2008 年转移性乳腺癌治疗护理的演变 (ESME-MBC)
2026年5月22日 更新者：UNICANCER
流行病学策略和医学经济学 (ESME) 研究计划/学术真实世界数据平台：2008 年以来法国综合癌症中心转移性乳腺癌治疗护理的演变
流行病学策略和医学经济学 (ESME) 卵巢癌数据平台是一个多中心现实生活数据库，使用回顾性数据收集过程（18 个 FCCC 超过 20 个站点）。
该数据库汇集了来自患者电子病历 (EMR)、住院患者住院记录和药房记录的数据。
研究概览
地位
招聘中
条件
详细说明
该数据库汇集了来自患者电子病历 (EMR)、住院患者住院记录和药房记录的数据。
患者数据库：患者相关数据整合了来自非结构化来源（电子病历）的数据，例如患者病历和多学科团队会议报告。 它可以提供有关患者人口统计、原始肿瘤、复发、病理报告、转移性疾病、治疗护理/环境和适用时退出原因以及临床事件的信息。
治疗数据库：与药房记录相关的数据是一个结构化数据库，包括与每个法国综合癌症中心 (FCCC) 内药房开出的处方和配药有关的所有数据，特别是化疗和联合处方。 它不包含有关在中心外开处方或交付的产品的信息。 从每个中心的药房数据库中，可以获得有关全身治疗模式的信息（日期、药物形式、治疗方案等）。
住院数据库：住院相关数据是一个结构化和系统化的数据库，包含 FCCC 中报告的与任何住院相关的所有医疗数据，并用于向法国国家健康保险基金 (Assurance Maladie) 开具账单。 它提供有关患者入院和出院日期以及所执行的诊断和治疗程序（包括放疗和手术）的信息。
导入最终数据库的数据在导入前根据数据管理计划进行控制、重新编码和协调。 所有编码程序都由数据管理员预先定义。 不传输个人数据；所有数据都使用共享的匿名格式集中在每个中心内。 所有数据均以追溯方式独家获得；不会尝试通过联系医疗保健提供者或患者来从患者的医疗记录中恢复不可用的数据。
ESME MBC 数据平台旨在成为一个临床和治疗数据库，集中来自 FCCC 中使用的不同来源的现有和可用数据。
研究类型
观察性的
注册 (估计的)
42000
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Mathieu Robain, MD, PhD
- 邮箱：m-robain@unicancer.fr
研究联系人备份
- 姓名：Lise Bosquet, MsC
- 邮箱：l-bosquet@unicancer.fr
学习地点
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Angers、法国、49933
- 招聘中
- Institut de Cancérologie de l'Ouest - Paul Papin
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接触：
- Geneviève PERROCHEAU
- 电话号码：+33 2 40 67 99 77
- 邮箱：genevieve.perrocheau@ico.unicancer.fr
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接触：
- Loïc CAMPION
- 邮箱：loic.campion@ico.unicancer.fr
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Bordeaux、法国、33076
- 招聘中
- Institut Bergonie
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接触：
- Anne JAFFRE
- 电话号码：+33 5 56 33 78 48
- 邮箱：a.jaffre@bordeaux.unicancer.fr
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Caen、法国、14076
- 招聘中
- Centre Francois Baclesse
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接触：
- Anne-Valérie GUIZARD
- 电话号码：+33 2 31 45 52 45
- 邮箱：av.guizard@baclesse.unicancer.fr
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Clermont-Ferrand、法国、63011
- 招聘中
- Centre Jean Perrin
-
接触：
- Marie-Ange MOURET-REYNIER
- 电话号码：+33 4 73 27 81 37
- 邮箱：marie-ange.mouret-reynier@clermont.unicancer.fr
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Dijon、法国、21079
- 招聘中
- Centre Georges-Francois Leclerc
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接触：
- Sandrine DABAYUKO
- 电话号码：+33 45 34 80 67
- 邮箱：SDabakuyo@cgfl.fr
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Lille、法国、59020
- 招聘中
- Centre Oscar Lambret
-
接触：
- Marie-paule LEBITASY
- 电话号码：+33 3 20 29 55 60
- 邮箱：m-lebitasy@o-lambret.fr
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Lyon、法国、69373
- 招聘中
- Centre Leon Berard
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接触：
- Thomas BACHELOT
- 电话号码：+33 4 78 78 26 54
- 邮箱：thomas.bachelot@lyon.unicancer.fr
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Marseille、法国、13273
- 招聘中
- Institut Paoli-Calmettes
-
接触：
- Lilian LABORDE
- 电话号码：+33 4 91 22 35 10
- 邮箱：LABORDEL@ipc.unicancer.fr
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Montpellier、法国、34298
- 招聘中
- Institut régional du Cancer Montpellier / Val d'Aurelle
-
接触：
- Stéphanie DELAINE
- 电话号码：+33 4 67 61 47 39
- 邮箱：Stephanie.delaine@icm.unicancer.fr
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Nancy、法国
- 招聘中
- Institut de Cancérologie de Lorraine
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接触：
- Carine LAURENT
- 电话号码：+33 3 83 59 83 32
- 邮箱：c.laurent@nancy.unicancer.fr
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Nantes、法国、44805
- 招聘中
- Institut de cancérologie de l'Ouest - René Gauducheau
-
接触：
- Geneviève PERROCHEAU
- 电话号码：+33 2 40 67 99 77
- 邮箱：genevieve.perrocheau@ico.unicancer.fr
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接触：
- Loïc CAMPION
- 邮箱：loic.campion@ico.unicancer.fr
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Nice、法国、06189
- 招聘中
- Centre Antoine Lacassagne
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接触：
- Emmanuel CHAMOREY
- 电话号码：+33 4 92 03 15 29
- 邮箱：emmanuel.chamorey@nice.unicancer.fr
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Paris、法国、75005
- 招聘中
- Institut Curie
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接触：
- Etienne BRAIN
- 邮箱：etienne.brain@curie.fr
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Reims、法国、51056
- 招聘中
- Institut Jean Godinot
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接触：
- Damien PARENT
- 电话号码：+33 3 26 50 42 76
- 邮箱：damien.parent@reims.unicancer.fr
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Rennes、法国、35042
- 招聘中
- Centre Eugene Marquis
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接触：
- Mathias BRETON
- 电话号码：+33 2 99 25 32 67
- 邮箱：m.breton@rennes.unicancer.fr
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Rouen、法国、76038
- 招聘中
- Centre Henri Becquerel
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接触：
- Agnès LOEB
- 电话号码：+33 2 32 08 22 80
- 邮箱：agnes.loeb@chb.unicancer.fr
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Saint-Cloud、法国、92210
- 招聘中
- Institut Curie - Hôpital René Huguenin
-
接触：
- Etienne BRAIN
- 电话号码：+33 1 47 11 15 15
- 邮箱：etienne.brain@curie.fr
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Strasbourg、法国、67065
- 招聘中
- Centre Paul Strauss
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接触：
- Michel VELTEN
- 电话号码：+33 3 88 25 24 53
- 邮箱：mvelten@strasbourg.unicancer.fr
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Toulouse、法国、31059
- 招聘中
- Institut Claudius Regaud
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接触：
- Delphine BERCHERY
- 电话号码：05 31 15 50 60
- 邮箱：Berchery.Delphine@iuct-oncopole.fr
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Villejuif、法国、94805
- 招聘中
- Institut Gustave Roussy
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接触：
- Valérie DEJEAN
- 电话号码：+33 1 42 11 46 49
- 邮箱：valerie.dejean@gustaveroussy.fr
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
取样方法
非概率样本
研究人群
在选择期间，所有在法国综合癌症中心接受转移性乳腺癌治疗的连续患者。
描述
纳入标准：
- 18岁患者
- 在法国综合癌症中心接受化疗、靶向治疗、免疫治疗、放射治疗和激素治疗的患者。
排除标准：无
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 观测模型：队列
- 时间观点：追溯
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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描述治疗护理的演变
大体时间：基线
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患者特征、肿瘤特征和治疗模式
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基线
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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描述治疗策略对生存标准的影响
大体时间：从诊断或首次治疗之日起直至因任何原因死亡之日。跟进至2023年。
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总体生存率
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从诊断或首次治疗之日起直至因任何原因死亡之日。跟进至2023年。
|
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描述治疗策略对生存标准的影响
大体时间：从诊断或首次治疗之日起，直至首次记录到病情进展之日或因任何原因死亡的日期。跟进至2023年。
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无进展生存
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从诊断或首次治疗之日起，直至首次记录到病情进展之日或因任何原因死亡的日期。跟进至2023年。
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
合作者
调查人员
- 研究主任：Lise Bosquet, MsC、UNICANCER
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Gobbini E, Ezzalfani M, Dieras V, Bachelot T, Brain E, Debled M, Jacot W, Mouret-Reynier MA, Goncalves A, Dalenc F, Patsouris A, Ferrero JM, Levy C, Lorgis V, Vanlemmens L, Lefeuvre-Plesse C, Mathoulin-Pelissier S, Petit T, Uwer L, Jouannaud C, Leheurteur M, Lacroix-Triki M, Cleaud AL, Robain M, Courtinard C, Cailliot C, Perol D, Delaloge S. Time trends of overall survival among metastatic breast cancer patients in the real-life ESME cohort. Eur J Cancer. 2018 Jun;96:17-24. doi: 10.1016/j.ejca.2018.03.015. Epub 2018 Apr 13.
- Delaloge S, Perol D, Courtinard C, Brain E, Asselain B, Bachelot T, Debled M, Dieras V, Campone M, Levy C, Jacot W, Lorgis V, Veyret C, Dalenc F, Ferrero JM, Uwer L, Kerbrat P, Goncalves A, Mouret-Reynier MA, Petit T, Jouannaud C, Vanlemmens L, Chenuc G, Guesmia T, Robain M, Cailliot C. Paclitaxel plus bevacizumab or paclitaxel as first-line treatment for HER2-negative metastatic breast cancer in a multicenter national observational study. Ann Oncol. 2016 Sep;27(9):1725-32. doi: 10.1093/annonc/mdw260. Epub 2016 Jul 19.
- Jacquet E, Lardy-Cleaud A, Pistilli B, Franck S, Cottu P, Delaloge S, Debled M, Vanlemmens L, Leheurteur M, Guizard AV, Laborde L, Uwer L, Jacot W, Berchery D, Desmoulins I, Ferrero JM, Perrocheau G, Courtinard C, Brain E, Chabaud S, Robain M, Bachelot T. Endocrine therapy or chemotherapy as first-line therapy in hormone receptor-positive HER2-negative metastatic breast cancer patients. Eur J Cancer. 2018 May;95:93-101. doi: 10.1016/j.ejca.2018.03.013. Epub 2018 Apr 11.
- Cabel L, Carton M, Cheaib B, Pierga JY, Dalenc F, Mailliez A, Levy C, Jacot W, Debled M, Leheurteur M, Desmoulins I, Lefeuvre C, Goncalves A, Uwer L, Ferrero JM, Eymard JC, Petit T, Mouret-Reynier MA, Perrocheau G, Piot I, Perol D, Simon G, Lerebours F. Oral etoposide in heavily pre-treated metastatic breast cancer: results from the ESME cohort and comparison with other chemotherapy regimens. Breast Cancer Res Treat. 2019 Jan;173(2):397-406. doi: 10.1007/s10549-018-5017-2. Epub 2018 Oct 24.
- Pons-Tostivint E, Kirova Y, Lusque A, Campone M, Geffrelot J, Mazouni C, Mailliez A, Pasquier D, Madranges N, Firmin N, Crouzet A, Goncalves A, Jankowski C, De La Motte Rouge T, Pouget N, de La Lande B, Mouttet-Boizat D, Ferrero JM, Uwer L, Eymard JC, Mouret-Reynier MA, Petit T, Robain M, Filleron T, Cailliot C, Dalenc F. Survival Impact of Locoregional Treatment of the Primary Tumor in De Novo Metastatic Breast Cancers in a Large Multicentric Cohort Study: A Propensity Score-Matched Analysis. Ann Surg Oncol. 2019 Feb;26(2):356-365. doi: 10.1245/s10434-018-6831-9. Epub 2018 Dec 11.
- Delaloge S, Perol D, Robain M, Cailliot C. Reply to 'The potential and perils of observational studies' by M. Buyse et al. Ann Oncol. 2017 Feb 1;28(2):436-437. doi: 10.1093/annonc/mdw572. No abstract available.
- Perol D, Robain M, Delaloge S, Cailliot C. Routinely collected data may usefully supplement randomised controlled data on treatment effects for mortality. BMJ. 2016 Dec 16;355:i6745. doi: 10.1136/bmj.i6745. No abstract available.
- Petitjean A, Smith-Palmer J, Valentine W, Tehard B, Roze S. Cost-effectiveness of bevacizumab plus paclitaxel versus paclitaxel for the first-line treatment of HER2-negative metastatic breast cancer in specialist oncology centers in France. BMC Cancer. 2019 Feb 11;19(1):140. doi: 10.1186/s12885-019-5335-8.
- Perol D, Robain M, Arveux P, Mathoulin-Pelissier S, Chamorey E, Asselain B, Berchery D, Gourgou S, Breton M, Delaine-Clisant S, Mons M, Dieras V, Carton M, Guizard AV, Laborde L, Laurent C, Loeb A, Mouret-Reynier MA, Parent D, Perrocheau G, Campion L, Velten M, Cailliot C, Ezzalfani M, Simon G. The ongoing French metastatic breast cancer (MBC) cohort: the example-based methodology of the Epidemiological Strategy and Medical Economics (ESME). BMJ Open. 2019 Feb 21;9(2):e023568. doi: 10.1136/bmjopen-2018-023568.
- Jacot W, Heudel PE, Fraisse J, Gourgou S, Guiu S, Dalenc F, Pistilli B, Campone M, Levy C, Debled M, Leheurteur M, Chaix M, Lefeuvre C, Goncalves A, Uwer L, Ferrero JM, Eymard JC, Petit T, Mouret-Reynier MA, Courtinard C, Cottu P, Robain M, Mailliez A. Real-life activity of eribulin mesylate among metastatic breast cancer patients in the multicenter national observational ESME program. Int J Cancer. 2019 Dec 15;145(12):3359-3369. doi: 10.1002/ijc.32402. Epub 2019 Jun 20.
- Le Saux O, Lardy-Cleaud A, Frank S, Debled M, Cottu PH, Pistilli B, Vanlemmens L, Leheurteur M, Levy C, Laborde L, Uwer L, D'hondt V, Berchery D, Lorgis V, Ferrero JM, Perrocheau G, Courtinard C, Mouret-Reynier MA, Velten M, Breton M, Parent D, Chabaud S, Robain M, Bachelot T. Assessment of the efficacy of successive endocrine therapies in hormone receptor-positive and HER2-negative metastatic breast cancer: a real-life multicentre national study. Eur J Cancer. 2019 Sep;118:131-141. doi: 10.1016/j.ejca.2019.06.014. Epub 2019 Jul 19.
- Gougis P, Carton M, Tchokothe C, Campone M, Dalenc F, Mailliez A, Levy C, Jacot W, Debled M, Leheurteur M, Bachelot T, Hennequin A, Perrin C, Goncalves A, Uwer L, Eymard JC, Petit T, Mouret-Reynier MA, Chamorey E, Simon G, Saghatchian M, Cailliot C, Le Tourneau C. CineBreast-factors influencing the time to first metastatic recurrence in breast cancer: Analysis of real-life data from the French ESME MBC database. Breast. 2020 Feb;49:17-24. doi: 10.1016/j.breast.2019.10.004. Epub 2019 Oct 19.
- Darlix A, Louvel G, Fraisse J, Jacot W, Brain E, Debled M, Mouret-Reynier MA, Goncalves A, Dalenc F, Delaloge S, Campone M, Augereau P, Ferrero JM, Levy C, Fumet JD, Lecouillard I, Cottu P, Petit T, Uwer L, Jouannaud C, Leheurteur M, Dieras V, Robain M, Chevrot M, Pasquier D, Bachelot T. Impact of breast cancer molecular subtypes on the incidence, kinetics and prognosis of central nervous system metastases in a large multicentre real-life cohort. Br J Cancer. 2019 Dec;121(12):991-1000. doi: 10.1038/s41416-019-0619-y. Epub 2019 Nov 13.
- Pasquier D, Darlix A, Louvel G, Fraisse J, Jacot W, Brain E, Petit A, Mouret-Reynier MA, Goncalves A, Dalenc F, Deluche E, Fresnel JS, Augereau P, Ferrero JM, Geffrelot J, Fumet JD, Lecouillard I, Cottu P, Petit T, Uwer L, Jouannaud C, Leheurteur M, Dieras V, Robain M, Mouttet-Audouard R, Bachelot T, Courtinard C. Treatment and outcomes in patients with central nervous system metastases from breast cancer in the real-life ESME MBC cohort. Eur J Cancer. 2020 Jan;125:22-30. doi: 10.1016/j.ejca.2019.11.001. Epub 2019 Dec 10.
- Deluche E, Antoine A, Bachelot T, Lardy-Cleaud A, Dieras V, Brain E, Debled M, Jacot W, Mouret-Reynier MA, Goncalves A, Dalenc F, Patsouris A, Ferrero JM, Levy C, Lorgis V, Vanlemmens L, Lefeuvre-Plesse C, Mathoulin-Pelissier S, Petit T, Uwer L, Jouannaud C, Leheurteur M, Lacroix-Triki M, Courtinard C, Perol D, Robain M, Delaloge S. Contemporary outcomes of metastatic breast cancer among 22,000 women from the multicentre ESME cohort 2008-2016. Eur J Cancer. 2020 Apr;129:60-70. doi: 10.1016/j.ejca.2020.01.016. Epub 2020 Mar 2.
- Pons-Tostivint E, Kirova Y, Lusque A, Campone M, Geffrelot J, Rivera S, Mailliez A, Pasquier D, Madranges N, Firmin N, Crouzet A, Goncalves A, Jankowski C, De La Motte Rouge T, Pouget N, De La Lande B, Mouttet-Boizat D, Ferrero JM, Uwer L, Eymard JC, Mouret-Reynier MA, Petit T, Courtinard C, Filleron T, Robain M, Dalenc F. Radiation therapy to the primary tumor for de novo metastatic breast cancer and overall survival in a retrospective multicenter cohort analysis. Radiother Oncol. 2020 Apr;145:109-116. doi: 10.1016/j.radonc.2019.12.019. Epub 2020 Jan 10.
- Heudel P, Delaloge S, Parent D, Madranges N, Levy C, Dalenc F, Brain E, Uwer L, D'Hondt V, Augereau P, Mailliez A, Perrin C, Frenel JS, Sablin MP, Mouret-Reynier MA, Vermeulin T, Eymard JC, Petit T, Ferrero JM, Ilie S, Goncalves A, Chenuc G, Robain M, Simon G, Perol D. Real-world Evaluation of Oral Vinorelbine in the Treatment of Metastatic Breast Cancer: An ESME-MBC Study. Anticancer Res. 2020 Jul;40(7):3905-3913. doi: 10.21873/anticanres.14381.
- Frasca M, Sabathe C, Delaloge S, Galvin A, Patsouris A, Levy C, Mouret-Reynier MA, Desmoulins I, Vanlemmens L, Bachelot T, Goncalves A, Perotin V, Uwer L, Frenel JS, Ferrero JM, Bouleuc C, Eymard JC, Dieras V, Leheurteur M, Petit T, Dalenc F, Jaffre A, Chevrot M, Courtinard C, Mathoulin-Pelissier S. Palliative care delivery according to age in 12,000 women with metastatic breast cancer: Analysis in the multicentre ESME-MBC cohort 2008-2016. Eur J Cancer. 2020 Sep;137:240-249. doi: 10.1016/j.ejca.2020.07.007. Epub 2020 Aug 14.
- Frank S, Carton M, Dubot C, Campone M, Pistilli B, Dalenc F, Mailliez A, Levy C, D'Hondt V, Debled M, Vermeulin T, Coudert B, Perrin C, Goncalves A, Uwer L, Ferrero JM, Eymard JC, Petit T, Mouret-Reynier MA, Patsouris A, Guesmia T, Bachelot T, Robain M, Cottu P. Impact of age at diagnosis of metastatic breast cancer on overall survival in the real-life ESME metastatic breast cancer cohort. Breast. 2020 Aug;52:50-57. doi: 10.1016/j.breast.2020.04.009. Epub 2020 Apr 23.
- Saleh K, Carton M, Dieras V, Heudel PE, Brain E, D'Hondt V, Mailliez A, Patsouris A, Mouret-Reynier MA, Goncalves A, Ferrero JM, Petit T, Emile G, Uwer L, Debled M, Dalenc F, Jouannaud C, Ladoire S, Leheurteur M, Cottu P, Veron L, Savignoni A, Courtinard C, Robain M, Delaloge S, Deluche E. Impact of body mass index on overall survival in patients with metastatic breast cancer. Breast. 2021 Feb;55:16-24. doi: 10.1016/j.breast.2020.11.014. Epub 2020 Dec 1.
- Sirieix J, Fraisse J, Mathoulin-Pelissier S, Leheurteur M, Vanlemmens L, Jouannaud C, Dieras V, Levy C, Ung M, Mouret-Reynier MA, Petit T, Coudert B, Brain E, Pistilli B, Ferrero JM, Goncalves A, Uwer L, Patsouris A, Tredan O, Courtinard C, Gourgou S, Frenel JS. Management and outcome of male metastatic breast cancer in the national multicenter observational research program Epidemiological Strategy and Medical Economics (ESME). Ther Adv Med Oncol. 2020 Dec 23;12:1758835920980548. doi: 10.1177/1758835920980548. eCollection 2020.
- Bertho M, Fraisse J, Patsouris A, Cottu P, Arnedos M, Perol D, Jaffre A, Goncalves A, Lebitasy MP, D'Hondt V, Dalenc F, Ferrero JM, Levy C, Dabakuyo S, Rouzier R, Penault-Llorca F, Uwer L, Eymard JC, Breton M, Chevrot M, Thureau S, Petit T, Simon G, Frenel JS. Real-life prognosis of 5041 bone-only metastatic breast cancer patients in the multicenter national observational ESME program. Ther Adv Med Oncol. 2021 Jan 21;13:1758835920987657. doi: 10.1177/1758835920987657. eCollection 2021.
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研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2014年7月1日
初级完成 (估计的)
2027年3月1日
研究完成 (估计的)
2027年12月1日
研究注册日期
首次提交
2017年6月27日
首先提交符合 QC 标准的
2017年9月5日
首次发布 (实际的)
2017年9月7日
研究记录更新
最后更新发布 (实际的)
2026年5月27日
上次提交的符合 QC 标准的更新
2026年5月22日
最后验证
2026年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.