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Survey Conducted Among Early Breast Cancer Patients Treated With Arimidex for Evaluation of Treatment Adherence (ARIADNE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01081509
First received: March 4, 2010
Last updated: November 15, 2011
Last verified: November 2011
History of Changes
  Purpose

The aim of this study is to assess the patient's perception about and willingness to take his or her medication and the influencing factors interfering with taking medication.


Condition
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Survey and Follow-up of the Treatment Adherence and Medication Habits of Early Breast Cancer Patients on Adjuvant Hormonal Therapy With the Aromatase Inhibitor Arimidex

Resource links provided by NLM:

Drug Information available for: Anastrozole
U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Percent of patients remaining adherent to therapy with Arimidex [ Time Frame: Every 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Questionnaire for factors influencing adherence [ Time Frame: Every 3 months ] [ Designated as safety issue: No ]

Enrollment: 1077
Study Start Date: March 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Early breast cancer patients on adjuvant aromatase inhibitor

Criteria

Inclusion Criteria:

  • Early breast cancer
  • Post menopausal
  • Adjuvant hormonal Arimidex therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01081509

Locations
Hungary
Research Site
Balatonfoldvar, Hungary
Research Site
Bekescsaba, Hungary
Research Site
Budapest, Hungary
Research Site
Debrecen, Hungary
Research Site
Dombovar, Hungary
Research Site
Gyongyos, Hungary
Research Site
Gyor, Hungary
Research Site
Gyula, Hungary
Research Site
Kaposvar, Hungary
Research Site
Kecskemet, Hungary
Research Site
Miskolc, Hungary
Research Site
Mosdos, Hungary
Research Site
Nagyatad, Hungary
Research Site
Nyiregyhaza, Hungary
Research Site
Orfu, Hungary
Research Site
Papa, Hungary
Research Site
Pecs, Hungary
Research Site
Szeged, Hungary
Research Site
Szekesfehervar, Hungary
Research Site
Szekszard, Hungary
Research Site
Szentes, Hungary
Research Site
Szombathely, Hungary
Research Site
Veszprem, Hungary
Research Site
Zalaegerszeg, Hungary
Research Site
Zirc, Hungary
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Zsolt Horvath, M.D., Ph.D. Hungarian National Institute of Oncology
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01081509     History of Changes
Other Study ID Numbers: NIS-OHU-ARI-2010/1
Study First Received: March 4, 2010
Last Updated: November 15, 2011
Health Authority: Hungary: National Institute of Pharmacy

Keywords provided by AstraZeneca:
adherence
early breast cancer
Arimidex
Therapy adherence

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Anastrozole
Aromatase Inhibitors
 Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 17, 2012