Patient's Anastrozole Compliance to Therapy Programme (PACT)

December 22, 2011 updated by: AstraZeneca

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

4923

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
Standard routine care for breast cancer
Drug: Anastrozole
oral
Other Names:
  • ZD1033
  • Arimidex
2
Standard + Intervention arm: standard routine care for breast cancer and additional information material via post
Drug: Anastrozole
oral
Other Names:
  • ZD1033
  • Arimidex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Compliance rate and persistence rate
Time Frame: until discontinuation of treatment
until discontinuation of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to treatment discontinuation
Time Frame: date of last intake of anastrozole minus date of first prescription of anastrozole + 1
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
until treatment discontinuation
The percentage number of patients with disease free survival
Time Frame: after 12 months
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
date of recurrence or progression of the tumor minus date of primary breast cancer surgery + 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: AstraZeneca Germany Medical Director, AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

November 7, 2007

First Submitted That Met QC Criteria

November 7, 2007

First Posted (Estimate)

November 9, 2007

Study Record Updates

Last Update Posted (Estimate)

December 23, 2011

Last Update Submitted That Met QC Criteria

December 22, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1033GR/0002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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