Arthralgia During Anastrozole Therapy for Breast Cancer

Phase 4

Completed

• Conditions: Early Breast Cancer

• Registration Number: NCT00323479
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-05-08
• Study First Submitted QC: 2006-05-08
• Study First Posted: 2006-05-09
• Study Start: 2006-06
• Primary Completion: 2009-01
• Study Completion: 2009-01
• Results First Submitted: 2010-01-26
• Status Verified: 2012-03
• Results First Submitted QC: 2012-03-13
• Last Update Submitted: 2012-03-13
• Results First Posted: 2012-04-06
• Last Update Posted: 2012-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 114

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of Participants With New Events of Arthralgia	12 months

Secondary Outcome Measures

Name	Time	Method
Functional Index of Cochin at 12 Months in Patients Under Anastrozole.	12 months	Functional index of cochin score (from 0 to 90) : sum up of 18 questions on activities involving hands (each question scored from 0 = yes without difficulties (best) to 5 = impossible (worst)) based on 99 patients due to missing values.
Serum Collagen Degradation Type I - CTX-I at 12 Months in Patients Under Anastrozole	12 months	Results are based on 97 patients due to missing values
Kellgren and Lawrence Score at 12 Months in Patients Under Anastrozole	12 months	X ray evaluation of arthritis in 30 articulations ; each articulation scored from (0 = no arthritis to 4 = severe arthritis) based on 92 patients due to missing values
Synovial Membrane Thickness at 12 Months in Patients Under Anastrozole	12 months	X ray assessment on hands and wrists based on 99 patients due to missing values
Percentage of Participant With Therapeutic Maintenance Under Anastrozole	12 months	Treatment compliance. results based on 109 patients due to missing values

Trial Locations

Locations (1)

Research Site; 🇫🇷 Poitiers, France