Clinical trial NCT00936442: Arimidex Therapy Compliance Electronic Monitoring System
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Compliance
Early Breast Cancer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Aardex Pharmionic
First posted: 2009-07-10
Enrollment: 104
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Postmenopausal women with hormone sensitive early breast cancer

Brief summary: ARTEMIS is a study to assess how educational material affects overall adherence to anastrozole by evaluation of patients' electronically compiled dosing histories. Patients' dosing times are compiled electronically using Medication Event Monitoring System" (MEMS®) in order to be able to gather accurate, objective and up-to-date patients' dosing histories. For subjects in Group A, the control group, the adherence to anastrozole in the standard clinical practice will be evaluated. For subjects in Group B, on top of the standard clinical practice, they will also receive educational material by mail at week 0 (study registration), week 2, week 4, week 6, week 8, week 12, month 5, month 7, and at month 10. This procedure is the same as in the ongoing CARIATIDE study. One of the reasons of poor adherence (either early discontinuation of the treatment or missing doses while still engaged to the therapy) can be some side effects experienced by the patients during the anastrozole treatment. Recording the reasons at discontinuation allows us to identify reasons for treatment discontinuation. Recording reasons of anastrozole interruptions during the study period allows us to relate these events to patients' adherence to anastrozole. During the study, no pro-active safety data collection will take place. Spontaneous reported adverse drug reactions (ADRs) will be reported according to local post-marketing pharmacovigilance regulations.


Eligibility criteria: 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 MEMS® 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.

Primary outcomes:
measure: Overall adherence to anastrozole
timeFrame: 2/year (after 6 months and after one year)
Secondary outcomes:
measure: Patients' persistence with anastrozole
timeFrame: 2/year (after 6 months and after one year)
measure: Execution of the dosing regimen
timeFrame: 2/year (after 6 months and after one year)
measure: Reasons for treatment discontinuation
timeFrame: 1 year
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Research Site
city: Leuven
country: Belgium
facility: Research Site
city: Liege
country: Belgium
facility: Research Site
city: Overpelt
country: Belgium
facility: Research Site
Study officials:
affiliation: Jules Bordet Institute
name: Prof. Nogaret
role: PRINCIPAL_INVESTIGATOR
References: