Faslodex Specific Clinical Experience Investigation

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01501266
First received: December 27, 2011
Last updated: July 8, 2014
Last verified: July 2014

December 27, 2011
July 8, 2014
January 2012
July 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
Not Provided
Not Provided
 
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.
 
Active, not recruiting
500
July 2014
July 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 information is only displayed when the study is recruiting subjects
Japan
 
NCT01501266
D6997C00008
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Study Director: Shigeru Yoshida AstraZeneca KK
AstraZeneca
July 2014

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