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Faslodex Specific Clinical Experience Investigation

This study is currently recruiting participants.
Verified May 2013 by AstraZeneca
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01501266
First received: December 27, 2011
Last updated: May 17, 2013
Last verified: May 2013
History of Changes

December 27, 2011
May 17, 2013
January 2012
June 2014   (final data collection date for primary outcome measure)
  • Incidence of adverse drug reactions. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Incidence of serious adverse events. [ Time Frame: 1 Year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01501266 on ClinicalTrials.gov Archive Site
  • Incidence of adverse drug reactions with injection site reaction, thromboembolic events and hepatic impairment [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Progression-free survival [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
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Faslodex Specific Clinical Experience Investigation
Faslodex Specific Clinical Experience Investigation for Long-term Use

The purpose of this study is to confirm the safety profile such as the frequency of serious adverse events or any unexpected adverse events and overall efficacy of Faslodex for long term treatment in daily clinical practice.

MC MD
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients treated with Faslodex for the first time due to postmenopausal breast cancer
Breast Cancer
Not Provided
Faslodex
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
June 2014
June 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients treated with Faslodex for the first time due to postmenopausal breast cancer

Exclusion Criteria:

  • None
Female
Not Provided
No
Contact: AstraZeneca Clinical Study Information 800-236-9933 information.center@astrazeneca.com
Japan
 
NCT01501266
D6997C00008
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Study Director: Shigeru Yoshida AstraZeneca KK
AstraZeneca
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP