Faslodex Specific Clinical Experience Investigation
1 other identifier
observational
660
1 country
43
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2012
Typical duration for all trials
43 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 27, 2011
CompletedFirst Posted
Study publicly available on registry
December 29, 2011
CompletedStudy Start
First participant enrolled
February 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedMay 10, 2016
May 1, 2016
2.9 years
December 27, 2011
May 9, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Incidence of adverse drug reactions.
1 year
Incidence of serious adverse events.
1 Year
Secondary Outcomes (3)
Incidence of adverse drug reactions with injection site reaction, thromboembolic events and hepatic impairment
1 year
Progression-free survival
6 month
Progression-free survival
1 year
Study Arms (1)
Faslodex
Eligibility Criteria
Patients treated with Faslodex for the first time due to postmenopausal breast cancer
You may qualify if:
- Patients treated with Faslodex for the first time due to postmenopausal breast cancer
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (43)
Research Site
Aichi, Japan
Research Site
Akita, Japan
Research Site
Aomori, Japan
Research Site
Chiba, Japan
Research Site
Fukui, Japan
Research Site
Fukuoka, Japan
Research Site
Fukushima, Japan
Research Site
Gifu, Japan
Research Site
Gunma, Japan
Research Site
Hiroshima, Japan
Research Site
Hokkaido, Japan
Research Site
Hyōgo, Japan
Research Site
Ibaraki, Japan
Research Site
Ishikawa, Japan
Research Site
Kagawa, Japan
Research Site
Kagoshima, Japan
Research Site
Kanagawa, Japan
Research Site
Kochi, Japan
Research Site
Kumamoto, Japan
Research Site
Kyoto, Japan
Research Site
Miyagi, Japan
Research Site
Miyazaki, Japan
Research Site
Nagano, Japan
Research Site
Nagasaki, Japan
Research Site
Nara, Japan
Research Site
Niigata, Japan
Research Site
Okayama, Japan
Research Site
Okinawa, Japan
Research Site
Osaka, Japan
Research Site
Ōita, Japan
Research Site
Saga, Japan
Research Site
Saitama, Japan
Research Site
Shiga, Japan
Research Site
Shizuoka, Japan
Research Site
Tochigi, Japan
Research Site
Tokushima, Japan
Research Site
Tokyo, Japan
Research Site
Tottori, Japan
Research Site
Toyama, Japan
Research Site
Wakayama, Japan
Research Site
Yamagata, Japan
Research Site
Yamaguchi, Japan
Research Site
Yamanashi, Japan
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Shigeru Yoshida
AstraZeneca KK
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 27, 2011
First Posted
December 29, 2011
Study Start
February 1, 2012
Primary Completion
January 1, 2015
Study Completion
January 1, 2015
Last Updated
May 10, 2016
Record last verified: 2016-05