Clinical Trial: Patient's Anastrozole Compliance to Therapy Programme

Study Status: Terminated
Recruit Status: Terminated
Study Type: Observational

Official Title: A Randomised in Practice Evaluation of the Influence of Patient's Understanding of Her Disease and Therapy on Persistence and Compliance to Adjuvant Therapy for Post-menop

Brief Summary: Approximately 60 specialised clinics and 420 office based gynaecologists or oncologists will participate in this in practice evaluation program (NIS). The clinic and approximately 7 office based physicians will collaborate within their breast centre networks to conduct this program. A breast centre network should be able to recruit in this program approximately 80 patients (approximately 40 patients per year). It is planned to enroll approximately 4674 patients in this NIS (2337 patients per arm). The patient population will include postmenopausal women with hormone-receptor positive primary breast cancer scheduled for upfront adjuvant endocrine treatment with anastrozole according to the current standard medical procedures.

Detailed Summary:
Sponsor: AstraZeneca

Current Primary Outcome: Compliance rate and persistence rate [ Time Frame: until discontinuation of treatment ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Time to treatment discontinuation [ Time Frame: date of last intake of anastrozole minus date of first prescription of anastrozole + 1 ]
  • Demographics and other baseline characteristics as well as information regarding concomitant medication, quality of life [ Time Frame: until treatment discontinuation ]
  • The percentage number of patients with disease free survival [ Time Frame: after 12 months ]
  • Time of disease free survival [ Time Frame: date of recurrence or progression of the tumor minus date of primary breast cancer surgery + 1 ]


Original Secondary Outcome: Same as current

Information By: AstraZeneca

Dates:
Date Received: November 7, 2007
Date Started: October 2006
Date Completion:
Last Updated: December 22, 2011
Last Verified: December 2011