Arthralgia During Anastrozole Therapy for Breast Cancer

NCT ID: NCT00323479

Last Updated: 2012-04-06

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2009-01-31

Brief Summary

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The purpose of this study is to describe the joint symptoms and structural joint changes under anastrozole as adjuvant treatment in postmenopausal women with early breast cancer.

Detailed Description

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Conditions

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Early Breast Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Anastrozole

1mg/Day oral

Intervention Type DRUG

Other Intervention Names

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ARIMIDEX ZD1033

Eligibility Criteria

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Inclusion Criteria

* Post menopausal woman with a breast cancer and scheduled for an adjuvant treatment with anastrozole
* WHO performance status 0, 1 or 2
* Provision of written informed consent

Exclusion Criteria

* Recurrence of breast cancer, inflammatory rheumatism
* treatment by chondromodulator, oral glucocorticoid, aromatase inhibitor, anti estrogen, Herceptin
* Diabetes treated by insulin
* Severe renal or hepatic disease
* Known hypersensitivity to anastrozole
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 France Medical Director, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research Site

Bordeaux, , France

Site Status

Research Site

Caen, , France

Site Status

Research Site

Lyon, , France

Site Status

Research Site

Paris, , France

Site Status

Research Site

Poitiers, , France

Site Status

Countries

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France

Other Identifiers

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2005-00-5441-19 EUDRACT number

Identifier Type: -

Identifier Source: secondary_id

D5392L00013

Identifier Type: -

Identifier Source: org_study_id

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