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Completed

NCT Number: NCT00936442

Arimidex Therapy Compliance Electronic Monitoring System

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.

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Key information

Sex eligibility

Female

Study type

Observational

Primary location

Research Site, Brussels, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Anastrozole

Drug

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

Educational Materials

Other

Reception of educational material on regular basis.

Primary outcomes

  1. Overall adherence to anastrozole

    Time frame: 2/year (after 6 months and after one year)

Secondary outcomes

  1. Patients' persistence with anastrozole

    Time frame: 2/year (after 6 months and after one year)

  2. Execution of the dosing regimen

    Time frame: 2/year (after 6 months and after one year)

  3. Reasons for treatment discontinuation

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Aardex Pharmionic

Registry information

Official study 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

Acronym: ARTEMIS

Important dates

Study start
2009
Primary completion
2009
Study completion
2010
First posted
Jul 10, 2009
Registry last updated
Feb 14, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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