Clinical trial · Observational
CARIATIDE (Compliance of ARomatase Inhibitors AssessmenT In Daily Practice Through Educational Approach)
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- 1
- description
- Standard therapy
- label
- 2
- description
- Standard therapy + educational material
Primary outcomes (1)
- measure
- The compliance rate for the adjuvant AI medication will be analysed at one year based on the subject's assessment.
- timeFrame
- once after one year
Secondary outcomes (3)
- measure
- 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:
- timeFrame
- After one and two years.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available