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

NCT00279448 | Completed Phase 3 DMC

• 2 other identifiers: EXEAPO-0028-118A5991081
• Study Type: interventional
• Target: 9,779
• Locations: 1 country
• Sites: 59

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

Conditions

Breast Neoplasms

Outcome Measures

Primary Outcomes (1)

• To compare recurrence free survival between two treatment groups.

  2.75 years and 5 years

Secondary Outcomes (4)

• 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

• Overall survival between the 2 treatment groups

  Every 3 months during first year then every 6 months for 4 years

• 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

• 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

Study Arms (2)

A

EXPERIMENTAL

Drug: exemestane

B

ACTIVE COMPARATOR

Drug: tamoxifen

Interventions

exemestane DRUG

On tablet of 25 mg per day during 5 years

Also known as: Aromasin

A

tamoxifen DRUG

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

Also known as: Kessar

B

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HR+ post-menopausal patients with non-metastatic breast cancer

You may not qualify if:

• Any of the following: HR-, non-menopausal patient, metastatic breast cancer

Sponsors & Collaborators

• Pfizer: lead

Study Sites (59)

Pfizer Investigational Site

Marseille, Be1 01971, 13285, France

Location

Pfizer Investigational Site

Compiègne, Be1 02256, 60200, France

Location

Pfizer Investigational Site

Rennes, Be1 03677, 35033, France

Location

Pfizer Investigational Site

Brest, Be1 04292, 29609, France

Location

Pfizer Investigational Site

Aix-en-Provence, 13616, France

Location

Pfizer Investigational Site

Amiens, 80000, France

Location

Pfizer Investigational Site

Annecy, 74011, France

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Pfizer Investigational Site

Avignon, 84082, France

Location

Pfizer Investigational Site

Bayonne, 64100, France

Location

Pfizer Investigational Site

Blois, 41000, France

Location

Pfizer Investigational Site

Bordeaux, 33000, France

Location

Pfizer Investigational Site

Bordeaux, 33076, France

Location

Pfizer Investigational Site

Brest, 29283, France

Location

Pfizer Investigational Site

Cagne Sur Mer, 06805, France

Location

Pfizer Investigational Site

Chalon-sur-Saône, 71100, France

Location

Pfizer Investigational Site

Chaumont, 52000, France

Location

Pfizer Investigational Site

Croix, 59170, France

Location

Pfizer Investigational Site

Dijon, 21000, France

Location

Pfizer Investigational Site

Douai, 59500, France

Location

Pfizer Investigational Site

Draguignan, 83007, France

Location

Pfizer Investigational Site

Dunkirk, 59240, France

Location

Pfizer Investigational Site

Évreux, 27000, France

Location

Pfizer Investigational Site

Hyres, 83400, France

Location

Pfizer Investigational Site

L'Union, 31240, France

Location

Pfizer Investigational Site

Le Havre, 76600, France

Location

Pfizer Investigational Site

Lille, 59000, France

Location

Pfizer Investigational Site

Lorient, France

Location

Pfizer Investigational Site

Lyon, 69008, France

Location

Pfizer Investigational Site

Mareuil-lès-Meaux, France

Location

Pfizer Investigational Site

Marseille, 13006, France

Location

Pfizer Investigational Site

Marseille, 13009, France

Location

Pfizer Investigational Site

Marseille, 13012, France

Location

Pfizer Investigational Site

Metz, 57072, France

Location

Pfizer Investigational Site

Montauban, 82017, France

Location

Pfizer Investigational Site

Montbéliard, 25200, France

Location

Pfizer Investigational Site

Montélimar, 26026, France

Location

Pfizer Investigational Site

Montpellier, 34059, France

Location

Pfizer Investigational Site

Mougins, 06250, France

Location

Pfizer Investigational Site

Nancy, 54000, France

Location

Pfizer Investigational Site

Nantes, 44202, France

Location

Pfizer Investigational Site

Neuilly, 92200, France

Location

Pfizer Investigational Site

Nice, 06050, France

Location

Pfizer Investigational Site

Nîmes, 30900, France

Location

Pfizer Investigational Site

Paris, 75248, France

Location

Pfizer Investigational Site

Pessac, 33600, France

Location

Pfizer Investigational Site

Quincy-sous-Sénart, 91480, France

Location

Pfizer Investigational Site

Reims, 51100, France

Location

Pfizer Investigational Site

Ris-Orangis, 91130, France

Location

Pfizer Investigational Site

Saint-Brieuc, 22105, France

Location

Pfizer Investigational Site

Saint-Cloud, 92210, France

Location

Pfizer Investigational Site

Saint-Herblain, 44805, France

Location

Pfizer Investigational Site

Saint-Nazaire, 44600, France

Location

Pfizer Investigational Site

Strasbourg, 67000, France

Location

Pfizer Investigational Site

Toulon, 83056, France

Location

Pfizer Investigational Site

Toulouse, 31000, France

Location

Pfizer Investigational Site

Toulouse, 31400, France

Location

Pfizer Investigational Site

Vandœuvre-lès-Nancy, 54511, France

Location

Pfizer Investigational Site

Vannes, 56001, France

Location

Pfizer Investigational Site

Vannes, 58000, France

Location

Related Publications (7)

• 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.

  PMID: 40633461 DERIVED

• 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.

  PMID: 35100692 DERIVED

• 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.

  PMID: 29885375 DERIVED

• 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.

  PMID: 28732650 DERIVED

• 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.

  PMID: 28659176 DERIVED

• 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.

  PMID: 24091623 DERIVED

• 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.

  PMID: 21247627 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.
• Link to TEAM Trial \[971-ONC-0028-081/A5991026\] Study Results

MeSH Terms

Conditions

Breast Neoplasms

Interventions

exemestane; Tamoxifen

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2006
• First Posted: January 19, 2006
• Study Start: January 1, 2002
• Primary Completion: November 1, 2008
• Study Completion: June 1, 2009
• Last Updated: December 23, 2011

Record last verified: 2011-12

Locations

FR (59)