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
  Purpose

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.


Condition Intervention
Breast Cancer
Drug: Anastrozole

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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-menopausal Hormone Sensitive Early Breast Cancer

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Compliance rate and persistence rate [ Time Frame: until discontinuation of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 4923
Study Start Date: October 2006
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Standard routine care for breast cancer
Drug: Anastrozole
oral
Other Names:
  • Arimidex
  • ZD1033
2
Standard + Intervention arm: standard routine care for breast cancer and additional information material via post
Drug: Anastrozole
oral
Other Names:
  • Arimidex
  • ZD1033

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00555867

Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca Germany Medical Director AstraZeneca
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00555867     History of Changes
Other Study ID Numbers: 1033GR/0002
Study First Received: November 7, 2007
Last Updated: December 22, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by AstraZeneca:
hormone-receptor positive primary breast cancer
compliance
Postmenopausal women

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

ClinicalTrials.gov processed this record on July 28, 2014