Collection of Efficacy and Safety Data of Chinese Patients Who Have Received Faslodex 250mg Treatment
4 décembre 2017 mis à jour par: AstraZeneca
A Multicenter, Non-interventional, Prospective Study to Collect Efficacy and Safety Data in Chinese Patients Who Have Received Faslodex 250mg Treatment Under the Condition of Actual Usage in Clinical Practice
This study is a post-authorisation study, committed to Center for Drug Evaluation (CDE) and China Food and Drug Administration (CFDA), in order to provide more effectiveness and safety data about Faslodex in real world clinical practice in China.
The primary objective of this study was to evaluate the effectiveness of Faslodex 250mg monthly to treat post-menopausal women with oestrogen receptor-positive locally advanced or metastatic breast cancer, for disease relapse on or after adjuvant anti-oestrogen therapy or disease progression on therapy with an anti-oestrogen, in terms of progression-free survival (PFS), by collecting real world data according to Chinese physicians' clinical practice.
Aperçu de l'étude
Statut
Résilié
Les conditions
Description détaillée
A Multicenter, non-interventional, prospective study to collect effectiveness and safety data in Chinese patients who have received Faslodex treatment under the condition of actual usage in clinical practice
Type d'étude
Observationnel
Inscription (Réel)
231
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Beijing
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Beijing, Beijing, Chine
- Research Site
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Fujian
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Fuzhou, Fujian, Chine
- Research Site
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Guangdong
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Guangzhou, Guangdong, Chine
- Research Site
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Guizhou
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Guiyang, Guizhou, Chine
- Research Site
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Hebei
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Tangshan, Hebei, Chine
- Research Site
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Heilongjiang
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Ha'erbin, Heilongjiang, Chine
- Research Site
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Hubei
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Wuhan, Hubei, Chine
- Research Site
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Hunan
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Changsha, Hunan, Chine
- Research Site
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Inner Mongolia
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Huhehaote, Inner Mongolia, Chine
- Research Site
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Jiangsu
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Kunshan, Jiangsu, Chine
- Research Site
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Nanjing, Jiangsu, Chine
- Research Site
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Nantong, Jiangsu, Chine
- Research Site
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Xuzhou, Jiangsu, Chine
- Research Site
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Jilin
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Changchun, Jilin, Chine
- Research Site
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Shandong
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Qingdao, Shandong, Chine
- Research Site
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Weifang, Shandong, Chine
- Research Site
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Shanghai
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Shanghai, Shanghai, Chine
- Research Site
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Sichuan
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Chengdu, Sichuan, Chine
- Research Site
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Tianjin
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Tianjin, Tianjin, Chine
- Research Site
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Yunnan
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Kunming, Yunnan, Chine
- Research Site
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Zhejiang
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Hanghzou, Zhejiang, Chine
- Research Site
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Hangzhou, Zhejiang, Chine
- Research Site
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Zhoushan, Zhejiang, Chine
- Research Site
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Femelle
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
Medical units
La description
Inclusion Criteria:
- Chinese postmenopausal women with estrogen receptor positive, locally advanced or metastatic breast cancer Failure to previous anti-estrogen therapy, already received Faslodex 250mg treatment as determined by treating physician.
- The prescription of the Faslodex is clearly separated from the decision to include the subject in the NIS, and is part of normal medical practice. The recruitment of the patient to the study should be within 1 month of the first Faslodex injection.
- Provision of subject informed consent.
Exclusion Criteria:
- If participating in any controlled clinical trial, the subject cannot take part in this study.
- Hypersensitivity to the active substance, or to any of the other excipients.
- Pregnancy and lactation, or severe hepatic impairment.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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To evaluate the effectiveness of Faslodex 250mg monthly to treat post-menopausal women with ER+ locally advanced or MBC in terms of progression-free survival (PFS), by collecting real world data according to Chinese physicians' clinical practice.
Délai: Follow-up will be taken every 3 months after commencement of the protocol, through study completion, an average of 12 months.
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The primary objective of this study was to evaluate the effectiveness of Faslodex 250mg monthly to treat post-menopausal women with oestrogen receptor-positive locally advanced or metastatic breast cancer, for disease relapse on or after adjuvant anti-oestrogen therapy or disease progression on therapy with an anti-oestrogen, in terms of progression-free survival (PFS), by collecting real world data according to Chinese physicians' clinical practice.
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Follow-up will be taken every 3 months after commencement of the protocol, through study completion, an average of 12 months.
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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Objective response rate (ORR)
Délai: Follow-up will be taken every 3 months after commencement of the protocol, through the study completion, an average of 12 months.
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ORR was defined as the percentage of patients who had a best objective tumour response of either complete response (CR) or partial response (PR) among the evaluable patients with measurable disease at baseline.
The best overall response was the best response recorded from the start of the treatment until disease progression.
The RECIST1.1 criteria were used to assess objective tumour response.
ORR was summarized and expressed as the percentage together with the corresponding 95% confidence intervals (CI).
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Follow-up will be taken every 3 months after commencement of the protocol, through the study completion, an average of 12 months.
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Frequency of Adverse Events
Délai: Follow-up will be taken every 3 months after commencement of the protocol, through study completion, an average of 12 months.
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Adverse events (AEs) data were coded using Medical dictionary for Regulatory Activities (MedDRA) version 14.0 and summarized by preferred term (PT) and system organ class (SOC).
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Follow-up will be taken every 3 months after commencement of the protocol, through study completion, an average of 12 months.
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Severity of Adverse Events
Délai: Follow-up will be taken every 3 months after commencement of the protocol, through study completion, an average of 12 months.
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SAEs causally related to study drug, AEs leading to discontinuation, AEs leading to death, respectively.
Separate listings were provided for AEs causally related to study drug, AEs leading to death, respectively.
The severity of all adverse events was analyzed according to CTCAE grading.
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Follow-up will be taken every 3 months after commencement of the protocol, through study completion, an average of 12 months.
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- Ferlay J, Shin HR, Bray F, Forman D, Mathers C, Parkin DM. Estimates of worldwide burden of cancer in 2008: GLOBOCAN 2008. Int J Cancer. 2010 Dec 15;127(12):2893-917. doi: 10.1002/ijc.25516.
- Wakeling AE, Dukes M, Bowler J. A potent specific pure antiestrogen with clinical potential. Cancer Res. 1991 Aug 1;51(15):3867-73.
- Howell A, Robertson JF, Quaresma Albano J, Aschermannova A, Mauriac L, Kleeberg UR, Vergote I, Erikstein B, Webster A, Morris C. Fulvestrant, formerly ICI 182,780, is as effective as anastrozole in postmenopausal women with advanced breast cancer progressing after prior endocrine treatment. J Clin Oncol. 2002 Aug 15;20(16):3396-403. doi: 10.1200/JCO.2002.10.057.
- Osborne CK, Pippen J, Jones SE, Parker LM, Ellis M, Come S, Gertler SZ, May JT, Burton G, Dimery I, Webster A, Morris C, Elledge R, Buzdar A. Double-blind, randomized trial comparing the efficacy and tolerability of fulvestrant versus anastrozole in postmenopausal women with advanced breast cancer progressing on prior endocrine therapy: results of a North American trial. J Clin Oncol. 2002 Aug 15;20(16):3386-95. doi: 10.1200/JCO.2002.10.058.
- Kansra S, Yamagata S, Sneade L, Foster L, Ben-Jonathan N. Differential effects of estrogen receptor antagonists on pituitary lactotroph proliferation and prolactin release. Mol Cell Endocrinol. 2005 Jul 15;239(1-2):27-36. doi: 10.1016/j.mce.2005.04.008.
- Beverage JN, Sissung TM, Sion AM, Danesi R, Figg WD. CYP2D6 polymorphisms and the impact on tamoxifen therapy. J Pharm Sci. 2007 Sep;96(9):2224-31. doi: 10.1002/jps.20892.
- Gallo MA, Kaufman D. Antagonistic and agonistic effects of tamoxifen: significance in human cancer. Semin Oncol. 1997 Feb;24(1 Suppl 1):S1-71-S1-80.
- Osborne CK, Coronado-Heinsohn EB, Hilsenbeck SG, McCue BL, Wakeling AE, McClelland RA, Manning DL, Nicholson RI. Comparison of the effects of a pure steroidal antiestrogen with those of tamoxifen in a model of human breast cancer. J Natl Cancer Inst. 1995 May 17;87(10):746-50. doi: 10.1093/jnci/87.10.746.
- Howell A, DeFriend D, Robertson J, Blamey R, Walton P. Response to a specific antioestrogen (ICI 182780) in tamoxifen-resistant breast cancer. Lancet. 1995 Jan 7;345(8941):29-30. doi: 10.1016/s0140-6736(95)91156-1.
- Howell A, DeFriend DJ, Robertson JF, Blamey RW, Anderson L, Anderson E, Sutcliffe FA, Walton P. Pharmacokinetics, pharmacological and anti-tumour effects of the specific anti-oestrogen ICI 182780 in women with advanced breast cancer. Br J Cancer. 1996 Jul;74(2):300-8. doi: 10.1038/bjc.1996.357.
Liens utiles
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 août 2011
Achèvement primaire (Réel)
30 janvier 2016
Achèvement de l'étude (Réel)
30 janvier 2016
Dates d'inscription aux études
Première soumission
19 août 2011
Première soumission répondant aux critères de contrôle qualité
26 août 2011
Première publication (Estimation)
30 août 2011
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
5 décembre 2017
Dernière mise à jour soumise répondant aux critères de contrôle qualité
4 décembre 2017
Dernière vérification
1 décembre 2017
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- NIS-OCN-FAS-2011/1
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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