Clinical trial NCT00681122: CARIATIDE (Compliance of ARomatase Inhibitors AssessmenT In Daily Practice Through Educational Approach)
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Breast Cancer
hormone therapy
aromatase inhibitor
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-05-21
Enrollment: 2600
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: The compliance rate for the adjuvant AI medication will be analysed at one year based on the subject's assessment.
timeFrame: once after one year
Secondary outcomes:
measure: 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:
timeFrame: After one and two years.
measure: 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.
timeFrame: After one and two years
measure: 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.
timeFrame: After one and two years
Other outcomes:
Locations:
city: Canberra
country: Australia
facility: Research Site
state: Australian Capital Territory
city: Coffs Harbour
country: Australia
facility: Research Site
state: New South Wales
city: Newcastle
country: Australia
facility: Research Site
state: New South Wales
city: Port Macquarie
country: Australia
facility: Research Site
state: New South Wales
city: Tweed Heads
country: Australia
facility: Research Site
state: New South Wales
city: Brisbane
country: Australia
facility: Research Site
state: Queensland
city: Nambour
country: Australia
facility: Research Site
state: Queensland
city: Toowoomba
country: Australia
facility: Research Site
state: Queensland
city: Hobart
country: Australia
facility: Research Site
state: Tasmania
city: St. Veit
country: Austria
facility: Research Site
state: Carinthia
city: Wolfsberg
country: Austria
facility: Research Site
state: Carinthia
city: Weiz
country: Austria
facility: Research Site
state: Styria
city: Linz
country: Austria
facility: Research Site
state: Upper Austria
city: Salzburg
country: Austria
facility: Research Site
city: Vienna
country: Austria
facility: Research Site
city: Aalst
country: Belgium
facility: Research Site
city: Antwerpen
country: Belgium
facility: Research Site
city: Arlon
country: Belgium
facility: Research Site
city: Bonheiden
country: Belgium
facility: Research Site
city: Bornem
country: Belgium
facility: Research Site
city: Boussu
country: Belgium
facility: Research Site
city: Brussels
country: Belgium
facility: Research Site
city: Charleroi
country: Belgium
facility: Research Site
city: Dendermonde
country: Belgium
facility: Research Site
city: Edegem
country: Belgium
facility: Research Site
city: Eupen
country: Belgium
facility: Research Site
city: Geel
country: Belgium
facility: Research Site
city: Gent
country: Belgium
facility: Research Site
city: Geraardsbergen
country: Belgium
facility: Research Site
city: Gilly
country: Belgium
facility: Research Site
city: Haine St Paul
country: Belgium
facility: Research Site
city: Leuven
country: Belgium
facility: Research Site
city: Li?ge
country: Belgium
facility: Research Site
city: Libramont
country: Belgium
facility: Research Site
city: Namur
country: Belgium
facility: Research Site
city: Oostende
country: Belgium
facility: Research Site
city: Ottignies
country: Belgium
facility: Research Site
city: Overpelt
country: Belgium
facility: Research Site
city: Rocourt
country: Belgium
facility: Research Site
city: Seraing
country: Belgium
facility: Research Site
city: Tournai
country: Belgium
facility: Research Site
city: Turnhout
country: Belgium
facility: Research Site
city: Santiago
country: Chile
facility: Research Site
state: Metropolitana
city: Temuco
country: Chile
facility: Research Site
state: Novena Region
city: Medellin
country: Colombia
facility: Research Site
state: Antioquia
city: Barranquilla
country: Colombia
facility: Research Site
state: Atlantico
city: Bogota
country: Colombia
facility: Research Site
state: Cundinamarca
city: Neiva
country: Colombia
facility: Research Site
state: Huila
city: Pasto
country: Colombia
facility: Research Site
state: Nari?o
city: Cali
country: Colombia
facility: Research Site
state: Valle
city: Osijek
country: Croatia
facility: Research Site
city: Rijeka
country: Croatia
facility: Research Site
city: Zagreb
country: Croatia
facility: Research Site
city: Hradec Kralove
country: Czech Republic
facility: Research Site
city: Opava
country: Czech Republic
facility: Research Site
city: Ostrava
country: Czech Republic
facility: Research Site
city: Praha
country: Czech Republic
facility: Research Site
city: Helsinki
country: Finland
facility: Research Site
city: Tampere
country: Finland
facility: Research Site
city: Aix En Provence
country: France
facility: Research Site
city: Ales
country: France
facility: Research Site
city: Annecy
country: France
facility: Research Site
city: Arpajon
country: France
facility: Research Site
city: Avignon
country: France
facility: Research Site
city: Beauvais
country: France
facility: Research Site
city: Bordeaux
country: France
facility: Research Site
city: Brest
country: France
facility: Research Site
city: Brive La Gaillarde
country: France
facility: Research Site
city: Colmar
country: France
facility: Research Site
city: Creteil
country: France
facility: Research Site
city: Cucq
country: France
facility: Research Site
city: Dechy
country: France
facility: Research Site
city: Evreux
country: France
facility: Research Site
city: GAP
country: France
facility: Research Site
city: Grenoble
country: France
facility: Research Site
city: Hyeres
country: France
facility: Research Site
city: La Seyne Sur Mer
country: France
facility: Research Site
city: Limoges
country: France
facility: Research Site
city: Lyon
country: France
facility: Research Site
city: Mareuil Les Meaux
country: France
facility: Research Site
city: Marseille
country: France
facility: Research Site
city: Mont de Marsan
country: France
facility: Research Site
city: Mougins
country: France
facility: Research Site
city: Nancy
country: France
facility: Research Site
city: Nantes
country: France
facility: Research Site
city: Narbonne
country: France
facility: Research Site
city: Nice
country: France
facility: Research Site
city: Nimes
country: France
facility: Research Site
city: Perigueux
country: France
facility: Research Site
city: Perpignan
country: France
facility: Research Site
city: Quimper
country: France
facility: Research Site
city: Reims
country: France
facility: Research Site
city: Rennes
country: France
facility: Research Site
city: Rouen
country: France
facility: Research Site
city: Saint Brieux
country: France
facility: Research Site
city: Saint Cyr Sur Loire
country: France
facility: Research Site
city: Saint Gregoire
country: France
facility: Research Site
city: Saint Jean
country: France
facility: Research Site
city: Saint Mande
country: France
facility: Research Site
city: Saint Nazaire
country: France
facility: Research Site
city: Strasbourg
country: France
facility: Research Site
city: Thonon Les Bains
country: France
facility: Research Site
city: Toulon
country: France
facility: Research Site
city: Toulouse
country: France
facility: Research Site
city: Valence
country: France
facility: Research Site
city: Vannes
country: France
facility: Research Site
city: Villeneuve Sur Lot
country: France
facility: Research Site
city: Patras
country: Greece
facility: Research Site
state: Achaia
city: Athens
country: Greece
facility: Research Site
city: Piraeous
country: Greece
facility: Research Site
city: Thessaloniki
country: Greece
facility: Research Site
city: Trikala
country: Greece
facility: Research Site
city: Lido di Camaiore
country: Italy
facility: Research Site
state: Lucca
city: Bologna
country: Italy
facility: Research Site
city: Cosenza
country: Italy
facility: Research Site
city: Pavia
country: Italy
facility: Research Site
city: Roma
country: Italy
facility: Research Site
city: Treviso
country: Italy
facility: Research Site
city: Lima
country: Peru
facility: Research Site
city: Piura
country: Peru
facility: Research Site
city: Alba-Iulia
country: Romania
facility: Research Site
city: Baia Mare
country: Romania
facility: Research Site
city: Bucuresti
country: Romania
facility: Research Site
city: Cluj-Napoca
country: Romania
facility: Research Site
city: Oradea
country: Romania
facility: Research Site
city: Suceava
country: Romania
facility: Research Site
city: Karlskrona
country: Sweden
facility: Research Site
city: Skellefte?
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
city: Baden
country: Switzerland
facility: Research Site
city: Bern
country: Switzerland
facility: Research Site
city: Lugano
country: Switzerland
facility: Research Site
city: St. Gallen
country: Switzerland
facility: Research Site
city: Zurich
country: Switzerland
facility: Research Site
city: Ankara
country: Turkey
facility: Research Site
city: Diyarbakir
country: Turkey
facility: Research Site
city: Eskisehir
country: Turkey
facility: Research Site
city: Gaziantep
country: Turkey
facility: Research Site
city: Istanbul
country: Turkey
facility: Research Site
city: Izmir
country: Turkey
facility: Research Site
city: Kayseri
country: Turkey
facility: Research Site
city: Konya
country: Turkey
facility: Research Site
city: Malatya
country: Turkey
facility: Research Site
city: Mersin
country: Turkey
facility: Research Site
city: St Albans
country: United Kingdom
facility: Research Site
state: Hertfordshire
city: Brighton
country: United Kingdom
facility: Research Site
city: Bristol
country: United Kingdom
facility: Research Site
city: Cardiff
country: United Kingdom
facility: Research Site
city: Cheltenham
country: United Kingdom
facility: Research Site
city: Coventry
country: United Kingdom
facility: Research Site
city: Dundee
country: United Kingdom
facility: Research Site
city: Edinburgh
country: United Kingdom
facility: Research Site
city: Glasgow
country: United Kingdom
facility: Research Site
city: Liverpool
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: Macclesfield
country: United Kingdom
facility: Research Site
city: Manchester
country: United Kingdom
facility: Research Site
city: Northwood
country: United Kingdom
facility: Research Site
city: Nottingham
country: United Kingdom
facility: Research Site
city: Scarborough
country: United Kingdom
facility: Research Site
city: Shrewsbury
country: United Kingdom
facility: Research Site
city: York
country: United Kingdom
facility: Research Site
city: Caracas
country: Venezuela
facility: Research Site
state: Distrito Capital
city: Valencia
country: Venezuela
facility: Research Site
state: Estado Carabobo
Study officials:
affiliation: KUL
name: Neven, P. Prof.
role: PRINCIPAL_INVESTIGATOR
References: