Arimidex Therapy Compliance Electronic Monitoring System (ARTEMIS)

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Anastrozole; Other: Educational materials

• Study Type: Observational
• Enrollment (Actual): 104

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium
    • Research Site
  • Leuven, Belgium
    • Research Site
  • Liege, Belgium
    • Research Site
  • Overpelt, Belgium
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Postmenopausal women with hormone sensitive early breast cancer

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group A; Standard treatment: 12-month follow-up of anastrozole treatment according to SmPC and current clinical practice.	Drug: Anastrozole; (Standard Treatment) 12-month follow-up of anastrozole treatment according to SmPC and current clinical practice.
Group B; Standard treatment + educational material: 12-month follow-up of anastrozole treatment according to SmPC and current clinical practice plus reception of educational material on regular basis.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall adherence to anastrozole	2/year (after 6 months and after one year)

Secondary Outcome Measures

Outcome Measure	Time Frame
Patients' persistence with anastrozole	2/year (after 6 months and after one year)
Execution of the dosing regimen	2/year (after 6 months and after one year)
Reasons for treatment discontinuation	1 year

Collaborators and Investigators

• Sponsor: AstraZeneca
• Collaborators: Aardex Pharmionic
• Investigators: Principal Investigator: Prof. Nogaret, Jules Bordet Institute

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (ACTUAL): December 1, 2009
• Study Completion (ACTUAL): December 1, 2010

Study Registration Dates

• First Submitted: July 6, 2009
• First Submitted That Met QC Criteria: July 9, 2009
• First Posted (ESTIMATE): July 10, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): February 14, 2012
• Last Update Submitted That Met QC Criteria: February 13, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: Compliance; Early Breast Cancer
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Hormone Antagonists; Aromatase Inhibitors; Steroid Synthesis Inhibitors; Estrogen Antagonists; Anastrozole
• Other Study ID Numbers: D5390L00076