Trial Information
A Multicentre, Open Study Assessing Joint Disorders Under ARIMIDEX® (1mg/Day) as Adjuvant Treatment in Post Menopausal Women With Early Breast Cancer
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Number of Participants With New Events of Arthralgia
Outcome Time Frame:
12 months
Safety Issue:
No
Principal Investigator
AstraZeneca France Medical Director, MD
Investigator Role:
Study Director
Investigator Affiliation:
AstraZeneca
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
D5392L00013
NCT ID:
NCT00323479
Start Date:
June 2006
Completion Date:
January 2009
Related Keywords:
- Early Breast Cancer
- breast cancer treatment
- joint disorders
- Breast Neoplasms