Breast CancerCARIATIDENCT00681122
CARIATIDE (Compliance of ARomatase Inhibitors AssessmenT In Daily Practice Through Educational Approach)
An observational study of Breast Cancer, run by AstraZeneca at 164 sites in 18 countries.
Trial summary
This observational study is restricted to postmenopausal women with hormone-sensitive early breast cancer, who have decided to take prescribed adjuvant use of AIs, anastrozole or letrozole, according to the current product SmPCs. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 2,600 participants
- Where
- 164 sitesin 18 countries
- Study dates
- May 2008to May 2011
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Postmenopausal women with hormone sensitive early breast cancer that have been prescribed adjuvant AI medication (aromatase inhibitors; anastrozole or letrozole) according to the current product SmPC. The adjuvant AI medication must not have exceeded thirteen weeks of treatment duration.
Who may be able to join
- Postmenopausal woman with hormone sensitive early breast cancer
- Documented decision of treatment with upfront adjuvant AI (either anastrozole or letrozole) according to current SmPC OR current treatment with AI (either anastrozole or letrozole) according to current SmPC, that has not exceeded thirteen weeks
Who cannot join
- Upfront adjuvant AI medication which has exceeded thirteen weeks at randomisation
- Concomitant adjuvant treatment with tamoxifen or exemestane
- Previous use of adjuvant tamoxifen or exemestane exceeding thirteen weeks
Trial locations and contacts
164 sites in 18 countries.
164 sites in 18 countries
France48 sites
Research Site
Aix-en-Provence
Research Site
Alès, Ales
Research Site
Annecy, Annecy
Research Site
Arpajon, Arpajon
Research Site
Avignon
Research Site
Beauvais, Beauvais
Research Site
Bordeaux, Bordeaux
Research Site
Brest, Brest
Research Site
Brive-la-Gaillarde, Brive La Gaillarde
Research Site
Colmar
Research Site
Créteil
Research Site
Cucq
Research Site
Dechy, Dechy
Research Site
Évreux, Evreux
Research Site
Gap
Research Site
Grenoble, Grenoble
Research Site
Hyères, Hyeres
Research Site
La Seyne-sur-Mer
Research Site
Limoges, Limoges
Research Site
Lyon, Lyon
Research Site
Mareuil-lès-Meaux
Research Site
Marseille, Marseille
Research Site
Mont-de-Marsan, Mont de Marsan
Research Site
Mougins, Mougins
Research Site
Nancy
Research Site
Nantes, Nantes
Research Site
Narbonne
Research Site
Nice, Nice
Research Site
Nîmes, Nimes
Research Site
Périgueux, Perigueux
Research Site
Perpignan, Perpignan
Research Site
Quimper
Research Site
Reims, Reims
Research Site
Rennes, Rennes
Research Site
Rouen, Rouen
Research Site
Saint Brieux, Saint Brieux
Research Site
Saint-Cyr-sur-Loire, Saint Cyr Sur Loire
Research Site
Saint-Grégoire, Saint Gregoire
Research Site
Saint-Jean
Research Site
Saint-Mandé
Research Site
Saint-Nazaire, Saint Nazaire
Research Site
Strasbourg
Research Site
Thonon-les-Bains
Research Site
Toulon, Toulon
Research Site
Toulouse, Toulouse
Research Site
Valence, Valence
Research Site
Vannes
Research Site
Villeneuve-sur-Lot, Villeneuve Sur Lot
Belgium27 sites
Research Site
Aalst
Research Site
Antwerp
Research Site
Arlon
Research Site
Bonheiden
Research Site
Bornem
Research Site
Boussu
Research Site
Brussels
Research Site
Charleroi
Research Site
Dendermonde
Research Site
Edegem
Research Site
Eupen
Research Site
Geel
Research Site
Geraardsbergen
Research Site
Ghent
Research Site
Gilly
Research Site
Haine-Saint-Paul
Research Site
Leuven
Research Site
Libramont
Research Site
Liège
Research Site
Namur
Research Site
Ostend
Research Site
Ottignies
Research Site
Overpelt
Research Site
Rocourt
Research Site
Seraing
Research Site
Tournai
Research Site
Turnhout
United Kingdom18 sites
Research Site
Brighton
Research Site
Bristol
Research Site
Cardiff
Research Site
Cheltenham
Research Site
Coventry
Research Site
Dundee
Research Site
Edinburgh
Research Site
Glasgow
Research Site
Liverpool
Research Site
London
Research Site
Macclesfield
Research Site
Manchester
Research Site
Northwood
Research Site
Nottingham
Research Site
Scarborough
Research Site
Shrewsbury
Research Site
St Albans, Hertfordshire
Research Site
York
Turkey (Türkiye)10 sites
Research Site
Ankara
Research Site
Diyarbakır
Research Site
Eskişehir
Research Site
Gaziantep
Research Site
Istanbul
Research Site
Izmir
Research Site
Kayseri
Research Site
Konya
Research Site
Malatya
Research Site
Mersin
Australia9 sites
Research Site
Brisbane, Queensland
Research Site
Canberra, Australian Capital Territory
Research Site
Coffs Harbour, New South Wales
Research Site
Hobart, Tasmania
Research Site
Nambour, Queensland
Research Site
Newcastle, New South Wales
Research Site
Port Macquarie, New South Wales
Research Site
Toowoomba, Queensland
Research Site
Tweed Heads, New South Wales
Austria6 sites
Research Site
Linz, Upper Austria
Research Site
Salzburg, State of Salzburg
Research Site
Sankt Veit im Jauntal, Carinthia
Research Site
Vienna, State of Vienna
Research Site
Weiz, Styria
Research Site
Wolfsberg, Carinthia
Colombia6 sites
Research Site
Barranquilla, Atlántico
Research Site
Bogota, Cundinamarca
Research Site
Cali, Valle del Cauca Department
Research Site
Medellín, Antioquia
Research Site
Neiva, Huila Department
Research Site
Pasto, Nari?o
Italy6 sites
Research Site
Bologna, Bologna
Research Site
Cosenza, Cosenza
Research Site
Lido di Camaiore, Lucca
Research Site
Pavia, Pavia
Research Site
Roma, Roma
Research Site
Treviso, Treviso
Romania6 sites
Research Site
Alba Iulia
Research Site
Baia Mare
Research Site
Bucharest
Research Site
Cluj-Napoca
Research Site
Oradea
Research Site
Suceava
Greece5 sites
Research Site
Athens, Athens
Research Site
Pátrai, Achaia
Research Site
Piraeous, Piraeous
Research Site
Thessaloniki, Thessaloniki
Research Site
Trikala, Trikala
Switzerland5 sites
Research Site
Baden
Research Site
Bern
Research Site
Lugano
Research Site
Sankt Gallen
Research Site
Zurich
Czechia4 sites
Research Site
Hradec Králové
Research Site
Opava
Research Site
Ostrava
Research Site
Prague
Sweden3 sites
Research Site
Karlskrona, Karlskrona
Research Site
Skellefte?, Skellefte?
Research Site
Stockholm, Stockholm County
Chile2 sites
Research Site
Santiago, Santiago Metropolitan
Research Site
Temuco, Araucania
Venezuela2 sites
Research Site
Caracas, Distrito Federal
Research Site
Valencia, Carabobo
About this study
Official title: An International, Observational Study to Evaluate the Impact of Educational Material on the Compliance and Persistence Rates to Adjuvant Aromatase Inhibitor (AI) Medication for Postmenopausal Woman
This observational study is restricted to postmenopausal women with hormone-sensitive early breast cancer, who have decided to take prescribed adjuvant use of AIs, anastrozole or letrozole, according to the current product SmPCs. There is no Investigational Medicinal Product (IMP) to be taken in this observational study. The adjuvant AI medication must not have exceeded thirteen weeks. In CARIATIDE (Compliance of ARomatase Inhibitors AssessmenT In Daily practicE through Educational approach), impact of educational material on women's compliance and persistence rates will be evaluated.
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, hormone therapy, aromatase inhibitor
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Standard therapy | |
| 2 | Standard therapy + educational material |
What is being measured
The primary outcome is the main question the study is designed to answer.
The compliance rate for the adjuvant AI medication will be analysed at one year based on the subject's assessment.
Measured: once after one year
Secondary outcomes (3)
Persistence rate will be evaluated for the first time after one year and a second time after two years. The Investigator will ask the subject about her persistence as follows:
Measured: After one and two years.
Time to treatment discontinuation is defined as number of days between the date of first and last intake of AI medication. Dates for AI treatment start and discontinuation will be documented in the CRF.
Measured: After one and two years
Reasons for discontinuation of AI: recurrence, death, physician's recommendation, interactions with other medication, side effects, treatment with other hormone medication than anastrozole or letrozole, unfilled AI prescription, subject's wish, other.
Measured: After one and two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2008 (estimated)
- Study startMay 2008
- Primary completionMay 2011
- Study completionMay 2011
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
- 2,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Neven, P. Prof., Principal investigator, KUL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00681122
- Sponsor's protocol ID
- NIS-OEU-ARI-2007/1
- Acronym
- CARIATIDE
- Status last verified
- Oct 2011
- First submitted
- 20 May 2008
- Last updated
- 18 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An International, Observational Study to Evaluate the Impact of Educational Material on the Compliance and Persistence Rates to Adjuvant Aromatase Inhibitor (AI) Medication for Postmenopausal Woman
- ClinicalTrials.gov ID
- NCT00681122
- Acronym / sponsor ID
- CARIATIDE / NIS-OEU-ARI-2007/1
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, hormone therapy, aromatase inhibitor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,600 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 21 May 2008 (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.
This observational study is restricted to postmenopausal women with hormone-sensitive early breast cancer, who have decided to take prescribed adjuvant use of AIs, anastrozole or letrozole, according to the current product SmPCs. There is no Investigational Medicinal Product (IMP) to be taken in this observational study. The adjuvant AI medication must not have exceeded thirteen weeks. In CARIATIDE (Compliance of ARomatase Inhibitors AssessmenT In Daily practicE through Educational approach), impact of educational material on women's compliance and persistence rates will be evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Standard therapy |
| 2 | – | –Standard therapy + educational material |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Postmenopausal women with hormone sensitive early breast cancer that have been prescribed adjuvant AI medication (aromatase inhibitors; anastrozole or letrozole) according to the current product SmPC. The adjuvant AI medication must not have exceeded thirteen weeks of treatment duration.
Key inclusion criteria (2 listed)
- Postmenopausal woman with hormone sensitive early breast cancer
- Documented decision of treatment with upfront adjuvant AI (either anastrozole or letrozole) according to current SmPC OR current treatment with AI (either anastrozole or letrozole) according to current SmPC, that has not exceeded thirteen weeks
Key exclusion criteria (3 listed)
- Upfront adjuvant AI medication which has exceeded thirteen weeks at randomisation
- Concomitant adjuvant treatment with tamoxifen or exemestane
- Previous use of adjuvant tamoxifen or exemestane exceeding thirteen weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The compliance rate for the adjuvant AI medication will be analysed at one year based on the subject's assessment.
Time frame: once after one year
3 secondary outcomes
Persistence rate will be evaluated for the first time after one year and a second time after two years. The Investigator will ask the subject about her persistence as follows:
Time frame: After one and two years.
Time to treatment discontinuation is defined as number of days between the date of first and last intake of AI medication. Dates for AI treatment start and discontinuation will be documented in the CRF.
Time frame: After one and two years
Reasons for discontinuation of AI: recurrence, death, physician's recommendation, interactions with other medication, side effects, treatment with other hormone medication than anastrozole or letrozole, unfilled AI prescription, subject's wish, other.
Time frame: After one and two years
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 18 Jan 2016.
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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.
Neven, P. Prof. principal investigator
KUL
164 sites in 18 countries: 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 164 sites in 18 countries.
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 2 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 18 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 164 sites in France, Belgium, United Kingdom, Turkey (Türkiye), Australia and 13 more countries. 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?
The compliance rate for the adjuvant AI medication will be analysed at one year based on the subject's assessment. (time frame: once 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 18 Jan 2016.