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Patient's Anastrozole Compliance to Therapy Programme (PACT)

This study has been terminated.
(High drop-out rate leads to the conclusion: not enough data will be available to perform proper analyses of data collected after follow-up month 24 visit)
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00555867
First received: November 7, 2007
Last updated: December 22, 2011
Last verified: December 2011

November 7, 2007
December 22, 2011
October 2006
February 2011   (final data collection date for primary outcome measure)
Compliance rate and persistence rate [ Time Frame: until discontinuation of treatment ] [ Designated as safety issue: No ]
Compliance rate and persistence rate [ Time Frame: until discontinuation of treatment ]
Complete list of historical versions of study NCT00555867 on ClinicalTrials.gov Archive Site
  • Time to treatment discontinuation [ Time Frame: date of last intake of anastrozole minus date of first prescription of anastrozole + 1 ] [ Designated as safety issue: No ]
  • Demographics and other baseline characteristics as well as information regarding concomitant medication, quality of life [ Time Frame: until treatment discontinuation ] [ Designated as safety issue: No ]
  • The percentage number of patients with disease free survival [ Time Frame: after 12 months ] [ Designated as safety issue: No ]
  • Time of disease free survival [ Time Frame: date of recurrence or progression of the tumor minus date of primary breast cancer surgery + 1 ] [ Designated as safety issue: No ]
  • 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 ]
Not Provided
Not Provided
 
Patient's Anastrozole Compliance to Therapy Programme
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-menopausal Hormone Sensitive Early Breast Cancer

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Postmenopausal women with hormone receptor positive primary breast cancer scheduled for upfront adjuvant endocrine treatment with anastrozole according to the current standard medical practice

Breast Cancer
Drug: Anastrozole
oral
Other Names:
  • Arimidex
  • ZD1033
  • 1
    Standard routine care for breast cancer
    Intervention: Drug: Anastrozole
  • 2
    Standard + Intervention arm: standard routine care for breast cancer and additional information material via post
    Intervention: Drug: Anastrozole
Hadji P, Blettner M, Harbeck N, Jackisch C, Lück HJ, Windemuth-Kieselbach C, Zaun S, Kreienberg R. The Patient's Anastrozole Compliance to Therapy (PACT) Program: a randomized, in-practice study on the impact of a standardized information program on persistence and compliance to adjuvant endocrine therapy in postmenopausal women with early breast cancer. Ann Oncol. 2013 Jun;24(6):1505-12. doi: 10.1093/annonc/mds653. Epub 2013 Feb 1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
4923
February 2011
February 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histological/cytological confirmed primary diagnosis of early breast cancer
  • Postmenopausal
  • Hormone receptor positive

Exclusion Criteria:

  • Patients with severe renal function disorders
  • Patients with moderate or severe disorders of hepatic function
  • Concomitant treatment with drugs known to affect sex hormonal status and tamoxifen
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00555867
1033GR/0002
No
AstraZeneca
AstraZeneca
Not Provided
Study Director: AstraZeneca Germany Medical Director AstraZeneca
AstraZeneca
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP