Study Stopped
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
Patient's Anastrozole Compliance to Therapy Programme
PACT
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
1 other identifier
observational
4,923
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2006
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2006
CompletedFirst Submitted
Initial submission to the registry
November 7, 2007
CompletedFirst Posted
Study publicly available on registry
November 9, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2011
CompletedDecember 23, 2011
December 1, 2011
4.3 years
November 7, 2007
December 22, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Compliance rate and persistence rate
until discontinuation of treatment
Secondary Outcomes (4)
Time to treatment discontinuation
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
until treatment discontinuation
The percentage number of patients with disease free survival
after 12 months
Time of disease free survival
date of recurrence or progression of the tumor minus date of primary breast cancer surgery + 1
Study Arms (2)
1
Standard routine care for breast cancer
2
Standard + Intervention arm: standard routine care for breast cancer and additional information material via post
Interventions
Eligibility Criteria
Postmenopausal women with hormone receptor positive primary breast cancer scheduled for upfront adjuvant endocrine treatment with anastrozole according to the current standard medical practice
You may qualify if:
- Histological/cytological confirmed primary diagnosis of early breast cancer
- Postmenopausal
- Hormone receptor positive
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Related Publications (1)
Hadji P, Blettner M, Harbeck N, Jackisch C, Luck 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.
PMID: 23378537DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AstraZeneca Germany Medical Director
AstraZeneca
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 7, 2007
First Posted
November 9, 2007
Study Start
October 1, 2006
Primary Completion
February 1, 2011
Study Completion
February 1, 2011
Last Updated
December 23, 2011
Record last verified: 2011-12