Phase 1/2 Study of Intravaginal Tamoxifen (DARE-VVA1): Randomized, Double-blind, Placebo-controlled Study of Safety, Pharmacokinetics and Pharmacodynamics in Postmenopausal Participants With Moderate to Sever Vulvar and Vaginal Atrophy

The purpose of the study is to study the safety, PK and PD of Intravaginal Tamoxifen on postmenopausal women with vulvar vaginal atrophy.

开始日期2021-11-22

申办/合作机构

Daré Bioscience, Inc.

NCT02890082

/ Active, not recruiting临床2期IIT

Pilot Study of Preservation of Fertility by Ovarian Stimulation Associated With Tamoxifen, and Freezing Oocyte or Embryo Prior Chemotherapy for Breast Cancer

The rates of patients with spontaneous pregnancies reported after breast cancer is between 3 and 7%, particularly because of these treatments.
Therefore, it is essential to anticipate this problem by proposing the use of fertility preservation techniques for these young patients prior to any gonadotoxic treatment.
PRESAGE study offers to patients fewer than 40, to preserve their fertility before neoadjuvant or adjuvant chemotherapy for invasive breast cancer.
The aim of this study is to evaluate the feasibility of ovarian stimulation emergency order not to delay the start of treatment. This stimulation combined gonadotropin and tamoxifen followed by an oocyte retrieval. The patient may receive an oocyte vitrification and / or embryonic.
This procedure is already done in many countries, and by some French teams, by combining tamoxifen or letrozole to the classic gonadotropin stimulation.

开始日期2014-02-01

申办/合作机构

Institut de Cancerologie de L Ouest

NCT00002707

/ Completed临床3期IIT

A RANDOMIZED TRIAL COMPARING PREOPERATIVE DOXORUBICIN (ADRIAMYCIN)/CYCLOPHOSPHAMIDE (AC) TO PREOPERATIVE AC FOLLOWED BY PREOPERATIVE DOCETAXEL (TAXOTERE) AND TO PREOPERATIVE AC FOLLOWED BY POSTOPERATIVE DOCETAXEL IN PATIENTS WITH OPERABLE CARCINOMA OF THE BREAST

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if chemotherapy given before surgery is more effective with or without docetaxel given before or after surgery for breast cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy using doxorubicin and cyclophosphamide with or without docetaxel in treating women who have stage II or stage III breast cancer.

开始日期1995-12-01

申办/合作机构

NSABP Foundation, Inc.

[+1]

100 项与 Tamoxifen 相关的临床结果

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100 项与 Tamoxifen 相关的转化医学

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100 项与 Tamoxifen 相关的专利（医药）

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33,871

项与 Tamoxifen 相关的文献（医药）

2025-12-31·ASN Neuro

Analysis of Oligodendrocyte Lineage Cell Progression with Cre-Mediated RiboTag Reporter Lines

Article

作者: Rosko, Lauren M. ; Shah, Maya S. ; Hu, Jingwen ; Huang, Jeffrey K. ; Manavi, Zeeba ; Melchor, George S. ; Wang, Haiyang ; Baydyuk, Maryna

Cre-reporter strategies in transgenic mice are widely used to assess the specificity of gene promoter activities, and for fate-mapping studies during development and under injury conditions. The ribosome tagging strategy, RiboTag, is a transgenic approach, in which a hemagglutinin (HA) tag fused to the endogenous ribosomal protein, RPL22, is expressed through the Cre/loxP system. To profile RiboTag reporter expression in oligodendrocyte lineage cells (OLCs), we generated NG2^Cre:Rpl22^HA, Pdgfra^CreERT:Rpl22^HA, and Plp^CreERT:Rpl22^HA mice. We found that NG2^Cre:Rpl22^HA displayed strong HA reporter expression in OLCs and neuronal subpopulations in the postnatal CNS. Tamoxifen administration into Pdgfra^CreERT:Rpl22^HA and Plp^CreERT:Rpl22^HA mice led to widespread HA reporter expression in oligodendrocyte precursor cells (OPCs) and oligodendrocytes, respectively, throughout the brain and spinal cord. Following focal demyelinating injury, Pdgfra^CreERT:Rpl22^HA mice exhibited HA labeling in OPCs, with a gradual increase in oligodendrocyte labeling during remyelination. In contrast, Plp^CreERT:Rpl22^HA exhibited oligodendrocyte labeling in lesions and throughout the CNS parenchyma, presenting a challenge in distinguishing newly generated oligodendrocytes during remyelination from pre-existing oligodendrocytes. Notably, HA expression was induced in oligodendrocytes, but not OPCs in demyelinated lesions of Plp^CreERT:Rpl22^HA mice even when the demyelinating injury was conducted several days after tamoxifen had cleared. This suggests a potential regulation of gene expression in OPCs in demyelinated lesions, in which Rpl22^HA translation may be prevented until oligodendrocyte differentiation occurs. Overall, the RiboTag reporter demonstrates high sensitivity and stability, and its potential application should be carefully considered in relation to the experimental model, timeline in which it will be used, and cell tracking conditions.

2025-12-01·JOURNAL OF MAMMARY GLAND BIOLOGY AND NEOPLASIA

Intraductal Injection of Adenoviruses to Perform Lineage Tracing in the Mammary Gland

Review

作者: Han, Sen ; Li, Zhe ; Chen, Xueqing ; Zhao, Dongyi

Abstract:

Lineage tracing is a fundamental tool in developmental biology and cancer research, providing critical insights into cell fate decisions, tissue homeostasis and tumor initiation. The mammary gland is a highly dynamic organ with a complex cellular hierarchy, making it an ideal system for lineage-tracing studies. Classic approaches, such as tamoxifen-inducible CreER/loxP recombination, have significantly advanced our understanding of mammary epithelial cell (MEC) differentiation, homeostasis, and transformation. However, these methods have limitations, including potential effects of tamoxifen on estrogen signaling, low mammary gland specificity, and the requirement for transgenic model creation and mouse breeding. Adenovirus-Cre (Ad-Cre)-based lineage tracing has emerged as a powerful alternative, enabling rapid and organ-specific recombination. This review provides a comprehensive evaluation of the Ad-Cre approach in mammary gland biology, comparing its efficiency, specificity, and technical advantages over the CreER-based method. We discuss applications of Ad-Cre intraductal injection-based lineage tracing in mapping MEC fates, identifying the cellular origins of breast cancer, and modeling tumor progression. Additionally, we highlight its ability to induce genetic marking at a clonal level, facilitating precise investigations into MEC plasticity and tumor cell heterogeneity. Despite its advantages, Ad-Cre lineage tracing also presents challenges, such as low cell-targeting efficiency and potential effect on the mammary gland immune microenvironment. Future advancements, including the integration of CRISPR-based barcoding, may further enhance its utility for high-resolution fate mapping. By summarizing recent advancements and comparative analyses, this review underscores the significance of Ad-Cre lineage tracing as a versatile and powerful tool in mammary gland biology and breast cancer research.

2025-12-01·HUMAN & EXPERIMENTAL TOXICOLOGY

Enhancing breast cancer treatment: Evaluating the efficacy of hyaluronic acid-coated tamoxifen-loaded solid lipid nanoparticles on MCF7 cells

Article

作者: Ghafouri, Hossein ; Ghayoumipour, Niloufar

Introduction:

Tamoxifen (TMX) shows promise in treating breast cancer, but it faces challenges such as poor solubility, instability, and incomplete release when targeting tumors. Additionally, TMX therapy’s toxicity is a critical issue in breast cancer treatment. This study aimed to assess the impact of hyaluronic acid (HA)-coated TMX-loaded solid lipid nanoparticles (HA-TMX-SLNs) on MCF7 breast cancer cells.

Methods:

Solid lipid nanoparticles (SLNs) were prepared using hot homogenization. The HA-TMX-SLNs and TMX-SLNs were characterized and evaluated through transmission electron microscopy (TEM). Cytotoxicity was assessed using the MTT assay, and Western blot analysis was utilized to identify key factors in the cell cycle and apoptosis.

Results:

The nanoparticles (HA-TMX-SLNs) demonstrated approximately 55% loading efficiency after 100 h. HA-TMX-SLNs exhibited lower cytotoxicity in MCF7 cells compared to other treatments. Significant decreases in expression levels of cyclin-dependent kinase (CDK) 4, Cyclin D1, CDK2, and Bcl2 were observed after treatment with HA-TMX-SLNs, along with an increase in cleaved/procaspase-7.

Discussion:

The in vitro release study showed that HA-coated SLNs consistently released the drug into the media under controlled conditions. Furthermore, HA-TMX-SLNs exhibited cytotoxic effects, increasing apoptosis and inhibiting cancer cell proliferation. These findings suggest that HA-TMX-SLNs effectively deliver TMX to breast cancer cells.

项与 Tamoxifen 相关的新闻（医药）

2025-07-09

·生物谷

Nat Cancer：科学家破解乳腺癌耐药新机制——γδ T细胞与巨噬细胞的“共谋”

研究人员首次系统性地揭示了在CDK4/6抑制剂治疗HR+HER2−乳腺癌过程中γδ T细胞与CX3CR1+巨噬细胞之间的免疫调控轴，并明确了其在治疗耐药中的关键作用。乳腺癌是全球女性中最常见的恶性肿瘤之一，尤其在激素受体阳性（HR+）且HER2阴性（HER2−）的亚型中占据了约70%的比例。尽管CDK4/6抑制剂联合内分泌治疗已成为晚期HR+HER2−乳腺癌的一线标准治疗方案，但耐药问题依然严峻。据统计，超过一半的患者在接受CDK4/6抑制剂治疗后会出现疾病进展，导致治疗失败和生存期缩短。因此，揭示其耐药机制并寻找有效的干预策略成为了当前肿瘤免疫治疗领域的热点与难点。近年来，肿瘤微环境（TME）在肿瘤进展和治疗反应中的作用日益受到关注，尤其是免疫细胞，如γδ T细胞、肿瘤相关巨噬细胞（TAMs）等，在调控肿瘤免疫逃逸和治疗耐药中扮演着关键角色。近日，一篇发表在国际杂志Nature Cancer上题为“IL-17A-secreting γδ T cells promote resistance to CDK4/CDK6 inhibitors in HR+HER2− breast cancer via CX3CR1+ macrophages”的研究报告中，来自威尔康乃尔医学院等机构的科学家们通过研究深入探讨了CDK4/6抑制剂治疗HR+HER2−乳腺癌过程中γδ T细胞是如何通过分泌IL-17A来诱导巨噬细胞向免疫抑制型CX3CR1+表型极化从而促进治疗耐药发生的。文章中，研究人员首次系统性地揭示了在CDK4/6抑制剂治疗HR+HER2−乳腺癌过程中γδ T细胞与CX3CR1+巨噬细胞之间的免疫调控轴，并明确了其在治疗耐药中的关键作用，同时还提出了通过放疗或靶向干预该轴以增强治疗效果的潜在策略。研究人员采用了多种实验模型和技术手段，首先他们构建了一个高度模拟人类HR+HER2−乳腺癌的免疫健全小鼠模型（M/D模型），通过给予孕激素和致癌物诱导乳腺肿瘤形成；该模型不仅保留了HR表达还对CDK4/6抑制剂敏感，适合研究免疫微环境对治疗反应的影响。在实验设计上，研究人员分别给予小鼠不同的治疗方案，包括CDK4/6抑制剂（palbociclib）联合内分泌治疗（tamoxifen）、放疗（RT）及联合免疫检查点抑制剂（anti-PD-1）。通过单细胞RNA测序（scRNA-seq）、流式细胞术、免疫组化、ELISA等技术系统分析了肿瘤组织中免疫细胞亚群的动态变化及其功能状态。对CDK4/CDK6抑制剂的耐药与M/D驱动型乳腺癌中CX3CR1+巨噬细胞的积累有关实验结果表明，当进行CDK4/6抑制剂治疗后，肿瘤组织中γδ T细胞会显著增加且这些细胞能高表达IL-17A。进一步研究发现，IL-17A的分泌与CCL2的上调密切相关，CCL2通过其受体CCR2招募γδ T细胞进入肿瘤组织。值得注意的是，这些γδ T细胞对缺氧环境极为敏感，而放疗活能通过诱导肿瘤局部缺氧从而抑制CCL2的分泌并能阻止γδ T细胞的浸润。此外，研究人员还发现，γδ T细胞分泌的IL-17A能诱导肿瘤相关巨噬细胞向CX3CR1+表型极化，这类巨噬细胞具有强烈的免疫抑制功能，其能抑制CD8+ T细胞的活性从而削弱抗肿瘤免疫反应。通过阻断IL-17A、γδ T细胞或CX3CR1+巨噬细胞的功能均可显著增强CDK4/6抑制剂的疗效并延长小鼠的生存期。在人类样本中，研究者也观察到了类似的现象，在多个HR+HER2−乳腺癌患者队列中，肿瘤组织中γδ T细胞和CX3CR1+巨噬细胞的浸润水平与疾病进展和不良预后显著相关；尤其是在接受CDK4/6抑制剂治疗的患者中，外周血中γδ T细胞数量和CCL2水平的升高与较短的无进展生存期密切相关。本研究不仅揭示了CDK4/6抑制剂治疗HR+HER2−乳腺癌过程中一条全新的免疫耐药机制，即“CCL2-γδ T细胞-IL-17A-CX3CR1+巨噬细胞”轴，研究人员还提出了多种可行的干预策略，包括放疗、IL-17A中和抗体、CSF1R抑制剂等，这些发现为临床上克服CDK4/6抑制剂耐药提供了理论依据和实验基础。更重要的是，该研究还强调了肿瘤微环境中免疫细胞间复杂的相互作用，提示研究人员在设计联合治疗方案时应充分考虑免疫调控网络的动态变化。未来围绕该免疫轴的靶向治疗有望为HR+HER2−乳腺癌患者带来新的希望，尤其是对那些对现有治疗反应不佳的患者群体。（生物谷Bioon.com）参考文献： Petroni, G., Galassi, C., Gouin, K.H. et al. IL-17A-secreting γδ T cells promote resistance to CDK4/CDK6 inhibitors in HR+HER2− breast cancer via CX3CR1+ macrophages. Nat Cancer (2025). doi：10.1038/s43018-025-01007-z

免疫疗法细胞疗法

2025-07-05

·肿瘤界

早期乳腺癌辅助强化治疗策略

点击蓝字关注我们引用本文：黎立喜,刘姝宁,李巧佴,等. 早期乳腺癌辅助强化治疗策略[J]. 中国医学前沿杂志（电子版）,2025,17(04):7-11.作者：黎立喜，刘姝宁，李巧佴，李凤娟，马飞 (国家癌症中心国家肿瘤临床医学研究中心中国医学科学院北京协和医学院肿瘤医院肿瘤内科，北京 100021)通信作者：马飞 E-mail:drmafei@126.com摘要：辅助强化治疗在早期乳腺癌的治疗中逐渐展现出重要作用，尤其适用于高复发风险和新辅助治疗后未达到病理完全缓解的患者。该策略通过延长治疗周期、引入新药物或采用多重治疗手段，进一步降低疾病复发风险，提高治愈率。近年来，三阴性乳腺癌、激素受体阳性乳腺癌和人表皮生长因子受体阳性乳腺癌的强化治疗方案，如卡培他滨、周期蛋白依赖性激酶4/6抑制剂及双靶治疗等，显示了良好的临床疗效和可控的安全性。此外，针对乳腺癌遗传易感基因突变患者的聚腺苷二磷酸核糖聚合酶抑制剂的应用也获得了积极成果。未来，随着治疗策略的不断优化，辅助强化治疗将为早期乳腺癌患者带来更多获益。本文将综述不同分子分型早期乳腺癌，如三阴性乳腺癌、激素受体阳性乳腺癌、人表皮生长因子受体2阳性乳腺癌以及其他特殊类型的乳腺癌的辅助强化治疗策略，期望有助于提高临床对早期乳腺癌治疗效果。关键词：乳腺癌；早期；辅助强化治疗；不同分子分型早期乳腺癌的治疗策略随着对肿瘤生物学特征的深入了解和临床试验的推进不断演变。辅助强化治疗指的是在标准治疗(新辅助治疗及辅助治疗)基础上，通过增加药物剂量、延长治疗周期、添加新型药物或多种药物联合等更积极的治疗手段，进一步降低疾病复发风险、提高治愈率的治疗策略。该方法通常应用于具有高复发风险，以及对新辅助治疗反应不佳的患者群体。近年来，辅助强化治疗在降低复发风险、改善患者预后方面显示出显著的潜力。本文将综述不同分子分型早期乳腺癌，包括三阴性乳腺癌(triple-negative breast cancer，TNBC)、激素受体(hormone receptor，HR)阳性乳腺癌、人表皮生长因子受体2(human epidermal growth factor receptor 2，HER2)阳性乳腺癌以及其他特殊类型的乳腺癌的辅助强化治疗策略。1三阴性乳腺癌的强化策略由于缺乏雌激素受体(estrogen receptor，ER)、孕激素受体(progesterone receptor，PR)和HER2，TNBC往往具有较差的预后[1]。新辅助治疗通过减少肿瘤负荷、降低肿瘤分期，能进一步提高保乳率和根治性切除率，同时还能预测肿瘤对药物的敏感性。新辅助治疗能显著改善局部晚期乳腺癌患者的无病生存(disease free survival，DFS)期和总生存(overall survival，OS)期，已成为其主要治疗手段。新辅助治疗后达到病理完全缓解(pathological complete response，pCR)的通常显示出良好的预后，而未达到pCR的患者往往面临着更高的复发风险和较差的预后，尤其是在TNBC和HER2阳性乳腺癌中[2,3]。由于初诊分期晚、有淋巴结转移及新辅助治疗后未到达pCR的TNBC具有高复发风险[4]，其术后辅助治疗如何做加法也是一直被探索的临床问题。卡培他滨作为一种口服化疗药物，在多项临床试验中已被证实能够显著改善TNBC患者的预后。无论是基于标准治疗的联合应用，还是在标准治疗完成后作为强化治疗，卡培他滨都展现出降低复发风险、提高生存率的潜力[5,6,7]。CREATE-X是一项Ⅲ期随机对照临床试验，该研究纳入接受标准新辅助化疗后未达到pCR的TNBC乳腺癌患者，给予卡培他滨(1000 mg/m2体表面积，2次/d，连续服用14d，休息7d，共21d为1个周期)强化辅助治疗6～8个周期，评估是否能改善生存。研究结果显示，与安慰剂对照组相比，卡培他滨组的DFS率(69.8%比56.1%)和OS率(78.8%比70.3%)均得到了显著改善[6]。SYSUCC-001研究进一步证实，在接受标准辅助治疗的早期乳腺癌中，与对照组相比，卡培他滨(650 mg/m2体表面积，2次/d)维持治疗1年，5年DFS率绝对值提高了10%[5]。该研究采用的是低剂量、高频次的节拍化疗给药方式，这项研究中超过90%的患者按计划完成了1年的给药。而且不良反应发生率较传统给药方式显著降低，主要不良事件为手足综合征，但以1～2级为主[5,6]，患者的高依从性也从侧面证实了治疗的相关不良反应耐受性良好。目前国内外指南推荐，不同分子分型乳腺癌的新辅助或辅助化疗，均选择含蒽环类和/或紫杉类药物为主的方案[8,9]。蒽环和紫杉类药物能促进甲状腺素磷酸化酶(thymidine phosphorylase，TP)表达上调，而TP能进一步促使卡培他滨转化成具有活性的5-氟尿嘧啶，从而提高卡培他滨的疗效[10]。此外，氟尿嘧啶类抗代谢药物的半衰期短，具有时间依赖性，持续静脉输注或口服给药抗肿瘤作用更强。因此，在标准治疗基础上，卡培他滨持续给药辅助强化治疗能进一步改善具有高复发风险及新辅助治疗未达到pCR的TNBC患者的预后。免疫治疗在实体瘤治疗中的应用近年来取得了显著进展，在TNBC的新辅助和辅助强化治疗中也显示出一定的潜力。KEYNOTE-522研究结果显示，帕博利珠单抗联合化疗的pCR率达到64.8%，且在术后继续进行免疫辅助强化治疗能进一步改善DFS，帕博利珠单抗联合化疗组的3年DFS率可达到84.5%，显著高于单独化疗组的76.8%[11,12]。亚组分析结果提示，帕博利珠单抗联合化疗在不同亚组中均显示出良好的治疗效果，但在淋巴结阳性和PD-L1阳性人群中获益更明显[11,12]。2激素受体阳性乳腺癌的强化策略辅助内分泌治疗是HR阳性HER2阴性早期乳腺癌术后的标准治疗方法，能显著降低复发和死亡风险，但仍有约20%的患者会出现复发转移 [13]。因此，针对高复发风险的HR阳性HER2阴性早期乳腺癌，如何优化辅助治疗策略，以进一步降低复发风险是亟待解决的临床问题。目前已有研究证实，内分泌辅助强化治疗，包括标准内分泌治疗联合周期蛋白依赖性激酶4(cyclin-dependent kinase 4，CDK4)/周期蛋白依赖性激酶6(cyclin-dependent kinase 6，CDK6)抑制剂，以及延长内分泌治疗给药时间能降低复发转移风险和改善预后[14,15,16]。5年常规标准辅助内分泌治疗后是否需要延长治疗时间以及延长的时间范围一直是存在争议的。ATLAS研究[14]、aTTom研究[15]和MA.17R研究[17]证实，他莫昔芬或芳香化酶抑制剂辅助治疗时间延长至10年可提高DFS率。但也有研究显示，延长内分泌治疗至10年没有进一步获益，反而增加不良反应的发生风险。IDEAL研究[18]显示在标准5年内分泌标准治疗后，来曲唑治疗5年与2.5年相比，并不能改善DFS期和OS期，在所有亚组中均没获得阳性结果。ABCSG-16研究是一项前瞻性多中心、随机、对照、开放标签Ⅲ期临床试验[19]。这项研究显示，在绝经后、HR阳性乳腺癌患者中，完成5年内分泌治疗后，延长2年阿那曲唑辅助治疗与延长5年阿那曲唑治疗的DFS和OS相当，但延长5年阿那曲唑骨折风险增加40%[19]。大多数指南推荐高复发风险的患者延长内分泌治疗的时长，但基于目前的循证医学证据显示，7～8年的内分泌治疗能给高复发风险人群带来最大的获益，同时能减少不良反应事件的发生。卵巢功能抑制(ovarian function suppression，OFS)在HR阳性乳腺癌辅助强化治疗中的作用已被多项临床试验证实。SOFT研究对比了单独使用他莫昔芬与他莫昔芬联合OFS治疗，结果显示联合OFS能显著降低复发风险和延长OS期[20]，特别是在年龄小于35岁的高危患者中表现尤为突出[21]。TEXT研究进一步验证了OFS联合依西美坦的优越性，其DFS期显著优于单独使用他莫昔芬或OFS联合他莫昔芬的治疗方案[22]。上述研究表明，内分泌联合OFS治疗能进一步改善HR阳性乳腺癌的预后。CDK4/6抑制剂联合内分泌治疗在晚期乳腺癌中也展现出良好的疗效，实现了HR阳性HER2阴性晚期乳腺癌一线治疗的中位无进展生存时间超过24个月。因此，研究者们也探索了其在早期乳腺癌辅助强化治疗中的潜力。MonarchE研究是首个Ⅲ期临床证实了CDK4/6抑制剂联合标准内分泌治疗对高危HR阳性、HER2阴性早期乳腺癌辅助治疗价值的研究[16]。研究表明，与单纯内分泌治疗相比，阿贝西利的加入显著延长了患者的无浸润性疾病生存时间(invasive disease free survival，iDFS)[16]。NATALEE研究(NCT03701334)评估了瑞波西利联合内分泌治疗在HR阳性、HER2阴性早期乳腺癌患者中的疗效，该研究结果显示，瑞波西利显著延长了iDFS，尤其是在高危亚组患者中[23]，进一步验证了CDK4/6抑制剂在早期乳腺癌辅助强化治疗中的潜力。但在PALLAS研究中，哌柏西利联合内分泌治疗在Ⅱ～Ⅲ期HR阳性HER2阴性乳腺癌中的应用未能显示出显著的iDFS获益[24,25]。当然，这与MonarchE、NATALEE和PALLAS研究对高危人群的定义存在差异有关。MonarchE研究纳入人群为≥4枚阳性腋窝淋巴结或1～3枚阳性腋窝淋巴结并具有以下情况之一：组织学分级3级、肿瘤大小≥5 cm、Ki-67增殖指数≥20%。而NATALEE研究入组人群相对更加广泛，其中包括全部的N 1期患者和部分合并高危因素的N 0期患者(G3，或G2伴以下高危因素之一：Ki-67增殖指数≥20%或基因检测为高风险)。这也导致对CDK4/6抑制剂辅助强化治疗的适用人群存在争议，尤其是对于N 0期合并有其他复发高危因素的患者。但我们可以从NATALEE分层分析结果中看到，在Ⅱ期(包括所有N 0期和部分N 1期)患者中，瑞波西利组较安慰剂组的iDFS并没有显著差异。而PALLAS研究的亚组分析显示，无论是ⅡA期还是ⅡB～Ⅲ期的乳腺癌患者，哌柏西利并未改善这些患者的结局[24]。整体而言，对于N 0期或N 1期不合并其他危险因素的患者选择CDK4/6抑制剂进行辅助强化治疗获益有限，需要慎重考虑。此外，辅助强化治疗的疗效，不仅受治疗药物本身特性影响，入组人群、治疗周期、用药模式也很关键。因此，一项临床试验要取得阳性结果，研究设计要综合权衡上述因素。此外，OlympiA研究还纳入了淋巴结转移数量≥4枚或临床和病理分期加上ER和核分级评分>3分的HR阳性HER2阴性乳腺癌患者，亚组结果显示奥拉帕利较安慰剂组同样有iDFS和OS获益趋势[26]。随着医学技术发展，HR阳性乳腺癌的辅助强化治疗手段越来越多，但不同治疗方案缺乏头对头比较，如何取舍将是未来研究的重点。3人表皮生长因子受体2阳性乳腺癌的强化策略HER2阳性乳腺癌由于其较高的侵袭性和复发率，一直是预后不良的亚型。各种创新靶向药物的研发上市用于临床治疗，尤其是联合治疗策略的应用，显著降低了HER2阳性乳腺癌复发的风险。APHINITY研究确立了曲妥珠单抗联合帕妥珠单抗双靶治疗成为高复发风险早期HER2阳性乳腺癌患者标准治疗方案的地位，尤其对伴有淋巴结转移的患者能带来DFS显著获益[27]。奈拉替尼作为一种口服小分子酪氨酸激酶抑制剂，能够在曲妥珠单抗治疗后的维持阶段提供额外的疗效[28]，但是伴随着双靶向治疗的使用，奈拉替尼是否能进一步获益还需要探索。恩美曲妥珠单抗(trastuzumab emtansine，T-DM1)是首个获批应用于晚期乳腺癌的抗体药物偶联物，KATHERINE研究[29]对T-DM1辅助强化治疗HER2阳性乳腺癌进行了探索。该研究比较了新辅助治疗后仍有残留浸润性病灶的早期HER2阳性乳腺癌患者随机接受T-DM1与曲妥珠单抗的辅助治疗的疗效，结果显示T-DM1组在IDFS方面有显著改善，复发或死亡风险降低了50%。该试验重新定义了对于新辅助治疗后未达到pCR的HER2阳性乳腺癌患者的辅助治疗策略。4其他特殊类型的强化策略乳腺癌遗传易感基因(breast cancer susceptibility gene，BRCA)致病或可能致病胚系突变在乳腺癌整体人群中的频率约占5%，但合并乳腺癌家族史、TNBC或早发性乳腺癌的人群突变频率会明显提高[30]。携带BRCA突变的乳腺癌患者在聚腺苷二磷酸核糖聚合酶(polyADP-ribose polymerase，PARP)抑制剂获批上市前，只能通过常规随访检查进行监测，并没有针对性的辅助强化治疗策略降低此类患者的复发转移和对侧乳腺癌发生风险。OlympiA Ⅲ期临床试验显示，HER2阴性、BRCA胚系突变的高复发风险早期乳腺癌患者，在完成(新)辅助治疗以及局部治疗后，接受奥拉帕利治疗1年，与安慰剂相比可以显著延长iDFS，分别为85.9%和77.1%，奥拉帕利还能降低32%的死亡风险[26]。OlympiA研究展示了PARP抑制剂在基因突变相关的早期乳腺癌辅助治疗中的潜力，进一步强调了精准治疗在高风险患者中的重要性。但对于新辅助治疗未达到pCR的TNBC，同时合并BRCA，如何去选择后续辅助强化治疗目前仍存在争议。但对于术前使用免疫治疗的患者，可以考虑免疫治疗与卡培他滨或奥拉帕利联合使用。对于免疫治疗、PARP抑制剂以及卡培他滨的选择，可根据患者新辅助或辅助治疗阶段的治疗疗效及不良反应，结合患者的个体情况，多因素权衡评估，尽可能在降低复发风险的同时，把控好治疗相关的不良反应，以提高用药依从性及改善患者的生活质量。5正在研究中的辅助强化临床试验近年来，随着乳腺癌治疗模式的不断进步，越来越多的强化治疗方案开始进入临床试验阶段，特别是结合新兴的分子靶向药物和免疫治疗策略。这些临床试验入组的人群主要为具有高复发风险或新辅助治疗未达到pCR的患者，且覆盖了不同分子分型的乳腺癌，如靶向滋养层细胞表面抗原2的Dato-DXd联合度伐利尤单抗治疗新辅助治疗后未达到pCR的TNBC患者的Ⅲ期临床试验(TROPION)、高风险早期TNBC术后辅助治疗阶段加入吉西他滨和顺铂的联合治疗(BCTOP-T-A01)、口服选择性ER降解剂在HR阳性乳腺癌辅助治疗中的应用(CAMBRIA-1)、吡咯替尼在HER2阳性乳腺癌中的辅助强化治疗(PERSIST)，以及德曲妥珠单抗对比T-DM1新辅助治疗后未达到pCR的HER2阳性乳腺癌患者的研究(DESTINY-Breast05)。期待上述研究会有更多的阳性结果，可以进一步降低乳腺癌复发风险，提高早期乳腺癌治愈率。6总结早期乳腺癌的辅助强化治疗正在迅速发展，涵盖了从TNBC到HR阳性、HER2阳性等不同分子分型，以及针对特定基因改变的个体化治疗。随着乳腺癌分子生物学研究的深入和抗肿瘤新药的加速上市，早期乳腺癌的辅助强化治疗将迎来更多创新的药物和策略。个体化治疗的未来将更加注重根据肿瘤特征和患者情况制定最优的治疗方案，以期进一步提高患者的生存率和生活质量。参考文献[1] 李嘉琪，栾瑾微，张玉等. 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Adjuvant capecitabine with docetaxel and cyclophosphamide plus epirubicin for triple-negative breast cancer(CBCSG010)：An open-label，randomized，multicenter，phase Ⅲ trial[J] . J Clin Oncol， 2020，38(16)：1774-1784.[8] 中国抗癌协会乳腺癌专业委员会，中华医学会肿瘤学分会乳腺肿瘤学组，邵志敏．中国抗癌协会乳腺癌诊治指南与规范(2024年版)[J] . 中国癌症杂志， 2023，33(12)：1092-1186.[9] NATIONAL COMPHREHENSIVE CANCER NETWORK. NCCN Clinical Practice Guidelines in Oncology：Breast Cancer[R/OL] . https://wwwnccnorg/guidelines， 2024.[10] TOI M ， ATIQUR RAHMAN M ， BANDO H ，et al. Thymidine phosphorylase(pla telet-derived endothelial-cell growth factor)in cancer biology and treatment [J] . Lancet Oncol， 2005，6(3)：158-166.[11] SCHMID P ， CORTES J ， PUSZTAI L ，et al. Pembrolizumab for early triple-negative breast cancer[J] . N Engl J Med， 2020，382(9)：810-821.[12] SCHMID P ， CORTES J ， DENT R ，et al. Event-free survival with pembrolizumab in early triple-negative breast cancer[J] . N Engl J Med， 2022，386(6)：556-567.[13] EARLY BREAST CANCER TRIALISTS′COLLABORATIVE GROUP(EBCTCG). Aromatase inhibitors versus tamoxifen in early breast cancer：Patient-level meta-analysis of the randomised trials [J] . Lancet， 2015，386(10001)：1341-1352.[14] DAVIES C ， PAN H ， GODWIN J ，et al. Long-term effects of continuing adjuvant tamoxifen to 10 years versus stopping at 5 years after diagnosis of oestrogen receptor-positive breast cancer：ATLAS，a randomised trial[J] . Lancet， 2013，381(9869)：805-816.[15] GRAY RG ， REA D ， HANDLEY K ，et al. aTTom：Long-term effects of continuing adjuvant tamoxifen to 10 years versus stopping at 5 years in 6，953 women with early breast cancer[J] . J Clin Oncol， 2013，31(18_suppl)：5.[16] JOHNSTON SRD ， HARBECK N ， HEGG R ，et al. Abemaciclib combined with endocrine therapy for the adjuvant treatment of HR＋，HER2-，node-positive，high-risk，early breast cancer(monarchE)[J] . J Clin Oncol， 2020，38(34)：3987-3998.[17] GOSS PE ， INGLE JN ， PRITCHARD KI ，et al. Extending aromatase-inhibitor adjuvant therapy to 10 years[J] . N Engl J Med， 2016，375(3)：209-219.[18] BLOK EJ ， KROEP JR ， MEERSHOEK-KLEIN KRANENBARG E ，et al. Optimal duration of extended adjuvant endocrine therapy for early breast cancer；results of the IDEAL trial(BOOG 2006-05)[J] . J Natl Cancer Inst， 2018，110(1)：40-48.[19] GNANT M ， FITZAL F ， RINNERTHALER G ，et al. Duration of adjuvant aromatase-inhibitor therapy in postmenopausal breast cancer[J] . N Engl J Med， 2021，385(5)：395-405.[20] FRANCIS PA ， FLEMING GF ， LáNG I ，et al. Adjuvant endocrine therapy in premenopausal breast cancer：12-year results from SOFT[J] . J Clin Oncol， 2023，41(7)：1370-1375.[21] FRANCIS PA ， REGAN MM ， FLEMING GF ，et al. Adjuvant ovarian suppression in premenopausal breast cancer[J] . N Engl J Med， 2015，372(5)：436-446.[22] FRANCIS PA ， PAGANI O ， FLEMING GF ，et al. Tailoring adjuvant endocrine therapy for premenopausal breast cancer[J] . N Engl J Med， 2018，379(2)：122-137.[23] SLAMON D ， LIPATOV O ， NOWECKI Z ，et al. Ribociclib plus endocrine therapy in early breast cancer[J] . N Engl J Med， 2024，390(12)：1080-1091.[24] GNANT M ， DUECK AC ， FRANTAL S ，et al. Adjuvan t palbociclib for early breast cancer：The PALLAS trial results(ABCSG-42/AFT-05/BIG-14-03) [J] . J Clin Oncol， 2022，40(3)：282-293.[25] LOIBL S ， MARMÉ F ， MARTIN M ，et al. Palbociclib for residual high-risk invasive HR-positive and HER2-negative early breast cancer—The Penelope-B Trial[J] . J Clin Oncol， 2021，39(14)：1518-1530.[26] TUTT ANJ ， GARBER JE ， KAUFMAN B ，et al. Adjuvant olaparib for patients with BRCA1-or BRCA2-mutated breast cancer[J] . N Engl J Med， 2021，384(25)：2394-2405.[27] PICCART M ， PROCTER M ， FUMAGALLI D ，et al. Adjuvant pertuzumab and trastuzumab in early HER2-positive breast cancer in the APHINITY trial：6 years′follow-up[J] . J Clin Oncol， 2021，39(13)：1448-1457.[28] MARTIN M ， HOLMES FA ， EJLERTSEN B ，et al. Neratinib after trastuzumab-based adjuvant therapy in HER2-positive breast cancer(ExteNET)：5-year analysis of a randomised，double-blind，placebo-controlled，phase 3 trial[J] . Lancet Oncol， 2017，18(12)：1688-1700.[29] VON MINCKWITZ G ， HUANG CS ， MANO MS ，et al. Trastuzumab emtansine for residual invasive HER2-positive breast cancer[J] . N Engl J Med， 2019，380(7)：617-628.[30] KWONG A ， HO CYS ， LUK WP ，et al. Effect on germline mutation rate in a high-risk Chinese breast cancer cohort after compliance with the National Comprehensive Cancer Network(NCCN)2023 v．1 Testing Criteria[J] . Cancers， 2023，15(9)：2635.推荐阅读马飞教授：健康中国战略规划下的肿瘤生育学发展Cancer Cell | 徐兵河院士/马飞教授团队牵头首次揭示三阴性乳腺癌免疫联合化疗的协同机制马飞教授：乳腺癌免疫治疗更新盘点2024丨马飞教授：2024年乳腺癌内科治疗新进展声明：本文由“肿瘤界”整理与汇编，欢迎分享转载，如需使用本文内容，请务必注明出处。编辑：南星审核：lagertha

临床结果临床2期

2025-06-02

·PipelineReview

Elinzanetant Significantly Reduces Frequency of Moderate to Severe Vasomotor Symptoms Associated With Endocrine Therapy for Breast Cancer in Phase III Oasis-4 Study

Data from Phase III OASIS-4 study to be presented for the first time at 2025 ASCO Annual Meeting: BERLIN, Germany I June 02, 2025 I Detailed results from the Phase III OASIS-4 study found that the investigational compound elinzanetant showed a statistically significant reduction in the frequency of moderate to severe vasomotor symptoms (VMS, also known as hot flashes) from baseline to weeks 4 and 12 compared to placebo, in women taking endocrine therapy for treatment or prevention of hormone receptor (HR+) breast cancer. Key secondary endpoints showed statistically significant improvement of sleep disturbances and menopause-related quality of life from baseline to week 12 versus placebo. Additional secondary endpoints showed a reduction in VMS frequency at week 1 and improvements in VMS severity at weeks 4 and 12 versus placebo. These data are being presented at the American Society of Clinical Oncology (ASCO) Annual Meeting, taking place from May 30 – June 3 in Chicago, IL, USA, and have been simultaneously published in the New England Journal of Medicine ( NEJM ). OASIS-4 is the first pivotal international Phase III study to assess the safety and efficacy of elinzanetant for the treatment of moderate to severe VMS associated with endocrine therapy for the treatment or prevention of HR+ breast cancer. “Menopausal symptoms are frequent side effects of endocrine therapy for breast cancer, often leading to discontinuation, which is why management of these symptoms can play an important role in breast cancer treatment,” said Dr. Fatima Cardoso, Principal Investigator of OASIS-4, from Lisbon Portugal. “With no currently approved treatments for this indication, there is an unmet medical need for therapeutic options.” In OASIS-4, elinzanetant showed statistically significant mean reductions in frequency of VMS compared to placebo from baseline to week 4 with −6.5 (95% confidence interval [CI], −7.2 to −5.8) with elinzanetant and −3.0 (95% CI, −3.9 to −2.2) with placebo, with statistical significance between elinzanetant and placebo (least squares [LS] mean difference [95% CI]: −3.5 [−4.4, −2.6]; p<0.001). At week 12, reductions in VMS frequency were −7.8 (95% CI, −8.5 to −7.1) with elinzanetant and −4.2 (95% CI, −5.2 to −3.2) with placebo, with statistical significance between elinzanetant and placebo (LS mean difference [95% CI]: −3.4 [−4.2, −2.5]; p<0.001). The safety profile over 52 weeks observed in the OASIS-4 study is generally consistent with previously conducted studies and published data 1,2,3 on elinzanetant in postmenopausal women with VMS, with fatigue, somnolence and diarrhea being the most frequent treatment emergent adverse events (TEAEs) in the elinzanetant group. The mean change in the PROMIS SD SF 8b total T score from baseline to week 12 was −10.6 points (95% CI, −11.5 to −9.6) in the elinzanetant group and −4.1 points (95% CI, −5.3 to −2.9) in the placebo (LS mean difference between the trial groups, −6.1 points; 95% CI, −7.5 to −4.8; p<0.001). The mean change in the MENQOL total score from baseline to week 12 was −1.3 points (95% CI, −1.4 to −1.2) in the elinzanetant group and −0.5 points (95% CI, −0.7 to −0.3) in the placebo group (LS mean difference between the trial groups, −0.7 points; 95% CI, −0.9 to −0.5; p<0.001). Additional secondary endpoints showed a reduction in VMS frequency at week 1 and in VMS severity at weeks 4 and 12 with elinzanetant versus placebo. “The results from OASIS-4 represent a potential advancement in addressing a need for women undergoing breast cancer treatment. Vasomotor symptoms associated with endocrine therapy can impact patients’ quality of life and may impact their ability to adhere to other treatments,” said Dr. Christian Rommel, member of the Executive Committee of Bayer AG’s Pharmaceutical Division and Global Head of Research and Development. “Advancing elinzanetant as an investigational, hormone-free treatment option for these patients reaffirms our commitment at Bayer to bring forward innovative treatments for the different health needs of women.” Breast cancer is the most commonly diagnosed cancer in women globally with 2.3 million new cases in 2020, and nearly 70% of tumors being hormone-receptor positive. Adjuvant endocrine therapy is well established in guidelines worldwide and routinely prescribed to all women with hormone-positive breast cancer. Treatment with adjuvant endocrine therapy (such as tamoxifen) for up to 10 years substantially reduces the breast cancer mortality rate throughout the two decades after diagnosis. 4 Endocrine therapy can also be used as primary prevention, in women at high risk of developing breast cancer. Side effects of endocrine therapy, such as VMS (also referred to as hot flashes), may affect quality of life and treatment compliance, with potential impact on recurrence. 5 Currently, there are no approved treatment options available. There is an unmet medical need for an effective hormone-free treatment for VMS associated with endocrine therapy. Elinzanetant is the first dual neurokinin targeted therapy, antagonizing NK-1 and NK-3 receptors, in late-stage clinical development globally for the treatment of moderate to severe VMS due to menopause or associated with endocrine therapy for breast cancer, administered orally once daily. Data from OASIS-1 and -2 were published in the Journal of the American Medical Association ( JAMA ) 3 in August 2024. Detailed results of the Phase III study OASIS-3 providing additional efficacy and safety data over 52 weeks were presented at The Menopause Society (TMS) annual meeting in September 2024. Based on the positive results from the Phase III clinical development program, submissions for marketing authorizations for elinzanetant are ongoing in the US, EU and other markets around the world. About the Elinzanetant Clinical Development Program The Phase III clinical development program of elinzanetant, OASIS, currently comprises four Phase III studies: OASIS-1, -2, -3 and -4. OASIS-1 and -2 investigated the efficacy and safety of elinzanetant administered orally once daily in women with moderate to severe VMS associated with menopause over 26 weeks and randomized 396 and 400 postmenopausal women between 40 and 65 years across 184 sites in 15 countries. Patients in the elinzanetant arm received a 120 mg dose of elinzanetant once daily for 26 weeks and patients in the control arm received a matching placebo once daily for 12 weeks, followed by elinzanetant 120 mg dose for 14 weeks. OASIS-3 investigated the efficacy and safety of elinzanetant for the treatment of VMS due to menopause over 52 weeks and randomized 628 postmenopausal women between 40 and 65 years across 83 sites in 9 countries. OASIS-4 is a double-blind, randomized, placebo-controlled multicenter study to investigate the efficacy and safety of elinzanetant for the treatment of VMS associated with endocrine therapy for treatment or prevention of HR+ breast cancer over 52 weeks and optionally for an additional 2 years in women taking endocrine therapy, for treatment of breast cancer. 474 patients at 90 centers in 16 countries (excluding the US) were randomized. About Elinzanetant Elinzanetant is the first dual neurokinin targeted therapy, antagonizing NK-1 and NK-3 receptors, in late-stage clinical development globally for the treatment of moderate to severe VMS due to menopause or associated with endocrine therapy for breast cancer, administered orally once daily. Elinzanetant may address moderate to severe VMS by modulating a group of estrogen sensitive neurons in the hypothalamus region of the brain (the KNDy neurons) which, with the decrease of estrogen, become hypertrophic and lead to a hyperactivation of the thermoregulatory pathway, consequently disrupting body heat control mechanisms resulting in VMS. About Vasomotor Symptoms Vasomotor symptoms (VMS; also referred to as hot flashes) result from hyperactivation of the thermoregulatory pathway mediated by hypertrophy of the KNDy neurons. This is due to a decrease of estrogen, which can result from the progressive reduction of ovarian function due to natural menopause or medical intervention by bilateral oophorectomy or endocrine therapy. VMS are reported by up to 80% of women at some point during the menopausal transition and are one of the leading causes for seeking medical attention during this phase of a woman’s life. Over one-third of menopausal women report severe symptoms, which can last 10 years or more after the last menstrual period, with relevant impact on quality of life. VMS may also be caused by endocrine therapy, for the treatment or prevention of breast cancer, impacting quality of life and treatment adherence. For these women, there are currently no approved treatment options. About Menopause By 2030, the global population of women experiencing menopause is projected to increase to 1.2 billion, with 47 million women entering this phase each year. Menopause is a transitional phase in women’s lives, related to the progressive decline of ovarian function. It usually occurs in women during their 40s or early 50s. It can also be the result of surgical or medical treatment, such as breast cancer treatment. The hormonal decline can lead to various symptoms which can substantially affect a woman’s health, quality of life, healthcare utilization and work productivity. The most frequently reported and disruptive symptoms during the menopausal transition are VMS, sleep disturbances and mood changes. Addressing these symptoms is key to maintaining functional ability and quality of life in menopause, which is highly relevant from both a healthcare and socio-economic perspective. About Women’s Healthcare at Bayer Women’s Health is in Bayer’s DNA. As a global leader in women’s healthcare, Bayer has a long-standing commitment to delivering science for a better life by advancing a portfolio of innovative treatments. Bayer offers a wide range of effective short- and long-acting birth control methods as well as therapies for menopause management and gynecological diseases. Bayer is also focusing on innovative options to address the unmet medical needs of women worldwide and to broadening treatment choices such as in menopause. Additionally, Bayer intends to provide 100 million women per year in low-and-middle income countries by 2030 with access to family planning by funding multi-stakeholder aid programs for capacity building and by ensuring the supply of affordable modern contraceptives. This is part of the comprehensive sustainability measures and commitments from 2020 onwards and in line with the Sustainable Development Goals of the United Nations. About Bayer Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people, and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros. R&D expenses amounted to 6.2 billion euros. For more information, go to www.bayer.com . Find more information at https://pharma.bayer.com/ Follow us on Facebook: http://www.facebook.com/bayer Follow us on LinkedIn: Bayer | Pharmaceuticals kw (2025-0077E) SOURCE: Bayer

临床结果临床3期ASCO会议

100 项与 Tamoxifen 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
阴道疾病	临床1期	-	Daré Bioscience, Inc.	2023-09-21
性交困难	临床申请批准	美国	Daré Bioscience, Inc.	2023-12-07
外阴和阴道萎缩	临床申请批准	美国	Daré Bioscience, Inc.	2023-12-07

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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


SGO2023	N/A	子宫癌肉瘤	-	Tamoxifen users	鏇廠製餘衊網淵鹹夢醖(繭製積膚範淵鹹鬱鑰窪) = 衊築糧襯構齋範鹽鹽簾夢顧糧襯憲窪積艱夢範 (願糧構蓋齋選衊膚蓋蓋 ) 更多	-	2023-09-01
				Non-tamoxifen users	鏇廠製餘衊網淵鹹夢醖(繭製積膚範淵鹹鬱鑰窪) = 顧選鏇壓艱餘觸窪襯製夢顧糧襯憲窪積艱夢範 (願糧構蓋齋選衊膚蓋蓋 ) 更多
SGO2023	N/A	子宫癌	-	tamoxifen (Uterine cancer patients)	繭製繭築膚構艱選衊餘(壓窪繭窪窪醖選糧鑰築) = 衊衊願築繭鬱餘築選壓壓製網獵鬱顧鏇鬱窪獵 (積獵壓構製鏇齋艱製膚 )	-	2023-09-01
NCT05378269 (GlobeNewswire) 人工标引	临床1/2期	外阴和阴道萎缩	17	DARE-VVA1	糧衊製壓願網醖構積憲(鏇齋衊衊廠製顧繭鬱網) = Intravaginal administration of DARE-VVA1 was well tolerated and all treatment emergent adverse events were mild or moderate and equally distributed between participants randomized to study drug treatment versus placebo. 壓網選鬱夢衊廠糧繭網 (艱醖構夢願鑰醖範製構 ) 更多	积极	2022-11-14
				Placebo
APAO2019	N/A	青光眼	-	Oral Tamoxifen 10mg twice daily	衊憲膚醖顧顧膚製鑰齋(範獵淵憲夢衊淵醖遞選) = A PI was done, and the patient was started on AGM 衊選鹹蓋夢獵簾選夢鹹 (夢簾淵餘夢衊齋艱憲製 ) 更多	-	2019-03-06
				Topical AGM
P1-16-07 (SABCS2016)	N/A	乳腺癌 CYP2D6 polymorphisms \| CYP2C19	271	Tamoxifen (TAM)	夢壓醖醖醖網艱艱糧網(鏇壓簾糧築簾襯蓋醖願) = 鬱夢願繭齋鏇獵簾憲繭鹹餘鹽醖獵鑰廠觸艱築 (繭夢衊構製糧觸糧願憲 )	-	2016-02-15
				Toremifen (TOR)	夢壓醖醖醖網艱艱糧網(鏇壓簾糧築簾襯蓋醖願) = 鑰艱艱窪鏇遞鹽鑰鹽製鹹餘鹽醖獵鑰廠觸艱築 (繭夢衊構製糧觸糧願憲 )
NCT00003906 (NSABP, Pubmed \| Clin Trials)	临床3期	乳腺癌辅助	19,747	Tamoxifen 20 mg/day	範鏇鏇積鏇窪鬱選積餘(積鬱繭蓋齋餘顧鹹範鏇) = 構齋糧醖壓艱網選醖繭選襯淵鏇襯艱選鑰鹹範 (壓製選顧膚願醖選繭壓 )	-	2013-04-01
				Raloxifene 60 mg/day	範鏇鏇積鏇窪鬱選積餘(積鬱繭蓋齋餘顧鹹範鏇) = 糧壓鹽餘齋鹽製憲積獵選襯淵鏇襯艱選鑰鹹範 (壓製選顧膚願醖選繭壓 )
ASTRO2010	N/A	早期乳腺癌	-	Tamoxifen	遞壓構壓簾範淵築積顧(遞鹹壓顧鬱鏇獵膚糧淵) = 築蓋選衊積獵繭顧艱廠構餘遞鹽淵網遞憲膚鹹 (構遞製鬱鬱顧衊夢觸糧 ) 更多	-	2010-11-01
				No Tamoxifen	遞壓構壓簾範淵築積顧(遞鹹壓顧鬱鏇獵膚糧淵) = 觸廠獵衊淵廠遞製夢網構餘遞鹽淵網遞憲膚鹹 (構遞製鬱鬱顧衊夢觸糧 ) 更多
NCT00003906 (STAR, Pubmed \| Expert Rev Anticancer Ther)	临床3期	乳腺癌	19,747	Tamoxifen	齋願鬱壓鹹鹽構艱夢願(鏇築鏇構築壓壓簾蓋鹹): RR = 0.7 (95% CI, 0.54 ~ 0.91) 更多	-	2009-01-01
				Raloxifene
Pubmed \| J Clin Oncol	临床3期	转移性乳腺癌一线	371	Exemestane 25 mg	淵夢糧醖齋糧廠遞醖艱(構鹹願蓋夢獵壓膚廠膚) = 膚構夢蓋簾糧獵願齋壓壓獵襯廠繭淵壓齋醖網 (淵簾窪鬱遞網蓋衊築構 ) 更多	-	2008-10-20
				Tamoxifen 20 mg	淵夢糧醖齋糧廠遞醖艱(構鹹願蓋夢獵壓膚廠膚) = 範簾醖廠廠鏇淵壓襯製壓獵襯廠繭淵壓齋醖網 (淵簾窪鬱遞網蓋衊築構 ) 更多
ASTRO2007	N/A	早期乳腺癌	-	Radiotherapy plus Tamoxifen	鏇淵膚艱積遞淵顧鹹衊(衊衊構獵窪窪廠衊壓糧) = 選餘鹽構範繭齋繭鹹構網齋鏇窪廠選網蓋淵構 (網簾製網簾觸襯積壓鹹 )	-	2007-11-01