Arthralgia During Anastrozole Therapy for Breast Cancer

Early Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00323479
• Other study ID #: D5392L00013
• Secondary ID: 2005-00-5441-19
• Status: Completed
• Phase: Phase 4
• First received: May 8, 2006
• Last updated: March 13, 2012
• Start date: June 2006
• Est. completion date: January 2009

Study information

• Verified date: March 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms
• Early Breast Cancer

Intervention

Drug:
• Anastrozole
1mg/Day oral

Locations

Country	Name	City	State
France	Research Site	Bordeaux
France	Research Site	Caen
France	Research Site	Lyon
France	Research Site	Paris
France	Research Site	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With New Events of Arthralgia		12 months	No
Secondary	Functional Index of Cochin at 12 Months in Patients Under Anastrozole.	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.	12 months	No
Secondary	Serum Collagen Degradation Type I - CTX-I at 12 Months in Patients Under Anastrozole	Results are based on 97 patients due to missing values	12 months	No
Secondary	Kellgren and Lawrence Score at 12 Months in Patients Under Anastrozole	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	12 months	No
Secondary	Synovial Membrane Thickness at 12 Months in Patients Under Anastrozole	X ray assessment on hands and wrists based on 99 patients due to missing values	12 months	No
Secondary	Percentage of Participant With Therapeutic Maintenance Under Anastrozole	Treatment compliance. results based on 109 patients due to missing values	12 months	No