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Patient's Anastrozole Compliance to Therapy Programme

NCT ID: NCT00555867

Last Updated: 2011-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

4923 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-10-31

Study Completion Date

2011-02-28

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.

Detailed Description

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Conditions

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Breast Cancer

Keywords

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hormone-receptor positive primary breast cancer compliance Postmenopausal women

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Standard routine care for breast cancer

Anastrozole

Intervention Type DRUG

oral

2

Standard + Intervention arm: standard routine care for breast cancer and additional information material via post

Anastrozole

Intervention Type DRUG

oral

Interventions

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Anastrozole

oral

Intervention Type DRUG

Other Intervention Names

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Arimidex ZD1033

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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AstraZeneca Germany Medical Director

Role: STUDY_DIRECTOR

AstraZeneca

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 23378537 (View on PubMed)

Other Identifiers

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1033GR/0002

Identifier Type: -

Identifier Source: org_study_id