Clinical trial NCT00279448: Exemestane As Treatment In Adjuvant For Post-Menopausal Patients With Non-Metastatic Breast Cancer
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Neoplasms
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-01-19
Enrollment: 9779
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: To compare recurrence free survival between two treatment groups.
timeFrame: 2.75 years and 5 years
Secondary outcomes:
measure: The quality of life of patients treated with exemestane to that of patients treated with tamoxifen
timeFrame: Every 3 months during first year then every 6 months for 4 years
measure: Overall survival between the 2 treatment groups
timeFrame: Every 3 months during first year then every 6 months for 4 years
measure: Incidence of a second breast cancer (contralateral) between the 2 treatment groups
timeFrame: Every 3 months during first year then every 6 months for 4 years
measure: General tolerance in the short- and long-term between the 2 treatment groups
timeFrame: Every 3 months during first year then every 6 months dor 4 years
Other outcomes:
Locations:
city: Marseille
country: France
facility: Pfizer Investigational Site
state: Be1 01971
city: Compiegne
country: France
facility: Pfizer Investigational Site
state: Be1 02256
city: Rennes
country: France
facility: Pfizer Investigational Site
state: Be1 03677
city: Brest
country: France
facility: Pfizer Investigational Site
state: Be1 04292
city: Aix en Provence
country: France
facility: Pfizer Investigational Site
city: Amiens
country: France
facility: Pfizer Investigational Site
city: Annecy Cedex
country: France
facility: Pfizer Investigational Site
city: Avignon Cedex 2
country: France
facility: Pfizer Investigational Site
city: Bayonne
country: France
facility: Pfizer Investigational Site
city: Blois
country: France
facility: Pfizer Investigational Site
city: Bordeaux CEDEX
country: France
facility: Pfizer Investigational Site
city: Bordeaux
country: France
facility: Pfizer Investigational Site
city: Brest
country: France
facility: Pfizer Investigational Site
city: Cagne sur Mer
country: France
facility: Pfizer Investigational Site
city: Chalon sur Saone
country: France
facility: Pfizer Investigational Site
city: Chaumont
country: France
facility: Pfizer Investigational Site
city: Croix
country: France
facility: Pfizer Investigational Site
city: Dijon
country: France
facility: Pfizer Investigational Site
city: Douai
country: France
facility: Pfizer Investigational Site
city: Draguignan
country: France
facility: Pfizer Investigational Site
city: Dunkerque
country: France
facility: Pfizer Investigational Site
city: Evreux
country: France
facility: Pfizer Investigational Site
city: Hyres
country: France
facility: Pfizer Investigational Site
city: L'Union
country: France
facility: Pfizer Investigational Site
city: Le Havre
country: France
facility: Pfizer Investigational Site
city: Lille
country: France
facility: Pfizer Investigational Site
city: Lorient
country: France
facility: Pfizer Investigational Site
city: Lyon
country: France
facility: Pfizer Investigational Site
city: Mareuil les Meaux
country: France
facility: Pfizer Investigational Site
city: Marseille
country: France
facility: Pfizer Investigational Site
city: Marseille
country: France
facility: Pfizer Investigational Site
city: Marseille
country: France
facility: Pfizer Investigational Site
city: Metz
country: France
facility: Pfizer Investigational Site
city: Montauban
country: France
facility: Pfizer Investigational Site
city: Montbeliard
country: France
facility: Pfizer Investigational Site
city: Montelimar
country: France
facility: Pfizer Investigational Site
city: Montpellier
country: France
facility: Pfizer Investigational Site
city: Mougins
country: France
facility: Pfizer Investigational Site
city: Nancy
country: France
facility: Pfizer Investigational Site
city: Nantes Cedex 2
country: France
facility: Pfizer Investigational Site
city: Neuilly
country: France
facility: Pfizer Investigational Site
city: NICE Cedex 1
country: France
facility: Pfizer Investigational Site
city: Nimes
country: France
facility: Pfizer Investigational Site
city: Paris
country: France
facility: Pfizer Investigational Site
city: Pessac
country: France
facility: Pfizer Investigational Site
city: Quincy sous Senart
country: France
facility: Pfizer Investigational Site
city: Reims
country: France
facility: Pfizer Investigational Site
city: Ris Orangis
country: France
facility: Pfizer Investigational Site
city: Saint Brieuc
country: France
facility: Pfizer Investigational Site
city: Saint Nazaire
country: France
facility: Pfizer Investigational Site
city: St Cloud
country: France
facility: Pfizer Investigational Site
city: St Herblain
country: France
facility: Pfizer Investigational Site
city: Strasbourg
country: France
facility: Pfizer Investigational Site
city: Toulon
country: France
facility: Pfizer Investigational Site
city: Toulouse
country: France
facility: Pfizer Investigational Site
city: Toulouse
country: France
facility: Pfizer Investigational Site
city: Vandoeuvre les Nancy
country: France
facility: Pfizer Investigational Site
city: Vannes
country: France
facility: Pfizer Investigational Site
city: Vannes
country: France
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.