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Trial record 1 of 1 for:    NCT00279448
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Exemestane As Treatment In Adjuvant For Post-Menopausal Patients With Non-Metastatic Breast Cancer (TEAM)

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ClinicalTrials.gov Identifier: NCT00279448
Recruitment Status : Completed
First Posted : January 19, 2006
Last Update Posted : December 23, 2011
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE January 17, 2006
First Posted Date  ICMJE January 19, 2006
Last Update Posted Date December 23, 2011
Study Start Date  ICMJE January 2002
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 10, 2008)
To compare recurrence free survival between two treatment groups. [ Time Frame: 2.75 years and 5 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 18, 2006)
To compare recurrence free survival between two treatment groups.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 14, 2011)
  • 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 ]
  • Overall survival between the 2 treatment groups [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Every 3 months during first year then every 6 months dor 4 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 18, 2006)
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Exemestane As Treatment In Adjuvant For Post-Menopausal Patients With Non-Metastatic Breast Cancer
Official Title  ICMJE 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
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

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Neoplasms
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: A
    Intervention: Drug: exemestane
  • Active Comparator: B
    Intervention: Drug: tamoxifen
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 23, 2009)
9779
Original Enrollment  ICMJE
 (submitted: January 18, 2006)
1500
Actual Study Completion Date  ICMJE June 2009
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • Any of the following: HR-, non-menopausal patient, metastatic breast cancer
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00279448
Other Study ID Numbers  ICMJE EXEAPO-0028-118
A5991081
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date December 2011

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