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

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ClinicalTrials.gov Identifier: NCT00681122
Recruitment Status : Completed
First Posted : May 21, 2008
Last Update Posted : January 18, 2016
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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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.

Condition or disease
Breast Cancer

Study Design
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Study Type : Observational
Estimated Enrollment : 2600 participants
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
Study Start Date : May 2008
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

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Groups and Cohorts
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Group/Cohort
1
Standard therapy
2
Standard therapy + educational material


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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. ]
  2. 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 ]
  3. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00681122


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Sponsors and Collaborators
AstraZeneca
Investigators
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Principal Investigator: Neven, P. Prof. KUL
More Information
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00681122     History of Changes
Other Study ID Numbers: NIS-OEU-ARI-2007/1
First Posted: May 21, 2008    Key Record Dates
Last Update Posted: January 18, 2016
Last Verified: October 2011
Keywords provided by AstraZeneca:
Breast Cancer
hormone therapy
aromatase inhibitor
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
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