Exemestane As Treatment In Adjuvant For Post-Menopausal Patients With Non-Metastatic Breast Cancer
NCT ID: NCT00279448
Last Updated: 2011-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
9779 participants
INTERVENTIONAL
2002-01-31
2009-06-30
Brief Summary
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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
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A
exemestane
On tablet of 25 mg per day during 5 years
B
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
Interventions
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exemestane
On tablet of 25 mg per day during 5 years
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
50 Years
FEMALE
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Marseille, Be1 01971, France
Pfizer Investigational Site
Compiègne, Be1 02256, France
Pfizer Investigational Site
Rennes, Be1 03677, France
Pfizer Investigational Site
Brest, Be1 04292, France
Pfizer Investigational Site
Aix-en-Provence, , France
Pfizer Investigational Site
Amiens, , France
Pfizer Investigational Site
Annecy, , France
Pfizer Investigational Site
Avignon, , France
Pfizer Investigational Site
Bayonne, , France
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Blois, , France
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Bordeaux, , France
Pfizer Investigational Site
Bordeaux, , France
Pfizer Investigational Site
Brest, , France
Pfizer Investigational Site
Cagne Sur Mer, , France
Pfizer Investigational Site
Chalon-sur-Saône, , France
Pfizer Investigational Site
Chaumont, , France
Pfizer Investigational Site
Croix, , France
Pfizer Investigational Site
Dijon, , France
Pfizer Investigational Site
Douai, , France
Pfizer Investigational Site
Draguignan, , France
Pfizer Investigational Site
Dunkirk, , France
Pfizer Investigational Site
Évreux, , France
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Hyres, , France
Pfizer Investigational Site
L'Union, , France
Pfizer Investigational Site
Le Havre, , France
Pfizer Investigational Site
Lille, , France
Pfizer Investigational Site
Lorient, , France
Pfizer Investigational Site
Lyon, , France
Pfizer Investigational Site
Mareuil-lès-Meaux, , France
Pfizer Investigational Site
Marseille, , France
Pfizer Investigational Site
Marseille, , France
Pfizer Investigational Site
Marseille, , France
Pfizer Investigational Site
Metz, , France
Pfizer Investigational Site
Montauban, , France
Pfizer Investigational Site
Montbéliard, , France
Pfizer Investigational Site
Montélimar, , France
Pfizer Investigational Site
Montpellier, , France
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Mougins, , France
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Nancy, , France
Pfizer Investigational Site
Nantes, , France
Pfizer Investigational Site
Neuilly, , France
Pfizer Investigational Site
Nice, , France
Pfizer Investigational Site
Nîmes, , France
Pfizer Investigational Site
Paris, , France
Pfizer Investigational Site
Pessac, , France
Pfizer Investigational Site
Quincy-sous-Sénart, , France
Pfizer Investigational Site
Reims, , France
Pfizer Investigational Site
Ris-Orangis, , France
Pfizer Investigational Site
Saint-Brieuc, , France
Pfizer Investigational Site
Saint-Cloud, , France
Pfizer Investigational Site
Saint-Herblain, , France
Pfizer Investigational Site
Saint-Nazaire, , France
Pfizer Investigational Site
Strasbourg, , France
Pfizer Investigational Site
Toulon, , France
Pfizer Investigational Site
Toulouse, , France
Pfizer Investigational Site
Toulouse, , France
Pfizer Investigational Site
Vandœuvre-lès-Nancy, , France
Pfizer Investigational Site
Vannes, , France
Pfizer Investigational Site
Vannes, , France
Countries
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References
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Beltran-Bless AA, Pond GR, Bayani J, Barker SL, Spears M, Mallon E, Taylor KJ, Hasenburg A, Markopoulos C, Dirix L, Meershoek-Klein Kranenbarg E, van de Velde CJH, Rea DW, Vandermeer L, Hilton J, Bartlett JMS, Clemons M. Does RSClin provide additional information over classic clinico-pathologic scores (PREDICT 2.1, INFLUENCE 2.0, CTS5)? Breast. 2025 Oct;83:104528. doi: 10.1016/j.breast.2025.104528. Epub 2025 Jul 4.
Bayani J, Kornaga EN, Crozier C, Jang GH, Bathurst L, Kalatskaya I, Trinh QM, Yao CQ, Livingstone J, Boutros PC, Spears M, McPherson JD, Stein LD, Rea D, Bartlett JMS. Identification of Distinct Prognostic Groups: Implications for Patient Selection to Targeted Therapies Among Anti-Endocrine Therapy-Resistant Early Breast Cancers. JCO Precis Oncol. 2019 Dec;3:1-13. doi: 10.1200/PO.18.00373.
Derks MGM, Bastiaannet E, van de Water W, de Glas NA, Seynaeve C, Putter H, Nortier JWR, Rea D, Hasenburg A, Markopoulos C, Dirix LY, Portielje JEA, van de Velde CJH, Liefers GJ. Impact of age on breast cancer mortality and competing causes of death at 10 years follow-up in the adjuvant TEAM trial. Eur J Cancer. 2018 Aug;99:1-8. doi: 10.1016/j.ejca.2018.04.009. Epub 2018 Jun 6.
Derks MGM, Blok EJ, Seynaeve C, Nortier JWR, Kranenbarg EM, Liefers GJ, Putter H, Kroep JR, Rea D, Hasenburg A, Markopoulos C, Paridaens R, Smeets JBE, Dirix LY, van de Velde CJH. Adjuvant tamoxifen and exemestane in women with postmenopausal early breast cancer (TEAM): 10-year follow-up of a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2017 Sep;18(9):1211-1220. doi: 10.1016/S1470-2045(17)30419-9. Epub 2017 Jul 18.
Kalatskaya I, Trinh QM, Spears M, McPherson JD, Bartlett JMS, Stein L. ISOWN: accurate somatic mutation identification in the absence of normal tissue controls. Genome Med. 2017 Jun 29;9(1):59. doi: 10.1186/s13073-017-0446-9.
Bartlett JM, Brookes CL, Piper T, van de Velde CJ, Stocken D, Lyttle N, Hasenburg A, Quintayo MA, Kieback DG, Putter H, Markopoulos C, Kranenbarg EM, Mallon EA, Dirix LY, Seynaeve C, Rea DW. Do type 1 receptor tyrosine kinases inform treatment choice? A prospectively planned analysis of the TEAM trial. Br J Cancer. 2013 Oct 29;109(9):2453-61. doi: 10.1038/bjc.2013.609. Epub 2013 Oct 3.
van de Velde CJ, Rea D, Seynaeve C, Putter H, Hasenburg A, Vannetzel JM, Paridaens R, Markopoulos C, Hozumi Y, Hille ET, Kieback DG, Asmar L, Smeets J, Nortier JW, Hadji P, Bartlett JM, Jones SE. Adjuvant tamoxifen and exemestane in early breast cancer (TEAM): a randomised phase 3 trial. Lancet. 2011 Jan 22;377(9762):321-31. doi: 10.1016/S0140-6736(10)62312-4.
Related Links
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To obtain contact information for a study center near you, click here.
Link to TEAM Trial \[971-ONC-0028-081/A5991026\] Study Results
Other Identifiers
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A5991081
Identifier Type: -
Identifier Source: secondary_id
EXEAPO-0028-118
Identifier Type: -
Identifier Source: org_study_id