Trial Information
ARimidex Therapy Compliance Electronic MonitorIng System. A Study to Evaluate the Impact of Educational Material on the Adherence to Treatment With Adjuvant Anastrozole for Postmenopausal Women With Hormone Sensitive Early Breast Cancer
Inclusion Criteria:
- Postmenopausal women with hormone sensitive early breast cancer.
- Documented decision of treatment with anastrozole which will start in 13 weeks
according to current SmPC OR current treatment with anastrozole according to current
SmPC, that has not exceeded thirteen weeks before enrollment.
- Subjects who accept to use MEMSĀ® monitors to automatically compile their drug dosing
histories.
Exclusion Criteria:
- Concomitant or previous use of adjuvant tamoxifen, letrozole or exemestane for the
current tumour.
- Involvement in the planning and/or conduct of the study (applies to both AstraZeneca
staff or staff at the study site).
- Participation in another clinical study with an investigational product during the
last 3 months.
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Overall adherence to anastrozole
Outcome Time Frame:
2/year (after 6 months and after one year)
Safety Issue:
No
Principal Investigator
Prof. Nogaret
Investigator Role:
Principal Investigator
Investigator Affiliation:
Institut Jules Bordet
Authority:
Belgium: Institutional Review Board
Study ID:
D5390L00076
NCT ID:
NCT00936442
Start Date:
June 2009
Completion Date:
December 2010
Related Keywords:
- Breast Cancer
- Compliance
- Early Breast Cancer
- Breast Neoplasms