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
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  
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 ]

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
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Time Frame No text entered.
Additional Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Frequency Threshold
Threshold above which other adverse events are reported   2%  

Reporting Groups
  Description
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.
Exemestane Exemestane (Aromasin®) 25 mg QD for 5 years

Other Adverse Events
    Tamoxifen Followed by Exemestane     Exemestane  
Total, other (not including serious) adverse events      
# participants affected / at risk     3551/4814     3567/4852  
Ear and labyrinth disorders      
Vertigo * 1    
# participants affected / at risk     78/4814 (1.62%)     96/4852 (1.98%)  
Gastrointestinal disorders      
Abdominal pain * 1    
# participants affected / at risk     150/4814 (3.12%)     141/4852 (2.91%)  
Constipation * 1    
# participants affected / at risk     274/4814 (5.69%)     236/4852 (4.86%)  
Diarrhoea * 1    
# participants affected / at risk     258/4814 (5.36%)     302/4852 (6.22%)  
Dry mouth * 1    
# participants affected / at risk     98/4814 (2.04%)     70/4852 (1.44%)  
Dyspepsia * 1    
# participants affected / at risk     135/4814 (2.80%)     151/4852 (3.11%)  
Nausea * 1    
# participants affected / at risk     482/4814 (10.01%)     419/4852 (8.64%)  
Vomiting * 1    
# participants affected / at risk     106/4814 (2.20%)     96/4852 (1.98%)  
General disorders      
Asthenia * 1    
# participants affected / at risk     188/4814 (3.91%)     235/4852 (4.84%)  
Chest pain * 1    
# participants affected / at risk     91/4814 (1.89%)     100/4852 (2.06%)  
Fatigue * 1    
# participants affected / at risk     800/4814 (16.62%)     796/4852 (16.41%)  
Oedema * 1    
# participants affected / at risk     287/4814 (5.96%)     276/4852 (5.69%)  
Oedema peripheral * 1    
# participants affected / at risk     214/4814 (4.45%)     166/4852 (3.42%)  
Pain * 1    
# participants affected / at risk     492/4814 (10.22%)     541/4852 (11.15%)  
Infections and infestations      
Bronchitis * 1    
# participants affected / at risk     135/4814 (2.80%)     128/4852 (2.64%)  
Cystitis * 1    
# participants affected / at risk     76/4814 (1.58%)     102/4852 (2.10%)  
Herpes zoster * 1    
# participants affected / at risk     76/4814 (1.58%)     112/4852 (2.31%)  
Infection * 1    
# participants affected / at risk     197/4814 (4.09%)     168/4852 (3.46%)  
Nasopharyngitis * 1    
# participants affected / at risk     99/4814 (2.06%)     110/4852 (2.27%)  
Urinary tract infection * 1    
# participants affected / at risk     114/4814 (2.37%)     129/4852 (2.66%)  
Vaginal infection * 1    
# participants affected / at risk     100/4814 (2.08%)     47/4852 (0.97%)  
Investigations      
Weight decreased * 1    
# participants affected / at risk     140/4814 (2.91%)     187/4852 (3.85%)  
Weight increased * 1    
# participants affected / at risk     415/4814 (8.62%)     339/4852 (6.99%)  
Metabolism and nutrition disorders      
Decreased appetite * 1    
# participants affected / at risk     118/4814 (2.45%)     132/4852 (2.72%)  
Hypercholesterolaemia * 1    
# participants affected / at risk     99/4814 (2.06%)     190/4852 (3.92%)  
Hyperglycaemia * 1    
# participants affected / at risk     97/4814 (2.01%)     113/4852 (2.33%)  
Musculoskeletal and connective tissue disorders      
Arthralgia * 1    
# participants affected / at risk     1002/4814 (20.81%)     1157/4852 (23.85%)  
Arthritis * 1    
# participants affected / at risk     130/4814 (2.70%)     161/4852 (3.32%)  
Back pain * 1    
# participants affected / at risk     269/4814 (5.59%)     273/4852 (5.63%)  
Bone pain * 1    
# participants affected / at risk     230/4814 (4.78%)     261/4852 (5.38%)  
Muscle spasms * 1    
# participants affected / at risk     245/4814 (5.09%)     133/4852 (2.74%)  
Musculoskeletal pain * 1    
# participants affected / at risk     128/4814 (2.66%)     176/4852 (3.63%)  
Myalgia * 1    
# participants affected / at risk     360/4814 (7.48%)     364/4852 (7.50%)  
Osteoarthritis * 1    
# participants affected / at risk     142/4814 (2.95%)     165/4852 (3.40%)  
Osteoporosis * 1    
# participants affected / at risk     219/4814 (4.55%)     428/4852 (8.82%)  
Pain in extremity * 1    
# participants affected / at risk     147/4814 (3.05%)     171/4852 (3.52%)  
Nervous system disorders      
Amnesia * 1    
# participants affected / at risk     143/4814 (2.97%)     188/4852 (3.87%)  
Carpal tunnel syndrome * 1    
# participants affected / at risk     76/4814 (1.58%)     109/4852 (2.25%)  
Dizziness * 1    
# participants affected / at risk     289/4814 (6.00%)     243/4852 (5.01%)  
Headache * 1    
# participants affected / at risk     372/4814 (7.73%)     369/4852 (7.61%)  
Neuropathy peripheral * 1    
# participants affected / at risk     120/4814 (2.49%)     174/4852 (3.59%)  
Paraesthesia * 1    
# participants affected / at risk     66/4814 (1.37%)     100/4852 (2.06%)  
Psychiatric disorders      
Anxiety * 1    
# participants affected / at risk     174/4814 (3.61%)     167/4852 (3.44%)  
Depression * 1    
# participants affected / at risk     417/4814 (8.66%)     404/4852 (8.33%)  
Insomnia * 1    
# participants affected / at risk     452/4814 (9.39%)     549/4852 (11.31%)  
Libido decreased * 1    
# participants affected / at risk     164/4814 (3.41%)     196/4852 (4.04%)  
Mood altered * 1    
# participants affected / at risk     147/4814 (3.05%)     151/4852 (3.11%)  
Sleep disorder * 1    
# participants affected / at risk     61/4814 (1.27%)     110/4852 (2.27%)  
Reproductive system and breast disorders      
Breast pain * 1    
# participants affected / at risk     104/4814 (2.16%)     121/4852 (2.49%)  
Vaginal discharge * 1    
# participants affected / at risk     316/4814 (6.56%)     111/4852 (2.29%)  
Vaginal haemorrhage * 1    
# participants affected / at risk     186/4814 (3.86%)     94/4852 (1.94%)  
Vulvovaginal dryness * 1    
# participants affected / at risk     268/4814 (5.57%)     321/4852 (6.62%)  
Respiratory, thoracic and mediastinal disorders      
Cough * 1    
# participants affected / at risk     252/4814 (5.23%)     235/4852 (4.84%)  
Dyspnoea * 1    
# participants affected / at risk     243/4814 (5.05%)     223/4852 (4.60%)  
Skin and subcutaneous tissue disorders      
Alopecia * 1    
# participants affected / at risk     299/4814 (6.21%)     329/4852 (6.78%)  
Dry skin * 1    
# participants affected / at risk     122/4814 (2.53%)     114/4852 (2.35%)  
Hyperhidrosis * 1    
# participants affected / at risk     175/4814 (3.64%)     103/4852 (2.12%)  
Night sweats * 1    
# participants affected / at risk     102/4814 (2.12%)     87/4852 (1.79%)  
Pruritus * 1    
# participants affected / at risk     158/4814 (3.28%)     153/4852 (3.15%)  
Rash * 1    
# participants affected / at risk     216/4814 (4.49%)     227/4852 (4.68%)  
Vascular disorders      
Flushing * 1    
# participants affected / at risk     183/4814 (3.80%)     114/4852 (2.35%)  
Hot flush * 1    
# participants affected / at risk     1690/4814 (35.11%)     1517/4852 (31.27%)  
Hypertension * 1    
# participants affected / at risk     224/4814 (4.65%)     291/4852 (6.00%)  
Lymphoedema * 1    
# participants affected / at risk     247/4814 (5.13%)     227/4852 (4.68%)  
* Events were collected by non-systematic assessment
1 Term from vocabulary, MedDRA 14.0



  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.


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