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

Breast Neoplasms Clinical Trial

— TEAM  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00279448
• Other study ID #: EXEAPO-0028-118
• Secondary ID: A5991081
• Status: Completed
• Phase: Phase 3
• First received: January 17, 2006
• Last updated: December 22, 2011
• Start date: January 2002
• Est. completion date: June 2009

Study information

• Verified date: December 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9779
• Est. completion date: June 2009
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Drug:
• 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

Locations

Country	Name	City	State
France	Pfizer Investigational Site	Aix en Provence
France	Pfizer Investigational Site	Amiens
France	Pfizer Investigational Site	Annecy Cedex
France	Pfizer Investigational Site	Avignon Cedex 2
France	Pfizer Investigational Site	Bayonne
France	Pfizer Investigational Site	Blois
France	Pfizer Investigational Site	Bordeaux
France	Pfizer Investigational Site	Bordeaux CEDEX
France	Pfizer Investigational Site	Brest	Be1 04292
France	Pfizer Investigational Site	Brest
France	Pfizer Investigational Site	Cagne sur Mer
France	Pfizer Investigational Site	Chalon sur Saone
France	Pfizer Investigational Site	Chaumont
France	Pfizer Investigational Site	Compiegne	Be1 02256
France	Pfizer Investigational Site	Croix
France	Pfizer Investigational Site	Dijon
France	Pfizer Investigational Site	Douai
France	Pfizer Investigational Site	Draguignan
France	Pfizer Investigational Site	Dunkerque
France	Pfizer Investigational Site	Evreux
France	Pfizer Investigational Site	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 les Meaux
France	Pfizer Investigational Site	Marseille
France	Pfizer Investigational Site	Marseille
France	Pfizer Investigational Site	Marseille
France	Pfizer Investigational Site	Marseille	Be1 01971
France	Pfizer Investigational Site	Metz
France	Pfizer Investigational Site	Montauban
France	Pfizer Investigational Site	Montbeliard
France	Pfizer Investigational Site	Montelimar
France	Pfizer Investigational Site	Montpellier
France	Pfizer Investigational Site	Mougins
France	Pfizer Investigational Site	Nancy
France	Pfizer Investigational Site	Nantes Cedex 2
France	Pfizer Investigational Site	Neuilly
France	Pfizer Investigational Site	NICE Cedex 1
France	Pfizer Investigational Site	Nimes
France	Pfizer Investigational Site	Paris
France	Pfizer Investigational Site	Pessac
France	Pfizer Investigational Site	Quincy sous Senart
France	Pfizer Investigational Site	Reims
France	Pfizer Investigational Site	Rennes	Be1 03677
France	Pfizer Investigational Site	Ris Orangis
France	Pfizer Investigational Site	Saint Brieuc
France	Pfizer Investigational Site	Saint Nazaire
France	Pfizer Investigational Site	St Cloud
France	Pfizer Investigational Site	St Herblain
France	Pfizer Investigational Site	Strasbourg
France	Pfizer Investigational Site	Toulon
France	Pfizer Investigational Site	Toulouse
France	Pfizer Investigational Site	Toulouse
France	Pfizer Investigational Site	Vandoeuvre les Nancy
France	Pfizer Investigational Site	Vannes
France	Pfizer Investigational Site	Vannes

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare recurrence free survival between two treatment groups.		2.75 years and 5 years	Yes
Secondary	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	No
Secondary	Overall survival between the 2 treatment groups		Every 3 months during first year then every 6 months for 4 years	Yes
Secondary	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	Yes
Secondary	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	Yes

External Links

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