Collection of Efficacy and Safety Data of Chinese Patients Who Have Received Faslodex 250mg Treatment
4 de diciembre de 2017 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
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
Tipo de estudio
De observación
Inscripción (Actual)
231
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Beijing
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Beijing, Beijing, Porcelana
- Research Site
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Fujian
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Fuzhou, Fujian, Porcelana
- Research Site
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Guangdong
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Guangzhou, Guangdong, Porcelana
- Research Site
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Guizhou
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Guiyang, Guizhou, Porcelana
- Research Site
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Hebei
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Tangshan, Hebei, Porcelana
- Research Site
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Heilongjiang
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Ha'erbin, Heilongjiang, Porcelana
- Research Site
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Hubei
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Wuhan, Hubei, Porcelana
- Research Site
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Hunan
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Changsha, Hunan, Porcelana
- Research Site
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Inner Mongolia
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Huhehaote, Inner Mongolia, Porcelana
- Research Site
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Jiangsu
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Kunshan, Jiangsu, Porcelana
- Research Site
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Nanjing, Jiangsu, Porcelana
- Research Site
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Nantong, Jiangsu, Porcelana
- Research Site
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Xuzhou, Jiangsu, Porcelana
- Research Site
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Jilin
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Changchun, Jilin, Porcelana
- Research Site
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Shandong
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Qingdao, Shandong, Porcelana
- Research Site
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Weifang, Shandong, Porcelana
- Research Site
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Shanghai
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Shanghai, Shanghai, Porcelana
- Research Site
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Sichuan
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Chengdu, Sichuan, Porcelana
- Research Site
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Tianjin
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Tianjin, Tianjin, Porcelana
- Research Site
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Yunnan
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Kunming, Yunnan, Porcelana
- Research Site
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Zhejiang
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Hanghzou, Zhejiang, Porcelana
- Research Site
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Hangzhou, Zhejiang, Porcelana
- Research Site
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Zhoushan, Zhejiang, Porcelana
- Research Site
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Femenino
Método de muestreo
Muestra no probabilística
Población de estudio
Medical units
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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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.
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Objective response rate (ORR)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Enlaces Útiles
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de agosto de 2011
Finalización primaria (Actual)
30 de enero de 2016
Finalización del estudio (Actual)
30 de enero de 2016
Fechas de registro del estudio
Enviado por primera vez
19 de agosto de 2011
Primero enviado que cumplió con los criterios de control de calidad
26 de agosto de 2011
Publicado por primera vez (Estimar)
30 de agosto de 2011
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
5 de diciembre de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
4 de diciembre de 2017
Última verificación
1 de diciembre de 2017
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- NIS-OCN-FAS-2011/1
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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