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Randomized Phase III Study Of Exemestane (Aromasin) For 5 Years Versus Tamoxifen for 2.5 to 3 Years Followed By Exemestane (TEAM)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00036270
First received: May 8, 2002
Last updated: March 27, 2012
Last verified: March 2012
History of Changes
Results First Received: October 30, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Breast Neoplasms
Interventions: Drug: exemestane (Aromasin)
Drug: tamoxifen + exemestane

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Exemestane Exemestane (Aromasin®) 25 milligram (mg) once daily (QD) for 5 years.
Tamoxifen Followed by Exemestane Tamoxifen 20 mg QD; upon completing 2.5 years to 3 years of tamoxifen, participants were to be switched to exemestane 25 mg QD and then were to complete a total of 5 years endocrine therapy.

Participant Flow for 2 periods

 Period 1:   Randomized to Study Treatment
    Exemestane     Tamoxifen Followed by Exemestane  
STARTED     4904     4875  
COMPLETED     4898     4868  
NOT COMPLETED     6     7  
Withdrawal by Subject                 6                 7  

Period 2:   Study Treatment to 5 Year Report
    Exemestane     Tamoxifen Followed by Exemestane  
STARTED     4898     4868  
Treated     4852     4814  
COMPLETED     2333     1380  
NOT COMPLETED     2565     3488  
Ongoing                 1081                 736  
Disease- Free Survival (DFS) event                 507                 447  
Adverse Event                 501                 782  
Unspecified                 277                 288  
Treatment refusal                 113                 208  
Randomized but not treated                 46                 54  
Protocol Violation                 23                 91  
Intercurrent illness                 17                 29  
Too early switch                 0                 103  
No/too late switch/refusal to switch                 0                 750  



  Baseline Characteristics
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Reporting Groups
  Description
Exemestane Exemestane (Aromasin®) 25 mg QD for 5 years.
Tamoxifen Followed by Exemestane Tamoxifen 20 mg QD; upon completing 2.5 years to 3 years of tamoxifen, participants were to be switched to exemestane 25 mg QD and then were to complete a total of 5 years endocrine therapy.
Total Total of all reporting groups

Baseline Measures
    Exemestane     Tamoxifen Followed by Exemestane     Total  
Number of Participants  
[units: participants]
 		  4898     4868     9766  
Age  
[units: Years]
Mean ± Standard Deviation 		  65  ± 9     64  ± 9     64  ± 9  
Age, Customized  
[units: Participants]
 		     
Less than 50 years     171     160     331  
50 to 59 years     1510     1507     3017  
60 to 69 years     1835     1896     3731  
Greater than and equal to 70 years     1382     1305     2687  
Gender  
[units: Participants]
 		     
Female     4898     4868     9766  
Male     0     0     0  



  Outcome Measures
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1.  Primary:   Disease Free Survival (DFS): Number of Events (Disease Relapse or Death) From Baseline up to 2.75 Years   [ Time Frame: Baseline (Month 0) up to 2.75 years ]
  Show Outcome Measure 1

2.  Primary:   Disease Free Survival (DFS): Number of Events (Disease Relapse or Death) From Baseline up to 5 Years   [ Time Frame: Baseline (Month 0) up to 5 years ]
  Show Outcome Measure 2

3.  Secondary:   Number of Events for Overall Survival (OS)   [ Time Frame: Baseline (Month 0) up to 5 years ]
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4.  Secondary:   Time to New Primary Breast Cancers   [ Time Frame: Baseline (Month 0) up to 5 years ]
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5.  Secondary:   Number of Events for Time to Relapse   [ Time Frame: Baseline (Month 0) up to 5 years ]
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6.  Secondary:   Number of Participants With New Primary Non-breast Cancers   [ Time Frame: Baseline (Month 0) up to 5 years ]
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  Serious Adverse Events
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  Other Adverse Events
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  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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
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.


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
Overall Survival was reported as number of events which otherwise reported as time.  


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


No publications provided by Pfizer

Publications automatically indexed to this study:


Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00036270     History of Changes
Other Study ID Numbers: 971-ONC-0028-081, A5991026
Study First Received: May 8, 2002
Results First Received: October 30, 2009
Last Updated: March 27, 2012
Health Authority: United States: Food and Drug Administration