The Efficacy and Safety of Pyrotinib Plus Capecitabine in Human Epidermal Growth Factor Receptor 2-positive Breast Cancer Patients With Active Brain Metastases That Have Failed Antibody-drug Conjugate(ADC): a Prospective, Single Arm, Trial

To evaluate the efficacy and safety of pyrotinib plus capecitabine in HER2-positive breast cancer patients with active brain metastases that have failed ADCs

开始日期2024-06-15

申办/合作机构

河南省肿瘤医院

NCT05781633

/ RecruitingN/AIIT

A Single-arm, Open-label， Phase Ⅱ Clinical Trial of Eutideron, Etoposide Combined With Bevacizumab for Breast Cancer Patients With Brain Metastases

This study was a single-arm, open-label, phase II study of breast cancer patients with brain metastases. Eligible patients received a regimen of eutidrone(30mg/m2/d,iv,d1-5,21d/cycle), etoposide(30mg/m2/d,iv,d1-3,21d/cycle), and bevacizumab (10mg/kg,d1,21d/cycle).At least 4 to 6 cycles were administered, and if patients had a response or stable disease, bevacizumab was used as maintenance therapy until disease progression or intolerable toxicity.

开始日期2022-07-20

申办/合作机构

天津市肿瘤研究所

100 项与乳腺癌脑转移相关的临床结果

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100 项与乳腺癌脑转移相关的转化医学

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0 项与乳腺癌脑转移相关的专利（医药）

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项与乳腺癌脑转移相关的文献（医药）

2025-03-01·Technology in Cancer Research & Treatment

Treatment Outcome of Brain Metastases from Breast Cancer Following Gamma Knife Radiosurgery: A Retrospective Study in Vietnam

Article

作者: Nguyen, Hoa Thi ; Nguyen, Tung Van ; Dang, Giang Tien ; Phan, Duong Thanh ; Le, Yen Thi ; Nguyen, Long Thanh ; Phung, Huyen Thi ; Nguyen, Quang Hong

BackgroundGamma Knife radiosurgery has proven to be highly effective for small brain lesions and those with a limited number of metastases. This study aimed to evaluate the treatment outcome of Gamma Knife radiosurgery in Vietnamese breast cancer patients with brain metastasis.MethodsThis retrospective descriptive study included 75 patients treated between January 2019 and December 2023. Eligible patients had 1 to 5 brain lesions ≤ 3 cm, a Karnofsky Performance Status (KPS) score of ≥ 60, and no prior whole-brain radiotherapy or brain tumor resection. Clinical characteristics were documented, and imaging responses were evaluated using RECIST criteria. Overall survival (OS), brain-specific progression-free survival (BSPFS), and overall response rates were analyzed using Kaplan-Meier survival curves and Cox regression.Results Seventy-five patients were included in the study, with a median follow-up time of 15.9 months. The median age was 53.0 years (range: 29-73 years), and 39 patients (52%) were HER2-positive. The median total tumor volume per patient was 3.78 cm 3 . A total of 152 brain tumors were identified, of which 131 (86.2%) were <2 cm in diameter, 36 patients (48.0%) had a single lesion. The intracranial tumor control rates were 96% at 3 months and 92.5% at 6 months. The median overall survival (OS) was 17.2 months (range: 13.7-20.7 months). Multivariate analysis revealed that the total volume of metastatic lesions ≤7.0 cm 3 , hormone receptor negativity, ≤ 3 lines of systemic treatment before brain metastasis and controlled extracranial metastases were correlated with both BSPFS and OS. ConclusionGamma Knife radiosurgery is an effective treatment for limited brain metastases, demonstrating a high rate of local control over brain lesions, which contributed to the promising survival outcome in Vietnamese breast cancer patients.

2024-08-01·Journal of Controlled Release

Auto-loaded TRAIL-exosomes derived from induced neural stem cells for brain cancer therapy

Article

作者: Satterlee, Andrew Benson ; Baldwin, Albert ; Valdivia, Alain ; Taylor, Hannah ; Corcoran, David L ; Herring, Laura E ; Kanchi, Krishna ; Dasari, Rajaneekar ; Steindler, Dennis A ; Hingtgen, Shawn ; Zhang, Xiaopei ; Buckley, Andrew ; Nguyen, Juliane ; Bonacquisti, Emily

Transdifferentiation (TD), a somatic cell reprogramming process that eliminates pluripotent intermediates, creates cells that are ideal for personalized anti-cancer therapy. Here, we provide the first evidence that extracellular vesicles (EVs) from TD-derived induced neural stem cells (Exo-iNSCs) are an efficacious treatment strategy for brain cancer. We found that genetically engineered iNSCs generated EVs loaded with the tumoricidal gene product TRAIL at nearly twice the rate of their parental fibroblasts, and TRAIL produced by iNSCs was naturally loaded into the lumen of EVs and arrayed across their outer membrane (Exo-iNSC-TRAIL). Uptake studies in ex vivo organotypic brain slice cultures showed that Exo-iNSC-TRAIL selectively accumulates within tumor foci, and co-culture assays demonstrated that Exo-iNSC-TRAIL killed metastatic and primary brain cancer cells more effectively than free TRAIL. In an orthotopic mouse model of brain cancer, Exo-iNSC-TRAIL reduced breast-to-brain tumor xenografts by approximately 3000-fold compared to treatment with free TRAIL, with all Exo-iNSC-TRAIL treated animals surviving through 90 days post-treatment. In additional in vivo testing against aggressive U87 and invasive GBM8 glioblastoma tumors, Exo-iNSC-TRAIL also induced a statistically significant increase in survival. These studies establish a novel, easily generated, stable, tumor-targeted EV to efficaciously treat multiple forms of brain cancer.

2022-02-01·Life Sciences3区 · 医学

Olvanil activates sensory nerve fibers, increases T cell response and decreases metastasis of breast carcinoma

3区 · 医学

Article

作者: Akman, Muhlis ; Tanrıöver, Gamze ; Aliyev, Elnur ; Korcum, Aylin F ; Erin, Nuray

BACKGROUNDInactivation of sensory neurons expressing transient receptor potential vanilloid 1 (TRPV1) enhances breast cancer metastasis. Sensory neurons have profound effects on immune response to a wide range of diseases including cancer. Hence, activation of sensory nerves using feasible approaches such as specific TRPV1 agonists may inhibit breast cancer metastasis through neuroimmune pathways. TRPV1 agonists are considered for the treatment of pain and inflammatory diseases.METHODSWe here first determined the effects of four different TRPV1 agonists on proliferation of three different metastatic breast carcinoma cells since TRPV1 is also expressed in cancer cells. Based on the results obtained under in-vitro conditions, brain metastatic breast carcinoma cells (4TBM) implanted orthotopically into the mammary-pad of Balb-c mice followed by olvanil treatment (i.p.). Changes in tumor growth, metastasis and immune response to cancer cells were determined.RESULTSOlvanil dose-dependently activated sensory nerve fibers and markedly suppressed lung and liver metastasis without altering the growth of primary tumors. Olvanil (5 mg/kg) systemically increased T cell count, enhanced intra-tumoral recruitment of CD8+ T cells and increased IFN-γ response to irradiated cancer cells and Con-A. Anti-inflammatory changes such as increased IL-10 and decrease IL-6 as well as S100A8+ cells were observed following olvanil treatment.CONCLUSIONSOur results show that anti-metastatic effects of olvanil is mainly due to activation of neuro-immune pathways since olvanil dose used here is not high enough to directly activate immune cells. Furthermore, olvanil effectively depletes sensory neuropeptides; hence, olvanil is a good non-pungent alternative to capsaicin.

项与乳腺癌脑转移相关的新闻（医药）

2024-12-09

·华昊中天

华昊中天荣获“年度卓越创新力IPO”奖

中国北京，2024年12月6日，北京华昊中天生物医药股份有限公司（下称“华昊中天”，股票代码：2563.HK），一家依托于合成生物学研发平台专注于开发具有自主知识产权抗癌新药的生物医药公司，凭借优异的研发创新实力，多元化、高质量的产品管线以及全球市场的精准布局，荣获“年度卓越创新力IPO”奖。华昊中天董事兼副总经理关津博士出席活动并领奖（左四）格隆汇“金格奖 · 年度卓越创新力IPO”是对公司过去一年在产品创新、模式创新、组织创新等方面进行考量，旨在表彰以持续创新紧跟市场步伐，在模式与路径上获得优秀成果的新上市公司，通过定量数据分析和专家评审团等方式得出最终结果。本次华昊中天的入选代表了资本市场以及产、学、研各界的一致认可与赞许。 2024年10月31日，华昊中天正式在香港联合交易所主板挂牌上市，成为港股合成生物学医药第一股。在过去的一年里，华昊中天在资本市场取得亮眼成绩的同时，业务里程碑持续兑现。3月，FDA分别授予优替德隆治疗乳腺癌脑转移和胃癌的孤儿药资格认定；6月，华昊中天在美国ASCO年会上公布五项海内外临床研究成果；7月，FDA批准优替德隆注射液乳腺癌脑转移美国关键临床研究；8月，全球首个口服固体微管稳定剂优替德隆胶囊在美国完成1期临床全部患者入组；11月，华昊中天宣布与百洋医药达成市场推广合作，获得可观的首付款和里程碑付款。此次创新力奖，是业界对华昊中天可持续创新与发展的认可与鼓励，未来，公司将继续深耕全球抗肿瘤创新药研发，立足中国，布局全球，从患者未被满足的临床需求出发，不断加大创新力度，加速创新药管线的研发和落地，加速产品在全球市场的商业化进程，让创新产品惠及更多患者，同时为股东和投资者创造更大价值。关于格隆汇“金格奖” “格隆汇·第九届·全球投资嘉年华·2025”携手最具前沿思想力的经济学家、风投圈大咖、千家顶级投资机构以及百家港、A、美股三地中国优秀上市公司，以全球视野眼光，共同探讨百年变局下，全球及中国经济发展新动能以及资本市场的变革和发展。格隆汇“金格奖”年度卓越上市公司评选以“全球视野，下注中国”为初衷，以上海、深圳、中国香港和美国的上市公司为对象，旨在打造投资圈中最具参考意义的上市公司榜单。往期回顾华昊中天成功登陆香港联交所主板，合成生物学引领创新药研发新时代强强联合，携手共赢丨华昊中天与百洋医药达成战略合作华昊中天“优替德隆注射液乳腺癌新辅助Ⅲ期注册临床试验”研究者会议圆满召开亦庄路书｜一支“创新药”的健康答卷冲击癌王 ▏优替德隆一线治疗晚期胰腺癌临床研究初步数据公布华昊中天优替德隆注射液治疗肺癌脑转移II期临床获批优替德隆胶囊美国I期临床完成全部患者入组 FDA批准华昊中天优替德隆注射液治疗乳腺癌脑转移临床试验华昊中天携五项海内外临床研究成果亮相ASCO 2024

引进/卖出IPO孤儿药ASCO会议临床3期

2024-09-13

·CPHI制药在线

罗氏斥巨资购入的HER2 BIC小分子新药拟纳入突破性治疗品种

近日，苏州赞荣医药自主研发的ZN-A-1041肠溶胶囊获得了国家药品监督管理局药品审评中心（CDE）的突破性疗法认定。ZN-A-1041的突破性在于其独特的联合治疗方案，即与卡培他滨和曲妥珠单抗联合使用，针对那些已经接受过含曲妥珠单抗治疗但仍出现病情进展的HER2阳性晚期脑转移乳腺癌患者。这一患者群体面临着极大的治疗挑战，传统疗法往往难以有效控制病情，而ZN-A-1041的加入为他们提供了新的治疗选择和希望。罗氏以总额6.8亿元购买了该药的全球权益授权。 ZN-A-1041是一款由赞荣医药自主研发的口服小分子HER2酪氨酸激酶抑制剂（TKI），它不仅具有高度的选择性，能够精准靶向HER2受体，还展现出卓越的血脑屏障通透性。这一特性在当前的抗癌药物中极为罕见，使得ZN-A-1041能够有效地穿越血脑屏障，针对脑转移病灶进行治疗，从而填补了当前市场的空白。此外，ZN-A-1041在临床试验中还表现出良好的安全性和耐受性，即使在联合治疗中也能保持稳定的疗效，这为其在临床上的广泛应用奠定了坚实的基础。在分子设计层面，ZN-A-1041通过精妙的化学结构调整，实现了对HER2的高选择性抑制，同时避免了对野生型EGFR等无关受体的影响，从而减少了不良反应的发生。这种"精准打击"的策略不仅提高了治疗效果，还改善了患者的生活质量。此外，ZN-A-1041还具备出色的药物代谢动力学特性，确保了药物在体内的稳定释放和有效浓度，为持续治疗提供了有力保障。 ZN-A-1041的I期临床试验还纳入了多种类型的肿瘤患者，包括伴或不伴脑转移的乳腺癌患者以及胃癌患者等。这一广泛的适应症研究不仅验证了ZN-A-1041的广谱治疗潜力，也为其在未来的药物开发和商业化道路上提供了更多的可能性。 ZN-A-1041在临床试验中展现出的疗效令人振奋。在2023年ASCO年会上公布的早期临床数据显示，ZN-A-1041在治疗HER2阳性乳腺癌脑转移患者方面取得了显著成果。在单药治疗组中，对于既往未接受TKI治疗的HER2阳性肿瘤患者，总客观缓解率（ORR）和颅内客观缓解率（iORR）均达到了50%，最长治疗时间更是达到了15个月。而在联合卡培他滨和曲妥珠单抗的联合治疗组中，对于完成至少两次肿瘤评估的脑转移乳腺癌（BCBM）患者，总ORR提升至78.9%，iORR达到73.7%，疾病控制率（DCR）更是实现了惊人的100%。这一数据不仅证明了ZN-A-1041在治疗HER2阳性乳腺癌脑转移方面的巨大潜力，也为其未来的广泛应用提供了有力支持。值得一提的是，ZN-A-1041的I期临床试验还纳入了多种类型的肿瘤患者，包括伴或不伴脑转移的乳腺癌患者以及胃癌患者等。这一广泛的适应症研究不仅验证了ZN-A-1041的广谱治疗潜力，也为其在未来的药物开发和商业化道路上提供了更多的可能性。罗氏斥资6.8亿美元购入ZN-A-1041的全球权益，是其在HER2阳性肿瘤治疗领域的重要布局。ZN-A-1041作为一款潜在的BIC小分子药物，凭借其高度的血脑屏障通透性和卓越的临床数据，展现了其在治疗HER2阳性乳腺癌脑转移方面的巨大潜力。此外，罗氏与赞荣医药的此次合作，不仅彰显了双方对创新药物研发的共同追求与坚定信念，也为全球肿瘤治疗领域注入了新的活力。罗氏作为全球制药巨头，其丰富的市场资源、强大的研发能力和广泛的销售网络，将为ZN-A-1041的后续研发、临床试验及市场推广提供强有力的支持。参考文献 1. 中国国家药监局药品评审中心官网 2. 罗氏制药宣布收购赞荣医药ZN-A-1041全球权益https://www.roche.com/media/releases/med-cor-2023-05-09 3. ZN-A-1041：一款潜在的BIC小分子HER2抑制剂在HER2阳性乳腺癌脑转移治疗中的早期临床研究内容来源于网络，如有侵权，请联系删除。

临床结果ASCO会议突破性疗法

2024-09-06

·Pharma CMC

今日，2款1类新药拟纳入突破性治疗品种！

今日（9月6日），CDE官网显示，赞荣医药的ZN-A-1041肠溶胶囊与武田的TAK-861片拟纳入突破性治疗品种。 ZN-A-1041肠溶胶囊适应症为：联合卡培他滨和曲妥珠单抗用于既往接受过含曲妥珠单抗治疗进展的人表皮生长因子受体2 阳性（HER2 阳性）晚期脑转移乳腺癌患者。 TAK-861片适应症为：治疗发作性睡病1型 ZN-A-1041是一款靶向人表皮生长因子受体2（HER2）的口服选择性酪氨酸激酶抑制剂，同时具备高度血脑屏障通透性，因此可潜在用于治疗HER2阳性乳腺癌脑转移的患者以及预防脑转移的发生。高达50%的HER2阳性转移性乳腺癌患者在病程中会发生脑转移。 2023年5月9日，赞荣医药宣布与罗氏就收购口服小分子HER2抑制剂ZN-A-1041的全球权益达成协议。根据协议，罗氏将获得ZN-A-1041在全球的进一步开发、生产和商业化权利。为此，罗氏将向赞荣医药支付7000万美金首付款和近期里程碑付款，另外高达6.1亿美元的开发和商业化里程碑付款，以及未来基于全球年度销售净额的梯度分成。 TAK-861片是一种口服食欲素受体2（OX2R）激动剂。今年6月，武田宣布TAK-861在治疗1型发作性睡病的2b期临床试验中获得的积极结果。这项随机双盲、含安慰剂对照的临床试验（n=112）达到主要和次要终点。2b期试验的主要终点显示，在维持清醒测试（MWT）中，所有剂量组与安慰剂组相比在推迟睡眠发生指标上均表现出统计学显著和具有临床意义的改善（p≤0.001）。改善在8周内持续保持。内容来源于网络，如有侵权，请联系删除。