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

NCT01425294 | Terminated DMC

• 1 other identifier: NIS-OCN-FAS-2011/1
• Study Type: observational
• Target: 231
• Locations: 1 country
• Sites: 23

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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  Follow-up will be taken every 3 months after commencement of the protocol, through study completion, an average of 12 months.

Secondary Outcomes (3)

• Objective response rate (ORR)

  Follow-up will be taken every 3 months after commencement of the protocol, through the study completion, an average of 12 months.

• Frequency of Adverse Events

  Follow-up will be taken every 3 months after commencement of the protocol, through study completion, an average of 12 months.

• Severity of Adverse Events

  Follow-up will be taken every 3 months after commencement of the protocol, through study completion, an average of 12 months.

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Medical units

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (23)

Research Site

Beijing, Beijing Municipality, China

Location

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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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Research Site

Zhoushan, Zhejiang, China

Location

Related Publications (10)

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  PMID: 21351269 BACKGROUND

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

  PMID: 1855205 BACKGROUND

• 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.

  PMID: 15950373 BACKGROUND

• 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.

  PMID: 17518364 BACKGROUND

• 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.

  PMID: 9045319 BACKGROUND

• 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.

  PMID: 7563152 BACKGROUND

• 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.

  PMID: 7799704 BACKGROUND

• 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.

  PMID: 8688341 BACKGROUND

• 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.

  PMID: 12177099 BACKGROUND

• 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.

  PMID: 12177098 BACKGROUND

Related Links

• NIS-OCN-FAS-2011-1StudyReportSynopsisfinal

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Binghe Xu, MD

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2011
• First Posted: August 30, 2011
• Study Start: August 1, 2011
• Primary Completion: January 30, 2016
• Study Completion: January 30, 2016
• Last Updated: December 5, 2017

Record last verified: 2017-12

Locations

CN (23)