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Collection of Efficacy and Safety Data of Chinese Patients Who Have Received Faslodex 250mg Treatment

NCT ID: NCT01425294

Last Updated: 2017-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

231 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-08-01

Study Completion Date

2016-01-30

Brief Summary

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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.

Detailed Description

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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

Conditions

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Breast Cancer

Keywords

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Chinese post-menopausal women oestrogen receptor-positive locally advanced metastatic breast cancer fulvestrant 250 mg failure to adjuvant anti-oestrogen therapy

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Binghe Xu, MD

Role: PRINCIPAL_INVESTIGATOR

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Locations

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Research Site

Beijing, Beijing Municipality, China

Site Status

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Fuzhou, Fujian, China

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Guangzhou, Guangdong, China

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Guiyang, Guizhou, China

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Tangshan, Hebei, China

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Harbin, Heilongjiang, China

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Wuhan, Hubei, China

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Changsha, Hunan, China

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Hohhot, Inner Mongolia, China

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Kunshan, Jiangsu, China

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Nanjing, Jiangsu, China

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Nantong, Jiangsu, China

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Xuzhou, Jiangsu, China

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Changchun, Jilin, China

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Qingdao, Shandong, China

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Weifang, Shandong, China

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Shanghai, Shanghai Municipality, China

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Chengdu, Sichuan, China

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Tianjin, Tianjin Municipality, China

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Kunming, Yunnan, China

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Hanghzou, Zhejiang, China

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Hangzhou, Zhejiang, China

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Zhoushan, Zhejiang, China

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Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 21351269 (View on PubMed)

Wakeling AE, Dukes M, Bowler J. A potent specific pure antiestrogen with clinical potential. Cancer Res. 1991 Aug 1;51(15):3867-73.

Reference Type BACKGROUND
PMID: 1855205 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15950373 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17518364 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9045319 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7563152 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7799704 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8688341 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12177099 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12177098 (View on PubMed)

Related Links

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http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=979&filename=NIS-OCN-FAS-2011-1StudyReportSynopsisfinal.docx

NIS-OCN-FAS-2011-1StudyReportSynopsisfinal

Other Identifiers

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NIS-OCN-FAS-2011/1

Identifier Type: -

Identifier Source: org_study_id