An International, Observational Study to Evaluate the Impact of Educational Material on the Compliance and Persistence Rates to Adjuvant Aromatase Inhibitor (AI) Medication for Postmenopausal Woman
N/A
18 Years
N/A
18 Years
N/A
Not Enrolling
Female
Breast Cancer
Female
Breast Cancer
Trial Information
An International, Observational Study to Evaluate the Impact of Educational Material on the Compliance and Persistence Rates to Adjuvant Aromatase Inhibitor (AI) Medication for Postmenopausal Woman
Inclusion Criteria:
- Postmenopausal woman with hormone sensitive early breast cancer
- Documented decision of treatment with upfront adjuvant AI (either anastrozole or
letrozole) according to current SmPC OR current treatment with AI (either anastrozole
or letrozole) according to current SmPC, that has not exceeded thirteen weeks
Exclusion Criteria:
- Upfront adjuvant AI medication which has exceeded thirteen weeks at randomisation
- Concomitant adjuvant treatment with tamoxifen or exemestane
- Previous use of adjuvant tamoxifen or exemestane exceeding thirteen weeks
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
The compliance rate for the adjuvant AI medication will be analysed at one year based on the subject's assessment.
Outcome Time Frame:
once after one year
Safety Issue:
No
Principal Investigator
Neven, P. Prof.
Investigator Role:
Principal Investigator
Investigator Affiliation:
KUL
Authority:
Austria: Ethikkommission
Study ID:
NIS-OEU-ARI-2007/1
NCT ID:
NCT00681122
Start Date:
May 2008
Completion Date:
May 2011
Related Keywords:
- Breast Cancer
- Breast Cancer
- hormone therapy
- aromatase inhibitor
- Breast Neoplasms
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