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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00279448
First received: January 17, 2006
Last updated: December 22, 2011
Last verified: December 2011

January 17, 2006
December 22, 2011
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.
Not Provided
Not Provided
 
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. 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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Neoplasms
  • Drug: exemestane
    On tablet of 25 mg per day during 5 years
    Other Name: Aromasin
  • Drug: 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 Name: Kessar
  • Experimental: A
    Intervention: Drug: exemestane
  • Active Comparator: B
    Intervention: Drug: tamoxifen

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
9779
June 2009
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
EXEAPO-0028-118, A5991081
Yes
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2011

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