Patient's Anastrozole Compliance to Therapy Programme

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Anastrozole


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Standard routine care for breast cancer | Drug: Anastrozole<br>* oral<br>* Other names: ZD1033;|
| 2<br>Standard + Intervention arm: standard routine care for breast cancer and additional information material via post | Drug: Anastrozole<br>* oral<br>* Other names: ZD1033;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance rate and persistence rate |  | until discontinuation of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hormone-receptor positive primary breast cancer, compliance, Postmenopausal women