Breast CancerARTEMISNCT00936442
Arimidex Therapy Compliance Electronic Monitoring System
An observational study of Breast Cancer, run by AstraZeneca at 4 sites in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Anastrozole and Educational materials
- How many people
- 104 participants
- Where
- 4 sitesBelgium
- Study dates
- Jun 2009to Dec 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Postmenopausal women with hormone sensitive early breast cancer
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
Belgium4 sites
Research Site
Brussels
Research Site
Leuven
Research Site
Liège
Research Site
Overpelt
About this study
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
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.
- Conditions
- Breast Cancer
- Being tested
- Anastrozole, Educational materials
- Keywords
- Compliance, Early Breast Cancer
- Medical subject headings
- Breast Neoplasms, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnastrozoleDrug
(Standard Treatment) 12-month follow-up of anastrozole treatment according to SmPC and current clinical practice.
Educational materialsOther
Reception of educational material on regular basis.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Standard treatment: 12-month follow-up of anastrozole treatment according to SmPC and current clinical practice. Receives: 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. Receives: Drug: Anastrozole; Other: Educational materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall adherence to anastrozole
Measured: 2/year (after 6 months and after one year)
Secondary outcomes (3)
Patients' persistence with anastrozole
Measured: 2/year (after 6 months and after one year)
Execution of the dosing regimen
Measured: 2/year (after 6 months and after one year)
Reasons for treatment discontinuation
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2009 (estimated)
- Study startJun 2009
- Primary completionDec 2009
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Aardex Pharmionic
- Responsible party
- Sponsor
- Investigators
- Prof. Nogaret, Principal investigator, Jules Bordet Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00936442
- Sponsor's protocol ID
- D5390L00076
- Acronym
- ARTEMIS
- Status last verified
- Feb 2012
- First submitted
- 6 Jul 2009
- Last updated
- 14 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00936442
- Acronym / sponsor ID
- ARTEMIS / D5390L00076
- Conditions
- Breast Cancer
- Keywords
- Compliance, Early Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Aardex Pharmionic
- Study start
- Jun 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 10 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Drug: AnastrozoleStandard treatment: 12-month follow-up of anastrozole treatment according to SmPC and current clinical practice. |
| Group B | – | Drug: Anastrozole, Other: Educational materialsStandard 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Postmenopausal women with hormone sensitive early breast cancer
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anastrozole(Standard Treatment) 12-month follow-up of anastrozole treatment according to SmPC and current clinical practice. | Drug | Group A, Group B |
| Educational materialsReception of educational material on regular basis. | Other | Group B |
Primary outcome
Overall adherence to anastrozole
Time frame: 2/year (after 6 months and after one year)
3 secondary outcomes
Patients' persistence with anastrozole
Time frame: 2/year (after 6 months and after one year)
Execution of the dosing regimen
Time frame: 2/year (after 6 months and after one year)
Reasons for treatment discontinuation
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof. Nogaret principal investigator
Jules Bordet Institute
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by AstraZeneca at 4 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall adherence to anastrozole (time frame: 2/year (after 6 months and after one year)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2012.