Arimidex Therapy Compliance Electronic Monitoring System (ARTEMIS)

This study has been completed.
Sponsor:
Collaborator:
Aardex Pharmionic
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00936442
First received: July 6, 2009
Last updated: February 13, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention
Breast Cancer
Drug: Anastrozole
Other: Educational materials

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Overall adherence to anastrozole [ Time Frame: 2/year (after 6 months and after one year) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patients' persistence with anastrozole [ Time Frame: 2/year (after 6 months and after one year) ] [ Designated as safety issue: No ]
  • Execution of the dosing regimen [ Time Frame: 2/year (after 6 months and after one year) ] [ Designated as safety issue: No ]
  • Reasons for treatment discontinuation [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 104
Study Start Date: June 2009
Study Completion Date: December 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Postmenopausal women with hormone sensitive early breast cancer

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00936442

Locations
Belgium
Research Site
Brussels, Belgium
Research Site
Leuven, Belgium
Research Site
Liege, Belgium
Research Site
Overpelt, Belgium
Sponsors and Collaborators
AstraZeneca
Aardex Pharmionic
Investigators
Principal Investigator: Prof. Nogaret Institut Jules Bordet
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00936442     History of Changes
Other Study ID Numbers: D5390L00076
Study First Received: July 6, 2009
Last Updated: February 13, 2012
Health Authority: Belgium: Institutional Review Board

Keywords provided by AstraZeneca:
Compliance
Early Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Anastrozole
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014