CARIATIDE (Compliance of ARomatase Inhibitors AssessmenT In Daily Practice Through Educational Approach) - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00681122

Purpose

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
Breast Cancer

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, 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

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 ] [ Designated as safety issue: No ]

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. ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	2600
Study Start Date:	May 2008
Estimated Study Completion Date:	February 2011

Groups/Cohorts
1 Standard therapy
2 Standard therapy + educational material

Eligibility

Ages Eligible for Study:	18 Years and older
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00681122

Contacts

Contact: AstraZeneca Belgium Clinical Study Information

+3223704931

sylvie.vanhoorde@astrazeneca.com

Show 79 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:

Neven, P. Prof.

KUL

More Information

Responsible Party:	AstraZeneca Pharmaceuticals ( Guy Vandenhoven, MD, Medical Director )
Study ID Numbers:	NIS-OEU-ARI-2007/1
Study First Received:	May 20, 2008
Last Updated:	November 6, 2008
ClinicalTrials.gov Identifier:	NCT00681122
Health Authority:	Austria: Ethikkommission; Czech Republic: Ethics Committee; Czech Republic: State Institute for Drug Control; France: Afssaps - French Health Products Safety Agency; Finland: Ethics Committee; Finland: Ministry of Social Affairs and Health; Finland: National Agency for Medicines; Greece: Ethics Committee; Greece: Ministry of Health and Welfare; Greece: National Organization of Medicines; Italy: Ethics Committee; Romania: National Medicines Agency; Sweden: Regional Ethical Review Board; Switzerland: Ethikkommission; Turkey: Ministry of Health; United Kingdom: Research Ethics Committee

Keywords provided by AstraZeneca:

Breast Cancer
hormone therapy
aromatase inhibitor

Study placed in the following topic categories:

Skin Diseases
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009