|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT00735215 |
|
Date of registration:
|
12/08/2008 |
|
Primary sponsor: |
|
|
Public title:
|
Faslodex Registry: Fulvestrant in Current Clinical Practice
|
|
Scientific title:
|
Faslodex Registry: a Belgian Observational Study to Evaluate the Use of Fulvestrant in Current Clinical Practice |
|
Date of first enrolment:
|
October 2008 |
|
Target sample size:
|
200 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00735215 |
|
Study type:
|
Observational |
|
Study design:
|
Observational Model: Case-Only, Time Perspective: Prospective
|
|
|
Countries of recruitment
|
|
Belgium
| | | | | | | |
|
Contacts
|
|
Name:
|
Neven P Prof |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
KUL |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Postmenopausal women with hormone receptor-positive locally advanced or metastatic breast cancer
Exclusion Criteria:
Age minimum:
N/A
Age maximum:
N/A
Gender:
Female
|
|
Health Condition(s) or Problem(s) studied
|
|
Metastatic Breast Cancer
|
|
Primary Outcome(s)
|
|
to collect real life data on the use of fulvestrant in clinical practice in Belgium. Previous therapies (hormonal and chemo) for breast cancer and for advanced breast cancer will be documented for each patient.
[Time Frame: Visit 1, Visit 2]
|
|
Secondary Outcome(s)
|
|
Document reasons for fulvestrant treatment discontinuation
[Time Frame: Visit 2]
|
|
Document treatment during observation period and number of fulvestrant injections
[Time Frame: Visit 1, Visit 2]
|
|
Secondary ID(s)
|
|
NIS-OBE-FAS-2008/1
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|