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| Name | Class |
|---|---|
| Aardex Pharmionic | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anastrozole | Drug | (Standard Treatment) 12-month follow-up of anastrozole treatment according to SmPC and current clinical practice. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall adherence to anastrozole | 2/year (after 6 months and after one year) |
| Measure | Description | 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) | |
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Inclusion Criteria:
Exclusion Criteria:
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Postmenopausal women with hormone sensitive early breast cancer
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| Name | Affiliation | Role |
|---|---|---|
| Prof. Nogaret | Jules Bordet Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Brussels | Belgium | ||||
| Research Site |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D010349 | Patient Compliance |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000077384 | Anastrozole |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 |
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| Educational materials | Other | Reception of educational material on regular basis. |
|
| Reasons for treatment discontinuation |
| 1 year |
| Leuven |
| Belgium |
| Research Site | Liège | Belgium |
| Research Site | Overpelt | Belgium |
| D017437 |
| Skin and Connective Tissue Diseases |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |