CARIATIDE (Compliance of ARomatase Inhibitors AssessmenT In Daily Practice Through Educational Approach)

Completed

• Conditions: Breast Cancer

• Registration Number: NCT00681122
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-05-20
• Study First Submitted QC: 2008-05-20
• Study First Posted: 2008-05-21
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Status Verified: 2011-10
• Last Update Submitted: 2016-01-15
• Last Update Posted: 2016-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 2600

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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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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The compliance rate for the adjuvant AI medication will be analysed at one year based on the subject's assessment.	once after one year

Secondary Outcome Measures

Name	Time	Method
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.	After one and two years
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:	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.	After one and two years

Trial Locations

Locations (1)

Research Site; 🇻🇪 Valencia, Estado Carabobo, Venezuela