Patient's Anastrozole Compliance to Therapy Programme

Breast Cancer Clinical Trial

— PACT  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00555867
• Other study ID #: 1033GR/0002
• Status: Terminated
• Phase: N/A
• First received: November 7, 2007
• Last updated: December 22, 2011
• Start date: October 2006
• Est. completion date: February 2011

Study information

• Verified date: December 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4923
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Anastrozole
oral

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compliance rate and persistence rate		until discontinuation of treatment	No
Secondary	Time to treatment discontinuation		date of last intake of anastrozole minus date of first prescription of anastrozole + 1	No
Secondary	Demographics and other baseline characteristics as well as information regarding concomitant medication, quality of life		until treatment discontinuation	No
Secondary	The percentage number of patients with disease free survival		after 12 months	No
Secondary	Time of disease free survival		date of recurrence or progression of the tumor minus date of primary breast cancer surgery + 1	No