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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:
ClinicalTrials.gov Identifier:
NCT00036270
First Posted: May 9, 2002
Last Update Posted: October 28, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
Results First Submitted: October 30, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (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 
Other                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


  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 ]

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 ]

3.  Secondary:   Number of Events for Overall Survival (OS)   [ Time Frame: Baseline (Month 0) up to 5 years ]

4.  Secondary:   Time to New Primary Breast Cancers   [ Time Frame: Baseline (Month 0) up to 5 years ]

5.  Secondary:   Number of Events for Time to Relapse   [ Time Frame: Baseline (Month 0) up to 5 years ]

6.  Secondary:   Number of Participants With New Primary Non-breast Cancers   [ Time Frame: Baseline (Month 0) up to 5 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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.


  More Information