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CompletedNCT00681122CARIATIDEUpdated Jan 18, 2016

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

An observational study in Breast Cancer, sponsored by AstraZeneca. Completed at 164 sites in 18 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-01-18.

Sponsored by AstraZeneca · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,600
Ages
18 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Breast Cancer

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Keywords

  • Breast Cancer
  • hormone therapy
  • aromatase inhibitor
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 2,600 is above the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,600 participants (estimated)

Groups and cohorts

  • 1

    Standard therapy

  • 2

    Standard therapy + educational material

06

What researchers measure

Primary outcomes

  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 outcomes

  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

07

Study locations

164 sites
  • Research Site
    Canberra, Australian Capital Territory, Australia
  • Research Site
    Coffs Harbour, New South Wales, Australia
  • Research Site
    Newcastle, New South Wales, Australia
  • Research Site
    Port Macquarie, New South Wales, Australia
  • Research Site
    Tweed Heads, New South Wales, Australia
  • Research Site
    Brisbane, Queensland, Australia
  • Research Site
    Nambour, Queensland, Australia
  • Research Site
    Toowoomba, Queensland, Australia
  • Research Site
    Hobart, Tasmania, Australia
  • Research Site
    St. Veit, Carinthia, Austria
  • Research Site
    Wolfsberg, Carinthia, Austria
  • Research Site
    Weiz, Styria, Austria
  • Research Site
    Linz, Upper Austria, Austria
  • Research Site
    Salzburg, Austria
  • Research Site
    Vienna, Austria
  • Research Site
    Aalst, Belgium
  • Research Site
    Antwerpen, Belgium
  • Research Site
    Arlon, Belgium
  • Research Site
    Bonheiden, Belgium
  • Research Site
    Bornem, Belgium
  • Research Site
    Boussu, Belgium
  • Research Site
    Brussels, Belgium
  • Research Site
    Charleroi, Belgium
  • Research Site
    Dendermonde, Belgium
  • Research Site
    Edegem, Belgium
  • Research Site
    Eupen, Belgium
  • Research Site
    Geel, Belgium
  • Research Site
    Gent, Belgium
  • Research Site
    Geraardsbergen, Belgium
  • Research Site
    Gilly, Belgium
  • Research Site
    Haine St Paul, Belgium
  • Research Site
    Leuven, Belgium
  • Research Site
    Li?ge, Belgium
  • Research Site
    Libramont, Belgium
  • Research Site
    Namur, Belgium
  • Research Site
    Oostende, Belgium
  • Research Site
    Ottignies, Belgium
  • Research Site
    Overpelt, Belgium
  • Research Site
    Rocourt, Belgium
  • Research Site
    Seraing, Belgium
  • Research Site
    Tournai, Belgium
  • Research Site
    Turnhout, Belgium
  • Research Site
    Santiago, Metropolitana, Chile
  • Research Site
    Temuco, Novena Region, Chile
  • Research Site
    Medellin, Antioquia, Colombia
  • Research Site
    Barranquilla, Atlantico, Colombia
  • Research Site
    Bogota, Cundinamarca, Colombia
  • Research Site
    Neiva, Huila, Colombia
  • Research Site
    Pasto, Nari?o, Colombia
  • Research Site
    Cali, Valle, Colombia
  • Research Site
    Osijek, Croatia
  • Research Site
    Rijeka, Croatia
  • Research Site
    Zagreb, Croatia
  • Research Site
    Hradec Kralove, Czech Republic
  • Research Site
    Opava, Czech Republic
  • Research Site
    Ostrava, Czech Republic
  • Research Site
    Praha, Czech Republic
  • Research Site
    Helsinki, Finland
  • Research Site
    Tampere, Finland
  • Research Site
    Aix En Provence, France
  • Research Site
    Ales, France
  • Research Site
    Annecy, France
  • Research Site
    Arpajon, France
  • Research Site
    Avignon, France
  • Research Site
    Beauvais, France
  • Research Site
    Bordeaux, France
  • Research Site
    Brest, France
  • Research Site
    Brive La Gaillarde, France
  • Research Site
    Colmar, France
  • Research Site
    Creteil, France
  • Research Site
    Cucq, France
  • Research Site
    Dechy, France
  • Research Site
    Evreux, France
  • Research Site
    GAP, France
  • Research Site
    Grenoble, France
  • Research Site
    Hyeres, France
  • Research Site
    La Seyne Sur Mer, France
  • Research Site
    Limoges, France
  • Research Site
    Lyon, France
  • Research Site
    Mareuil Les Meaux, France
  • Research Site
    Marseille, France
  • Research Site
    Mont de Marsan, France
  • Research Site
    Mougins, France
  • Research Site
    Nancy, France
  • Research Site
    Nantes, France
  • Research Site
    Narbonne, France
  • Research Site
    Nice, France
  • Research Site
    Nimes, France
  • Research Site
    Perigueux, France
  • Research Site
    Perpignan, France
  • Research Site
    Quimper, France
  • Research Site
    Reims, France
  • Research Site
    Rennes, France
  • Research Site
    Rouen, France
  • Research Site
    Saint Brieux, France
  • Research Site
    Saint Cyr Sur Loire, France
  • Research Site
    Saint Gregoire, France
  • Research Site
    Saint Jean, France
  • Research Site
    Saint Mande, France
  • Research Site
    Saint Nazaire, France

Showing the first 100 of 164 sites across 18 countries.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 18, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00681122
Lead sponsor
AstraZeneca
Responsible party
Sponsor
First posted
May 21, 2008
Start date
May 2008
Primary completion
May 2011
Completion
May 2011
Last update
Jan 18, 2016

Study contacts

Neven, P. Prof.
principal investigator · KUL

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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