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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
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Carinthia
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Austria
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Styria
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Austria
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Upper Austria
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Austria
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Salzburg
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Austria
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Vienna
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Belgium
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Aalst
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Belgium
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Estado Carabobo

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

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT00681122
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00681122