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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 ]

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 (73.76%)   3567/4852 (73.52%) 
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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