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Exemestane As Treatment In Adjuvant For Post-Menopausal Patients With Non-Metastatic Breast Cancer (TEAM)
This study is ongoing, but not recruiting participants.
Study NCT00279448   Information provided by Pfizer
First Received: January 17, 2006   Last Updated: November 20, 2009   History of Changes

January 17, 2006
November 20, 2009
January 2002
November 2008   (final data collection date for primary outcome measure)
To compare recurrence free survival between two treatment groups. [ Time Frame: 2.75 years and 5 years ] [ Designated as safety issue: Yes ]
To compare recurrence free survival between two treatment groups.
Complete list of historical versions of study NCT00279448 on ClinicalTrials.gov Archive Site
  • The quality of life of patients treated with exemestane to that of patients treated with tamoxifen [ Time Frame: Every 3 months during first year then every 6 months for 4 years ] [ Designated as safety issue: No ]
  • Overall survival between the 2 treatment groups [ Time Frame: Every 3 months during first year then every 6 months for 4 years ] [ Designated as safety issue: Yes ]
  • incidence of a second breast cancer (contralateral) between the 2 treatment groups [ Time Frame: Every 3 months during first year then every 6 months for 4 years ] [ Designated as safety issue: Yes ]
  • General tolerance in the short- and long-term between the 2 treatment groups [ Time Frame: Every 3 months during first year then every 6 months dor 4 years ] [ Designated as safety issue: Yes ]
  • To compare the following between the 2 treatment groups:
  • -Overall survival.
  • -The incidence of a second breast cancer (contralateral).
  • -General tolerance in the short- and long-term.
 
Exemestane As Treatment In Adjuvant For Post-Menopausal Patients With Non-Metastatic Breast Cancer
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

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.

 
Phase III
Interventional
Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Breast Neoplasms
  • Drug: exemestane
  • Drug: tamoxifen
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
9779
September 2011
November 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Any of the following: HR-, non-menopausal patient, metastatic breast cancer
Female
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00279448
Director, Clinical Trial Disclosure Group, Pfizer Inc
EXEAPO-0028-118
Pfizer
 
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP