Clinical trial NCT01425294: Collection of Efficacy and Safety Data of Chinese Patients Who Have Received Faslodex 250mg Treatment
Official title: 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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Breast Cancer
Keywords: Chinese post-menopausal women
oestrogen receptor-positive locally advanced
metastatic breast cancer
fulvestrant 250 mg
failure to adjuvant anti-oestrogen therapy
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2011-08-30
Enrollment: 231
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Medical units

Brief summary: 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: 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

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: Follow-up will be taken every 3 months after commencement of the protocol, through study completion, an average of 12 months.
Secondary outcomes:
measure: Objective response rate (ORR)
timeFrame: Follow-up will be taken every 3 months after commencement of the protocol, through the study completion, an average of 12 months.
measure: Frequency of Adverse Events
timeFrame: Follow-up will be taken every 3 months after commencement of the protocol, through study completion, an average of 12 months.
measure: Severity of Adverse Events
timeFrame: Follow-up will be taken every 3 months after commencement of the protocol, through study completion, an average of 12 months.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Research Site
state: Beijing
city: Fuzhou
country: China
facility: Research Site
state: Fujian
city: Guangzhou
country: China
facility: Research Site
state: Guangdong
city: Guiyang
country: China
facility: Research Site
state: Guizhou
city: Tangshan
country: China
facility: Research Site
state: Hebei
city: Ha'erbin
country: China
facility: Research Site
state: Heilongjiang
city: Wuhan
country: China
facility: Research Site
state: Hubei
city: Changsha
country: China
facility: Research Site
state: Hunan
city: Huhehaote
country: China
facility: Research Site
state: Inner Mongolia
city: Kunshan
country: China
facility: Research Site
state: Jiangsu
city: Nanjing
country: China
facility: Research Site
state: Jiangsu
city: Nantong
country: China
facility: Research Site
state: Jiangsu
city: Xuzhou
country: China
facility: Research Site
state: Jiangsu
city: Changchun
country: China
facility: Research Site
state: Jilin
city: Qingdao
country: China
facility: Research Site
state: Shandong
city: Weifang
country: China
facility: Research Site
state: Shandong
city: Shanghai
country: China
facility: Research Site
state: Shanghai
city: Chengdu
country: China
facility: Research Site
state: Sichuan
city: Tianjin
country: China
facility: Research Site
state: Tianjin
city: Kunming
country: China
facility: Research Site
state: Yunnan
city: Hanghzou
country: China
facility: Research Site
state: Zhejiang
city: Hangzhou
country: China
facility: Research Site
state: Zhejiang
city: Zhoushan
country: China
facility: Research Site
state: Zhejiang
Study officials:
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Binghe Xu, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.