Trial Review

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00681122




Registration number
NCT00681122
Ethics application status
Date submitted
20/05/2008
Date registered
21/05/2008
Date last updated
18/01/2016

Titles & IDs
Public title
CARIATIDE (Compliance of ARomatase Inhibitors AssessmenT In Daily Practice Through Educational Approach)
Scientific 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
Secondary ID [1] 0 0
NIS-OEU-ARI-2007/1
Universal Trial Number (UTN)
Trial acronym
CARIATIDE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
1 - Standard therapy

2 - Standard therapy + educational material
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The compliance rate for the adjuvant AI medication will be analysed at one year based on the subject's assessment.
Timepoint [1] 0 0
once after one year
Secondary outcome [1] 0 0
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:
Timepoint [1] 0 0
After one and two years.
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
After one and two years
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
After one and two years

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2011
Sample size
Target
2600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,TAS
Recruitment hospital [1] 0 0
Research Site - Canberra
Recruitment hospital [2] 0 0
Research Site - Coffs Harbour
Recruitment hospital [3] 0 0
Research Site - Newcastle
Recruitment hospital [4] 0 0
Research Site - Port Macquarie
Recruitment hospital [5] 0 0
Research Site - Tweed Heads
Recruitment hospital [6] 0 0
Research Site - Brisbane
Recruitment hospital [7] 0 0
Research Site - Nambour
Recruitment hospital [8] 0 0
Research Site - Toowoomba
Recruitment hospital [9] 0 0
Research Site - Hobart
Recruitment postcode(s) [1] 0 0
- Canberra
Recruitment postcode(s) [2] 0 0
- Coffs Harbour
Recruitment postcode(s) [3] 0 0
- Newcastle
Recruitment postcode(s) [4] 0 0
- Port Macquarie
Recruitment postcode(s) [5] 0 0
- Tweed Heads
Recruitment postcode(s) [6] 0 0
- Brisbane
Recruitment postcode(s) [7] 0 0
- Nambour
Recruitment postcode(s) [8] 0 0
- Toowoomba
Recruitment postcode(s) [9] 0 0
- Hobart
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Carinthia
Country [2] 0 0
Austria
State/province [2] 0 0
Styria
Country [3] 0 0
Austria
State/province [3] 0 0
Upper Austria
Country [4] 0 0
Austria
State/province [4] 0 0
Salzburg
Country [5] 0 0
Austria
State/province [5] 0 0
Vienna
Country [6] 0 0
Belgium
State/province [6] 0 0
Aalst
Country [7] 0 0
Belgium
State/province [7] 0 0
Antwerpen
Country [8] 0 0
Belgium
State/province [8] 0 0
Arlon
Country [9] 0 0
Belgium
State/province [9] 0 0
Bonheiden
Country [10] 0 0
Belgium
State/province [10] 0 0
Bornem
Country [11] 0 0
Belgium
State/province [11] 0 0
Boussu
Country [12] 0 0
Belgium
State/province [12] 0 0
Brussels
Country [13] 0 0
Belgium
State/province [13] 0 0
Charleroi
Country [14] 0 0
Belgium
State/province [14] 0 0
Dendermonde
Country [15] 0 0
Belgium
State/province [15] 0 0
Edegem
Country [16] 0 0
Belgium
State/province [16] 0 0
Eupen
Country [17] 0 0
Belgium
State/province [17] 0 0
Geel
Country [18] 0 0
Belgium
State/province [18] 0 0
Gent
Country [19] 0 0
Belgium
State/province [19] 0 0
Geraardsbergen
Country [20] 0 0
Belgium
State/province [20] 0 0
Gilly
Country [21] 0 0
Belgium
State/province [21] 0 0
Haine St Paul
Country [22] 0 0
Belgium
State/province [22] 0 0
Leuven
Country [23] 0 0
Belgium
State/province [23] 0 0
Li?ge
Country [24] 0 0
Belgium
State/province [24] 0 0
Libramont
Country [25] 0 0
Belgium
State/province [25] 0 0
Namur
Country [26] 0 0
Belgium
State/province [26] 0 0
Oostende
Country [27] 0 0
Belgium
State/province [27] 0 0
Ottignies
Country [28] 0 0
Belgium
State/province [28] 0 0
Overpelt
Country [29] 0 0
Belgium
State/province [29] 0 0
Rocourt
Country [30] 0 0
Belgium
State/province [30] 0 0
Seraing
Country [31] 0 0
Belgium
State/province [31] 0 0
Tournai
Country [32] 0 0
Belgium
State/province [32] 0 0
Turnhout
Country [33] 0 0
Chile
State/province [33] 0 0
Metropolitana
Country [34] 0 0
Chile
State/province [34] 0 0
Novena Region
Country [35] 0 0
Colombia
State/province [35] 0 0
Antioquia
Country [36] 0 0
Colombia
State/province [36] 0 0
Atlantico
Country [37] 0 0
Colombia
State/province [37] 0 0
Cundinamarca
Country [38] 0 0
Colombia
State/province [38] 0 0
Huila
Country [39] 0 0
Colombia
State/province [39] 0 0
Nari?o
Country [40] 0 0
Colombia
State/province [40] 0 0
Valle
Country [41] 0 0
Croatia
State/province [41] 0 0
Osijek
Country [42] 0 0
Croatia
State/province [42] 0 0
Rijeka
Country [43] 0 0
Croatia
State/province [43] 0 0
Zagreb
Country [44] 0 0
Czech Republic
State/province [44] 0 0
Hradec Kralove
Country [45] 0 0
Czech Republic
State/province [45] 0 0
Opava
Country [46] 0 0
Czech Republic
State/province [46] 0 0
Ostrava
Country [47] 0 0
Czech Republic
State/province [47] 0 0
Praha
Country [48] 0 0
Finland
State/province [48] 0 0
Helsinki
Country [49] 0 0
Finland
State/province [49] 0 0
Tampere
Country [50] 0 0
France
State/province [50] 0 0
Aix En Provence
Country [51] 0 0
France
State/province [51] 0 0
Ales
Country [52] 0 0
France
State/province [52] 0 0
Annecy
Country [53] 0 0
France
State/province [53] 0 0
Arpajon
Country [54] 0 0
France
State/province [54] 0 0
Avignon
Country [55] 0 0
France
State/province [55] 0 0
Beauvais
Country [56] 0 0
France
State/province [56] 0 0
Bordeaux
Country [57] 0 0
France
State/province [57] 0 0
Brest
Country [58] 0 0
France
State/province [58] 0 0
Brive La Gaillarde
Country [59] 0 0
France
State/province [59] 0 0
Colmar
Country [60] 0 0
France
State/province [60] 0 0
Creteil
Country [61] 0 0
France
State/province [61] 0 0
Cucq
Country [62] 0 0
France
State/province [62] 0 0
Dechy
Country [63] 0 0
France
State/province [63] 0 0
Evreux
Country [64] 0 0
France
State/province [64] 0 0
GAP
Country [65] 0 0
France
State/province [65] 0 0
Grenoble
Country [66] 0 0
France
State/province [66] 0 0
Hyeres
Country [67] 0 0
France
State/province [67] 0 0
La Seyne Sur Mer
Country [68] 0 0
France
State/province [68] 0 0
Limoges
Country [69] 0 0
France
State/province [69] 0 0
Lyon
Country [70] 0 0
France
State/province [70] 0 0
Mareuil Les Meaux
Country [71] 0 0
France
State/province [71] 0 0
Marseille
Country [72] 0 0
France
State/province [72] 0 0
Mont de Marsan
Country [73] 0 0
France
State/province [73] 0 0
Mougins
Country [74] 0 0
France
State/province [74] 0 0
Nancy
Country [75] 0 0
France
State/province [75] 0 0
Nantes
Country [76] 0 0
France
State/province [76] 0 0
Narbonne
Country [77] 0 0
France
State/province [77] 0 0
Nice
Country [78] 0 0
France
State/province [78] 0 0
Nimes
Country [79] 0 0
France
State/province [79] 0 0
Perigueux
Country [80] 0 0
France
State/province [80] 0 0
Perpignan
Country [81] 0 0
France
State/province [81] 0 0
Quimper
Country [82] 0 0
France
State/province [82] 0 0
Reims
Country [83] 0 0
France
State/province [83] 0 0
Rennes
Country [84] 0 0
France
State/province [84] 0 0
Rouen
Country [85] 0 0
France
State/province [85] 0 0
Saint Brieux
Country [86] 0 0
France
State/province [86] 0 0
Saint Cyr Sur Loire
Country [87] 0 0
France
State/province [87] 0 0
Saint Gregoire
Country [88] 0 0
France
State/province [88] 0 0
Saint Jean
Country [89] 0 0
France
State/province [89] 0 0
Saint Mande
Country [90] 0 0
France
State/province [90] 0 0
Saint Nazaire
Country [91] 0 0
France
State/province [91] 0 0
Strasbourg
Country [92] 0 0
France
State/province [92] 0 0
Thonon Les Bains
Country [93] 0 0
France
State/province [93] 0 0
Toulon
Country [94] 0 0
France
State/province [94] 0 0
Toulouse
Country [95] 0 0
France
State/province [95] 0 0
Valence
Country [96] 0 0
France
State/province [96] 0 0
Vannes
Country [97] 0 0
France
State/province [97] 0 0
Villeneuve Sur Lot
Country [98] 0 0
Greece
State/province [98] 0 0
Achaia
Country [99] 0 0
Greece
State/province [99] 0 0
Athens
Country [100] 0 0
Greece
State/province [100] 0 0
Piraeous
Country [101] 0 0
Greece
State/province [101] 0 0
Thessaloniki
Country [102] 0 0
Greece
State/province [102] 0 0
Trikala
Country [103] 0 0
Italy
State/province [103] 0 0
Lucca
Country [104] 0 0
Italy
State/province [104] 0 0
Bologna
Country [105] 0 0
Italy
State/province [105] 0 0
Cosenza
Country [106] 0 0
Italy
State/province [106] 0 0
Pavia
Country [107] 0 0
Italy
State/province [107] 0 0
Roma
Country [108] 0 0
Italy
State/province [108] 0 0
Treviso
Country [109] 0 0
Peru
State/province [109] 0 0
Lima
Country [110] 0 0
Peru
State/province [110] 0 0
Piura
Country [111] 0 0
Romania
State/province [111] 0 0
Alba-Iulia
Country [112] 0 0
Romania
State/province [112] 0 0
Baia Mare
Country [113] 0 0
Romania
State/province [113] 0 0
Bucuresti
Country [114] 0 0
Romania
State/province [114] 0 0
Cluj-Napoca
Country [115] 0 0
Romania
State/province [115] 0 0
Oradea
Country [116] 0 0
Romania
State/province [116] 0 0
Suceava
Country [117] 0 0
Sweden
State/province [117] 0 0
Karlskrona
Country [118] 0 0
Sweden
State/province [118] 0 0
Skellefte?
Country [119] 0 0
Sweden
State/province [119] 0 0
Stockholm
Country [120] 0 0
Switzerland
State/province [120] 0 0
Baden
Country [121] 0 0
Switzerland
State/province [121] 0 0
Bern
Country [122] 0 0
Switzerland
State/province [122] 0 0
Lugano
Country [123] 0 0
Switzerland
State/province [123] 0 0
St. Gallen
Country [124] 0 0
Switzerland
State/province [124] 0 0
Zurich
Country [125] 0 0
Turkey
State/province [125] 0 0
Ankara
Country [126] 0 0
Turkey
State/province [126] 0 0
Diyarbakir
Country [127] 0 0
Turkey
State/province [127] 0 0
Eskisehir
Country [128] 0 0
Turkey
State/province [128] 0 0
Gaziantep
Country [129] 0 0
Turkey
State/province [129] 0 0
Istanbul
Country [130] 0 0
Turkey
State/province [130] 0 0
Izmir
Country [131] 0 0
Turkey
State/province [131] 0 0
Kayseri
Country [132] 0 0
Turkey
State/province [132] 0 0
Konya
Country [133] 0 0
Turkey
State/province [133] 0 0
Malatya
Country [134] 0 0
Turkey
State/province [134] 0 0
Mersin
Country [135] 0 0
United Kingdom
State/province [135] 0 0
Hertfordshire
Country [136] 0 0
United Kingdom
State/province [136] 0 0
Brighton
Country [137] 0 0
United Kingdom
State/province [137] 0 0
Bristol
Country [138] 0 0
United Kingdom
State/province [138] 0 0
Cardiff
Country [139] 0 0
United Kingdom
State/province [139] 0 0
Cheltenham
Country [140] 0 0
United Kingdom
State/province [140] 0 0
Coventry
Country [141] 0 0
United Kingdom
State/province [141] 0 0
Dundee
Country [142] 0 0
United Kingdom
State/province [142] 0 0
Edinburgh
Country [143] 0 0
United Kingdom
State/province [143] 0 0
Glasgow
Country [144] 0 0
United Kingdom
State/province [144] 0 0
Liverpool
Country [145] 0 0
United Kingdom
State/province [145] 0 0
London
Country [146] 0 0
United Kingdom
State/province [146] 0 0
Macclesfield
Country [147] 0 0
United Kingdom
State/province [147] 0 0
Manchester
Country [148] 0 0
United Kingdom
State/province [148] 0 0
Northwood
Country [149] 0 0
United Kingdom
State/province [149] 0 0
Nottingham
Country [150] 0 0
United Kingdom
State/province [150] 0 0
Scarborough
Country [151] 0 0
United Kingdom
State/province [151] 0 0
Shrewsbury
Country [152] 0 0
United Kingdom
State/province [152] 0 0
York
Country [153] 0 0
Venezuela
State/province [153] 0 0
Distrito Capital
Country [154] 0 0
Venezuela
State/province [154] 0 0
Estado Carabobo

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Neven, P. Prof.
Address 0 0
KUL
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00681122