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

This study has been completed.
Information provided by (Responsible Party):
AstraZeneca Identifier:
First received: May 20, 2008
Last updated: January 15, 2016
Last verified: October 2011
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.

Breast Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official 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

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • The compliance rate for the adjuvant AI medication will be analysed at one year based on the subject's assessment. [ Time Frame: once after one year ]

Secondary Outcome Measures:
  • 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: [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: After one and two years ]

Estimated Enrollment: 2600
Study Start Date: May 2008
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Standard therapy
Standard therapy + educational material


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Postmenopausal women with hormone sensitive early breast cancer that have been prescribed adjuvant AI medication (aromatase inhibitors; anastrozole or letrozole) according to the current product SmPC. The adjuvant AI medication must not have exceeded thirteen weeks of treatment duration.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00681122

  Show 164 Study Locations
Sponsors and Collaborators
Principal Investigator: Neven, P. Prof. KUL
  More Information

Responsible Party: AstraZeneca Identifier: NCT00681122     History of Changes
Other Study ID Numbers: NIS-OEU-ARI-2007/1
Study First Received: May 20, 2008
Last Updated: January 15, 2016

Keywords provided by AstraZeneca:
Breast Cancer
hormone therapy
aromatase inhibitor

Additional relevant MeSH terms:
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs processed this record on September 21, 2017