Arimidex Therapy Compliance Electronic Monitoring System

Breast Cancer Clinical Trial

— ARTEMIS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00936442
• Other study ID #: D5390L00076
• Status: Completed
• Phase: N/A
• First received: July 6, 2009
• Last updated: February 13, 2012
• Start date: June 2009
• Est. completion date: December 2010

Study information

• Verified date: February 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: December 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Anastrozole
(Standard Treatment) 12-month follow-up of anastrozole treatment according to SmPC and current clinical practice.

Other:
• Educational materials
Reception of educational material on regular basis.

Locations

Country	Name	City	State
Belgium	Research Site	Brussels
Belgium	Research Site	Leuven
Belgium	Research Site	Liege
Belgium	Research Site	Overpelt

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Aardex Pharmionic

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall adherence to anastrozole		2/year (after 6 months and after one year)	No
Secondary	Patients' persistence with anastrozole		2/year (after 6 months and after one year)	No
Secondary	Execution of the dosing regimen		2/year (after 6 months and after one year)	No
Secondary	Reasons for treatment discontinuation		1 year	No