A Multicentre, Open Study Assessing Joint Disorders Under ARIMIDEX® (1mg/Day) as Adjuvant Treatment in Post Menopausal Women With Early Breast Cancer

AstraZeneca1 site in 1 country114 target enrollmentJune 2006

ConditionsEarly Breast Cancer

DrugsAnastrozole

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Early Breast Cancer
Sponsor: AstraZeneca
Enrollment: 114
Locations: 1
Primary Endpoint: Number of Participants With New Events of Arthralgia
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

June 2006

End Date

January 2009

Last Updated

14 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

AstraZeneca

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Number of Participants With New Events of Arthralgia

Time Frame: 12 months

Secondary Outcomes

Functional Index of Cochin at 12 Months in Patients Under Anastrozole.(12 months)
Serum Collagen Degradation Type I - CTX-I at 12 Months in Patients Under Anastrozole(12 months)
Kellgren and Lawrence Score at 12 Months in Patients Under Anastrozole(12 months)
Synovial Membrane Thickness at 12 Months in Patients Under Anastrozole(12 months)
Percentage of Participant With Therapeutic Maintenance Under Anastrozole(12 months)