A Phase I, Open-label, 2 Part, Fixed Sequence Study to Assess the Effect of Co-administration of Camizestrant (AZD9833) on the Pharmacokinetics of Midazolam Exposure (CYP3A4/5 Substrate) and of Carbamazepine (CYP3A4/5 Inducer) on Camizestrant Exposure in Healthy Post Menopausal Female Participants

This study will be conducted in order to determine the effect of repeated oral doses of camizestrant on the pharmacokinetics (PK) of midazolam and to determine the effect of repeated oral titrated doses of carbamazepine on the PK of camizestrant in healthy post-menopausal female participants.

开始日期2024-08-27

申办/合作机构

AstraZeneca PLC

NCT06380751

/ Recruiting临床3期

A Randomised, Open-Label, Phase III Study of Saruparib (AZD5305) Plus Camizestrant Compared With Physician's Choice CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant for the First-Line Treatment of Patients With BRCA1, BRCA2, or PALB2 Mutations and Hormone Receptor Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified) Advanced Breast Cancer (EvoPAR-Breast01)

The primary objective of the study is to measure efficacy of saruparib (AZD5305) plus camizestrant compared with physician's choice CDK4/6i plus ET in patients with BRCA1, BRCA2, or PALB2m, HR-positive, HER2-negative (defined as IHC 0, 1+, 2+/ ISH non-amplified) advanced breast cancer.

开始日期2024-08-01

申办/合作机构

AstraZeneca PLC

CTR20233662

/ Recruiting临床3期

CAMBRIA-2：在已完成根治性局部区域治疗且无疾病证据的中-高或高复发风险的 ER+/HER2- 早期乳腺癌患者中评估 Camizestrant（AZD9833，下一代口服选择性雌激素受体降解剂）对比标准内分泌治疗（芳香化酶抑制剂或他莫昔芬）作为辅助治疗的疗效和安全性的 III 期、开放标签、随机研究

主要疗效：通过评估无浸润性乳腺癌生存期 (IBCFS)，证明 Camizestrant ± 阿贝西利相较于标准内分泌治疗±阿贝西利有优效性。次要终点：通过评估无浸润性疾病生存期 (IDFS)、无远处复发生存期 (DRFS)、总生存期 (Overall Survival, OS)，证明 Camizestrant±阿贝西利相较于标准内分泌治疗±阿贝西利有优效性。通过评估出现给药中断或感觉至少“有点”受治疗副作用困扰的研究治疗时间的比例，证明 Camizestrant±阿贝西利具有更好的耐受性。评估患者报告的 Camizestrant±阿贝西利与标准内分泌治疗±阿贝西利相比的关节痛、潮热和阴道干燥治疗相关症状。评估接受 Camizestrant±阿贝西利与接受标准内分泌治疗±阿贝西利治疗的患者相比，患者报告的健康相关生活质量 (QoL)。评估根据研究方案接受至少 1 剂 Camizestrant 且至少有 1 个可报告 PK 浓度的患者中 Camizestrant 的稳态 PK。安全性：评估 Camizestrant±阿贝西利相较于标准内分泌治疗±阿贝西利的安全性。

开始日期2024-03-29

申办/合作机构

AstraZeneca AB

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100 项与 Camizestrant 相关的临床结果

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100 项与 Camizestrant 相关的转化医学

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100 项与 Camizestrant 相关的专利（医药）

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项与 Camizestrant 相关的文献（医药）

2025-03-16·Future Oncology

CAMBRIA-1 & CAMBRIA-2 phase III trials: camizestrant versus standard endocrine therapy in ER+/HER2– early breast cancer

Article

作者: Stuart, Mary ; Syta, Emilia ; Park, Yeon Hee ; Nunes, Raquel ; Saini, Kamal S. ; Loibl, Sibylle ; Gioni, Ioanna ; Niikura, Naoki ; Hamilton, Erika P. ; Tolaney, Sara M. ; Quintana, Angela ; Johnston, Simon ; Pistilli, Barbara ; Rastogi, Priya ; Mayer, Ingrid A. ; Walding, Andrew ; Klinowska, Teresa ; Gnant, Michael ; Bachelot, Thomas

Novel selective estrogen receptor degraders (SERDs) are a promising therapeutic option under investigation for patients with estrogen receptor (ER)-positive/human epidermal growth factor receptor 2 (HER2)-negative breast cancer. The efficacy of novel SERDs in the treatment of advanced disease has prompted investigation into their use in the early disease setting, to reduce breast cancer recurrence. Here, we describe the design and rationale of the phase III, randomized, open-label CAMBRIA-1 and CAMBRIA-2 studies. CAMBRIA-1 and CAMBRIA-2 are comparing the next-generation oral SERD camizestrant versus standard-of-care endocrine therapy (aromatase inhibitors or tamoxifen) in patients with ER-positive/HER2-negative early breast cancer, who are at intermediate or high risk of disease recurrence. CAMBRIA-1 is comparing 5 years of camizestrant versus endocrine therapy in patients who have already received 2-5 years of standard endocrine therapy, with or without cyclin-dependent kinase 4/6 inhibitors, and are without recurrence. CAMBRIA-2 is comparing 7 years of upfront adjuvant camizestrant versus endocrine therapy, with abemaciclib permitted in both treatment arms for the first 2 years. The primary endpoint for both studies is invasive breast cancer-free survival. Secondary endpoints include invasive disease-free survival, distant recurrence-free survival, overall survival, pharmacokinetics, patient-reported outcomes, safety and tolerability.Tweetable abstract: CAMBRIA-1 and CAMBRIA-2 are ongoing, randomized, open-label trials of adjuvant camizestrant, either as an upfront treatment or as a treatment after standard endocrine therapy, in patients with HR+/HER2- early breast cancer at intermediate to high risk of disease recurrence.Clinical Trial Registration: NCT05774951 (CAMBRIA-1); NCT05952557 (CAMBRIA-2).

2025-02-26·ACS Central Science

Single Dose of a Small Molecule Leads to Complete Regressions of Large Breast Tumors in Mice

Article

作者: Zhu, Junyao ; Nelson, Erik R. ; Bouwens, Brooke A. ; Mulligan, Michael P. ; Boudreau, Matthew W. ; Shapiro, David J. ; Mousses, Spyro ; Hergenrother, Paul J. ; Lee, Yoongyeong ; Carrell, Hunter W. ; Fan, Timothy M.

Patients with estrogen receptor α positive (ERα+) breast cancer typically undergo surgical resection, followed by 5-10 years of treatment with adjuvant endocrine therapy. This prolonged intervention is associated with a host of undesired side effects that reduce patient compliance, and ultimately therapeutic resistance and disease relapse/progression are common. An ideal anticancer therapy would be effective against recurrent and refractory disease with minimal dosing; however, there is little precedent for marked tumor regression with a single dose of a small molecule therapeutic. Herein we report ErSO-TFPy as a small molecule that induces quantitative or near-quantitative regression of tumors in multiple mouse models of breast cancer with a single dose. Importantly, this effect is robust and independent of tumor size with eradication of even very large tumors (500-1500 mm³) observed. Mechanistically, these tumor regressions are a consequence of rapid induction of necrotic cell death in the tumor and are immune cell independent. If successfully translated to human cancer patients, the benefits of such an anticancer drug that is effective with a single dose would be significant.

2025-01-27·Annual Review of Medicine

New Oral Selective Estrogen Receptor Degraders Redefine Management of Estrogen Receptor–Positive Breast Cancer

Review

作者: Oliveira, Mafalda ; Pathak, Neha

Oral selective estrogen receptor degraders (SERDs) are pure estrogen receptor antagonists that have the potential to overcome common resistance mechanisms to endocrine therapy in estrogen receptor–positive breast cancer. There are currently five oral SERDs in published and ongoing clinical trials—elacestrant, camizestrant, giredestrant, imlunestrant, and amcenestrant—with more in development. They offer a reasonably well-tolerated oral therapy option with low discontinuation rates in studies. This review summarizes the currently available literature on this new class of drugs.

129

项与 Camizestrant 相关的新闻（医药）

2025-04-29

·BioSpace

AstraZeneca Abandons Neuroscience, Prioritizes Weight Loss, Immunology

iStock, hapabapa Following the recent discontinuations of assets in Alzheimer’s and migraine, AstraZeneca is stepping away from neuro altogether. AstraZeneca will no longer play in the neuroscience space, company executives said in an investor call on Tuesday, presenting the pharma’s first-quarter 2025 earnings report. “There’s a lot of things we can’t fund and we cannot be everywhere,” CEO Pascal Soriot said during the call. “CNS really is probably better managed by other companies that have a focus on that.” In the quarter, AstraZeneca discontinued the development of MEDI1814, an early-stage anti-amyloid beta antibody for Alzheimer’s disease, and MEDI0618, a Phase II monoclonal antibody for migraine, according to its latest pipeline document . These moves leave the company with no active neuroscience program. “We have closed our neuro programs and identified partners for some of them,” noted Sharon Barr, executive vice president of BioPharmaceuticals R&D at AstraZeneca. “This represents the closure of our neuroscience group at AstraZeneca,” which will allow the company to focus on its “core therapeutic priorities and fund our high-value programs.” The move away from neuroscience, according to Barr, will allow the pharma to instead channel its resources into weight management, dyslipidemia, respiratory diseases and immunology indications. “This prioritization allows us to reinvest in the programs that we think are important for AstraZeneca.” In the first three months of 2025, AstraZeneca recorded 10% revenue growth , nearly hitting $13.6 billion. The pharma’s performance in the quarter fell short of the analyst forecast , however, which pegged its Q1 sales to hit $13.68 billion. On a per-share basis, on the other hand, AstraZeneca came out ahead, earning $1.88 in the quarter versus the consensus of $1.10. Cancer remained the pharma’s strongest area, racking up more than $5.6 billion in sales across its various products. While its top-selling product was the type 2 diabetes therapy Farxiga—which surged 15% year-on-year to bring in more than $2 billion in Q1—most of its main growth drivers come from its oncology business. The kinase inhibitor Tagrisso, for instance, brought in nearly $1.7 billion in the quarter, a 12% increase from the same period last year. Imfinzi, a PD-1 blocker indicated for lung cancer, earned $1.26 billion in Q1, while the lymphoma drug Calquence and the PARP inhibitor Lynparza raked in $762 million and $726 million, respectively. Looking ahead to the rest of the year, AstraZeneca expects its total revenue to grow by a high single-digit percentage, while core earnings per share will increase by a low double-digit percentage. Tariffs Unlikely To Have Major Impact AstraZeneca executives on Tuesday refused to commit to a substantial investment package in the U.S., emphasizing that the potential effects of tariffs on its business would be “manageable,” particularly since the majority of its products in the U.S. are being manufactured domestically, Chief Financial Officer Aradhana Sarin said during the investor call. The pharma made a $3.5 billion injection into its U.S. footprint last November, money that it earmarked for an R&D facility in Massachusetts and a couple of manufacturing facilities. “We’ve said this year that our [capital expenditure] would be 50% higher than last year, but going forward, we need to look at how the portfolio develops,” Sarin added. For instance, before making any major infrastructure investments, the pharma will first want to see how its oral GLP-1 drug performs in clinical trials and how its breast cancer candidate camizestrant progresses, Sarin said. “We will then start to plan for success for these molecules and we’ll build and manage supply accordingly.” Several of AstraZeneca’s Big Pharma peers have in recent weeks announced hefty multi-billion investments in the U.S., largely in response to the threat of tariffs from President Donald Trump. Eli Lilly was first out the door in February with a $27 billion pledge to construct four new plants. J&J was close behind, with a $55 billion commitment that it will make over the next four years. Novartis , Roche and Regeneron have all also announced U.S.-based investments.

临床2期财报临床1期

2025-04-29

·astrazeneca.com

Q1 2025 results

Pascal Soriot, Chief Executive Officer, AstraZeneca, commenting on the results said: “Our strong growth momentum has continued into 2025 and we have now entered an unprecedented catalyst-rich period for our company. Already this year we have announced five positive Phase III study readouts, including most recently the highly anticipated DESTINYBreast09 for Enhertu, as well as SERENA-6 for camizestrant and MATTERHORN for Imfinzi; the latter two of these will feature in the ASCO 2025 plenary sessions, reflecting the significance of these data to the oncology community. Our company is firmly committed to investing and growing in the US and we continue to benefit from our broad-based source of revenue and global manufacturing footprint, including eleven production sites in the US covering small molecules, biologics as well as cell therapy. Additionally, we have even greater US investment in manufacturing and R&D planned, leveraging our two large R&D sites in Gaithersburg MD and Cambridge MA. Overall, we are making excellent progress toward our ambition of eighty billion dollars in Total Revenue by 2030.” Q1 2025 results announcement PDF 965KB Q1 2025 results presentation PDF 3,268KB Q1 2025 results clinical trials appendix PDF 3,212KB Adrian Kemp Company Secretary AstraZeneca PLC Corporate and financial

临床3期细胞疗法临床结果财报

2025-04-22

·阿斯利康中国

荃科得®联合氟维司群在华获批用于HR阳性晚期乳腺癌患者

首个且唯一*在华获批、用于特定生物标志物（PIK3CA、AKT1 或 PTEN）改变的乳腺癌患者的AKT抑制剂此次获批基于CAPItello-291全球研究，其结果显示在生物标志物改变人群中，该药物联合氟维司群相较氟维司群单药可将疾病进展或死亡风险降低50%重磅发布2025年4月22日，上海——阿斯利康今日宣布，中国国家药品监督管理局于2025年4月15日正式批准荃科得®（英文商品名: Truqap®，通用名：卡匹色替片）联合氟维司群用于转移性阶段至少接受过一种内分泌治疗后疾病进展，或在辅助治疗期间或完成辅助治疗后12个月内复发的激素受体（HR）阳性、人表皮生长因子受体2（HER2）阴性且伴有一种或多种PIK3CA/AKT1/PTEN改变的局部晚期或转移性乳腺癌成人患者。此次在华获批是基于早前发表在《新英格兰医学杂志》上的CAPItello-291全球III期研究的积极结果1，2023年欧洲肿瘤内科学会亚洲年会（ESMO Asia）上公布的中国队列的积极结果与全球研究结果一致，也支持了本次获批。2在该试验的全球人群中，69%的患者曾接受过细胞周期蛋白依赖性激酶 (CDK) 4/6 抑制剂治疗，研究结果显示，对于携带PI3K/AKT通路中生物标志物改变的患者，卡匹色替联合氟维司群相较于氟维司群单药治疗可将疾病进展或死亡风险降低50%（风险比0.50，95%置信区间0.38-0.65；p=<0.001；中位无进展生存期 (PFS) 为7.3个月对比3.1个月）。1在中国人群中，相较于氟维司群单药治疗，卡匹色替联合氟维司群可将携带PIK3CA、AKT1或PTEN基因改变患者的疾病进展或死亡风险降低59%（风险比0.41；中位PFS为5.7个月对比1.9个月）。2乳腺癌是中国女性最高发的恶性肿瘤之一，仅2022年确诊病例就超过35万例，并造成约75,000例患者死亡。3在全球范围内，HR阳性乳腺癌（表达雌激素和/或孕激素受体）是最常见的乳腺癌亚型， 70%的乳腺癌被认为是HR阳性、HER2阴性。4内分泌治疗联合细胞周期蛋白依赖性激酶 (CDK) 4/6 抑制剂在晚期乳腺癌患者的初始治疗中被广泛使用，但肿瘤仍会对这些疗法产生耐药，尤其是当肿瘤携带PIK3CA、AKT1或PTEN改变时，因此亟需更多基于内分泌治疗的联合用药方案以优化内分泌治疗的获益时间和疗效。5全球数据显示，约 50% 的HR阳性晚期乳腺癌患者携带PIK3CA、AKT1或PTEN基因的改变。6-8在中国人群中，约57%的HR阳性、HER2阴性乳腺癌患者携带PIK3CA、AKT1或PTEN改变，其中携带PTEN或AKT1改变的比例分别高达8.4%和7.7%。9胡夕春教授复旦大学附属肿瘤医院大内科首席，ESMO 国际乳腺癌专家委员会委员，CAPItello-291中国牵头研究者晚期HR阳性乳腺癌患者往往在一线内分泌疗法中出现疾病进展或耐药。很高兴看到此次获批为伴有PIK3CA、AKT1或PTEN基因改变的晚期HR阳性乳腺癌患者带来全新治疗选择，有望帮助患者延缓疾病进程并延长生存时间，同时也彰显了乳腺癌精准诊疗的重要性。何静博士阿斯利康全球高级副总裁，全球研发中国负责人乳腺癌严重威胁中国女性的生命健康，患者亟需创新治疗方案的需求尚未被满足。卡匹色替是首个且唯一在中国获批用于PIK3CA/AKT1/PTEN改变的乳腺癌患者的AKT抑制剂，此次获批充分彰显了我们药物的创新价值, 未来我们将继续借助自身研发实力和管线布局，倾力攻克乳腺癌这一致死疾病。关冬梅女士阿斯利康中国肿瘤业务总经理卡匹色替有望延长目前被广泛使用的内分泌治疗的获益，并帮助HR阳性晚期乳腺癌患者延缓疾病进展，它的获批是阿斯利康中国持续探索乳腺癌领域的又一重要里程碑。阿斯利康与健康中国2030癌症防治目标同心同行，我们期待能将更多全球创新肿瘤药物带给广大中国患者，并为“健康中国2030”宏伟目标的达成贡献力量。在CAPItello-291试验中，卡匹色替联合氟维司群的安全性与此前开展的联合用药试验中观察到的结果基本一致。1基于CAPItello-291试验结果，目前卡匹色替已在美国、欧盟、日本等其他国家和地区获批用于治疗HR阳性晚期乳腺癌患者。关于HR阳性乳腺癌乳腺癌是全球第二高发的癌症，也是全球癌症相关死亡的主要原因之一。10 2022年，全球超过 200 多万名患者被诊断为乳腺癌，有近665,000 名患者死亡。10HR 阳性乳腺癌细胞的生长通常由雌激素受体驱动，内分泌疗法被广泛用作ER驱动的晚期乳腺癌的一线治疗，并通常与 CDK4/6 抑制剂联合使用。5,11,12然而，许多晚期乳腺癌患者会对 CDK4/6 抑制剂和目前的内分泌疗法产生耐药性。11一旦出现这种情况，治疗选择就会相对有限（化疗是目前的标准治疗方法），并且生存率较低，预计只有35%的患者在诊断后能够存活五年以上。4,11,13优化内分泌治疗并克服耐药，以使患者能够继续从内分泌治疗中获益，同时为那些不太可能受益的患者寻找新的治疗方法，是目前乳腺癌研究的活跃关注领域。关于CAPItello-291CAPItello-291是一项III期、双盲、随机试验，旨在评估卡匹色替联合氟维司群对比安慰剂联合氟维司群在局部晚期（不可手术）或转移性激素受体阳性、HER2低表达或阴性（免疫组化[IHC] 0或1+，或IHC 2+/原位杂交[ISH]阴性）乳腺癌患者中的疗效。这项全球研究招募了708名患有组织学确认的激素受体阳性、HER2低表达或阴性乳腺癌的成年患者。这些患者的疾病在芳香化酶抑制剂治疗期间或之后复发或进展，可能已经接受了CDK4/6抑制剂治疗及晚期一线化疗。该试验具有双重主要终点：总体人群中的PFS和PI3K/AKT通路改变（PIK3CA、AKT1或PTEN基因改变）患者人群的PFS。本研究纳入约40%的通路改变人群，近 70% 的患者曾使用过 CDK4/6 抑制剂。该研究的中国队列以与全球研究相同的入排标准招募了134 名来自中国大陆和中国台湾地区的成年患者。在该队列中，约35%的患者的肿瘤携带PIK3CA、AKT1或PTEN改变，约40%的患者曾接受过CDK4/6抑制剂治疗。关于荃科得®荃科得®（卡匹色替）是一款first-in-class高效的三磷酸腺苷(ATP)竞争性抑制剂，可抑制所有三种AKT异构体（AKT1/2/3）。根据早期试验中的耐受性和靶点抑制程度进行给药方案的选择，卡匹色替每天两次，每次400mg，按照四天用药、三天停药的间歇剂量方案给药。根据 CAPItello-291 试验的结果，卡匹色替已在美国、欧盟、日本、中国及其他几个国家获得批准，用于治疗 HR 阳性、HER2 阴性局部晚期或转移性乳腺癌成人患者，这些患者在接受内分泌治疗期间或之后出现复发或进展，且具有一种或多种生物标志物改变（PIK3CA、AKT1 或 PTEN）。根据这些试验结果，卡匹色替还在澳大利亚获得批准，用于治疗在接受内分泌治疗期间或之后出现复发或进展的 HR 阳性、HER2 阴性局部晚期或转移性乳腺癌成人患者。卡匹色替目前正在开展多项III期临床试验，以评估其单独应用或者与既定治疗方案联合应用在乳腺癌(CAPItello-292)和前列腺癌(CAPItello-280及CAPItello-281)中的治疗效果。卡匹色替是阿斯利康与Astex Therapeutics 合作（以及与伦敦癌症研究所和癌症研究技术有限公司的合作）之后开发的。关于芙仕得®芙仕得®（氟维司群）是一种内分泌疗法，适用于在抗雌激素辅助治疗后或治疗过程中复发的，或是在抗雌激素治疗中进展的绝经后雌激素受体阳性的局部晚期或转移性乳腺癌。在美国、欧盟、中国和日本，氟维司群还被批准与CDK4/6抑制剂联合使用，用于治疗HR阳性、HER2阴性的晚期或转移性乳腺癌女性患者，这些患者在接受内分泌治疗后出现进展。氟维司群代表了一种激素治疗方法，通过阻断和降解雌激素受体（疾病进展的关键驱动因素）来帮助减缓肿瘤的生长。氟维司群被批准作为单一疗法或与包括CDK4/6和PI3K抑制剂在内的各类药物联合治疗HR阳性晚期乳腺癌患者，并且正在评估与其他药物的联合使用。关于阿斯利康在乳腺癌领域的研究在对乳腺癌生物学认识不断深化的驱动下，阿斯利康开始挑战并重新定义当前的乳腺癌分型及临床治疗模式，以为有需要的患者提供更为精准而有效的治疗方案。阿斯利康雄心勃勃，希望有朝一日可以消除乳腺癌这一致死病因。阿斯利康研发了一系列已获批或有望获批的药物，通过多种机制应对乳腺癌肿瘤微环境的生物多样性。凭借靶向HER2的抗体偶联药物——优赫得（德曲妥珠单抗），阿斯利康和第一三共致力于改善先前接受过治疗的HER2阳性、HER2低表达与HER2超低表达转移性乳腺癌患者的预后，并正在探索其在更早线的治疗和其他乳腺癌治疗阶段中的潜力。在HR阳性乳腺癌中，阿斯利康继续通过基石药物芙仕得 (氟维司群) 和诺雷得 (戈舍瑞林) 改善预后，并旨在通过first-in-class的AKT抑制剂荃科得 (卡匹色替)、靶向Trop2的ADC药物Datroway (datopotamab deruxtecan) 以及新一代口服SERD camizestrant重塑HR阳性乳腺癌的治疗。PARP抑制剂利普卓（奥拉帕利）是一种靶向治疗药物，已在遗传性BRCA突变的早期和转移性乳腺癌患者中进行了研究。阿斯利康与默沙东（默沙东是美国新泽西州罗威市默克公司的公司商号）将继续利普卓在这些领域的相关研究，并探索其在疾病早期治疗中的潜力。阿斯利康还在探索Saruparib（一种强效的PARP1选择性抑制剂）与camizestrant联合治疗BRCA突变、HR阳性、HER2阴性晚期乳腺癌的有效性和安全性。为了给三阴性乳腺癌（一种侵袭性乳腺癌）患者提供急需的治疗选择，阿斯利康正在评估 Datroway单独使用或与免疫药物英飞凡(度伐利尤单抗)联合使用的潜在效果。关于阿斯利康在肿瘤领域的研究阿斯利康正引领着肿瘤领域的一场革命，致力于提供多元化的肿瘤治疗方案，以科学探索肿瘤领域的复杂性，发现、研发并向患者提供改变生命的药物。阿斯利康专注于最具挑战性的肿瘤疾病，通过持续不断的创新，阿斯利康已经建立了行业领先的多元化的产品组合和管线，持续推动医疗实践变革，改变患者体验。阿斯利康以期重新定义癌症治疗并在未来攻克癌症。声明：* 截至2025年4月22日，在中国大陆是唯一本文涉及尚未在中国大陆获批的产品或者适应症，阿斯利康不推荐任何未被批准的药品使用。内容来源：新闻稿 (内部审批号:CN-158608）参考文献（滑动查看更多）1.Turner N, et al. Capivasertib in Hormone Receptor–Positive Advanced Breast Cancer. NEJM. 2023; 388:2058–70.2.Xichun H, et al. Capivasertib + fulvestrant for patients with aromatase inhibitor resistant HR positive/HER2 negative advanced breast cancer: Phase 3 CAPItello 291 trial Chinese cohort. Annals of Oncology (2023) 34 (suppl_4): S1485-S1493. 10.1016/annonc/annonc1376.3.Zhonghua Z, et al. Breast Cancer Expert Committee of National Cancer Quality Control Center. Chinese Journal of Oncology. 2024; 46,12: 1079-1106.4.National Cancer Institute. Surveillance, Epidemiology and End Results Program. Available at: https://seer.cancer.gov/statfacts/html/breast-subtypes.html. Accessed April 2025.5.Lin M, et al. Comparative Overall Survival of CDK4/6 Inhibitors Plus Endocrine Therapy vs. Endocrine Therapy Alone for Hormone receptor-positive, HER2-negative metastatic breast cancer. J Cancer. 2020; 10.7150/jca.48944.6.Howell S J, et al. Fulvestrant plus capivasertib versus placebo after relapse or progression on an aromatase inhibitor in metastatic, oestrogen receptor-positive, HER2-negative breast cancer (FAKTION). J Clin Oncol. 2022; 23:851-64.7.Hortobagyi G N, et al. Correlative Analysis of Genetic Alterations and Everolimus Benefit in Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer: Results From BOLERO-2. J Clin Oncol. 2016; 34:419-26.8.Millis S Z, et al. Landscape of phosphatidylinositol-3-kinase pathway alterations across 19784 diverse solid tumors. JAMA Oncol. 2016;2(12):1565-73.9.Ziang Li, et al. 2024 SABCS. P3-10-13: A Comprehensive Analysis of Dysregulation in the PTEN/PI3K/AKT Pathway in Breast Cancer Among the Chinese Population10.American Cancer Society. Key Statistics for Breast Cancer. Available at: https://www.cancer.org/cancer/breast-cancer/about/how-common-is-breast-cancer.html. Accessed April 2025.11.Lloyd M R, et al. Mechanisms of Resistance to CDK4/6 Blockade in Advanced Hormone Receptor–positive, HER2-negative Breast Cancer and Emerging Therapeutic Opportunities. Clin Cancer Res. 2022; 28(5):821-30.12.Scabia V, et al. Estrogen receptor positive breast cancers have patient specific hormone sensitivities and rely on progesterone receptor. Nat Commun. 2022; 10.1038/s41467-022-30898-0.13.National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology (NCCN Guidelines). Available at: https://www.nccn.org/guidelines/guidelines-detail?category=1&id=1419. Accessed April 2025.

临床结果临床3期上市批准

100 项与 Camizestrant 相关的药物交易

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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3期	斯洛伐克	AstraZeneca PLC	2021-01-28
ER阳性乳腺癌	临床3期	波兰	AstraZeneca PLC	2021-01-28
ER阳性乳腺癌	临床3期	智利	AstraZeneca PLC	2021-01-28
ER阳性乳腺癌	临床3期	墨西哥	AstraZeneca PLC	2021-01-28
ER阳性乳腺癌	临床3期	保加利亚	AstraZeneca PLC	2021-01-28
ER阳性乳腺癌	临床3期	日本	AstraZeneca PLC	2021-01-28
ER阳性/HER2阴性乳腺癌	临床3期	瑞典	阿斯利康投资（中国）有限公司	2021-01-18
ER阳性/HER2阴性乳腺癌	临床3期	韩国	阿斯利康投资（中国）有限公司	2021-01-18
ER阳性/HER2阴性乳腺癌	临床3期	韩国	AstraZeneca AB	2021-01-18
ER阳性/HER2阴性乳腺癌	临床3期	瑞典	AstraZeneca AB	2021-01-18

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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


NCT04964934 (SERENA-6, BusinessWire) 人工标引	临床3期	ER阳性/HER2阴性/ESR1突变乳腺癌一线 \| \|	315	Camizestrant + CDK4/6i	(鹽遞醖鏇構顧願窪鑰齋) = a highly statistically significant and clinically meaningful improvement in the primary endpoint of progression-free survival (PFS). 鑰選範壓鏇夢襯憲餘衊 (襯遞壓構製築膚糧糧衊 ) 更多	积极	2025-02-26
NCT04588298 (SERENA-3, CTgov)	临床2期	ER阳性/HER2阴性乳腺癌 \| HER2 阴性乳腺癌	135	AZD9833 (AZD9833 75 mg (Stage 1 + 2))	膚廠製鏇觸積簾襯範鬱(糧憲膚蓋膚積糧網鹹鑰) = 蓋積窪艱鹽鏇範製鹽鏇觸遞窪餘鏇觸齋鹽衊醖 (齋夢壓鏇窪淵觸選積糧, 窪積繭製蓋築憲構夢艱 ~ 範襯鬱觸鑰鹽蓋鑰積鹽) 更多	-	2025-01-24
				AZD9833 (AZD9833 150 mg (Stage 1 + 2))	膚廠製鏇觸積簾襯範鬱(糧憲膚蓋膚積糧網鹹鑰) = 觸遞鑰構顧壓醖膚壓壓觸遞窪餘鏇觸齋鹽衊醖 (齋夢壓鏇窪淵觸選積糧, 廠壓艱壓鹽獵餘淵鹹製 ~ 網獵醖範醖衊壓鑰膚繭) 更多
NCT04214288 (SERENA-2, Literature) 人工标引	临床2期	ER阳性/HER2阴性乳腺癌	240	camizestrant 75 mg	(網觸淵壓鏇鹽簾積鬱繭) = 鹽鏇積積襯糧鹹淵繭遞鹽範窪齋顧觸簾廠衊構 (艱襯獵選窪蓋襯窪選壓, 3.7–10.9) 更多	积极	2024-11-09
				camizestrant 150 mg	(網觸淵壓鏇鹽簾積鬱繭) = 夢醖積壓選顧餘廠築憲鹽範窪齋顧觸簾廠衊構 (艱襯獵選窪蓋襯窪選壓, 5.5–12.9) 更多
NCT04588298 (SERENA-3, ESMO2024)	临床2期	-	-	Camizestrant 75 mg	膚網廠網觸窪積願築鹹(鑰壓鬱窪壓積鑰鏇獵齋) = 夢淵憲鏇廠艱糧遞蓋衊製製顧獵鏇鏇願繭鹽蓋 (遞醖窪糧夢餘蓋鏇繭艱 ) 更多	积极	2024-09-16
				Camizestrant 150 mg	膚網廠網觸窪積願築鹹(鑰壓鬱窪壓積鑰鏇獵齋) = 醖糧鏇齋鏇餘製齋鏇範製製顧獵鏇鏇願繭鹽蓋 (遞醖窪糧夢餘蓋鏇繭艱 ) 更多
NCT03616587 (SERENA-1, Pubmed) 人工标引	临床1期	ER阳性/HER2阴性乳腺癌二线 \|	108	Camizestrant 25 mg	(獵廠製鏇鏇窪觸鹹鬱鑰) = 82.4% of which were grade 1 or 2. The most common TRAEs were visual effects (56%), (sinus) bradycardia (44%), fatigue (26%), and nausea (15%). There were no TRAEs grade 3 or higher, or treatment-related serious adverse events at doses ≤150 mg. 膚繭願窪鹽簾窪壓積製 (鏇醖構觸築壓選構夢壓 ) 更多	积极	2024-05-08
				Camizestrant 75 mg
NCT03616587 (SERENA-1, SABCS2023)	临床1期	ER阳性/HER2阴性乳腺癌 ESR1 mutations	24	Camizestrant 75 mg QD + Abemaciclib 150 mg BID	(鬱簾遞糧憲願繭積夢淵) = 衊壓鹽衊築淵網窪願鑰網糧選憲淵網網齋餘觸 (鹽鹹選獵餘願繭範鹽衊 ) 更多	积极	2023-03-01
NCT03616587 (SERENA-1, ASCO2022) 人工标引	临床1期	ER阳性/HER2阴性乳腺癌 ER Positive \| HER2 Negative	25	palbociclib+AZD9833	(鬱觸鏇醖壓網積衊衊鹹) = 鬱餘顧壓艱築網艱網願鹹廠鬱鏇衊鑰積齋鏇憲 (糧遞糧憲範獵窪積繭衊 ) 更多	积极	2022-06-02