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TEAM: Exemestane As Treatment In Adjuvant For Post-Menopausal Patients With Non-Metastatic Breast Cancer

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00279448
Collaborator
(none)
9,779
Enrollment
59
Locations
2
Arms
89
Duration (Months)
165.7
Patients Per Site
1.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To compare recurrence free survival between two treatment groups (5 years with exemestane vs 2.5 to 3 years tamoxifen followed by 2 to 2.5 years of exemestane for a total duration of 5 years)

This Pfizer sponsored trial is part of an international collaboration of investigators conducting 7 similar yet independent studies in 9 countries. This study is designed to be part of the larger TEAM trial where the data from these 7 studies will be combined. A pre-specified analysis of the pooled data will be conducted. Link to TEAM Trial [971-ONC-0028-081/A5991026] Study Results: http://clinicaltrials.gov/ct2/show/results/NCT00036270?term=971-ONC-0028-081&rank=1

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
9779 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Multicenter, Randomized, Open-Label Study To Compare The Efficacy, Tolerance And Quality Of Life Of 5 Years Of Adjuvant Exemestane (Aromasin) Therapy With 2.5 To 3 Years Of Adjuvant Tamoxifen Therapy, Followed By 2 To 2.5 Years Of Exemestane For A Total Duration Of 5 Years To Treat HR+ Post-Menopausal Patients With Non-Metastatic Breast Cancer
Study Start Date :
Jan 1, 2002
Actual Primary Completion Date :
Nov 1, 2008
Actual Study Completion Date :
Jun 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: A

Drug: exemestane
On tablet of 25 mg per day during 5 years
Other Names:
  • Aromasin

    		•
    Active Comparator: B

    Drug: tamoxifen
    Two tablets of tamoxifen 10 mg per day during 2.5 to 3 years followed by one tablet of exemestane 25 mg per day during 2 to 2.5 years for a total duration of 5 years of treatment
    Other Names:
  • Kessar

    		•

    Outcome Measures

    Primary Outcome Measures

    1. To compare recurrence free survival between two treatment groups. [2.75 years and 5 years]

    Secondary Outcome Measures

    1. The quality of life of patients treated with exemestane to that of patients treated with tamoxifen [Every 3 months during first year then every 6 months for 4 years]

    2. Overall survival between the 2 treatment groups [Every 3 months during first year then every 6 months for 4 years]

    3. Incidence of a second breast cancer (contralateral) between the 2 treatment groups [Every 3 months during first year then every 6 months for 4 years]

    4. General tolerance in the short- and long-term between the 2 treatment groups [Every 3 months during first year then every 6 months dor 4 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • HR+ post-menopausal patients with non-metastatic breast cancer
    Exclusion Criteria:
    • Any of the following: HR-, non-menopausal patient, metastatic breast cancer

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pfizer Investigational Site Marseille Be1 01971 France 13285
    2 Pfizer Investigational Site Compiegne Be1 02256 France 60200
    3 Pfizer Investigational Site Rennes Be1 03677 France 35033
    4 Pfizer Investigational Site Brest Be1 04292 France 29609
    5 Pfizer Investigational Site Aix en Provence France 13616
    6 Pfizer Investigational Site Amiens France 80000
    7 Pfizer Investigational Site Annecy Cedex France 74011
    8 Pfizer Investigational Site Avignon Cedex 2 France 84082
    9 Pfizer Investigational Site Bayonne France 64100
    10 Pfizer Investigational Site Blois France 41000
    11 Pfizer Investigational Site Bordeaux CEDEX France 33000
    12 Pfizer Investigational Site Bordeaux France 33076
    13 Pfizer Investigational Site Brest France 29283
    14 Pfizer Investigational Site Cagne sur Mer France 06805
    15 Pfizer Investigational Site Chalon sur Saone France 71100
    16 Pfizer Investigational Site Chaumont France 52000
    17 Pfizer Investigational Site Croix France 59170
    18 Pfizer Investigational Site Dijon France 21000
    19 Pfizer Investigational Site Douai France 59500
    20 Pfizer Investigational Site Draguignan France 83007
    21 Pfizer Investigational Site Dunkerque France 59240
    22 Pfizer Investigational Site Evreux France 27000
    23 Pfizer Investigational Site Hyres France 83400
    24 Pfizer Investigational Site L'Union France 31240
    25 Pfizer Investigational Site Le Havre France 76600
    26 Pfizer Investigational Site Lille France 59000
    27 Pfizer Investigational Site Lorient France
    28 Pfizer Investigational Site Lyon France 69008
    29 Pfizer Investigational Site Mareuil les Meaux France
    30 Pfizer Investigational Site Marseille France 13006
    31 Pfizer Investigational Site Marseille France 13009
    32 Pfizer Investigational Site Marseille France 13012
    33 Pfizer Investigational Site Metz France 57072
    34 Pfizer Investigational Site Montauban France 82017
    35 Pfizer Investigational Site Montbeliard France 25200
    36 Pfizer Investigational Site Montelimar France 26026
    37 Pfizer Investigational Site Montpellier France 34059
    38 Pfizer Investigational Site Mougins France 06250
    39 Pfizer Investigational Site Nancy France 54000
    40 Pfizer Investigational Site Nantes Cedex 2 France 44202
    41 Pfizer Investigational Site Neuilly France 92200
    42 Pfizer Investigational Site NICE Cedex 1 France 06050
    43 Pfizer Investigational Site Nimes France 30900
    44 Pfizer Investigational Site Paris France 75248
    45 Pfizer Investigational Site Pessac France 33600
    46 Pfizer Investigational Site Quincy sous Senart France 91480
    47 Pfizer Investigational Site Reims France 51100
    48 Pfizer Investigational Site Ris Orangis France 91130
    49 Pfizer Investigational Site Saint Brieuc France 22105
    50 Pfizer Investigational Site Saint Nazaire France 44600
    51 Pfizer Investigational Site St Cloud France 92210
    52 Pfizer Investigational Site St Herblain France 44805
    53 Pfizer Investigational Site Strasbourg France 67000
    54 Pfizer Investigational Site Toulon France 83056
    55 Pfizer Investigational Site Toulouse France 31000
    56 Pfizer Investigational Site Toulouse France 31400
    57 Pfizer Investigational Site Vandoeuvre les Nancy France 54511
    58 Pfizer Investigational Site Vannes France 56001
    59 Pfizer Investigational Site Vannes France 58000

    Sponsors and Collaborators

    • Pfizer

    Investigators

    • Study Director: Pfizer CT.gov Call Center, Pfizer

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Pfizer
    ClinicalTrials.gov Identifier:
    NCT00279448
    Other Study ID Numbers:
    • EXEAPO-0028-118
    • A5991081
    First Posted:
    Jan 19, 2006
    Last Update Posted:
    Dec 23, 2011
    Last Verified:
    Dec 1, 2011
    Additional relevant MeSH terms:
    Breast Neoplasms
    Tamoxifen
    Exemestane

    Study Results

    No Results Posted as of Dec 23, 2011