Liver Safety Under Upfront Arimidex vs Tamoxifen

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

384 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2011-12-31

Brief Summary

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The primary objective is to compare ARIMIDEX (anastrozole) 1 mg once daily with Tamoxifen 20 mg once daily as adjuvant treatment in terms of: incidence of fatty liver diseases.

The second objectives are to compare ARIMIDEX (anastrozole) 1 mg once daily with Tamoxifen 20 mg once daily as adjuvant treatment in terms of: incidences of abnormal liver function test, and time to treatment failure.

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Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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1

Anastrozole (ARIMIDEX)

Group Type EXPERIMENTAL

Anastrozole

Intervention Type DRUG

1 mg once daily oral dose

2

Tamoxifen

Group Type ACTIVE_COMPARATOR

Tamoxifen

Intervention Type DRUG

20 mg once daily oral dose

Interventions

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Tamoxifen

20 mg once daily oral dose

Intervention Type DRUG

Anastrozole

1 mg once daily oral dose

Intervention Type DRUG

Other Intervention Names

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ARIMIDEX ZD1033 NOLVADEX

Eligibility Criteria

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Inclusion Criteria

* Histologically proven HR+ invasive breast cancer
* Completed all primary surgery and chemotherapy (if given), and were candidates to receive hormonal adjuvant therapy
* Postmenopausal woman