.7%。达到CR和深度PR的患者显示了更长的治疗时间和持续缓解。CR、深度PR、PR（＜80%）、SD/PD患者的中位治疗时间为28.0、25.4、20.6和4.4个月。24个月时CR、深度PR、PR（＜80%）患者仍维持最佳缓解状态的比例分别为85.0%、78.9%、60.4%。此外，从达到最佳缓解的时间数据可以看出，T-DXd+P组CR /深度PR患者的中位达最佳缓解时间（8.4/9.6 个月）显著长于非深度PR患者（＜80%）（1.5 个月），提示实现深度缓解是一个需要足够治疗时间、逐步加深的过程。随着随访时间的进一步延长，DB-09 研究中患者的缓解深度仍有提升空间，未来CR率有望进一步提高。对照组（THP）其 CR、深度 PR、PR（＜80%）、SD/PD 患者的2年PFS率分别为 75.6%、60.7%、48.5% 和 31.7%。值得注意的是，与T-DXd+P组不同的是，无论是 CR 患者还是深度PR患者，THP组的生存获益均显著低于T-DXd+P组：THP组 CR患者的2年PFS 率（75.6%）低于T-DXd+P组CR患者（85.1%），THP组深度PR患者的2年PFS率（60.7%）同样低于T-DXd+P组深度PR患者（80.0%）；这提示我们即便在深度部分缓解的这部分人群中，不同治疗方案为患者带来的缓解深度可能还有不同，T-DXd+P带来的深度缓解可能更接近于CR，而THP组带来的可能更接近于80%缩瘤的下限。在安全性方面，尽管总体上不同缓解者亚组中，药物相关的≥3级不良事件的暴露调整发生率（EAIRs）相似，但CR和深度PR患者也显示了更好的治疗安全性和耐受性，≥3级EAIR仅为0.30和0.28，低于SD/PD患者的0.57；导致治疗终止的不良事件EAIR则分别为0.14、0.10和0.16事件/患者年。此外，CR、深度PR、PR患者均未发生≥3级间质性肺病/非感染性肺炎（ILD/p），SD/PD患者≥3级ILD/p EAIRs发生率为4.1%（2例）。综合当前报道数据来看，DB-09研究T-DXd联合组不仅展现了良好的PFS2结果，而且显示了非常高的肿瘤缓解疗效，且达到CR与深度PR的患者，PFS 结局显著更优，并且表现了更好的治疗安全性和耐受性。这些结果均预示该治疗方案有望取得积极的OS获益结果。 DB-11研究主要终点pCR率的“充分考量” DB-11研究是一项针对HER2阳性早期乳腺癌新辅助治疗的随机对照研究，旨在探讨8周期T-DXd或ddAC→T-DXd对比ddAC→THP用于HER2阳性高危乳腺癌患者新辅助治疗的疗效和安全性。去年ESMO大会报道ddAC→T-DXd组达到了主要终点——其病理完全缓解（pCR）率显著高于ddAC→THP组（67.3% vs 56.3%，△11.2%，P=0.003），尤其HR+亚组的绝对获益达到了16.1%（83.1% vs 67.1%）[1]。基于此，该方案已经获中国NMPA、美国FDA批准相关适应症[2-3]。 DB-11研究的主要终点选择了pCR，且阳性结果快速得到药监部门认可，其背后有着充分的统计学与临床考量。首先，pCR与患者的预后密切相关，大量研究表明，达到pCR的HER2阳性早期乳腺癌患者，其长期生存显著优于未达到pCR者。其次，监管先例已经存在——作为标准治疗的HER2双靶向联合化疗的新辅助方案正是基于pCR结果获得批准，后续并无确证性III期研究证实其EFS或OS获益，NeoSphere研究即为一个典型案例，该研究以pCR为主要终点，成功支持了THP方案的首次获批。第三，从可行性来看，若以EFS为主要终点，所需样本量将大幅增加，研究周期显著延长，可能延缓有效药物惠及患者的时间。在主要终点pCR的α控制策略上，DB-11研究采用了精细化的分配方案。单药组分配α为0.02，联合组分配α为0.03，且α可在两组之间互相传递。但由于单药组提前终止，其分得的α并未重新分配给联合组，联合组仍维持0.03的α水平。这一设计体现了对更高风险、更高预期获益方案的“倾斜”，同时也保证了整体I类错误率控制在0.05以内。在解读pCR亚组分析结果时，一个常见的误区需要引起警惕：认为某个亚组的95%置信区间上限超过1或pCR差值下限小于0，就代表该亚组“无效”。这是典型的统计功效不足所导致的误解。置信区间的宽度不仅取决于疗效大小，更取决于该亚组的人数和事件数。当某个亚组人数很少时，即使疗效非常突出，其置信区间上限仍可能跨越1。正确的做法是：首先关注HR是否小于1，而非是否达到统计学显著性；其次，需要通过交互检验来判断不同亚组间疗效是否存在差异。在DB-11研究中，各亚组的pCR获益趋势一致，尚未发现显著的交互作用，这意味着T-DXd的疗效在不同亚组间具有较好的一致性。 EFS是该研究的次要终点。值得注意的是，该研究的样本量从最初的624例增加至900例，其目的是为了提升EFS估计的精度（缩窄置信区间），从而更可靠地评估其获益趋势（即提高观察到HR点估计＜1的概率）。结语理解研究设计的统计学逻辑，是正确解读临床证据的基础；谨慎对待亚组分析和探索性分析，避免因P值的显著性而得出误导性结论；关注暴露校正后的安全性数据，更科学地评估药物的风险-获益比；重视期中分析的α消耗策略，理解“早期成功”背后的统计学严谨性。从DB-09到DB-11，DESTINY-Breast系列研究以其严谨的统计学设计和突破性的研究成果，不断推动着HER2阳性乳腺癌治疗格局的变革。T-DXd已成为HER2阳性乳腺癌治疗的重要武器，而科学的统计学思维，将帮助我们在海量数据中看清真相，为患者做出更精准的临床决策。参考文献上下滑动查看更多内容 [1]Harbeck N, et al. Neoadjuvant trastuzumab deruxtecan alone or followed by paclitaxel, trastuzumab, and pertuzumab for high-risk HER2-positive early breast cancer (DESTINY-Breast11): a randomised, open-label, multicentre, phase III trial. Ann Oncol. 2026;37(2):166-179. [2]优赫得®序贯THP用于HER2阳性乳腺癌新适应症在华获批.第一三共公众号.https://mp.weixin.qq.com/s/AX6MLEDgYwqmTKWRXUb_1A [3]注射用德曲妥珠单抗在美国获批两项HER2阳性早期乳腺癌新适应症.第一三共公众号.https://mp.weixin.qq.com/s/KfInZvPd3IPKXeZAUTEMnA [4]Tolaney SM, Jiang Z, Zhang Q, et al. Trastuzumab Deruxtecan plus Pertuzumab for HER2-Positive Metastatic Breast Cancer. N Engl J Med. 2026;394(6):551-562. doi:10.1056/NEJMoa2508668 [5]注射用德曲妥珠单抗联合帕妥珠单抗在美国获FDA批准.第一三共公众号.https://mp.weixin.qq.com/s/miydmqL2p7fyjRAAwBirYQ [6]Sara M, 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 LBA1008. [7] Saura C, Cortés J, Modi S, et al. Pooled analysis by best confirmed response to trastuzumab deruxtecan and related biomarkers in patients with HER2-positive metastatic breast cancer from DESTINY-Breast01, DESTINY-Breast02, and DESTINY-Breast03. Ann Oncol. Published online November 17, 2025. doi:10.1016/j.annonc.2025.11.007 [8]Yeon Hee Park, et al. A DESTINY-Breast09 analysis of treatment duration and clinical outcomes by best response to trastuzumab deruxtecan (T-DXd) + pertuzumab (P). ASCO 2026;Abstract 1021 梁斐教授复旦附属中山医院生物统计室统计师中国初级卫生保健基金会肿瘤临床转化委员会常委中国老年保健协会肿瘤防治和临床研究委员会常委中国医师协会外科分会临床研究工作组委员中国医药教育协会肿瘤药物临床研究评价委员会委员 CSCO青年委员会统计小组成员上海抗癌协会癌症预防与筛查委员会委员以第一作者(含共一)或通讯作者在NEJM、Lancet Oncology、JCO、Annals of Oncology、JNCI、 European Journal of Cancer 等杂志发表SCI论著20篇,累计影响因子超过200 Nature Medicine、JNCI、 Clinical Cancer Research杂志统计学审稿人作为统计师设计/分析的临床研究发表于NEJM、Lancet、JAMA、BMJ、Nature Medicine、Lancet Oncology 、 Lancet Gastroenterology & Hepatology 、Annals of Oncology、 JCO 、 Annals of Surgery等杂志主要研究方向：临床试验设计及统计，临床研究方法学（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。

ASCO会议临床结果临床1期

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·ioncology

指南优解丨邱妙珍教授：从DG02到DG04——新型ADC药物精准突围，终结HER2阳性胃癌二线治疗十年僵局

点击蓝字，关注我们编者按：2026年以前，HER2阳性晚期胃癌患者在一线接受含曲妥珠单抗方案治疗后出现疾病进展，二线治疗中尚无针对HER2靶点的靶向药物可用。临床实践中常采用紫杉醇联合雷莫西尤单抗（Ram+Pac）等化疗联合抗血管生成方案，患者中位总生存期（mOS）仅徘徊在8.7~11.4个月[1]，疗效存在一定局限。这一困局在今年迎来历史性转折，基于DESTINY-Gastric04（DG04）研究的阳性结果，德曲妥珠单抗（T-DXd）被证实在HER2阳性晚期胃癌二线治疗中显著优于传统标准方案，2026年1月，国家药品监督管理局（NMPA）正式批准T-DXd用于既往接受过含曲妥珠单抗方案治疗的HER2阳性（IHC 3+或IHC 2+/ISH+）局部晚期或转移性胃癌/胃食管结合部腺癌患者的二线治疗。《中国临床肿瘤学会（CSCO）胃癌诊疗指南2026》亦将T-DXd纳入唯一I级推荐方案（1A类证据）[2]，此填补了HER2阳性胃癌二线治疗缺乏有效靶向药物的空白。那么，这款ADC药物凭何打破领域十余年的探索僵局？从DG02概念验证到DG04头对头确证的研究接力，如何逐步奠定其"二线唯一推荐"的地位？本期【指南优解】邀请了中山大学肿瘤防治中心邱妙珍教授，对该标准疗法的研究证据进行深度解析。机制破局：超越单抗耐药的“空间-时间”双重解构 HER2阳性胃癌的二线耐药困境，根源并非靶点缺失，而是肿瘤异质性与现有药物作用机制的天然局限。胃癌HER2表达存在显著的瘤内异质性、瘤间异质性与时间异质性。传统单抗类药物依赖HER2信号通路阻断发挥作用，面对异质性病灶与已发生的靶点下调，难以实现有效杀伤。新一代ADC药物T-DXd从作用机制层面实现了对耐药困局的破局，核心优势体现在三个维度[3]：高药物抗体比（DAR≈8）：相较于传统ADC的DAR仅为2~4，T-DXd单位抗体可携带约8个细胞毒载荷（DXd），能够精准向肿瘤细胞递送更高剂量的细胞毒性药物，放大杀伤效能；强效旁观者效应：DXd具有良好的膜渗透性，被释放后可穿透至肿瘤细胞周围，杀伤邻近的HER2低表达甚至HER2阴性癌细胞，精准清除异质性病灶，从根源上解决了胃癌HER2异质性导致的耐药问题；非信号通路依赖的杀伤模式：T-DXd的核心作用机制是“精准毒素递送”而非HER2信号通路阻断，即使一线曲妥珠单抗因靶点下调耐药，T-DXd仍可通过DXd的细胞毒性实现有效杀伤，为二线耐药患者提供了生物学层面的有效选择。证据跃迁：从DG02“火种”到DG04“标尺”的决定性跨越 T-DXd在HER2阳性晚期胃癌二线治疗的证据积累，是一场从概念验证到金标准确证的完整科学探索，DG02与DG04分别承担了不可替代的关键角色。 DG02：单臂验证的“可行性基石” DESTINY-Gastric02[4]是一项针对西方人群的Ⅱ期单臂临床研究，旨在评估T-DXd在既往接受过曲妥珠单抗治疗的HER2阳性晚期胃癌/胃食管结合部腺癌中的疗效与安全性。研究结果证实，T-DXd二线应用展现出稳健的抗肿瘤活性：客观缓解率（cORR）达到41.8%，中位总生存期（mOS）达到12.1个月，中位无进展生存期（mPFS）为5.6个月，安全性特征与既往研究一致，间质性肺疾病（ILD）发生率可控。 DG02的核心价值在于快速验证了T-DXd二线应用的可行性，推动EMA与FDA加速批准T-DXd用于HER2阳性晚期胃癌的二线治疗，回答了该领域“是否存在有效药物”的初步问题，但由于研究设计为单臂，无法回答“T-DXd是否优于现有标准治疗”这一关键临床问题，而这一命题必须通过头对头Ⅲ期研究才能给出确切答案。 DG02研究关键生存获益结果 DG04：头对头Ⅲ期的“金标准确证” DESTINY-Gastric04[5]是全球首个在HER2阳性晚期胃癌二线治疗中，将新型HER2-ADC与现有标准治疗进行头对头比较的Ⅲ期临床研究，研究在全球22个国家的168个中心开展，共纳入741例既往接受过一线曲妥珠单抗联合化疗治疗失败的HER2阳性晚期胃癌/胃食管结合部腺癌患者，按1:1随机分配接受T-DXd单药治疗，或研究者选择的雷莫芦单抗联合紫杉醇（Ram+Pac）标准治疗，主要终点为总生存期（OS）。最终研究数据展现出压倒性优效：生存获益显著：死亡风险降低30%：T-DXd组mOS达到14.7个月，显著优于Ram+Pac组的11.4个月（HR=0.70，P=0.0003），2年总生存率达到29.0%，是Ram+Pac组13.9%的两倍多；缓解深度更优：近半数患者实现肿瘤退缩：T-DXd组cORR达到44.3%，显著高于对照组的29.1%，中位缓解持续时间（DoR）达到8.6个月，优于对照组的6.1个月；安全性可耐受：≥3级治疗相关不良事件（TRAE）发生率T-DXd组为45.5%，低于对照组的55.8%，任意级别ILD/肺炎发生率为10.6%，其中≥3级仅为2.4%，不良反应可控。 DG04研究不仅是一项获得阳性结果的Ⅲ期研究，更是全球首个证实HER2靶向药物在晚期胃癌二线治疗中带来显著生存获益的Ⅲ期研究，彻底打破了ToGA研究后十余年二线治疗的探索僵局，为T-DXd成为新标准提供了最高级别的循证医学证据。 DG04研究关键生存获益结果真实世界加固： PSM研究填补“证据真空期”的临床决策生命线在DG04最终研究数据公布之前，临床亟需真实世界数据填补RCT证据与临床决策之间的空窗期。一项来自荷兰的全国性研究，通过倾向评分匹配（PSM）分析，比较了真实世界中T-DXd与Ram+Pac在二线治疗中的疗效[6]。该研究基于荷兰全国癌症登记库，对入组患者进行9个强临床协变量匹配（包括肾功能、肝转移状态、一线治疗无进展生存期等），匹配后标准化均数差（SMD）<0.10，方法学严谨可靠。结果显示，匹配队列中T-DXd组mOS达到11.6个月，显著优于Ram+Pac组的6.2个月（HR=0.39，死亡风险降低61%），这一结果进一步在真实世界人群中验证了DG04研究结论，为临床决策提供了不可替代的外部证据支撑，也为DG04最终数据公布前的临床实践提供了关键参考。 DG02研究和荷兰癌症登记处队列匹配患者的总生存期Kaplan-Meier 曲线倾向得分匹配后不同DG02研究组的总生存期Kaplan-Meier 曲线不止于“换药”： T-DXd重构HER2阳性胃癌全程管理生态 T-DXd的成功，其意义远不止为HER2阳性晚期胃癌二线治疗提供了一款更有效的药物，而是从治疗理念、临床路径到全程管理，对现有诊疗范式进行了根本性重构，具体体现在四个维度： 1. 治疗时机革命：“好药先用”取代“阶梯化疗” 此前临床普遍存在“把好药留到最后”的思维惯性，认为ADC应保留到三线及以后使用。但DG04研究数据明确显示，T-DXd二线治疗的mOS达到14.7个月，显著优于既往三线治疗的生存数据（既往研究中T-DXd三线mOS约为10个月左右），提示T-DXd在二线治疗中较三线具有更优的生存获益，“好药先用”能够为患者带来更长的生存获益。这一结论直接推动临床治疗理念转变，推动抗HER2治疗前移。 2. 检测理念升维：二线治疗前“再次检测HER2”值得重视 DG04研究严格入组经中心实验室确认的HER2阳性（IHC 3+/IHC 2+且FISH+）患者，获益结果进一步提示：HER2状态动态变化是临床不可忽视的现实，一线抗HER2治疗后约2/3患者会出现HER2表达下调或丢失。DG04的阳性结果，从侧面印证了规范检测的重要性，在条件允许的情况下，二线治疗前考虑进行二次活检与规范HER2检测，有助于避免因默认HER2状态不变导致治疗错配，让真正获益的患者得到有效治疗。 3. 治疗策略“大洗牌”：从治疗断档进入“连续抗HER2时代” 在DG04研究成功之前，HER2阳性晚期胃癌的治疗模式是“一线曲妥珠单抗联合化疗→二线化疗±抗血管→三线再靶向”，抗HER2治疗存在明显断档，患者错失持续靶向获益的机会。DG04研究确立T-DXd二线标准地位后，临床正式构建起“一线曲妥珠单抗联合化疗→二线T-DXd→后线HER2-ADC或联合免疫”的无缝抗HER2靶向治疗链条，延长了患者接受抗HER2治疗的总时长，最大化发挥靶向治疗的生存价值。 4. 可及性全面落地：从“临床试验”到“指南强制覆盖” 2026年1月14日，国家药品监督管理局（NMPA）正式批准T-DXd用于既往接受过曲妥珠单抗治疗的HER2阳性局部晚期或转移性胃癌/胃食管结合部腺癌，紧接着CSCO指南就将其列为二线I级推荐，意味着T-DXd快速进入临床路径，随后医保谈判也将进一步提升药物可及性，真正让这一突破性方案惠及广大中国患者，为HER2阳性晚期胃癌二线治疗提供了新的标准选择。小结： DG02与DG04——一部精准肿瘤学时代的循证进化论从DG02研究到DG04研究，T-DXd在HER2阳性晚期胃癌二线治疗的证据演进，展现了精准肿瘤学时代循证医学的发展路径：DG02作为探索性研究，以单臂设计快速验证了T-DXd二线应用的可行性，回答了该领域“是否存在有效药物”的初步问题；DG04作为确证性研究，以头对头Ⅲ期试验数据证实了T-DXd优于传统标准方案，为临床决策提供了更高级别的循证医学证据；而PSM真实世界研究则在RCT证据与临床实践之间起到补充作用，在特定证据空窗期为治疗选择提供参考依据。 T-DXd成为HER2阳性晚期胃癌二线治疗唯一I级推荐，得益于其机制优势、循证强度、指南认可与临床可及等多方面因素。它不仅改写了二线治疗的选择，也推动了HER2阳性胃癌诊疗模式向更精准、全程管理的方向发展。从DG02到DG04的研究历程，其意义已超越单一药物的获批，为优化胃癌诊疗策略提供了参考，并使更多晚期胃癌患者获得了潜在的生存获益。参考文献：（滑动查看） 1. Sato S, et al. Pharmacotherapy for previously treated gastric cancer patients: current options and future developments. Expert Rev Clin Pharmacol. 2025 Aug;18(8):607-623. 2. 中国临床肿瘤学会指南工作委员会.《中国临床肿瘤学会（CSCO）胃癌诊疗指南2026》 3. 谢意, 等. 胃癌抗HER2靶向治疗进展与展望. 科学通报, 2026, 71(7): 1431-1449. 4. Van Cutsem E, et al. Trastuzumab deruxtecan in patients in the USA and Europe with HER2-positive advanced gastric or gastroesophageal junction cancer with disease progression on or after a trastuzumab-containing regimen (DESTINY-Gastric02): primary and updated analyses from a single-arm, phase 2 study. Lancet Oncol. 2023;24(7):744–756. 5. Shitara K, et al. Trastuzumab deruxtecan or ramucirumab plus paclitaxel in gastric cancer. N Engl J Med. Published online 2025 May 31;393(4):336–348. 6. Rob H A Verhoeven, Steven C Kuijper, Florian Lordick, et al. Trastuzumab Deruxtecan Versus Ramucirumab-Paclitaxel as Second-Line Therapy for Patients With HER2-Positive Gastric or GEJ Adenocarcinoma. J Natl Compr Canc Netw. 2025 Sep 11;23(10):e257058. 邱妙珍教授中山大学肿瘤防治中心中山大学肿瘤医院内科主任医师、教授、博士生导师华南恶性肿瘤防治全国重点实验室PI教育部青年长江学者四大慢病科技重大专项项目负责人广东省自然科学杰出青年基金获得者入选2024/2025全球前2%顶尖科学家“年度科学影响力排行榜”主持科技重大专项、国自然面上等国家级和省部级基金12项荣获国家科技进步二等奖和省部级科技进步一等奖等奖项5项在BMJ、Nature Medicine、JAMA Oncol、Signal Transduct Target Ther等杂志发表第一/通讯作者SCI论文90余篇，H-index 48美国约翰霍普金斯大学博士后ESMO Merit Award获得者美中抗癌协会 & 亚州癌症研究基金获得者人民好医生（胃癌领域）金山茶花.杰出贡献奖CSCO胃癌专家委员会委员、CSCO胃癌指南撰写成员相关推荐 1 指南优解丨刘德林教授解读2026CSCO胃癌指南更新：HER2阳性胃癌二线治疗正式迈入抗HER2靶向时代 2 指南优解丨王峰教授：胃癌二线抗HER2治疗十年瓶颈破局：从化疗到ADC的范式转移 3 指南优解丨王育生教授：2026版CSCO胃癌指南二线抗HER2治疗更新解读 4 指南优解丨邓婷教授回顾胃癌抗HER2治疗史，见证T-DXd补全晚期抗HER2治疗版图 5 指南优解丨顾康生教授：CSCO指南抗HER2治疗新格局，规范落实晚期胃癌全程抗HER2治疗（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 项与德曲妥珠单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	德曲妥珠单抗	L01XC	DB14962

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阳性转移性乳腺癌	美国	Daiichi Sankyo, Inc.	2026-05-15
胃癌	印度	AstraZeneca PLC	2025-10-07
HER2阳性实体瘤	英国	Daiichi Sankyo UK Ltd.	2025-04-09
HR阳性/HER2低表达乳腺癌	美国	Daiichi Sankyo Co., Ltd.	2025-01-28
HR阳性/HER2阳性乳腺癌	韩国	Daiichi Sankyo Co., Ltd.	2022-09-19
HER2突变型非小细胞肺癌	美国	Daiichi Sankyo, Inc.	2022-08-11
HER2阳性胃腺癌	澳大利亚	AstraZeneca Pty Ltd.	2021-10-08
HER2低表达乳腺癌	澳大利亚	AstraZeneca Pty Ltd.	2021-10-08
转移性乳腺癌	加拿大	AstraZeneca Canada, Inc.	2021-04-15
HER2阳性胃食管结合部腺癌	美国	Daiichi Sankyo, Inc.	2021-01-15
HER2阳性胃癌	日本	Daiichi Sankyo Co., Ltd.	2020-09-25
HER2阳性乳腺癌	美国	Daiichi Sankyo, Inc.	2019-12-20

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
实体瘤	临床3期	美国	Daiichi Sankyo, Inc.	2025-12-23
实体瘤	临床3期	中国	Daiichi Sankyo, Inc.	2025-12-23
实体瘤	临床3期	日本	Daiichi Sankyo, Inc.	2025-12-23
实体瘤	临床3期	澳大利亚	Daiichi Sankyo, Inc.	2025-12-23
实体瘤	临床3期	巴西	Daiichi Sankyo, Inc.	2025-12-23
实体瘤	临床3期	法国	Daiichi Sankyo, Inc.	2025-12-23
实体瘤	临床3期	以色列	Daiichi Sankyo, Inc.	2025-12-23
实体瘤	临床3期	意大利	Daiichi Sankyo, Inc.	2025-12-23
实体瘤	临床3期	韩国	Daiichi Sankyo, Inc.	2025-12-23
实体瘤	临床3期	西班牙	Daiichi Sankyo, Inc.	2025-12-23

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临床结果

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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


NCT07151586 (ALTER, AACR2026)	临床2期	三阴性乳腺癌 HER2-low	260	Alternating sacituzumab-govitecan and trastuzumab-deruxtecan	獵窪顧鬱襯壓齋遞醖鏇(遞膚觸選簾襯糧鹽淵遞) = 衊夢蓋積壓憲餘窪膚築顧範觸鹹壓醖夢鏇遞齋 (觸醖顧獵窪膚鑰繭鹽構 ) 更多	积极	2026-04-21
				Sacituzumab-govitecan	獵窪顧鬱襯壓齋遞醖鏇(遞膚觸選簾襯糧鹽淵遞) = 艱簾淵鏇製醖餘憲餘淵顧範觸鹹壓醖夢鏇遞齋 (觸醖顧獵窪膚鑰繭鹽構 ) 更多
NCT04379596 (DESTINY-Gastric03, AACR2026)	临床1/2期	食管腺癌 \| HER2阳性胃癌 \| 胃食管交界处腺癌一线 HER2-positive	30	trastuzumab deruxtecan + rilvegostomig + fluoropyrimidine (HER2-positive gastric cancer, gastroesophageal junction adenocarcinoma, or esophageal adenocarcinoma)	顧繭遞繭廠簾壓壓窪鏇(餘鬱範醖餘選遞築築齋) = 鬱積顧淵構築齋憲繭築願齋齋鹹廠鏇願壓窪顧 (餘鏇壓繭簾選壓鏇壓壓 ) 更多	积极	2026-04-21
AACR2026	N/A	HER2阳性卵巢癌 \| HER2表达子宫内膜癌 HER2 expressing	33	Trastuzumab deruxtecan	餘鹽願蓋構鹽淵蓋繭醖(製襯鹹積構憲構願築淵) = 鹽簾繭鬱膚積繭選獵憲醖蓋積鏇醖鏇糧願鬱蓋 (夢築襯簾鑰壓醖鑰憲繭 ) 更多	积极	2026-04-20
				Trastuzumab deruxtecan (Ovarian cancer)	餘鹽願蓋構鹽淵蓋繭醖(製襯鹹積構憲構願築淵) = 構網憲網願積簾餘鬱鬱醖蓋積鏇醖鏇糧願鬱蓋 (夢築襯簾鑰壓醖鑰憲繭 ) 更多
AACR2026	N/A	转移性结直肠癌二线 HER2-amplified \| MSS	3,734	trastuzumab deruxtecan	壓願夢獵顧繭願齋鬱廠(糧觸構壓夢憲築衊淵觸): HR = 1.14 (95.0% CI, 1.05 ~ 1.24), P-Value = 0.0024 更多	积极	2026-04-19
				Standard Chemotherapy
ESMO_ELCC2026	N/A	转移性非小细胞肺癌二线 ERBB2 altered	5	Trastuzumab deruxtecan	鏇糧襯簾齋願製鏇襯製(齋憲糧製遞鏇觸鏇窪鏇) = No ILD/pneumonitis 鹹簾糧選繭襯鬱糧繭鑰 (淵願鬱襯鑰鬱蓋繭範淵 ) 更多	积极	2026-03-25
ESMO_TAT2026	N/A	HER2-positive \| ERBB2-mutated	61	Trastuzumab deruxtecan (ERBB2 mutations)	鹹選鹹廠鹽網製獵顧範(簾夢鹽淵鹹願獵夢構齋) = 衊鏇願顧夢選餘膚築糧襯選觸廠衊願製築膚糧 (鹽艱網鹽鹽鹽衊襯鏇觸 ) 更多	积极	2026-03-16
				Trastuzumab deruxtecan (HER2 IHC 3+)	鹹選鹹廠鹽網製獵顧範(簾夢鹽淵鹹願獵夢構齋) = 夢淵獵鹽憲鹹範鏇選憲襯選觸廠衊願製築膚糧 (鹽艱網鹽鹽鹽衊襯鏇觸 ) 更多
NCT05744375 (TRANSCENDER, CTgov)	临床2期	局部晚期乳腺癌 \| HER2阳性转移性乳腺癌	2	Trastuzumab deruxtecan	築夢廠廠壓蓋艱壓憲觸 = 鹹艱齋鬱獵鹽鹹廠淵製簾蓋選鹹顧廠艱窪憲網 (築蓋獵鹽範鑰憲遞糧蓋, 鹹築糧齋廠夢鬱憲壓艱 ~ 積觸築壓蓋鹹顧鹽鬱壓) 更多	-	2026-03-12
ESMO_SRC2026	N/A	实体瘤	9	Trastuzumab deruxtecan	衊範鏇繭簾積鏇窪膚範(鹹願壓襯選艱醖蓋膚選) = 選齋範積壓遞鹽襯醖窪鏇艱夢襯壓膚廠鑰網鹹 (構襯積鹽壓構淵鹹觸鏇 )	积极	2026-03-09
NCT06989112 (DESTINY-Endometrial01, ESGO2026)	临床3期	复发性子宫内膜癌一线 HER2-expressing \| mismatch repair-proficient (pMMR)	600	trastuzumab deruxtecan + rilvegostomig	網齋顧製觸醖淵顧蓋網(積築憲網廠齋簾簾鹹網) = 餘範壓蓋選衊鏇鑰選遞廠壓構夢夢膚鑰鏇蓋範 (醖範鹹壓鑰餘膚遞夢範, 24.9 ~ NR) 更多	积极	2026-02-28
				trastuzumab deruxtecan + pembrolizumab	淵選艱蓋製鑰蓋構餘夢(顧壓衊選壓憲艱襯鏇製) = 夢壓膚鹹製觸襯淵糧簾廠窪鹽鹽窪鏇選壓餘醖 (窪獵積選醖顧網構鏇構, 8.3 ~ 16.5) 更多
NCT06610825 (CARPET, ASCO_GU2026)	临床2期	转移性去势抵抗性前列腺癌 HER2-positive (IHC 1+, 2+, or 3+)	5	trastuzumab deruxtecan	選築壓顧衊衊願願膚窪(醖艱繭衊淵壓醖膚網網) = 淵繭襯醖窪積廠鑰鬱選衊顧憲築簾齋鹹壓襯顧 (簾餘網遞願糧艱齋窪繭 ) 更多	积极	2026-02-26