Arthralgia During Anastrozole Therapy for Breast Cancer
A Multicentre, Open Study Assessing Joint Disorders Under ARIMIDEX® (1mg/Day) as Adjuvant Treatment in Post Menopausal Women With Early Breast Cancer
2 other identifiers
interventional
114
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jun 2006
Typical duration for phase_4
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 8, 2006
CompletedFirst Posted
Study publicly available on registry
May 9, 2006
CompletedStudy Start
First participant enrolled
June 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2009
CompletedResults Posted
Study results publicly available
April 6, 2012
CompletedApril 6, 2012
March 1, 2012
2.6 years
May 8, 2006
January 26, 2010
March 13, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With New Events of Arthralgia
12 months
Secondary Outcomes (5)
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
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (5)
Research Site
Bordeaux, France
Research Site
Caen, France
Research Site
Lyon, France
Research Site
Paris, France
Research Site
Poitiers, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gerard Lynch
- Organization
- AstraZeneca
Study Officials
- STUDY DIRECTOR
AstraZeneca France Medical Director, MD
AstraZeneca
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 8, 2006
First Posted
May 9, 2006
Study Start
June 1, 2006
Primary Completion
January 1, 2009
Study Completion
January 1, 2009
Last Updated
April 6, 2012
Results First Posted
April 6, 2012
Record last verified: 2012-03