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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Breast Cancer

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Standard therapy | |
| 2<br>Standard therapy + educational material | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, hormone therapy, aromatase inhibitor