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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
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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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)
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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
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Secondary ID [1]
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0
NIS-OEU-ARI-2007/1
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Universal Trial Number (UTN)
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Trial acronym
CARIATIDE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Breast Cancer
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0
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Condition category
Condition code
Cancer
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0
0
0
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Breast
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
1 - Standard therapy
2 - Standard therapy + educational material
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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0
The compliance rate for the adjuvant AI medication will be analysed at one year based on the subject's assessment.
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Assessment method [1]
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0
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Timepoint [1]
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once after one year
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Secondary outcome [1]
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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:
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Assessment method [1]
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0
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Timepoint [1]
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After one and two years.
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Secondary outcome [2]
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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.
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Assessment method [2]
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0
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Timepoint [2]
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After one and two years
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Secondary outcome [3]
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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.
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Assessment method [3]
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0
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Timepoint [3]
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After one and two years
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/05/2008
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/05/2011
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Sample size
Target
2600
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,TAS
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Recruitment hospital [1]
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Research Site - Canberra
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Recruitment hospital [2]
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Research Site - Coffs Harbour
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Research Site - Newcastle
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Research Site - Hobart
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Recruitment postcode(s) [1]
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- Canberra
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Recruitment postcode(s) [2]
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- Coffs Harbour
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- Newcastle
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- Port Macquarie
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- Tweed Heads
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- Brisbane
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Recruitment postcode(s) [7]
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- Nambour
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- Toowoomba
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Recruitment postcode(s) [9]
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- Hobart
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Recruitment outside Australia
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Austria
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Carinthia
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Austria
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Styria
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Austria
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Glasgow
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Country [144]
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United Kingdom
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Liverpool
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Country [145]
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United Kingdom
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London
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Country [146]
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United Kingdom
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Macclesfield
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Country [147]
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United Kingdom
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Manchester
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Country [148]
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United Kingdom
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State/province [148]
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Northwood
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Country [149]
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United Kingdom
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State/province [149]
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Nottingham
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Country [150]
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United Kingdom
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State/province [150]
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Scarborough
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Country [151]
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United Kingdom
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State/province [151]
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Shrewsbury
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Country [152]
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United Kingdom
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State/province [152]
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York
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Country [153]
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Venezuela
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State/province [153]
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Distrito Capital
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Country [154]
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Venezuela
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Estado Carabobo
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
AstraZeneca
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Address
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Ethics approval
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00681122
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Neven, P. Prof.
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Address
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KUL
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00681122
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