Arthralgia During Anastrozole Therapy for Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00323479
First received: May 8, 2006
Last updated: March 13, 2012
Last verified: March 2012
Results First Received: January 26, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Early Breast Cancer
Intervention: Drug: Anastrozole

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were included by an investigator-oncologist between 15 June 2006 and 31 December 2007

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients were included by an investigator-oncologist who followed them up every 3 months over a period of one year (i.e., 5 visits). An investigator rheumatologist carried out the rheumatological evaluations at inclusion and then every 6 months over a period of one year (i.e., 3 visits)

Reporting Groups
  Description
Anastrozole 1 mg Anastrozole 1 mg once daily

Participant Flow:   Overall Study
    Anastrozole 1 mg  
STARTED     114  
Safety Population     110 [1]
COMPLETED     106 [2]
NOT COMPLETED     8  
Adverse Event                 2  
Withdrawal by Subject                 2  
Protocol Violation                 3  
house moving                 1  
[1] Patients who taken at least one dose of treatment
[2] with at least 1 evaluation for primary efficacy endpoint



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Anastrozole 1 mg Anastrozole 1 mg once daily

Baseline Measures
    Anastrozole 1 mg  
Number of Participants  
[units: participants]
  106  
Age  
[units: year]
Mean ± Standard Deviation
  62.87  ± 6.87  
Gender  
[units: Participants]
 
Female     106  
Male     0  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With New Events of Arthralgia   [ Time Frame: 12 months ]

2.  Secondary:   Functional Index of Cochin at 12 Months in Patients Under Anastrozole.   [ Time Frame: 12 months ]

3.  Secondary:   Serum Collagen Degradation Type I - CTX-I at 12 Months in Patients Under Anastrozole   [ Time Frame: 12 months ]

4.  Secondary:   Kellgren and Lawrence Score at 12 Months in Patients Under Anastrozole   [ Time Frame: 12 months ]

5.  Secondary:   Synovial Membrane Thickness at 12 Months in Patients Under Anastrozole   [ Time Frame: 12 months ]

6.  Secondary:   Percentage of Participant With Therapeutic Maintenance Under Anastrozole   [ Time Frame: 12 months ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Gerard Lynch
Organization: AstraZeneca
e-mail: ClinicalTrialTransparency@astrazeneca.com


No publications provided


Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00323479     History of Changes
Other Study ID Numbers: D5392L00013, 2005-00-5441-19 EUDRACT number
Study First Received: May 8, 2006
Results First Received: January 26, 2010
Last Updated: March 13, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)