Status:
TERMINATED
Collection of Efficacy and Safety Data of Chinese Patients Who Have Received Faslodex 250mg Treatment
Lead Sponsor:
AstraZeneca
Conditions:
Breast Cancer
Eligibility:
FEMALE
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 Fasl...
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 p...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 30 2016
Estimated Enrollment :
231 Patients enrolled
Trial Details
Trial ID
NCT01425294
Start Date
August 1 2011
End Date
January 30 2016
Last Update
December 5 2017
Active Locations (23)
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1
Research Site
Beijing, Beijing Municipality, China
2
Research Site
Fuzhou, Fujian, China
3
Research Site
Guangzhou, Guangdong, China
4
Research Site
Guiyang, Guizhou, China