This is a prospective, single-center, two-arm Phase 1 safety and feasibility trial evaluating anti-estrogen therapy in men age 50 years and older with symptomatic unilateral inguinal hernias. Participants will be randomized to receive Fulvestrant 250 mg intramuscularly or anastrozole 1 mg orally for 6 months. The study will evaluate safety, tolerability, feasibility, hormone changes, hernia size, patient-reported outcomes, bone density, and imaging-based hernia classification.

开始日期2026-10-02

申办/合作机构

Northwestern University

NCT07716046

/ Not yet recruiting临床2期IIT

Efficacy and Safety of Fulvestaciclib Combined With Anti-HER2 and Endocrine Therapy for First-line Maintenance or Upfront Chemo-Free Treatment in HR+/HER2+ Advanced Breast Cancer: A Multicenter, Open-label, Randomized Controlled Phase II Study

This phase II, multicenter, open-label, randomized controlled trial (FACET study) evaluates the efficacy and safety of fulvestaciclib, a novel oral CDK4/6 inhibitor, combined with anti-HER2 dual blockade (trastuzumab and pertuzumab, HP) and endocrine therapy (ET) in hormone receptor-positive (HR+) and HER2-positive advanced breast cancer (ABC).
Patients with HR+/HER2+ ABC without prior systemic therapy for advanced disease are randomized in a 1:1:1 ratio into three arms, stratified by visceral metastasis status (yes vs. no) and metastatic type (de novo vs. recurrent).
Arm A: After 4-8 cycles of induction chemotherapy (taxane) plus HP, patients receive fulvestaciclib + HP + ET as maintenance therapy.
Arm B: After 4-8 cycles of induction chemotherapy (taxane) plus HP, patients receive HP + ET alone (without fulvestaciclib) as maintenance therapy.
Arm C (exploratory): Patients receive upfront fulvestaciclib + HP + ET as first-line therapy without induction chemotherapy (chemo-free).
For premenopausal/perimenopausal patients, ovarian function suppression (OFS) is added in all arms. Treatment continues until disease progression, unacceptable toxicity, withdrawal of consent, or death.
The primary endpoint is investigator-assessed progression-free survival (PFS) comparing Arm A versus Arm B. Secondary endpoints include PFS (Arm A vs. Arm C), overall survival (OS), objective response rate (ORR), clinical benefit rate (CBR), duration of response (DoR), cumulative incidence of central nervous system (CNS) metastases, safety, and patient-reported outcomes (PROs).

开始日期2026-10-01

申办/合作机构

复旦大学

[+1]

NCT07391774

/ Recruiting临床3期IIT

A Phase III Trial of Rx Therapy Guided by Genomic Risk Assessment For High Anatomic Stage ER-pos/HER2-neg Breast Cancer With RS Less Than or Equal to 25 (RxFINE-Low)

This phase III trial compares standard of care hormone therapy plus ribociclib to chemotherapy followed by hormone therapy plus ribociclib for the treatment of patients with high anatomic stage breast cancer with low risk of the cancer returning (low risk recurrence). Ribociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Hormone therapy, with letrozole, anastrozole or exemestane, lowers the amount of estrogen made by the body. This may help stop the growth of tumor cells that need estrogen to grow. 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. Hormone therapy plus ribociclib may work as well as chemotherapy followed by hormone therapy plus ribociclib for the treatment of high anatomic stage breast cancer with low recurrence risk.

开始日期2026-08-10

申办/合作机构

National Cancer Institute

100 项与阿那曲唑相关的临床结果

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100 项与阿那曲唑相关的转化医学

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100 项与阿那曲唑相关的专利（医药）

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2,887

项与阿那曲唑相关的文献（医药）

2026-12-01·Case reports in women's health

Advanced vulvar adenocarcinoma of mammary gland type: a case report

Article

作者: Levin, Lane ; Reeson, Monica ; Hoekstra, Anna

Vulvar adenocarcinoma of mammary gland type (AMGT) is a rare, locally aggressive neoplasm of anogenital mammary-like glands that mimics the histologic and immunophenotypic features of breast carcinoma. Fewer than 60 cases have been described in the literature since the first documented case in 1936. The extreme rarity and resemblance to breast carcinoma complicate diagnosis and treatment. This report presents a case of AMGT in a 61-year-old woman who presented with a palpable, subcutaneous lesion of the lateral mons pubis and labia minora. Initial biopsy identified the lesion as metastatic carcinoma, but immunohistochemical (IHC) analysis and PET/CT indicated a vulvar adenocarcinoma with local nodal metastasis. Aggressive management with radical vulvectomy and bilateral inguinofemoral lymphadenectomy with thorough specimen evaluation by surgical pathology led to the final diagnosis of AMGT TNM stage pT1bpN2cM0 and vulvar FIGO Stage IIIC. IHC staining identified the tumor as ER, PR, and 3+ HER2 positive. Breast cancer treatment guidelines informed the ultimate systemic therapy regimen of docetaxel, carboplatin, trastuzumab, and pertuzumab. Maintenance therapy with trastuzumab and anastrozole was utilized. The patient remained in remission from AMGT 24 months following completion of chemotherapy. While the diagnosis of AMGT poses a unique challenge, IHC staining and imaging to rule out metastatic carcinoma can support the ultimate diagnosis. The sustained remission in this case supports the extrapolation of treatment from vulvar and breast cancer guidelines. Additionally, this case suggests the utility of hormone receptor- and HER2-targeted therapies for systemic treatment.

2026-10-05·Cureus Journal of Medical Science

Real-World Effectiveness, Safety, and Tolerability of Adjuvant CDK4/6 Inhibitor Therapy

Article

作者: Patel, Apurva ; Shah, Kajal ; Yadav, Rajan ; Panchal, Harsha P

BACKGROUND:

This study evaluates the real-world effectiveness, safety, and tolerability of adjuvant abemaciclib or ribociclib combined with a non-steroidal aromatase inhibitor (NSAI) in high-risk hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) early breast cancer in Western India.

METHODS:

We conducted a retrospective, single-institution study at The Gujarat Cancer and Research Institute (GCRI) in Ahmedabad, India, evaluating high-risk, stage II or III HR+/HER2- early breast cancer patients treated between November 2021 and May 2026. A total of 418 patients were evaluated across three groups: Group 1 received abemaciclib (150 mg twice daily for two years) plus NSAI (letrozole or anastrozole) (n = 138); Group 2 received ribociclib (400 mg daily, three weeks on, one week off for three years) plus NSAI (letrozole or anastrozole) (n = 138); and Group 3 received NSAI (letrozole or anastrozole) alone for ≥ 5 years (n = 142). The primary endpoint was invasive disease-free survival (iDFS), and secondary endpoints included overall survival (OS) and safety.

RESULTS:

Baseline characteristics were well-balanced across all three groups, with approximately three-quarters of the patients presenting with advanced stage III disease (77.8%, n=325/418). Adjuvant CDK4/6 inhibitor therapy significantly improved iDFS compared to NSAI alone. Abemaciclib plus NSAI (Group 1) was associated with an approximately 50% relative hazard reduction for an iDFS event compared to NSAI alone (HR 0.50; 95% CI, 0.27-0.91; p = 0.023). Ribociclib plus NSAI (Group 2) demonstrated a 48% relative hazard reduction compared to NSAI alone (HR 0.52; 95% CI, 0.29-0.93; p = 0.027). The estimated two-year iDFS rates were 93.5% (n = 129/138) in Group 1, 88.4% (n = 122/138) in Group 2, and 78.2% (n = 111/142) in Group 3. After applying a Bonferroni correction (α = 0.025), the iDFS benefit remained statistically significant for abemaciclib (p = 0.023), whereas ribociclib (p = 0.027) demonstrated a strong numerical trend that did not meet the adjusted threshold. Overall survival was not estimable due to insufficient events. Adverse events were consistent with established safety profiles: diarrhea was the most frequent adverse event in Group 1 (78.2%, n = 108/138), whereas neutropenia (63.0%, n = 87/138) and arthralgia (71.0%, n = 98/138) were prominent in Group 2. Permanent treatment discontinuation due to adverse events occurred in 13.8% (19/138) of patients in Group 1 and 13% (18/138) in Group 2.

CONCLUSION:

In this retrospective non-randomized study, adding adjuvant abemaciclib or ribociclib to NSAI therapy was associated with two-year iDFS improvements in high-risk HR+/HER2- early breast cancer. However, after Bonferroni correction, the iDFS benefit remained statistically significant for abemaciclib and did not remain statistically significant for ribociclib. The therapies proved highly feasible and manageable in routine clinical practice.

2026-10-01·TISSUE & CELL

Dose-dependent neurotoxic effects of anastrozole via disrupting NLRP3 inflammasome and α-synuclein pathways

Article

作者: Alkhoshaiban, Abdulaziz Saleh ; Alzahrani, Khalid J ; Alghamdi, Amani ; Alzahrani, Fuad M ; Jamil, Salim ; Hassan, Hesham M ; Azmat, Muhammad Bilal ; Alsharif, Khalaf F

Anastrozole (ANZ) is a commonly used aromatase inhibitor in the treatment of hormone-dependent breast cancer. Despite its toxicity profile reported in different studies, the neurotoxic effects against this drug have not been explored yet. The present study was aimed at investigating the neurotoxic effects of ANZ in Sprague Dawley rats using comprehensive biochemical, molecular and histopathological analysis. Rats were divided into control and ANZ treated (0.1, 0.2 and 0.5 mg/ kg) doses. It was found that ANZ intoxication promoted the gene expression of NLRP3, PYCARD, CASP1, IL1-β, IL18, TXNIP, SNCA, and LRRK2 while suppressing the expression of PARK2, PINK1, PARK7 and UCHL1 in dose dependent manner. Moreover, ANZ exposure significantly reduced the antioxidant defense systems as shown by reduction in the activities of catalase (CAT), superoxide dismutase (SOD), glutathione reductase (GSR), glutathione-peroxidase (GPx) and heme oxygenase-1 (HO-1) coupled with elevated levels of malondialdehyde (MDA) and reactive oxygen species (ROS). Similarly, ANZ administration showed marked reductions in the levels of BDNF, NGF, GDNF PSD-95, and synaptophysin while increasing the levels of NF-κB, COX-2, TNF-α, IL-1β, and IL-6. Nonetheless, ANZ exposure provoked the levels of Caspase-9, Bax, and Caspase-3 while inhibiting the levels of Bcl-2. Histological examination confirmed the dose-dependent neuronal degeneration such as vacuolization, pyknosis and structural disorganization. Collectively, these results showed that ANZ causes significant neurotoxicity due to oxidative stress, inflammation, and apoptosis resulting in neuronal survival and function dysfunction. This study shows the importance of careful therapeutic use of ANZ and laid down the foundation for further research on the neurological safety profile of ANZ.

453

项与阿那曲唑相关的新闻（医药）

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。

2026-10-22

·第一三共中国

第一三共在ESMO大会发布最新研究进展，展现行业领先ADC管线的持续突破

免责声明：本新闻稿仅供医学药学专业人士阅读，文中内容不涉及任何处方药推广。本新闻稿中涉及未在中国获批的适应症，第一三共不推荐任何未获批药品或适应症的使用。本新闻稿内容仅作为第一三共最新研究成果分享，不代表任何对我司药品的承诺。 ●六项里程碑研究的最新数据进一步证实了德曲妥珠单抗与德达博妥单抗在乳腺癌和肺癌广泛患者人群中有望改变临床实践的治疗价值 ●两项R-DXd卵巢癌研究的最新分析显示，该药物在妇科肿瘤领域展现出新兴潜力东京—（2026年10月22日）—第一三共（东京证券交易所代码：4568）将在2026 年欧洲肿瘤内科学会（#ESMO26）大会上，通过 30 余篇摘要（其中包括 4 项最新突破性报告）展示其肿瘤管线在多种癌症中的最新临床研究数据。六项里程碑研究的最新数据体现了公司在为乳腺癌和肺癌患者推动新治疗标准方面取得的进展，包括 DESTINY-Breast05（539RO）、DESTINY-Breast06（4279P）、DESTINY-Breast09（LBA49)、DESTINY-Breast11（543RO）以及 DESTINY-Lung04（LBA74）等德曲妥珠单抗（优赫得®）III 期研究，以及 TROPION-Breast02（LBA96）——德达博妥单抗（达卓优®）的 III 期研究数据。 ESMO 大会上的其他数据还将彰显公司致力于为不同治疗线的晚期卵巢癌患者推进研究的承诺。基于REJOICE-Ovarian01（1331P）II/III 期研究的一项更新分析将报告无进展生存期和缓解持续时间结果，该研究评估R-DXd用于复发性铂耐药卵巢癌、原发性腹膜癌或输卵管癌患者。另有一场小型口头报告将介绍 REJOICE-Ovarian02（1247RO）Ib/II 期研究的初步结果，该研究评估R-DXd联合贝伐珠单抗用于铂耐药复发卵巢癌患者的表现。 John Tsai 医学博士第一三共全球研发负责人 R-DXd在卵巢癌中令人鼓舞的数据，以及我们整个管线所展现的强劲科学创新，体现了我们在为多种癌症患者推进研究方面取得的进展，第一三共将继续凭借其科学与技术专长，把科学转化为能够改变治疗标准的新药。数据彰显 DXd ADC 在脑转移患者中的获益本届大会将重点展示 DXd ADC 在脑转移患者中作用的最新研究，包括来自DESTINY-Breast09（LBA49）III 期研究，该研究评估德曲妥珠单抗联合帕妥珠单抗用于 HER2 阳性转移性乳腺癌患者的一线治疗，以及来自TROPION-Breast02（LBA96）III 期研究，该研究评估德达博妥单抗用于不适用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的一线治疗。此外，TUXEDO-3（690O）II 期研究的最终总生存结果将作为优选论文报告公布，该研究评估HER3-DXd用于转移性乳腺癌或晚期非小细胞肺癌活动性脑转移患者，或任何实体瘤的软脑膜转移患者。 DXd ADC产品组合：最新数据与在研试验展示展示 DXd ADC 管线最新研究的其他数据将以口头报告和壁报形式呈现，其中包括TALENT（LBA23）II 期研究的最终结果，该研究评估德曲妥珠单抗单药、联合阿那曲唑或序贯化疗用于 HR 阳性、HER2 低表达早期乳腺癌患者的新辅助治疗。非小细胞肺癌（NSCLC）领域的新数据还包括 NeoCOAST-2（4244RO）II 期研究报告的无事件生存结果，以及在可切除早期非小细胞肺癌患者中 ctDNA 清除与临床结局相关性的研究结果（这些患者接受德达博妥单抗联合度伐利尤单抗及化疗治疗），同时还包括 TROPION-Lung01（4551P）III 期研究中对晚期非小细胞肺癌患者亚组德达博妥单抗载荷不敏感机制的回顾性分析。此外，还将公布 EPOC2003（2888P）II 期研究的更新结果，该研究评估新辅助化疗联合德曲妥珠单抗和度伐利尤单抗用于 HER2 阳性胃癌患者；以及在黑色素瘤患者中评估HER3-DXd单药治疗的 HERTHENA-PanTumor01（2073RO）II 期研究的主要分析结果。在研研究壁报包括一项全球性、干预性、开放标签研究（DESTINY-Breast Guide，1795TiP），评估德曲妥珠单抗联合帕妥珠单抗为基础序贯哌柏西利、内分泌治疗及双重HER2阻断维持用于HER2阳性、HR阳性晚期或转移性乳腺癌的一线治疗，以及维持治疗进展后 T-DXd 再治疗；以及 TROY（1335TiP）II 期研究，该研究评估德曲妥珠单抗用于既往接受 PARP 抑制剂治疗后疾病进展的复发性卵巢癌患者。第一三共 ADC 管线的最新突破性研究、临床数据及在研研究（TiP）报告概览如下：　　　关于第一三共 ADC 管线　第一三共的ADC产品组合包括9款处于临床开发阶段的ADC，这些ADC基于第一三共开发的两个ADC技术平台。第一三共的DXd ADC技术平台拥有7个处于临床开发阶段的ADC药物，每款ADC药物由单克隆抗体通过可裂解四肽连接子与多个拓扑异构酶I抑制剂有效载荷（一种依喜替康衍生物，DXd）连接组成。目前DXd ADC产品组合包括：T-DXd和Dato-DXd，由第一三共与阿斯利康共同开发并在全球范围内商业化；I-DXd、R-DXd和HER3-DXd由第一三共与默沙东共同开发并在全球范围内商业化；DS-3939 和DS3790由第一三共开发。第一三共正在研发的ADC药物还包括DS3610和DS1025，其中，DS3610由抗体与一种新型免疫调节有效载荷连接组成，可作为STING激动剂发挥作用；DS1025由靶向CD25的抗体与肿瘤免疫型细胞毒性载荷连接而成。 I-DXd、R-DXd 、 HER3-DXd 、DS-3939、DS3610、DS3790和DS-1025均为在研药物，尚未在任何国家/地区获批用于任何适应症。尚未完全确定安全性和疗效。关于第一三共　　　　　第一三共是一家全球医疗保健公司，致力于成为值得信赖的医疗创新引领者，依托其科学和技术优势改变人们的生活。公司专注于发现和开发新的标准疗法，以满足多样化的医疗需求，践行其为提高世界各地患者的生活质量做出贡献的宗旨。第一三共战略聚焦肿瘤领域，着力打造卓越的抗体偶联药物（ADC）产品组合，并不懈探索突破性前沿技术，旨在为患者、医疗卫生专业人士和社会带来变革临床实践的创新药物。更多信息，请访问www.daiichisankyo.com。参考文献： 1 LBA23 https://cslide.ctimeetingtech.com/esmo2026/attendee/confcal/show/session/240 2 LBA96 https://cslide.ctimeetingtech.com/esmo2026/attendee/confcal/show/session/254 3 LBA74 https://cslide.ctimeetingtech.com/esmo2026/attendee/confcal/show/session/255 4 LBA49 https://cslide.ctimeetingtech.com/esmo2026/attendee/confcal/show/session/287 5 543RO https://cslide.ctimeetingtech.com/esmo2026/attendee/confcal/show/session/248 6 539RO https://cslide.ctimeetingtech.com/esmo2026/attendee/confcal/show/session/248 7 4449RO https://cslide.ctimeetingtech.com/esmo2026/attendee/confcal/show/session/287 8 4279P https://cslide.ctimeetingtech.com/esmo2026/attendee/confcal_1/presentation/list?r=pt~75 9 1771P https://cslide.ctimeetingtech.com/esmo2026/attendee/confcal_1/presentation/list?r=pt~77 10 12P https://cslide.ctimeetingtech.com/esmo2026/attendee/confcal_1/presentation/list?r=pt~76 11 287P https://cslide.ctimeetingtech.com/esmo2026/attendee/confcal_1/presentation/list?r=pt~71 12 1795TiP https://cslide.ctimeetingtech.com/esmo2026/attendee/confcal_1/presentation/list?r=pt~77 13 4244RO https://cslide.ctimeetingtech.com/esmo2026/attendee/confcal/show/session/269 14 4551P https://cslide.ctimeetingtech.com/esmo2026/attendee/confcal_1/presentation/list?r=pt~75 15 3842P https://cslide.ctimeetingtech.com/esmo2026/attendee/confcal_1/presentation/list?r=pt~69 16 1247RO https://cslide.ctimeetingtech.com/esmo2026/attendee/./show/session/257 17 1331P https://cslide.ctimeetingtech.com/esmo2026/attendee/confcal_1/presentation/list?r=pt~34 18 1335TiP https://cslide.ctimeetingtech.com/esmo2026/attendee/confcal_1/presentation/list?r=pt~34 19 2925P https://cslide.ctimeetingtech.com/esmo2026/attendee/confcal_1/presentation/list?r=pt~43 20 2888P https://cslide.ctimeetingtech.com/esmo2026/attendee/confcal_1/presentation/list?r=pt~43 21 690O https://cslide.ctimeetingtech.com/esmo2026/attendee/confcal/show/session/273 22 2073RO https://cslide.ctimeetingtech.com/esmo2026/attendee/confcal/show/session/274 23 1014P https://cslide.ctimeetingtech.com/esmo2026/attendee/confcal_1/presentation/list?r=pt~8

2026-10-22

·BioSpace

Daiichi Sankyo Highlights Ongoing Progress Across Industry-Leading ADC Portfolio with New Research Updates at ESMO

New data from six landmark trials reinforce practice-changing results of Enhertu and Datroway across a broad spectrum of patients in breast and lung cancer Additional analyses from two trials of raludotatug deruxtecan in ovarian cancer demonstrate emerging potential in gynecological cancers TOKYO--(BUSINESS WIRE)--Daiichi Sankyo (TSE: 4568) will present new clinical research across its oncology portfolio with more than 30 abstracts, including four late breaking presentations, in multiple cancers at the 2026 European Society for Medical Oncology (#ESMO26) Congress. New data from six landmark trials demonstrate the company’s progress toward advancing new standards of care for patients in breast and lung cancer, including the DESTINY-Breast05 ( 539RO ), DESTINY-Breast06 ( 4279P ), DESTINY-Breast09 ( LBA49 ), DESTINY-Breast11 ( 543RO ) and DESTINY-Lung04 ( LBA74 ) phase 3 trials of Enhertu ® (trastuzumab deruxtecan) and the TROPION-Breast02 ( LBA96 ) phase 3 trial of Datroway ® (datopotamab deruxtecan). Additional data at ESMO also will spotlight the company’s commitment to advancing research for patients with advanced ovarian cancer across lines of therapy. An updated analysis, including progression-free survival and duration of response, will be presented from the REJOICE-Ovarian01 ( 1331P ) phase 2/3 trial evaluating raludotatug deruxtecan (R-DXd) in patients with platinum-resistant ovarian cancer. A mini oral presentation will highlight preliminary findings from the REJOICE-Ovarian02 ( 1247RO ) phase 1b/2 trial evaluating raludotatug deruxtecan in combination with bevacizumab in patients with platinum-resistant ovarian cancer. “The promising data for raludotatug deruxtecan in ovarian cancer and the robust scientific innovation demonstrated across our pipeline reflects our progress in advancing research for patients across multiple types of cancer,” said John Tsai, MD, Global Head, R&D, Daiichi Sankyo. “Daiichi Sankyo continues to draw from its scientific and technological expertise to turn science into new medicines that can change the standard of care.” Data Demonstrate Benefit of DXd ADCs in Patients with Brain Metastases Research updates highlighting the impact of DXd ADCs in patients with brain metastases include late-breaking rapid oral and proffered paper presentations from the DESTINY-Breast09 ( LBA49 ) phase 3 trial evaluating Enhertu in combination with pertuzumab as a first-line treatment for patients with HER2 positive metastatic breast cancer and the TROPION-Breast02 ( LBA96 ) phase 3 trial evaluating Datroway as a first-line treatment for patients with locally recurrent inoperable or metastatic triple negative breast cancer for whom immunotherapy was not an option. Final overall survival results of the TUXEDO-3 ( 690O ) phase 2 trial of patritumab deruxtecan (HER3-DXd) in patients with active brain metastases from metastatic breast cancer, advanced non-small cell lung cancer (NSCLC) or leptomeningeal disease from any solid tumor will be presented as a proffered paper. New Data and Trials-in-Progress Presentations Across DXd ADC Portfolio Additional data highlighting new research across the DXd ADC portfolio include oral and poster presentations, including final results of the TALENT ( LBA23 ) phase 2 trial of Enhertu alone or in combination with anastrozole, or in sequence with chemotherapy, as neoadjuvant treatment for patients with HR positive, HER2 low early stage breast cancer. New data in NSCLC include the NeoCOAST-2 ( 4244RO ) phase 2 trial reporting event-free survival results, as well as findings on the association of ctDNA clearance with clinical outcomes in patients with resectable, early stage NSCLC treated with a combination of Datroway plus durvalumab and chemotherapy, and a retrospective analysis evaluating mechanisms of insensitivity to the Datroway payload in subgroups of patients with advanced NSCLC in the TROPION-Lung01 ( 4451P ) phase 3 trial. Updated findings from the EPOC2003 ( 2888P ) phase 2 trial evaluating neoadjuvant chemotherapy in combination with Enhertu in patients with HER2 positive gastric cancer: results from ESPERANZA ( 1014P ), an external comparator study evaluating Enhertu versus real-world standard of care as a second line or later treatment for patients with HER2 IHC 3+ solid tumors; and, the primary analysis evaluating patritumab deruxtecan monotherapy in patients with melanoma in the HERTHENA-PanTumor01 ( 2073RO ) phase 2 trial also will be presented. Trials-in-progress poster presentations include the DESTINY-Breast Guide ( 1795TiP ) prospective and interventional trial evaluating first-line treatment with Enhertu plus pertuzumab followed by palbociclib, endocrine therapy and dual HER2 blockade (trastuzumab plus pertuzumab), as well as retreatment with Enhertu following progression on maintenance therapy (palbociclib, endocrine therapy and trastuzumab plus pertuzumab) in previously untreated patients with HER2 positive advanced or metastatic breast cancer and the TROY ( 1335TiP ) phase 2 trial evaluating Enhertu in patients with recurrent ovarian cancer with disease progression on prior PARP inhibitor therapy. An overview of late-breaking, clinical data and trials-in-progress presentations from the ADC portfolio of Daiichi Sankyo includes: Presentation Title Author Abstract Presentation (CEST) LBAs 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 S. Hurvitz LBA23 Proffered Paper Presentation Friday, October 23 1:30 pm – 3:00 pm First-line datopotamab deruxtecan (Dato-DXd) vs. chemotherapy in patients with locally recurrent inoperable or metastatic triple negative breast cancer for whom immunotherapy was not an option: exploratory analysis of patients with brain metastases in TROPION-Breast02 R. Dent LBA96 Proffered Paper Presentation Saturday, October 24 8:30 am – 10:00 am First-line trastuzumab deruxtecan (T-DXd) in patients with HER2-mutant NSCLC: patient-reported outcomes from DESTINY-Lung04 S. Novello LBA74 Rapid Oral Presentation Saturday, October 24 8:30 am – 10:00 am DESTINY-Breast09 analysis of trastuzumab deruxtecan (T-DXd) + pertuzumab vs taxane + trastuzumab + pertuzumab for patients with HER2+ advanced/metastatic breast cancer and baseline brain metastases C. Saura LBA49 Rapid Oral Presentation Monday, October 26 10:15 am – 11:45 am Breast DESTINY-Breast11: MRI-assessed objective responses during neoadjuvant treatment with trastuzumab deruxtecan (T-DXd) followed by paclitaxel + trastuzumab + pertuzumab vs. dose-dense doxorubicin + cyclophosphamide followed by THP in HER2+ early breast cancer J.F. Boileau 543RO Rapid Oral Presentation Friday, October 23 4:15 pm – 5:45 pm Patient-reported outcomes from DESTINY-Breast05: health-related quality of life with trastuzumab deruxtecan (T-DXd) versus trastuzumab emtansine (T-DM1) in patients with high-risk HER2 positive early breast cancer C. Barrios 539RO Rapid Oral Presentation Friday, October 23 4:15 pm – 5:45 pm Paired-biopsy multi-omic analysis reveals target-independent mechanisms of antibody-drug conjugate resistance in metastatic breast cancer P. Tarantino 4449RO Rapid Oral Presentation Monday, October 26 10:15 am – 11:45 am Trastuzumab deruxtecan (T-DXd) vs. physician’s choice of chemotherapy in HR+, HER2 low metastatic breast cancer: a DESTINY-Breast06 ctDNA molecular response analysis G. Curigliano 4279P Poster Presentation Friday, October 23 3:15 pm – 4:00 pm Trastuzumab deruxtecan (T-DXd) + pembrolizumab in previously treated human epidermal growth factor receptor 2-expressing advanced or metastatic breast cancer: primary analyses of the breast cohorts from the open-label, multicenter, phase 1b study DS8201-A-U106 H. Rugo 1771P Poster Presentation Saturday, October 24 12:00 pm – 12:45 pm DESTINY-Breast Respond HER2 low Europe non-interventional study of trastuzumab deruxtecan (T-DXd) in HER2 low metastatic breast cancer: update on baseline characteristics and anti-emetic treatment J.Y. Pierga 12P Poster Presentation Saturday, October 24 12:00 pm – 12:45 pm Improving accuracy in HER2 ultralow identification: multi-site validation of an AI-decision support tool B. Van der Vegt 1784P Poster Presentation Saturday, October 24 12:00 pm – 12:45 pm Comparative evaluation of 7 artificial intelligence tools for HER2-low and ultralow scoring in breast cancer J.S. Frenel 287P Poster Presentation Sunday, October 25 12:00 pm – 12:45 pm A global, interventional, open-label trial of trastuzumab deruxtecan (T-DXd)-based therapy followed by palbociclib, endocrine therapy, and dual HER2 blockade in first-line human epidermal growth factor receptor positive, hormone receptor-positive advanced or metastatic breast cancer and retreatment with T-DXd (DESTINY-Breast Guide) S. Sammons 1795TiP Poster Presentation Saturday, October 24 12:00 pm – 12:45 pm Lung NeoCOAST-2: association of ctDNA clearance with clinical outcomes in a global platform phase 2 perioperative trial T. Cascone 4244RO Rapid Oral Presentation Sunday, October 25 8:30 am – 10:00 am Mechanisms of insensitivity to the datopotamab deruxtecan (Dato-DXd) payload in subgroups of patients with advanced non-small cell lung cancer in TROPION Lung01 N. Girard 4451P Poster Presentation Friday, October 23 3:15 pm – 4:00 pm Ifinatamab deruxtecan (I-DXd) in extensive-stage small cell lung cancer: IDeate-Lung01 updated results M. Ahn 3842P Poster Presentation Monday, October 26 12:00 pm – 12:45 pm Ovarian Raludotatug deruxtecan (R-DXd) + bevacizumab in participants with platinum-resistant recurrent ovarian cancer: results for cohort B-1 of the phase 1b/2 REJOICE-Ovarian02 study A. Oaknin 1247RO Rapid Oral Presentation Saturday, October 24 08:30 am – 10:00 am Raludotatug deruxtecan (R-DXd) in patients with platinum-resistant ovarian cancer: an updated analysis of efficacy and tolerability from the phase 2 part of REJOICE-Ovarian01 K. Hasegawa 1331P Poster Presentation Monday, October 26 12:00 pm – 12:45 pm A randomized phase 2, open-label, multicenter, study of trastuzumab deruxtecan versus investigator’s choice chemotherapy in recurrent ovarian cancer that progressed on prior PARP inhibitor therapy: TROY (APGOT-OV14) J.Y. Lee 1335TiP Poster Presentation Monday, October 26 12:00 pm – 12:45 pm Gastric Quality-adjusted time without symptoms or toxicity (Q-TWiST) of trastuzumab deruxtecan (T-DXd) vs ramucirumab plus paclitaxel in second-line treatment of patients with HER2+ unresectable/metastatic gastric cancer/gastroesophageal junction adenocarcinoma from DESTINY-Gastric04 M. Gumus 2925P Poster Presentation Sunday, October 25 12:00 pm – 12:45 pm Perioperative trastuzumab deruxtecan plus capecitabine and durvalumab in HER2 positive gastric or gastroesophageal junction cancer: a phase II study (EPOC2003) D. Takahari 2888P Poster Presentation Sunday, October 25 12:00 pm – 12:45 pm PanTumor Final results of the TUXEDO-3 phase II trial of patritumab deruxtecan (HER3-DXd) in active brain metastases and leptomeningeal disease M. Preusser 690O Proffered Paper Presentation Sunday, October 25 10:15 am – 11:45 am Patritumab deruxtecan (HER3-DXd) in melanoma after anti-PD-(L)1 therapy: primary analysis from HERTHENA-PanTumor01 M. McKean 2073RO Rapid Oral Presentation Sunday, October 25 10:15 am – 11:45 am ESPERANZA: Results from an external comparator study of trastuzumab deruxtecan in HER2 IHC3+ solid tumors F. Meric-Bernstam 1014P Poster Presentation Friday, October 23 3:15 pm – 4:00 pm About the ADC Portfolio of Daiichi Sankyo The Daiichi Sankyo ADC portfolio consists of nine ADCs in clinical development crafted from ADC technology discovered in-house by Daiichi Sankyo. The DXd ADC Technology platform of Daiichi Sankyo consists of seven ADCs in clinical development where each ADC is comprised of a monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. The DXd ADCs include Enhertu and Datroway, which are being jointly developed and commercialized globally with AstraZeneca, and ifinatamab deruxtecan (I-DXd), raludotatug deruxtecan (R-DXd) and patritumab deruxtecan (HER3-DXd), which are being jointly developed and commercialized globally with Merck & Co., Inc, Rahway, NJ, USA. DS-3939 and DS3790 are being developed by Daiichi Sankyo. Additional ADCs being developed by Daiichi Sankyo include DS3610, which consists of an antibody attached to a novel payload that acts as an agonist of STING, and DS1025, which consists of a CD25 directed antibody attached to an immuno-oncology optimized cytotoxic payload. Ifinatamab deruxtecan, raludotatug deruxtecan, patritumab deruxtecan, DS-3939, DS3610, DS3790 and DS1025 are investigational medicines that have not been approved for any indication in any country. Safety and efficacy have not been established. About Daiichi Sankyo Daiichi Sankyo (TSE: 4568) is a global healthcare company committed to becoming a trusted healthcare innovator, transforming the lives of people through its strength in science and technology. The company discovers and develops new standards of care to address diverse medical needs to fulfill its purpose of contributing to the enrichment of quality of life around the world. With a strategic focus on oncology, Daiichi Sankyo is advancing an industry-leading antibody drug conjugate portfolio along with identifying new breakthrough generating technologies to deliver practice-changing medicines to patients, healthcare professionals and society. For more information, please visit . Contacts MEDIA CONTACTS: Global: Jennifer Brennan Jennifer.brennan@daiichisankyo.com +1 908 900 3183 (mobile) Japan: DS-PR_jp@daiichisankyo.com INVESTOR RELATIONS CONTACT: DaiichiSankyoIR_jp@daiichisankyo.com

临床2期临床3期临床结果抗体药物偶联物免疫疗法

100 项与阿那曲唑相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D00960	阿那曲唑	L02BG03	DB01217

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
多发性骨纤维性发育不良	美国	Astrazeneca /Cr/	2008-12-05
男子乳腺发育	美国	Astrazeneca /Cr/	2008-12-05
乳腺癌	日本	AstraZeneca KK	2000-12-22
转移性乳腺癌	美国	ANI Pharmaceuticals, Inc.	2000-09-01
晚期乳腺癌	澳大利亚	AstraZeneca Pty Ltd.	1996-12-17
早期乳腺癌	澳大利亚	AstraZeneca Pty Ltd.	1996-12-17
局部晚期乳腺癌	美国	ANI Pharmaceuticals, Inc.	1995-12-27

未上市

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适应症	最高研发状态	国家/地区	公司	日期
局部晚期恶性肿瘤	临床3期	日本	AstraZeneca PLC	2012-11-07
转移性肿瘤	临床3期	日本	AstraZeneca PLC	2012-11-07
绝经前乳腺癌	临床3期	日本	AstraZeneca PLC	2007-10-01
复发性乳腺癌	临床3期	日本	Pfizer Inc.	2005-04-01
生长激素缺乏症	临床3期	美国	AstraZeneca PLC	2001-11-01
ER阳性乳腺癌	临床3期	美国	AstraZeneca PLC	2000-08-01
ER阳性乳腺癌	临床3期	日本	AstraZeneca PLC	2000-08-01
ER阳性乳腺癌	临床3期	比利时	AstraZeneca PLC	2000-08-01
ER阳性乳腺癌	临床3期	巴西	AstraZeneca PLC	2000-08-01
ER阳性乳腺癌	临床3期	加拿大	AstraZeneca PLC	2000-08-01

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临床结果

适应症

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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


NCT00541086 (GIM3 FATA, ESMO2026)	临床3期	早期乳腺癌辅助 HR-positive	3,697	Anastrozoletamoxifen (Upfront or after 2 years of tamoxifen)	鏇鏇憲觸憲夢願鹹積觸(簾築選構鹽淵簾窪顧選) = 範醖蓋願鹹窪願鹽膚憲艱鹹簾繭簾觸憲艱網衊 (願壓廠鏇醖餘觸夢衊築, 76.1 ~ 81.7)	不佳	2026-10-23
				Exemestanetamoxifen (Upfront or after 2 years of tamoxifen)	鏇鏇憲觸憲夢願鹹積觸(簾築選構鹽淵簾窪顧選) = 廠構衊膚壓餘構簾艱網艱鹹簾繭簾觸憲艱網衊 (願壓廠鏇醖餘觸夢衊築, 70.9 ~ 77.2)
NCT03490513 (CTgov)	临床4期	继发性睾丸衰竭 \| 肥胖	121	anastrozole (1 mg/day) (Anastrozole)	艱製醖襯衊鹽膚鏇鏇糧(膚網選獵壓觸網蓋選積) = 醖鏇窪鬱鏇觸壓範網襯顧築鹽觸餘鏇艱範夢蓋 (繭製襯齋醖齋鏇鬱壓窪, 120.0) 更多	-	2026-10-19
				Placebo (Placebo)	艱製醖襯衊鹽膚鏇鏇糧(膚網選獵壓觸網蓋選積) = 遞壓膚範醖範積製廠製顧築鹽觸餘鏇艱範夢蓋 (繭製襯齋醖齋鏇鬱壓窪, 85.2) 更多
NCT02188745 (POLLY, CTgov)	临床2期	ER阳性/HER2阴性乳腺癌 \| 转移性乳腺癌	20	letrozole+Exemestane+17B-estradiol+anastrozole	餘繭餘簾糧繭窪齋齋艱 = 衊艱製醖鹹艱齋鹽顧鑰鹹淵築獵構壓齋繭鹹積 (齋獵獵齋醖艱積選鏇鑰, 網蓋糧夢夢糧顧衊窪積 ~ 襯觸衊鏇觸構醖窪願窪) 更多	-	2026-09-25
NCT06253702 (CTgov)	临床4期	脑血管疾病	22	Orilissa+estradiol (Female Participants Placebo First)	範衊鬱齋簾衊願窪鏇憲(選襯鬱餘鏇醖憲夢積繭) = 獵齋艱鹹衊鏇艱鹽製網淵艱壓廠範艱鏇膚繭壓 (襯製糧齋餘廠範製願艱, 9.35) 更多	-	2026-09-24
				Orilissa+estradiol (Female Participants Indo First)	範衊鬱齋簾衊願窪鏇憲(選襯鬱餘鏇醖憲夢積繭) = 獵網鏇餘遞鹹製願網獵淵艱壓廠範艱鏇膚繭壓 (襯製糧齋餘廠範製願艱, 15.88) 更多
NCT00053898 (NSABP B-35, Pubmed \| JAMA Surg)	临床3期	非浸润性导管内癌 hormone receptor (HR)-positive	3,104	Tamoxifen	獵觸膚築衊顧膚膚壓繭(醖選構夢襯艱糧選獵夢) = 繭獵鑰窪繭膚壓夢遞築蓋衊齋積鹽範衊襯選糧 (鏇夢觸願窪繭艱憲艱餘 ) 更多	积极	2026-09-01
				Anastrozole	獵觸膚築衊顧膚膚壓繭(醖選構夢襯艱糧選獵夢) = 衊製艱遞壓鹹餘醖觸範蓋衊齋積鹽範衊襯選糧 (鏇夢觸願窪繭艱憲艱餘 ) 更多
NCT02206984 (P3-05-14 \| TBCRC037, CTgov)	临床2期	乳腺浸润性小叶癌	201	fulvestrant (Fulvestrant)	遞獵憲觸窪製蓋艱窪餘(積鹹繭餘願膚壓鬱範廠) = 遞蓋廠襯願範網淵鏇鹽觸積願襯繭鬱艱網製廠 (簾鑰獵願餘膚淵壓糧鑰, 1.1) 更多	-	2026-08-07
				anastrozole (Anastrozole)	遞獵憲觸窪製蓋艱窪餘(積鹹繭餘願膚壓鬱範廠) = 餘鏇觸遞選願鬱鏇網淵觸積願襯繭鬱艱網製廠 (簾鑰獵願餘膚淵壓糧鑰, 1.1) 更多
ESMO_GCC2026	临床2期	转移性子宫内膜恶性肿瘤 estrogen receptor-positive	29	Palbociclib and anastrozole	顧窪簾壓鏇齋壓醖廠艱(築醖鹹壓鹽積網衊願憲) = 積餘鑰鏇餘鑰構觸繭襯顧糧鹹醖遞憲鏇糧製觸 (顧繭鹽構壓願壓遞鏇淵 ) 更多	积极	2026-06-18
NCT02095184 (CTgov)	N/A	乳腺癌 \| 肥胖	42	anastrozole (Cohort 1: Normal Weight Anastrozole)	蓋夢願簾膚網糧蓋餘壓(鏇憲鹹淵壓選獵築鹽衊) = 願繭鑰夢製蓋選壓獵構鏇鏇蓋夢淵淵構鏇廠鑰 (廠膚範襯壓鑰繭夢鏇簾, 餘淵鬱製夢壓鹽鬱齋網 ~ 顧顧繭夢襯糧廠獵簾鹽) 更多	-	2026-04-15
				anastrozole (Cohort 2: Overweight Anastrozole)	蓋夢願簾膚網糧蓋餘壓(鏇憲鹹淵壓選獵築鹽衊) = 鹽顧襯餘鑰淵築築壓膚鏇鏇蓋夢淵淵構鏇廠鑰 (廠膚範襯壓鑰繭夢鏇簾, 遞鑰蓋構顧積選襯積餘 ~ 鏇遞窪鏇鑰簾繭願範觸) 更多
NCT04272801 (POWER, CTgov)	临床2期	早期乳腺癌	84	Patient reported outcomes+letrozole+tamoxifen+exemestane+anastrozole	膚鑰網糧憲鹽淵繭築選 = 夢蓋餘構鑰獵製襯糧膚廠構鏇蓋艱觸積觸築壓 (範獵簾憲齋壓糧蓋獵鏇, 鹹築廠範繭獵窪糧醖鑰 ~ 膚鹽鑰遞鹹鹽衊築夢鏇) 更多	-	2025-10-22
NCT02206984 (TBCRC037, ESMO2025)	-	HR阴性/HER2阳性乳腺癌 hormone receptor-positive \| HER2-negative	172	Fulvestrant	鑰窪築憲顧齋襯襯顧壓(淵積網獵鬱糧繭鏇夢窪): P-Value = 0.042	积极	2025-10-17
				Tamoxifen