A Phase IIIb Study to Characterize the Effectiveness and Safety of Adjuvant Ribociclib in a Wide Patient Population With HR+ HER2- Early Breast Cancer (Adjuvant WIDER)

An open-label, multicenter, phase IIIb, single-arm study to evaluate the safety and efficacy of the combination of ribociclib and standard adjuvant endocrine therapy (ET) on invasive breast cancer-free survival (iBCFS), in a wide patient population with HR-positive (HR+), HER2-negative (HER2-), Anatomic Stage Group III, II (subset) or I (high-risk subset as exploratory cohort) early Breast Cancer (EBC)

开始日期2025-04-30

申办/合作机构

Novartis Pharmaceuticals Corp.

NCT06492616 / Recruiting临床3期

Elacestrant Versus Standard Endocrine Therapy in Women and Men With Node-positive, Estrogen Receptor-positive, HER2-negative, Early Breast Cancer With High Risk of Recurrence-A Global, Multicenter, Randomized, Open-label Phase 3 Study

The primary goal of this study is to evaluate the effectiveness of elacestrant versus standard endocrine therapy in participants with node-positive, Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor-2 negative (HER2-) early breast cancer with high risk of recurrence.

开始日期2024-09-27

申办/合作机构

Stemline Therapeutics, Inc.

NCT06086704 / Recruiting临床2期

Phase II Study of 18F-FFNP Breast PET/MRI in the Assessment of Early Response of Breast Cancer to Presurgical Endocrine Therapy

This clinical trial will investigate an estrogen-regulated parameter as an early measure of endocrine therapy response: progesterone receptor (PR) protein with a progestin-based radioligand, 18F-fluorofuranylnorprogesterone (18F-FFNP). The overall purpose of this research is to test the efficacy of 18F-FFNP PET/MRI for predicting response to presurgical endocrine therapy and to determine the quantitative reliability of 18F-FFNP breast PET/MRI in patients with newly diagnosed PR+ primary breast cancer.

开始日期2024-09-25

申办/合作机构

University of Wisconsin Madison

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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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2,168

项与阿那曲唑相关的文献（医药）

2024-11-01·Breast Cancer Research and Treatment

Ovarian function recovery in breast cancer patients receiving adjuvant anastrozole treatment: updated results from the phase 3 DATA trial

Article

作者: Geurts, Sandra M. E. ; Imholz, Alexander L. T. ; Vriens, Ingeborg J. H. ; van der Sangen, Maurice J. C. ; Kroep, Judith R. ; van Hellemond, Irene E. G. ; Tjan-Heijnen, Vivianne C. G. ; de Roos, Wilfred K. ; on behalf of the Dutch Breast Cancer Research Group for the DATA investigators ; van den Berkmortel, Franchette W. P. J. ; Smorenburg, Carolien H. ; Lammers, Senna W. M. ; Hermans, Karlijn E. P. E. ; Swinkels, Astrid C. P. ; Honkoop, Aafke H.

AbstractPurposePatients with chemotherapy-induced ovarian function failure (CIOFF) may experience ovarian function recovery (OFR). Earlier, we showed that OFR during treatment with anastrozole impacted the prognosis of hormone receptor-positive (HR+) breast cancer (BC) patients with CIOFF. Here, we present the long-term follow-up results.MethodsPostmenopausal women with HR+ BC who were 45–57 years of age and received chemotherapy were identified from the phase 3 DATA study (NCT00301457) on the extended use of anastrozole. Eligible patients were categorised into two groups: patients with CIOFF and definitely postmenopausal patients. Patients with CIOFF were monitored for OFR. Disease-free survival (DFS), distant recurrence-free survival (DRFS), and overall survival (OS) were compared between patients with OFR and patients without OFR using multivariable Cox regression analyses, including OFR as a time-dependent covariate. BC-specific mortality (BCSM) was compared between groups using the Fine and Gray method.ResultsThis study included 656 patients: 395 patients with CIOFF and 261 definitely postmenopausal patients. OFR occurred in 39 (12%) of 329 patients with CIOFF who were monitored for OFR. The median follow-up time was 13.3 years. Patients with OFR experienced a deterioration in DFS (hazard ratio (HR) = 1.54; 95% confidence interval (CI) 0.85–2.81), DRFS (HR = 1.51; 95% CI 0.73–3.11), OS (HR = 1.64; 95% CI 0.75–3.55), and BCSM (subdistribution HR = 1.98; 95% CI 0.84–4.63) when compared with patients without OFR.ConclusionIn patients with CIOFF, OFR during treatment with anastrozole was associated with a deterioration in BC outcomes. These findings underscore the importance of adequate ovarian function suppression in this subgroup of patients.

2024-11-01·American Journal of Respiratory and Critical Care Medicine

Pulmonary Hypertension and Anastrozole (PHANTOM): A Randomized, Double-Blind, Placebo-Controlled Trial

Article

作者: Hemnes, Anna ; Austin, Eric ; Moutchia, Jude ; Shou, Haochang ; Ellenberg, Susan S. ; Chakinala, Murali ; Andrew, Ruth ; Song, Nianfu ; DeMichele, Angela ; Feng, Rui ; Stasinopoulos, Ioannis ; Doyle, Margaret ; Kawut, Steven M. ; Mathai, Stephen C. ; MacLean, Margaret ; Ventetuolo, Corey E. ; Minhas, Jasleen ; Zamanian, Roham ; Bull, Todd ; Lin, Grace

Rationale: Inhibition of aromatase with anastrozole reduces pulmonary hypertension in experimental models. Objectives: We aimed to determine whether anastrozole improved the 6-minute-walk distance (6MWD) at 6 months in pulmonary arterial hypertension (PAH). Methods: We performed a randomized, double-blind, placebo-controlled phase II clinical trial of anastrozole in subjects with PAH at seven centers. Eighty-four postmenopausal women with PAH and men with PAH were randomized in a 1:1 ratio to receive anastrozole 1 mg or placebo by mouth daily, stratified by sex using permuted blocks of variable sizes. All subjects and study staff were masked. The primary outcome was the change from baseline in 6MWD at 6 months. By intention-to-treat analysis, we estimated the treatment effect of anastrozole using linear regression models adjusted for sex and baseline 6MWD. Assuming 10% loss to follow-up, we anticipated having 80% power to detect a difference in the change in 6MWD of 22 meters. Measurements and Main Results: Forty-one subjects were randomized to placebo and 43 to anastrozole, and all received the allocated treatment. Three subjects in the placebo group and two in the anastrozole group discontinued the study drug. There was no significant difference in the change in 6MWD at 6 months (placebo-corrected treatment effect, -7.9 m; 95% confidence interval, -32.7 to 16.9; P = 0.53). There was no difference in adverse events between the groups. Conclusions: Anastrozole did not show a significant effect on 6MWD compared with placebo in postmenopausal women with PAH and in men with PAH. Anastrozole was safe and did not have adverse effects. Clinical trial registered with www.clincialtrials.gov (NCT03229499).

2024-11-01·Journal of Women's Health

Initiation of Oral Endocrine Therapy and Survival Benefit Among Women with Early-Stage Breast Cancer

Article

作者: Truong, Bang ; Qian, Jingjing

Introduction: Endocrine therapy (ET) is the cornerstone of systemic treatment for patients with estrogen receptor positive breast cancer, but its uptake and adherence need further improvement. This observational study assessed ET initiation and 1-year adherence and its survival benefit among female Medicare beneficiaries with early-stage breast cancer. Materials and Methods: This retrospective cohort study analyzed the linked 2011-2019 Surveillance, Epidemiology, and End Results-Medicare data. Female beneficiaries newly diagnosed with hormone receptor positive, stage I-III breast cancer were included. Beneficiaries who initiated tamoxifen, anastrozole, letrozole, or exemestane within 3 months after cancer diagnosis were defined as initiators (n = 24,289), and those who never initiated these treatments were noninitiators (n = 8,899). Adherence was measured using proportion of days covered (PDC) in the continuous 12 months follow-up period. Multivariable logistic regression models were used to assess factors associated with ET initiation and adherence (PDC ≥ 80%), controlling for covariates. Weighted Cox proportional hazard models were used to estimate hazard ratios (HRs) and 95% confidence intervals (CIs) of all-cause and breast cancer related mortality between initiators and noninitiators and by adherence status. Results: Among eligible female beneficiaries (n = 55,893), 43% initiated ET within 3 months of cancer diagnosis. Among initiators, 77% had PDC ≥ 80% during the first year. Patient's demographics (e.g., older age, race/ethnicity) and baseline health services utilization (e.g., mammography) were associated with ET initiation and adherence. ET initiation and adherence was associated with reduced risk of all-cause (adjusted HR = 0.62, 0.59-0.66; HR = 0.55, 0.53-0.59; respectively) and breast cancer related (adjusted HR = 0.57, 0.50-0.64; HR = 0.41, 0.36-0.47; respectively) mortality compared with noninitiators. Conclusion: Women with early-stage breast cancer who initiate ET and are adherent to treatment may achieve survival benefits compared with noninitiators.

156

项与阿那曲唑相关的新闻（医药）

2024-11-18

·恒瑞医药

2024 SABCS前瞻︱恒瑞医药创新药26项乳腺癌领域研究将闪耀国际学术盛会

2024年第47届圣安东尼奥乳腺癌研讨会（SABCS）将于12月10日至13日在美国圣安东尼奥举行。作为乳腺癌研究领域规模最大、最负盛名的学术盛会之一，SABCS旨在为国际学术界、医生和研究人员提供乳腺癌及癌前乳腺疾病的实验生物学、病因学、预防、诊断和治疗的最新相关信息。本次大会，恒瑞医药共有人表皮生长因子1/2/4（HER1/HER2/HER4）靶向药物吡咯替尼、CDK4/6抑制剂达尔西利、PD-1抑制剂卡瑞利珠单抗、多靶点受体酪氨酸激酶抑制剂法米替尼、TPO受体激动剂海曲泊帕、PARP抑制剂氟唑帕利、VEGFR2抑制剂阿帕替尼、HER2抗体偶联药物（ADC）SHR-A1811等8款创新药的26项研究入围[1]，其中3项口头报告，3项壁报焦点（Poster Spotlight），20项壁报展示。本文特做梳理，一同浏览恒瑞医药在乳腺癌领域的系列重磅创新成果。 1. 摘要号：GS3-06 文章题目：卡瑞利珠单抗联合化疗新辅助治疗早期或局部晚期三阴性乳腺癌：一项随机、双盲、III期试验 Neoadjuvant camrelizumab plus chemotherapy (chemo) for early or locally advanced triple-negative breast cancer (TNBC): a randomized, double-blind, phase 3 trial 汇报形式：口头报告作者：邵志敏单位：复旦大学附属肿瘤医院 2. 摘要号：GS1-03 文章题目：吡咯替尼或安慰剂联合曲妥珠单抗与多西他赛用于未经治疗的转移性HER2阳性乳腺癌：III期PHILA试验的无进展生存（PFS）预设最终分析 Pyrotinib or placebo in combination with trastuzumab and docetaxel for untreated HER2-positive metastatic breast cancer (mBC): prespecified final analysis of progression-free survival (PFS) of the phase 3 PHILA trial 汇报形式：口头报告作者：徐兵河单位：中国医学科学院肿瘤医院 3. 摘要号：GS1-04 文章题目：HER2靶向抗体药物偶联物SHR-A1811新辅助治疗HER2阳性早期乳腺癌：一项前瞻性、随机、开放标签的II期试验 HER2-Directed Antibody-Drug Conjugate SHR-A1811 in the Neoadjuvant Treatment of HER2-positive Early Breast Cancer: a Prospective, Randomized, Open-label, Phase 2 Trial 汇报形式：口头报告作者：李俊杰单位：复旦大学附属肿瘤医院 4. 摘要号：PS2-01 文章题目：达尔西利联合来曲唑或阿那曲唑作为一线治疗HR+/HER2-晚期乳腺癌：III期DAWNA-2试验无进展生存（PFS）预设的最终分析 Dalpiciclib versus placebo in combination with letrozole or anastrozole as first-line treatment for women with HR+/HER2- advanced breast cancer: prespecified final analysis of progression-free survival of the phase 3 DAWNA-2 trial 汇报形式：焦点壁报作者：徐兵河单位：中国医学科学院肿瘤医院 5. 摘要号：PS3-07 文章题目：SHR-A1811新辅助治疗HR阳性、HER2低表达乳腺癌患者：一项开放标签、单臂、二阶段II期临床试验的第一阶段结果 SHR-A1811 as Neoadjuvant Treatment in Patients with HR-Positive, HER2-low Breast Cancer: The first-stage results from an open-label, single-arm, two-stage, phase II clinical trial 汇报形式：焦点壁报作者：刘真真单位：河南省肿瘤医院 6. 摘要号：PS8-08 文章题目：SHR-A1811（一种抗HER2 ADC）在391例经多线治疗的HER2表达或突变的晚期实体瘤中的疗效与安全性：一项全球多中心首次人体临床I期研究 Efficacy and safety of SHR-A1811, an anti-HER2 antibody-drug conjugate (ADC), in 391 heavily pretreated multiple solid tumors with HER2-expression or mutations: a global, multi-center, first-in-human, phase 1 study 汇报形式：焦点壁报作者：姚和瑞单位：中山大学孙逸仙纪念医院 7. 摘要号：P1-02-12 文章题目：海曲泊帕治疗乳腺癌患者癌症治疗引起的血小板减少症的疗效与安全性：一项前瞻性II期研究 Prospective phase II study on the efficacy and safety of hetrombopag for the treatment of cancer therapy-induced thrombocytopenia in patients with breast cancer 汇报形式：壁报展示作者：姜晗昉单位：北京大学肿瘤医院 8. 摘要号：P1-04-12 文章题目：优化吡咯替尼在HER2阳性早期高风险乳腺癌中的耐受性：一项多中心、随机、三队列研究 Optimizing Tolerability of Pyrotinib in HER2-Positive Early-Stage High-Risk Breast Cancer: A Multicenter, Randomized, Three-Cohort Study 汇报形式：壁报展示作者：厉红元、程巧单位：重庆医科大学附属第一医院 9. 摘要号：P1-05-24 文章题目：SHR-A1811在HER2阳性乳腺癌新辅助治疗中疗效的生物标志物与空间决定因素 Biomarkers and Spatial Determinants of SHR-A1811 Efficacy in Neoadjuvant Treatment for HER2-Positive Breast Cancer 汇报形式：壁报展示作者：邵志敏单位：复旦大学附属肿瘤医院 10. 摘要号：P1-06-01 文章题目：卡瑞利珠单抗联合治疗三阴性乳腺癌的疗效与安全性：一项系统性综述与荟萃分析 Efficacy and Safety of Camrelizumab Combination Therapy in Triple-Negative Breast Cancer: A Systematic Review and Meta-Analysis 汇报形式：壁报展示作者：Moazzam Shahzad 11. 摘要号：P2-09-28 文章题目：达尔西利联合内分泌治疗晚期乳腺癌伴内脏危象患者：一项多中心、前瞻性、外部对照II期研究 Dalpiciclib plus endocrine therapy for visceral crisis in advanced breast cancer: a multicenter, prospective, external controlled phase 2 study 汇报形式：壁报展示作者：马飞、莫红楠单位：中国医学科学院肿瘤医院 12. 摘要号：P2-11-06 文章题目：新辅助化疗联合卡瑞利珠单抗对比单纯化疗治疗局部晚期免疫调节型三阴性乳腺癌患者：一项前瞻性、随机、开放标签II期试验 Neoadjuvant chemotherapy plus camrelizumab vs. chemotherapy in patients with locally advanced immunomodulatory triple-negative breast cancer: a prospective, randomized, open-label, phase 2 trial 汇报形式：壁报展示作者：陈力单位：复旦大学附属肿瘤医院 13. 摘要号：P2-12-22 文章题目：口服CDK4/6抑制剂达尔西利联合内分泌治疗在激素受体阳性、HER2阴性女性乳腺癌辅助治疗中的多中心、单臂Ⅱ期临床试验 A multicenter, single arm, phase II clinical trial of oral CDK4/6 inhibitor dalpiciclib in combination with endocrine therapy in adjuvant treatment for hormone receptor positive, HER2 negative female breast cancer 汇报形式：壁报展示作者：欧阳杰单位：东莞东华医院 14. 摘要号：P3-11-24 文章题目：白蛋白紫杉醇联合曲妥珠单抗和吡咯替尼新辅助治疗HER2阳性早期或局部晚期HER2富集亚型乳腺癌：一项多中心、单臂、II期试验 Neoadjuvant Nab-paclitaxel combined with Trastuzumab and Pyrotinib for HER2-enriched subtype of HER2-positive early or locally advanced breast cancer: A multicenter, single-arm, phase 2 trial 汇报形式：壁报展示作者：周文斌单位：江苏省人民医院 15. 摘要号：P3-11-26 文章题目：达尔西利联合来曲唑、帕妥珠单抗和曲妥珠单抗新辅助治疗HR+/HER2+乳腺癌的II期研究 A Phase II study of dalpiciclib combined with letrozole, pertuzumab and trastuzumab as neoadjuvant therapy in HR+/HER2+ breast cancer 汇报形式：壁报展示作者：曾晓华、梁新瑞单位：重庆市肿瘤医院 16. 摘要号：P3-12-22 文章题目：吡咯替尼、皮下曲妥珠单抗和卡培他滨新辅助治疗HER2阳性早期乳腺癌：一项前瞻性、单臂、多中心研究 Neoadjuvant Therapy with Pyrotinib, Subcutaneous Trastuzumab, and Capecitabine for HER2-Positive Early Breast Cancer: A Prospective, Single-Arm, Multicenter Trial 汇报形式：壁报展示作者：张丽娜单位：天津市肿瘤医院 17. 摘要号：P5-05-02 文章题目：GQ1001（新一代HER2靶向ADC）联合吡咯替尼治疗HER2阳性转移性乳腺癌经治患者的药代动力学特征和初步疗效：一项Ib期临床试验 Pharmacokinetic profile and preliminary efficacy of GQ1001, a next generation HER2-targeting ADC, combined with pyrotinib in pretreated patients with HER2-positive metastatic breast cancer: A phase 1b clinical trial 汇报形式：壁报展示作者：王碧芸单位：复旦大学附属肿瘤医院 18. 摘要号：P5-05-07 文章题目：伊尼妥单抗联合吡咯替尼和卡培他滨/长春瑞滨治疗曲妥珠单抗经治耐药的HER2阳性转移性乳腺癌的前瞻性、多中心、单臂临床研究 A prospective, multicenter, single-arm clinical study of inetetamab combined with pyrotinib and capecitabine/vinorelbine in the treatment of HER2-positive metastatic breast cancer resistant to previous trastuzumab treatment 汇报形式：壁报展示作者：薛妍单位：西安国际医学中心医院 19. 摘要号：P5-05-09 文章题目：德曲妥珠单抗联合吡咯替尼一线治疗HER2阳性不可切除或转移性乳腺癌：一项探索性、多中心、单臂、Ib/II期研究（TROPHY） Trastuzumab deruxtecan combined with pyrotinib in first-line HER2-positive unresectable or metastatic breast cancer: an exploratory, multi-center, single-arm, phase Ib/II study (TROPHY) 汇报形式：壁报展示作者：樊英单位：中国医学科学院肿瘤医院 20. 摘要号：P5-05-14 文章题目：伊尼妥单抗联合吡咯替尼和化疗治疗HER2阳性转移性乳腺癌患者的真实世界治疗模式与临床结果：一项多中心回顾性研究 Real-World Treatment Patterns and Clinical Outcomes of Inetetamab combined with pyrotinib plus chemotherapy in Her-2 positive metastatic breast cancer patients : a multi-center retrospective study 汇报形式：壁报展示作者：周欢欢单位：浙江省肿瘤医院 21. 摘要号：P5-05-24 文章题目：维迪西妥单抗（RC48-ADC）联合吡咯替尼治疗曲妥珠单抗经治的HER2阳性复发或转移性乳腺癌：一项Ib/II期研究 RC48-ADC (Disitamab vedotin, a HER2-directed antibody-drug conjugate) in Combination with Pyrotinib for Trastuzumab-treated HER2-Positive Recurrent or Metastatic Breast Cancer: A Phase Ib/II Study 汇报形式：壁报展示作者：周鑫、梁新瑞单位：重庆市肿瘤医院 22. 摘要号：P5-07-20 文章题目：伊尼妥单抗联合吡咯替尼和白蛋白结合型紫杉醇新辅助治疗HER2阳性早期及局部晚期乳腺癌患者的前瞻性、开放标签、单臂II期临床研究：临床试验最新进展 A prospective, open-label, single-arm phase II clinical study of inetetamab in combination pyrotinib & albumin-bound paclitaxel for neoadjuvant treatment of patients with HER2+ early & locally advanced breast cancer: updates on clinical trial 汇报形式：壁报展示作者：李南林单位：空军军医大学西京医院 23. 摘要号：P5-07-23 文章题目：吡咯替尼联合曲妥珠单抗和芳香化酶抑制剂新辅助治疗HER2+/HR+乳腺癌的疗效与安全性：一项单臂、多中心、II期探索性研究 Efficacy and Safety of Pyrotinib Combined with Trastuzumab and Aromatase Inhibitor in Neoadjuvant Treatment of HER2+/HR+ Breast Cancer: A Single-Arm, Multi-Center Phase II Exploratory Study 汇报形式：壁报展示作者：葛洁单位：天津市肿瘤医院 24. 摘要号：P5-09-17 文章题目：基于SNF分型的多组学精准医学在CDK4/6抑制剂治疗失败的HR+/HER2-晚期乳腺癌中的应用：Linux试验（产品：卡瑞利珠单抗、法米替尼、氟唑帕利、阿帕替尼） Precision medicine based on similarity network fusion (SNF) subtypes of multi-omics in CDK4/6 inhibitor failed HR+/ HER2- advanced breast cancer: the Linux trial 汇报形式：壁报展示作者：邵志敏单位：复旦大学附属肿瘤医院 25. 摘要号：P5-09-28 文章题目：吡咯替尼联合曲妥珠单抗及达尔西利、来曲唑术前治疗早期或局部晚期HR阳性、HER2阳性乳腺癌的Ⅱ期前瞻性探索性临床研究（Chefoo-TP48） A phase Ⅱ, prospective exploratory clinical study of neoadjuvant pyrotinib plus trastuzumab, dalpiciclib, and letrozole for patients with HR-positive, HER2-positive early or locally advanced breast cancer (Chefoo-TP48) 汇报形式：壁报展示作者：乔广东、丛义滋单位：烟台毓璜顶医院 26. 摘要号：P5-09-29 文章题目：曲妥珠单抗联合吡咯替尼和卡培他滨作为HER2阳性早期乳腺癌新辅助治疗后未达病理完全缓解的术后辅助治疗：一项多中心II期研究 Trastuzumab Combined with Pyrotinib and Capecitabine as Postoperative Adjuvant Therapy in NonPathological Complete Response HER2-Positive Early Breast Cancer Following Neoadjuvant Therapy: A Multicenter Phase II study 汇报形式：壁报展示作者：王川单位：福建医科大学附属协和医院本次SABCS，恒瑞医药将亮相的8款创新药的26项重磅研究，覆盖了多种乳腺癌亚型，涉及一线、辅助、新辅助等多个疾病阶段适应症人群，将展现公司多款不同作用机制的创新产品布局乳腺癌治疗领域的实力，也将向世界展示中国乳腺癌领域的研发创新力量。作为创新型国际化制药企业，恒瑞医药多年来深入践行“科技为本、为人类创造健康生活”的使命，针对高发肿瘤领域持续进行创新研发，已在国内获批上市17款1类创新药、4款自研2类新药。未来，恒瑞医药将继续坚持“以患者为中心”的理念，重创新，强研发，力争研制出更多更好的新药，努力守护患者健康生活和生命质量。参考资料： 1.https://sabcs.org/FullProgram 声明： 1.本新闻旨在分享学术前沿动态，仅供医疗卫生专业人士基于学术目的参阅，非广告用途。 2.恒瑞医药不对任何药品和/或适应症作推荐。 3.本新闻中涉及的信息仅供参考，请遵从医生或其他医疗卫生专业人士的意见或指导。医疗卫生专业人士作出的任何与治疗有关的决定应根据患者的具体情况并遵照药品说明书。撰稿：中央医学事务部排版：程梦真责编：李玉莹往期精选 | 研发创新 | 慢病创新里程碑！恒瑞首个自免创新药夫那奇珠单抗获批上市恒瑞医药新突破！中国首个自研阿片类镇痛创新药富马酸泰吉利定获批上市 | 国际化 | 海外BD再传捷报！恒瑞医药GLP-1类创新药组合实现海外许可恒瑞医药与默克达成合作，携手推进癌症创新疗法 | 重磅奖项 | 喜报！恒瑞医药荣获2023年度国家科技进步奖恒瑞医药连续六年入选全球制药企业50强榜单！ | 社会公益 | “健康中国行·重走长征路”项目启动仪式圆满举行！恒瑞提供公益支持，助力健康中国恒瑞医药集团向中国扶贫基金会捐赠3000万设立“健康帮扶基金”

临床3期临床结果抗体药物偶联物临床2期临床成功

2024-11-13

·Business Wire

Havah Therapeutics Granted Additional Patent Protection for T+Ai™

BOULDER, Colo.--( BUSINESS WIRE )--Havah Therapeutics today, announced that the United States Patent and Trademark Office (USPTO) has granted a new patent (US Patent No. 12,128,055) for its innovative T+Ai combination therapy—a novel composition of testosterone and anastrozole in a long-acting, slow-release subcutaneous implant. “Our new patent for T+Ai is a critical milestone as we advance through the ongoing RECAST DCIS Phase 2 trial,” said Matthew Brewer, CEO of Havah Therapeutics. “With a sustained-release profile that shows significant therapeutic promise based on our previous clinical data, we are one step closer to bringing this innovative product to patients.” The newly granted patent for T+Ai further strengthens Havah Therapeutics’ intellectual property portfolio, securing protection for its innovative subcutaneous extended-release therapy. T+Ai was developed to provide a long-term, safe, and well-tolerated solution for hormonal modulation with a particular focus on breast cancer prevention and treatment. This unique formulation of testosterone and anastrozole is designed to address critical needs in oncology, offering potential in the early treatment of estrogen receptor-positive (ER+) cancers to reduce the risk of developing resistance to hormonal therapies. Currently in a Phase 2 platform study, T+Ai’s patented properties include rapid early induction of testosterone conversion to dihydrotestosterone within tissue, potentially enhancing anti-proliferative and anti-cancer effects, especially in women with high mammographic breast density. About Havah Therapeutics Havah Therapeutics is developing a novel therapeutic implant for treating hormonally sensitive cancers and other breast conditions. This groundbreaking method relies on stimulating (agonizing) the androgen receptor in breast tissue, utilizing natural hormonal mechanisms to treat women safely and with greatly reduced side effects. The product, T+Ai™ , is a combination of two registered agents (testosterone and anastrozole, a low dose aromatase inhibitor) that when dosed, provides three months of continuous medication enabling a superior product profile for compliance, safety and efficacy. Havah Therapeutics is currently participating in the Re-Evaluating Conditions for Active Surveillance Suitability as Treatment: Ductal Carcinoma In Situ (RECAST DCIS), a Phase 2 platform study aimed at preventing the progression of DCIS to breast cancer. For more information, visit www.havahtx.com .

临床2期

2024-11-10

·梅斯医学

停药后仍可持续抗癌！联合疗法对抗“最常见”乳腺癌，复发风险降低25%

激素受体阳性、人表皮生长因子2阴性（HR+/HER2-）是常见的乳腺癌类型，约占所有乳腺癌的3/4。对于早期HR+/HER2-乳腺癌，当前指南推荐采用外科手术切除和辅助内分泌治疗（如芳香化酶抑制剂），并根据个体情况，酌情考虑增加放化疗。但仍有约13%的患者在内分泌治疗后3年会出现疾病复发。细胞周期蛋白依赖性激酶4/6（CDK4/6）抑制剂的问世改变了HR+/HER2-复发转移乳腺癌的临床实践，内分泌联合CDK4/6抑制剂已成为该类患者的首选治疗方案。瑞波西利（ribociclib）是一种CDK4/6抑制剂，既往研究已证实其有益于延长HR+/HER2-乳腺癌无进展生存期（PFS）和总生存期（OS）。在此基础上，NATALEE试验探索了瑞波西利联合芳香化酶抑制剂（内分泌治疗药物）对早期HR+/HER2-乳腺癌患者辅助治疗中的疗效和耐受性，此前公布的中期疗效数据表明，相比于单独使用芳香化酶抑制剂，接受联合疗法的患者无侵袭性疾病生存期（iDFS）事件风险降低了25%（HR=0.75，95%CI：0.62~0.91，P=0.003）。无侵袭性疾病生存期（iDFS）：从随机化分组到首次出现以下任何一种情况的时间：远处复发、局部复发、同侧或对侧乳腺癌、第二种原发性（非乳腺）浸润性癌症或因任何原因死亡。近日，NATALEE试验的最终疗效结果发表于Annals of Oncology，结果表明相比于单独使用芳香化酶抑制剂，在随访时间延长和大多数患者逐步停用瑞波西利后，使用瑞波西利联合芳香化酶抑制剂仍可在iDFS上持续获益，且安全可控。截图来源：Annals of Oncology NATALEE是一项国际性、随机、开放标签的3期试验，研究纳入年龄≥18岁的早期HR+/HER2-乳腺癌患者5101例。研究人员以1：1的比例随机分配患者接受芳香化酶抑制剂（2552例），或是瑞波西利（2549例，给药3周后停药1周，持续治疗36个月）联合芳香化酶抑制剂（选用来曲唑或阿那曲唑，持续治疗60个月）。在最终分析数据截止日期时，中位iDFS随访时间（从随访起至末次完成复发评估）为33.3个月，相比于此前中期分析，整体iDFS随访时间延长了5.6个月。截至数据截止，共有1996例（78.3%）的患者停用瑞波西利，其中1091例（42.8%）的患者完成了为期3年的瑞波西利治疗，905例（35.5%）患者提前停用瑞波西利。研究结果显示，相比于单独使用芳香化酶抑制剂组，瑞波西利联合芳香化酶抑制剂组iDFS事件发生更少（226起 vs. 283起），风险降低了25.1%（HR=0.749，95%CI：0.628~0.892，P=0.0012）。两组3年iDFS率分别为90.7%和87.6%，瑞波西利联合芳香化酶抑制剂组绝对获益高出3.1%。 ▲瑞波西利联合芳香化酶抑制剂组（蓝色）和芳香化酶抑制剂组（灰色）iDFS事件风险对比（图片来源：参考文献[1]）在预先指定的分期（2/3期）以及淋巴结状态（阳性或阴性）亚组显示出一致性结果。此外，研究人员还观察到，相比于芳香化酶抑制剂组，瑞波西利联合芳香化酶抑制剂组无复发生存时间（RFS）事件风险降低27.3%（HR=0.727，95%CI：0.602~0.877，P=0.0008），无远处转移生存期（DDFS）事件风险降低25.1%（HR=0.749，95%CI：0.623~0.900，P=0.0020）。无复发生存时间（RFS）：患者治疗后获得完全缓解到出现复发或随访截止时间；无远处转移生存期（DDFS）：肿瘤患者经过治疗后，除了原发病灶，未发现全身其他地方有转移病灶的一段时间。目前，该研究总生存期（OS）数据尚不成熟，瑞波西利联合芳香化酶抑制剂组和芳香化酶抑制剂组的3年OS率分别为97.0%和96.1%。安全性方面，最常见的不良事件为中性粒细胞减少、关节痛和恶心。未发现新的安全性事件，整体安全可控。总之，在这项最终iDFS分析结果表明，在2期或3期早期HR+/HER2-乳腺癌患者辅助治疗中，相比于单独使用芳香化酶抑制剂，瑞波西利联合芳香化酶抑制剂在iDFS方面显示出持续的治疗获益，且安全性特征与此前中期分析相似。参考资料：[1] Hortobagyi GN, Lacko A, Sohn J, et al. A phase III trial of adjuvant ribociclib plus endocrine therapy vs endocrine therapy alone in patients with HR+/HER2- early breast cancer: final invasive disease-free survival results from the NATALEE trial. Ann Oncol. 2024 Oct 21:S0923-7534(24)04064-X. doi: 10.1016/j.annonc.2024.10.015. 来源 | 医学新视点编辑 | Swagpp ● 猪牛羊肉吃太多，患癌风险大增！每天多吃70g红肉，结直肠癌发生率高32%，背后机制首次明确！ ● 重磅！一堆硕博医生缝合结扎都不熟练，现学现卖！科主任愤怒要求：每月给年轻医生搞一次外科基本功培训！新一代医生技能普遍偏弱令人担忧 ● 幼年吃糖，老年得病！Science：生命早期控糖，老后糖尿病和高血压患病率降35%和20% 版权说明：梅斯医学（MedSci）是国内领先的医学科研与学术服务平台，致力于医疗质量的改进，为临床实践提供智慧、精准的决策支持，让医生与患者受益。欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。点击下方「阅读原文」立刻下载梅斯医学APP！

临床结果临床3期抗体药物偶联物

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 Plc /Anti Infective Business/	2008-12-05
男子乳腺发育	美国	Astrazeneca Plc /Anti Infective Business/	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

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
ER阳性乳腺癌	临床1期	法国	AstraZeneca PLC	2000-08-01
ER阳性乳腺癌	临床1期	巴西	AstraZeneca PLC	2000-08-01
ER阳性乳腺癌	药物发现	美国	AstraZeneca PLC	2000-08-01
ER阳性乳腺癌	药物发现	日本	AstraZeneca PLC	2000-08-01
ER阳性乳腺癌	药物发现	捷克	AstraZeneca PLC	2000-08-01
ER阳性乳腺癌	药物发现	荷兰	AstraZeneca PLC	2000-08-01
ER阳性乳腺癌	药物发现	匈牙利	AstraZeneca PLC	2000-08-01
ER阳性乳腺癌	药物发现	加拿大	AstraZeneca PLC	2000-08-01
乳腺癌	药物发现	-	AstraZeneca PLC	1996-07-01
HR阳性乳腺癌	药物发现	奥地利	AstraZeneca PLC	1996-01-01

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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


NCT02763566 (MONARCH plus, Pubmed \| Chin Med J (Engl)) 人工标引	临床3期	HR阳性/HER2阴性乳腺癌二线 \| 一线 \|	-	Abemaciclib+anastrozole or letrozole	(醖築選範觸廠觸膚築膚) = 廠製艱膚壓鏇襯網憲鬱夢衊鬱範顧遞網範構襯 (齋網遞積構艱蓋鑰選齋 )	积极	2024-10-10
				Placebo+anastrozole or letrozole	(醖築選範觸廠觸膚築膚) = 廠繭淵膚獵觸淵餘襯膚夢衊鬱範顧遞網範構襯 (齋網遞積構艱蓋鑰選齋 )
NCT00072462 (IBIS-II DCIS, CTgov)	临床3期	导管癌 \| 乳腺癌 \| 非浸润性导管内癌	2,980	anastrozole (Anastrozole)	積鹽製網選顧積衊膚衊(積膚選築鹽艱顧選淵醖) = 夢齋廠構糧選壓遞繭糧繭齋窪鬱衊遞範憲淵繭 (遞顧衊衊廠鹽鹽鑰壓鹹, 餘選憲襯襯範壓齋窪憲 ~ 簾膚蓋網鹽鑰簾餘繭襯) 更多	-	2024-09-19
				tamoxifen citrate (Tamoxifen)	積鹽製網選顧積衊膚衊(積膚選築鹽艱顧選淵醖) = 鏇製襯齋蓋觸簾壓製獵繭齋窪鬱衊遞範憲淵繭 (遞顧衊衊廠鹽鹽鑰壓鹹, 構衊顧願夢鏇鹹糧製範 ~ 憲艱衊膚壓艱築網鹹鑰) 更多
NCT05640778 (DANCER, ASCO2024) 人工标引	临床2期	HER2 阴性乳腺癌新辅助 \|	23	Dalpiciclib + Letrozole/anastrozole	(壓糧築壓積膚鏇顧顧積) = 餘構築鏇願壓鹹構窪鏇願觸鏇鑰鏇鏇獵鬱獵網 (積繭鑰鑰鹹壓艱鏇願淵, 76.0% ~ 98.8) 更多	积极	2024-05-24
NCT03229499 (PHANTOM, Pubmed \| Am J Respir Crit Care Med) 人工标引	临床2期	肺性高血压 post-menopausal	84	Anastrozole 1 mg	(築築餘選構範觸顧鹽膚) = 衊糧築鹹夢顧蓋膚鏇醖糧衊繭選夢醖遞選簾窪 (選衊襯夢繭鑰積鏇構齋, -32.7 ~ 16.9)	不佳	2024-05-15
NCT03229499 (PHANTOM, CTgov)	临床2期	肺动脉高压	84	anastrozole (Anastrozole)	鹹艱製壓繭蓋夢築廠製(餘鹹蓋範壓築淵遞衊選) = 蓋遞網獵壓蓋願膚夢壓醖鑰繭製齋獵餘糧鑰觸 (糧餘觸構觸廠積網繭糧, 蓋衊顧觸遞鏇壓觸鑰襯 ~ 鹽餘獵醖廠觸鏇遞窪餘) 更多	-	2024-05-01
				Placebo Oral Tablet (Placebo)	鹹艱製壓繭蓋夢築廠製(餘鹹蓋範壓築淵遞衊選) = 衊簾衊醖顧壓簾鬱廠衊醖鑰繭製齋獵餘糧鑰觸 (糧餘觸構觸廠積網繭糧, 壓襯鹹廠餘淵壓艱積積 ~ 遞觸壓艱憲餘廠鏇鹹鑰) 更多
NCT03822468 (AMALEE, CTgov)	临床2期	晚期癌症 \| HR阳性/HER2阴性乳腺癌	376	Letrozole+Ribociclib+Goserelin+anastrozole (Ribociclib 400 mg)	(選遞淵壓積鏇構選獵衊) = 繭鏇壓鹹獵鹹憲構簾願鏇蓋獵衊壓獵網餘憲窪 (獵夢鬱醖遞築鹹餘膚構, 遞襯選觸範鏇繭憲鑰願 ~ 衊製廠蓋鬱廠憲窪築顧) 更多	-	2024-04-05
				Letrozole+Ribociclib+Goserelin+anastrozole (Ribociclib 600 mg)	(選遞淵壓積鏇構選獵衊) = 鏇積糧醖膚網觸膚鹹窪鏇蓋獵衊壓獵網餘憲窪 (獵夢鬱醖遞築鹹餘膚構, 夢窪膚構餘觸顧憲醖選 ~ 夢獵艱糧網襯願觸鹹齋) 更多
NCT00295646 (ABCSG-12, CTgov)	临床3期	HR阳性乳腺癌	1,803	goserelin+zoledronic acid+anastrozole (AZ (Arimidex+Zoledronate))	顧衊積膚遞膚窪遞鹽齋(繭構鹽窪製壓繭襯願願) = 衊顧壓積憲網製憲遞壓憲製醖獵範齋選壓積壓 (鏇獵壓襯獵鏇艱壓積鏇, 鹽顧鏇齋衊廠觸積網醖 ~ 網窪糧築選願餘膚積構) 更多	-	2024-03-15
				goserelin+Tamoxifen+zoledronic acid (TZ (Tamoxifen+Zoledronate))	顧衊積膚遞膚窪遞鹽齋(繭構鹽窪製壓繭襯願願) = 網衊憲齋衊築膚餘鏇範憲製醖獵範齋選壓積壓 (鏇獵壓襯獵鏇艱壓積鏇, 願蓋夢遞選醖齋築願廠 ~ 獵襯廠襯鬱壓網願願顧) 更多
NCT01953588 (Pubmed)	临床3期	ER阴性乳腺癌新辅助 Ki67	1,362	Anastrozole	壓網廠遞繭鹹鑰壓壓鑰(積積淵顧簾艱選窪醖糧) = 顧襯築簾鏇壓壓膚壓壓選觸範窪範獵鏇窪願夢 (窪簾鬱繭壓鹽淵蓋鑰壓, 15.1 ~ 22.7)	-	2024-01-18
				Fulvestrant	壓網廠遞繭鹹鑰壓壓鑰(積積淵顧簾艱選窪醖糧) = 積蓋積醖廠鏇遞選鑰廠選觸範窪範獵鏇窪願夢 (窪簾鬱繭壓鹽淵蓋鑰壓, 18.9 ~ 27.1)
NCT01674140 (S1207 \| e3, CTgov)	临床3期	HR阳性/HER2阴性乳腺癌	1,939	placebo+letrozole+tamoxifen citrate+exemestane+leuprolide acetate+goserelin acetate+anastrozole (Placebo)	鹹鬱糧網積簾範鹹繭衊(蓋簾願醖壓築鑰壓遞糧) = 廠網夢獵鬱襯顧糧淵鑰襯製襯壓製憲積遞鬱醖 (廠鹹夢夢構簾鬱壓襯顧, 糧鏇襯簾艱簾憲鹽鹽選 ~ 網壓鑰構衊範壓衊壓齋) 更多	-	2023-12-20
				Everolimus (Everolimus)	鹹鬱糧網積簾範鹹繭衊(蓋簾願醖壓築鑰壓遞糧) = 壓糧選壓鹹憲製願醖遞襯製襯壓製憲積遞鬱醖 (廠鹹夢夢構簾鬱壓襯顧, 鏇觸顧鬱鏇壓衊齋積齋 ~ 蓋窪壓糧襯艱餘構憲廠) 更多
MONARCH 3 (Biospace) 人工标引	临床3期	HR阳性/HER2阴性乳腺癌 \|	493	anastrozole or letrozole+Verzenio	(憲鏇遞繭築艱餘夢顧築) = 艱糧齋襯築築構構構鬱觸遞範積憲顧製顧製夢 (顧艱鬱廠廠獵鬱鏇齋範 ) 更多	积极	2023-12-05
				anastrozole or letrozole+placebo	(憲鏇遞繭築艱餘夢顧築) = 膚遞遞構廠膚鑰蓋網構觸遞範積憲顧製顧製夢 (顧艱鬱廠廠獵鬱鏇齋範 ) 更多