BAriaTric Surgery After Breast Cancer Treatment (BATS) - A Randomized Trial of Sleeve Gastrectomy Versus Lifestyle Intervention in Women Diagnosed With Early Stage Breast and With a BMI of ≥ 35

This is a feasibility study to gain an understanding of the willingness of women with a history of early stage breast cancer and current obesity to enroll in a weight-loss study, accept an assigned intervention (bariatric surgery with lifestyle intervention or lifestyle intervention alone), and comply with the study plan for 1 year. If there is successful enrollment in this study, the plan is to use what is learned in this study to design a larger, longer-term clinical trial to look at the effect of weight loss and incidence of cancer recurrence.

开始日期2025-01-01

申办/合作机构

University of Minnesota Masonic Cancer Center

NCT06445738 / Not yet recruitingN/AIIT

A Two-arm, Non-randomised, Prospective, Multicentre Study Using Magnetic Resonance Imaging (MRI) Findings and Pathology Features to Select Patients With Early Breast Cancer for Omission of Post-operative Radiotherapy

The PROSPECTIVE trial aims to find out if using the results of Magnetic Resonance Imaging (MRI) for early breast cancer can select people to not have radiotherapy and still have a low chance of the cancer coming back after surgery.
The main question it aims to answer is:
* Will cancer come back in the same breast as the original cancer in patients who have surgery for their breast cancer, but who don't have radiotherapy afterwards because the results of an MRI before surgery showed favourable characteristics for not having radiotherapy.

开始日期2025-01-01

申办/合作机构

Australia & New Zealand Breast Cancer Trials Group

NCT06643585 / Not yet recruiting临床3期IIT

SURVIVE HERoes - a Randomized Secondary Adjuvant Treatment Intervention Study Comparing Trastuzumab-Deruxtecan to SOC Therapy in EBC Patients with Molecular Relapse

Prospective, multi-center, randomized, open label comparative Phase III study in patients with intermediate to high-risk (as defined in the SURVIVE trial) HER2-positive or HER2-low early breast cancer, who participate in the SURVIVE trial and experience a molecular relapse, as assessed based on a positive circulating tumor DNA (ctDNA) result, with 2:1 allocation to:
* Arm A: Trastuzumab-Deruxtecan (i.v. 5,4 mg/kg, q3w) + endocrine therapy (if hormonal-receptor-positive) for 16 cycles or until relapse, if earlier
* Arm B: Continuous treatment of physician's choice (may include endocrine treatment, CDK4/6-Inhibition, T-DM1, Olaparib, Trastuzumab, Pertuzumab, Capecitabine or Neratinib)

开始日期2024-12-01

申办/合作机构

Universität Ulm

100 项与早期乳腺癌相关的临床结果

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100 项与早期乳腺癌相关的转化医学

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0 项与早期乳腺癌相关的专利（医药）

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18,822

项与早期乳腺癌相关的文献（医药）

2024-12-31·Epigenetics

IL21R hypomethylation as a biomarker for distinguishing benign and malignant breast tumours

Article

作者: Yang, Rongxi ; Zhu, Qiang ; Zang, Zishan ; Liu, Chunlan ; Li, Hong ; Yin, Yifei ; Huang, Xuandong

Some benign and malignant breast tumours are similar in pathological morphology, which are difficult to be distinguished in clinical diagnosis. In this study, we intended to explore novel biomarkers for differential diagnosis of benign and malignant breast tumours. Methylation EPIC 850K beadchip and RNA-sequencing were used to analyse 29 tissue samples from patients with early-stage breast cancer (BC) and benign breast tumours for differently methylated and expressed genes. The altered methylation of IL21R was semi-quantitatively validated in an independent study with 566 tissue samples (279 BC vs. 287 benign breast tumours) using mass spectrometry. Binary logistic regression analysis was performed to evaluate the association between IL21R methylation and BC. BC-associated IL21R hypomethylation and overexpression were identified in the discovery round. In the validation round, BC patients presented significant IL21R hypomethylation compared to women with benign breast tumours (ORs ≥1.29 per-10% methylation, p-values ≤ 5.69E-14), and this hypomethylation was even enhanced in BC patients with ER-negative and PR-negative tumours as well as with triple-negative tumours. The methylation of IL21R showed efficient discriminatory power to distinguish benign breast tumours from BC (area under curve (AUC) = 0.88), and especially from ER-negative BC (AUC = 0.95), PR-negative BC (AUC = 0.93) and triple-negative BC (AUC = 0.96). We disclosed significant IL21R hypomethylation in patients with BC compared to women with benign breast tumours, and revealed the somatic change of DNA methylation could be a potential biomarker for molecular pathology of BC.

2024-12-31·Journal of Medical Economics

Costs of breast cancer recurrence after initial treatment for HR+, HER2−, high-risk early breast cancer: estimates from SEER-Medicare linked data

Article

作者: Liepa, Astra M ; Martin, Pam ; Vitko, Alexandra S ; Johnston, Adam ; Ohsfeldt, Robert ; Zhang, Sheng ; Zheng, Shen

OBJECTIVETo assess the costs of treated recurrence and survival in elderly patients with early breast cancer (EBC) at high risk of recurrence using Surveillance Epidemiology and End Results (SEER) registry-Medicare linked claims data.METHODSThis retrospective study included patients aged ≥65 years with hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-), node-positive EBC at high risk of recurrence. Treated recurrences were defined based on treatment events/procedure codes from claims. Primary outcomes were monthly total extra costs and cumulative extra costs of treated recurrence relative to patients with non/untreated recurrence. Costs were calculated using a Kaplan-Meier sampling average estimator method and inflated to 2021 US$. Secondary outcomes included analysis by recurrence type and overall survival (OS) after recurrence. Subgroup analysis evaluated costs in patients with Medicare Part D coverage.RESULTSAmong 3,081 eligible patients [mean (SD) age at diagnosis was 74.5 (7.1) years], the majority were females (97.4%) and white (87.8%). Treated recurrence was observed in 964 patients (31.3%). The monthly extra cost of treated recurrence was highest at the beginning of the first treated recurrence episode, with 6-year cumulative cost of $117,926. Six-year cumulative extra costs were higher for patients with distant recurrences ($168,656) than for patients with locoregional recurrences ($96,465). Median OS was 4.34 years for all treated recurrences, 1.92 years for distant recurrence, and 6.78 years for locoregional recurrence. Similar cumulative extra cost trends were observed in the subgroup with Part D coverage as in the overall population.LIMITATIONSThis study utilizes claims data to identify treated recurrence. Due to age constraints of the dataset, results may not extrapolate to a younger population where EBC is commonly diagnosed.CONCLUSIONEBC recurrence in this elderly population has substantial costs, particularly in patients with distant recurrences. Therapies that delay or prevent recurrence may reduce long-term costs significantly.

2024-12-31·Channels

Novel insights into voltage-gated ion channels: Translational breakthroughs in medical oncology

Article

作者: Chalkias, Athanasios ; Reet, Jashan ; Yoon, Sung Mi ; Sakellakis, Minas

Preclinical evidence suggests that voltage gradients can act as a kind of top-down master regulator during embryogenesis and orchestrate downstream molecular-genetic pathways during organ regeneration or repair. Moreover, electrical stimulation shifts response to injury toward regeneration instead of healing or scarring. Cancer and embryogenesis not only share common phenotypical features but also commonly upregulated molecular pathways. Voltage-gated ion channel activity is directly or indirectly linked to the pathogenesis of cancer hallmarks, while experimental and clinical studies suggest that their modulation, e.g., by anesthetic agents, may exert antitumor effects. A large recent clinical trial served as a proof-of-principle for the benefit of preoperative use of topical sodium channel blockade as a potential anticancer strategy against early human breast cancers. Regardless of whether ion channel aberrations are primary or secondary cancer drivers, understanding the functional consequences of these events may guide us toward the development of novel therapeutic approaches.

893

项与早期乳腺癌相关的新闻（医药）

2024-10-30

·空之客

【医苑观畴】2024年三季度海外药企进展更新：诺华NVS

1 整体表现 NVS依然保持着业绩的几乎匀速的增长，然而市场似乎仍然并不是很买账，市值虽有成长但依然没离开$200b左右的中枢。收入同比增长10%，核心营业利润同比增长20%（利润率提升了340bps），这超出了上个季度时的预期，能有这样的增长在MNC中已经是非常难得，而公司在年内第三次提高了全年的收入和利润指引。 2 已上市产品 NVS各种新花活儿整了不少，然而到目前为止给业绩增长扛大旗的依然是这几个老产品，反过来也说明公司的底蕴还是足够深厚，也有足够大的容错空间用于折腾。肿瘤板块整体亮眼：CDK4/6抑制剂Ribociclib仍在快速成长，市场份额不断提升，在美国市场新处方量已占据48%、总处方量尚低于Abemaciclib也已达到31%，LTM累计以超过$2.7b，特别是早期乳腺癌适应症的获批又带来一波新的驱动力；核药Pluvicto看起来还是在匀速增长，但主要靠来自欧洲的一次性收入调整，而美国环比已经只有6%增速，毕竟在VISION setting（post-taxane）公司给的峰值也就$2b，目前LTM累计已经有$1.3b、距离也并不太远，公司只能把增长预期都寄托在PSMAfore（pre-taxane）获批之后了。自免板块的基本盘也相当稳健：IL17A单抗Secukinumab在HS获批后可能带来$1b的增量，目前LTM累计已达到$5.8b，峰值确实有可能冲着$7b以上去了；CD20单抗Ofatumumab看着不声不响，凭借每月一次皮下注射的依从度优势还在持续爬坡，LTM累计已接近$3.0b；Iptacopan上市以来，在PNH的新处方量份额已超过30%，只是销售额绝对值还不多。心血管板块的形势就比较微妙：Entresto在专利悬崖之前终于勒马，峰值可能就会定格在$7.5b左右；肩负填坑重任的Inclisiran在前三个季度的线性环比增长之后，这个季度又慢了下来，单季度还没有跨过$200m，往好了想作为一款慢性病长期用药在早期新处方总需要这个漫长的积累过程，从曾经公司总是用来挽尊的这张与Entresto对比爬坡曲线图来看，Inclisiran的爬坡速度也确实还比较在线。其他产品更是没多少看点了，Lucentis和Zolgensma都已日薄西山，CGRP单抗 Erenumab也基本涨不动了。 3 在研管线在前几个季度的密集进展之后，近期处在大新闻的空窗期。肿瘤方面最大的进展，就是CDK4/6抑制剂Ribociclib凭借NATALEE三期临床的积极结果，获批早期HR+/HER2-乳腺癌的辅助治疗，且被NCCN指南一类推荐，此外还公布了长达4年的随访结果。 siRNA药物Inclisiran也宣布在重要的V-MONO三期临床中取得积极结果，Inclisiran单药对比Ezetimibe和安慰剂都展现出更好的降低LDL-C能力。补体药物Iptacopan在IgAN适应症获得FDA的加速批准，基于APPLAUSE三期临床的中期结果。接着还有一则奇闻，就在收购Morphosys刚交割还没几个月，其核心产品MET抑制剂Pelabresib就因安全性信号被评估认为需要更长的观察期，这样上市申请计划必然推迟，公司只能无奈计提了$0.8b的商誉减值损失（当初总收购价是€2.7b）。除此以外，值得关注的进展还包括：Pluvicto的pre-taxane mCRPC适应症已提交上市申请，Asciminib获批1L Ph+ CML-CP适应症；此外，公司还主动终止了NPR1单抗XXB-750对高血压的开发。 4 并购策略这个季度，分析师们还在继续挑战公司的战略选择问题，特别是Morphosys收购的光速翻车又给了口实，然而CEO很明显又有点生气了：“成熟投资人不应该纠结这种一次性的事件，而应该看看公司过去在Kesimpta、核药、AveXis等资产收购上做得怎么样”“再说一遍，我们不认为GLP-1/GIP还能做出差异化，而且将有大批来自中国等其他地区的公司涌入，与其慢慢跟在后面还不如专注于新资产”。从近年来NVS的战略选择来揣摩，确实给人一种没落贵族的心态失衡之感。作为一家原本底蕴相当深厚、很多既往产品也相当成功的大药企，在连续错失PD1+ADC+GLP1等全行业最大风口之后，就总试图在战略层面另辟蹊径来押中未来的重大方向，从早些年的CGT，再到近几年的核药、siRNA、肾病等，然而这些被寄予厚望的新贵们迟迟无法贡献与身价对等的业绩增量，最终给这些试错提供业绩兜底的恰恰还是Cosentyx、Entresto、Kisqali、Kesimpta这些“传统”的核心品种。作为这个体量的成熟巨头，仅靠剑走偏锋真的是一种合理的战略选择吗？

siRNA临床3期财报

2024-10-30

·ioncology

ESMO ASIA 2024丨划重点，乳腺癌领域这些内容值得重点关注

点击蓝字，关注我们编者按：2024年欧洲肿瘤内科学会亚洲年会（ESMO ASIA 2024）将于当地时间12月6日～8日在新加坡召开，将展示和讨论亚洲及全球肿瘤学领域的最新科学和临床研究，这些进展将进一步推动年末的学术交流热潮！近日ESMO ASIA官网已公布相关研究题目，肿瘤瞭望已将乳腺癌领域重磅研究及中国专家投稿内容进行汇总（按出场时间排序，如有遗漏或错误，请后台留言）。本文将补充乳腺癌领域值得关注的重要病例报告（讨论）及专家讲课内容，敬请关注！ Young Oncologists clinical cases discussion 日期：2024年12月6日时间：16:45 - 18:10 地点：Hall 407 主席：Elizabeth A. Connolly (Sydney, AU) Hongcheng Zhu (Shanghai, CN) Matteo Lambertini (Genova, IT) YO29 - Multiple primary cancers (MPC) of breast and lung with primary EGFR T790M mutation Responded to Aumolertinib: A case report 原发性EGFR T790M突变的乳腺和肺部多原发癌（MPC）对阿美替尼治疗有反应：一例病例报告报告时间：17:22 - 17:27 讲者：Shengnan Kong（中国，西安） YO1 - Trastuzumab deruxtecan and Stereotactic radiosurgery (SRS) in HER2-positive (HER2+) breast cancer with brain metastases (BM) 德曲妥珠单抗联合联合立体定向放疗（SRS）治疗伴脑转移（BM）的HER2阳性（HER2+）乳腺癌报告时间：17:44 - 17:49 讲者：Teng Meng（中国，重庆） YO2 - Taking Control With The Knife: Managing Brain Metastasis With Gamma Knife In Metastatic Breast Cancer in Pregnancy 以刀制控：运用伽马刀治疗妊娠期转移性乳腺癌的脑转移报告时间：17:49 - 17:54 讲者：Tan Keh Yee（马来西亚，吉隆坡） ESMO 2024 Highlights session 2 日期：2024年12月7日时间：10:45 - 12:15 地点：Hall 405 Locoregional hypo vs normofractionated RT in early breast cancer: 5 years results of the HypoG-01 phase III Unicancer trial 早期乳腺癌局部低分割放疗与常规分割放疗的比较：HypoG-01 III期Unicancer试验的5年结果报告时间：11:05 - 11:15 讲者：Sofia Rivera (Villejuif, FR) Neoadjuvant pembrolizumab or placebo plus chemotherapy followed by adjuvant pembrolizumab or placebo for high-risk early-stage TNBC: Overall survival results from the phase III KEYNOTE-522 study 高危早期三阴乳腺癌（TNBC）患者新辅助治疗采用帕博利珠单抗或安慰剂联合化疗，随后辅助治疗接受帕博利珠单抗或安慰剂治疗：III期KEYNOTE-522研究的总生存期结果报告时间：11:25 - 11:35 讲者：Rebecca A. Dent (Singapore, SG) Industry Satellite Symposium Novartis - Expanding evidence for CDK4/6 inhibitors in HR+/HER2- breast cancer: From clinical trials to clinical practice 日期：12月7日时间：12:45 - 14:15 地点：Hall 404 主席：Yoon-Sim Yap (Singapore, SG) Applying CDK4/6 inhibitor data to patient management in HR+/HER2- ABC 将CDK4/6抑制剂数据应用于HR+/HER2- ABC的患者管理讲者：江泽飞（解放军总医院）（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。

临床结果临床3期临床2期

2024-10-30

·Insight数据库

诺华财报：中国区 Q3 销售额增长 18%，Pluvicto 今年销售额破 10 亿美元

10 月 30 日，诺华发布 2024 年第三季度财报。第三季度，公司全球净销售额 128 亿美元，同比增长 10%；营业收入 36 亿美元，同比增长 123%。其中，中国区 Q3 净销售额 10 亿美元，同比增长 18%。图片来源：诺华官微其中，诺欣妥（沙库巴曲+缬沙坦）销售额 18.65 亿美元（YOY +26%），是诺华本季度收入 NO.1 的产品。可善挺（IL17A 单抗，司库奇尤单抗）销售额 16.93 亿美元（YOY +28%），收入位列第二。从产品销售额增幅来看，增长最快的是乐可为和 Pluvicto。乐可为（英克司兰钠）是一款靶向 PCSK9 的长效降脂 siRNA 疗法，该药于 2020 年 12 月在欧盟全球首批，随后又相继在美国（2021 年 12 月）、中国内地（2023 年 8 月）、日本（2023 年 9 月）获批上市。今年上半年，乐可为销售额 3.33 亿美元（YOY +137%）。Q3 期间，乐可为销售额 1.98 亿美元，YOY 增长 119%。截图来源：Insight 数据库 Pluvicto（镥 [177Lu]-特昔维匹肽）是一款靶向 PSMA 的放射性配体疗法。该药于 2022 年 3 月在美国全球首批，用于治疗去势抵抗性前列腺癌。后又在欧盟获批同一适应症。在中国，该药于今年 9 月被 CDE 纳入优先审评。今年上半年，Pluvicto 销售额为 6.55 亿美元，加上 Q3 的 3.86 亿美元（YOY +50%），Pluvicto 今年前三季度销售额已达 10.41 亿美元，跻进「十亿美元俱乐部」。截图来源：Insight 数据库此外，诺华第三季度还取得了一些关键的注册进展，包括：凯丽隆获美国 FDA 批准及欧盟人用药品委员会积极意见，用于治疗 HR+/HER2-II 期和 II1 期早期乳腺癌患者；飞赫达获 FDA 加速批准，用于治疗 IgA 肾病； Pluvicto 已经向 FDA 递交注册申请，获批后将用于治疗未经紫杉醇治疗的转移性去势抵抗性前列腺癌 (mCRPC)。封面来源：企业 logo 免责声明：本文仅作信息分享，不代表 Insight 立场和观点，也不作治疗方案推荐和介绍。如有需求，请咨询和联系正规医疗机构。编辑：馨药 PR 稿对接：微信 insightxb 投稿：微信 insightxb；邮箱 insight@dxy.cn 多样化功能、可溯源数据…… Insight 数据库网页版等你体验点击阅读原文，立刻解锁！

优先审批siRNA财报上市批准放射疗法