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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: October 6, 2015
Last verified: October 2015
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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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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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
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 
Overall Participants Analyzed 
[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 ]

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 ]
  Hide Outcome Measure 3

Measure Type Secondary
Measure Title Number of Events for Overall Survival (OS)
Measure Description Number of events (death) to time of observation for OS. OS is the duration from randomization to death. For participants who are alive, overall survival is censored at the last contact.
Time Frame Baseline (Month 0) up to 5 years  
Safety Issue No  

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.
ITT population: participants randomized to one of the two study arms (all randomized participants); (n) = number of participants at observation for exemestane and tamoxifen, respectively. All participants were censored at the data cut off date of 08 November 2009.

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.

Measured Values
   Exemestane   Tamoxifen Followed by Exemestane 
Participants Analyzed 
[Units: Participants]
 4898   4868 
Number of Events for Overall Survival (OS) 
[Units: Events (death)]
 485   476 


Statistical Analysis 1 for Number of Events for Overall Survival (OS)
Groups [1] All groups
Method [2] Log Rank
P Value [3] 0.951
Hazard Ratio (HR) [4] 1.00
95% Confidence Interval 0.89 to 1.14
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Analysis at 5 years post-randomization. Null hypothesis: no difference in OS between the two treatments for the first 5 years. Overall alpha of 0.05 was maintained.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Log rank (Mantel-Cox). Adjusted for overall stratification factor; 1 degree of freedom.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  A hazard ratio less than 1 favors the test treatment (exemestane only arm).



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