NCT00936442

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2009

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 6, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 10, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

February 14, 2012

Status Verified

February 1, 2012

Enrollment Period

6 months

First QC Date

July 6, 2009

Last Update Submit

February 13, 2012

Conditions

Breast Cancer

Keywords

ComplianceEarly Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Overall adherence to anastrozole

    2/year (after 6 months and after one year)

Secondary Outcomes (3)

  • 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

Study Arms (2)

Group A

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

Drug: Anastrozole

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: AnastrozoleOther: Educational materials

Interventions

AnastrozoleDRUG

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

Group AGroup B
Educational materialsOTHER

Reception of educational material on regular basis.

Group B

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Postmenopausal women with hormone sensitive early breast cancer

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Research Site

Brussels, Belgium

Location

Research Site

Leuven, Belgium

Location

Research Site

Liège, Belgium

Location

Research Site

Overpelt, Belgium

Location

MeSH Terms

Conditions

Breast NeoplasmsPatient Compliance

Interventions

Anastrozole

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Prof. Nogaret

    Jules Bordet Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2009

First Posted

July 10, 2009

Study Start

June 1, 2009

Primary Completion

December 1, 2009

Study Completion

December 1, 2010

Last Updated

February 14, 2012

Record last verified: 2012-02

Locations

BE(4)