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Randomized Phase III Study Of Exemestane (Aromasin) For 5 Years Versus Tamoxifen for 2.5 to 3 Years Followed By Exemestane (TEAM)

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ClinicalTrials.gov Identifier: NCT00036270
Recruitment Status : Completed
First Posted : May 9, 2002
Results First Posted : December 4, 2009
Last Update Posted : October 28, 2015
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE May 8, 2002
First Posted Date  ICMJE May 9, 2002
Results First Submitted Date  ICMJE October 30, 2009
Results First Posted Date  ICMJE December 4, 2009
Last Update Posted Date October 28, 2015
Study Start Date  ICMJE August 2001
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 27, 2012)
  • Disease Free Survival (DFS): Number of Events (Disease Relapse or Death) From Baseline up to 2.75 Years [ Time Frame: Baseline (Month 0) up to 2.75 years ]
    Number of events (disease relapse or death) to time of observation for DFS. DFS defined as time from randomization to earliest documentation of disease relapse or death from any cause in postmenopausal, receptor positive, node negative or node positive breast cancer patients for adjuvant treatment with exemestane compared with adjuvant tamoxifen therapy at 2.75 years. Disease relapse: primary tumor recurrence (locoregional or distant) and ipsilateral or contralateral breast cancer (CBC). Intercurrent death: death without disease relapse.
  • Disease Free Survival (DFS): Number of Events (Disease Relapse or Death) From Baseline up to 5 Years [ Time Frame: Baseline (Month 0) up to 5 years ]
    Number of events (disease relapse or death) to time of observation for DFS. DFS defined as time from randomization to earliest documentation of disease relapse or death from any cause in postmenopausal, receptor positive, node negative or node positive breast cancer patients for adjuvant treatment with exemestane compared with adjuvant tamoxifen therapy at 5 years. Disease relapse: primary tumor recurrence (locoregional or distant) and ipsilateral or contralateral breast cancer (CBC). Intercurrent death: death without disease relapse.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 27, 2012)
  • Number of Events for Overall Survival (OS) [ Time Frame: Baseline (Month 0) up to 5 years ]
    Number of events (death) to time of observation for OS. OS is the duration from randomization to death. For participants who are alive, overall survival is censored at the last contact.
  • Time to New Primary Breast Cancers [ Time Frame: Baseline (Month 0) up to 5 years ]
    New primary breast cancers were defined as events of ipsilateral/contralateral breast cancer (CBC).
  • Number of Events for Time to Relapse [ Time Frame: Baseline (Month 0) up to 5 years ]
    Number of events to time of observation for relapse. Relapse is defined as all recurrences of the primary tumor (loco-regional and distant recurrence), second primary breast cancer, contralateral breast cancer.
  • Number of Participants With New Primary Non-breast Cancers [ Time Frame: Baseline (Month 0) up to 5 years ]
    Number of participants with new primary non-breast cancers which included colorectal cancer, lung cancer, endometrial cancer, ductal carcinoma in situ (DCIS) and other primary cancer types.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Randomized Phase III Study Of Exemestane (Aromasin) For 5 Years Versus Tamoxifen for 2.5 to 3 Years Followed By Exemestane
Official Title  ICMJE Randomized Phase III Study Of Exemestane (Aromasin) For 5 Years Versus Tamoxifen For 2.5- 3 Years Followed By Exemestane (Aromasin) For A Total Of 5 Years As Adjuvant Therapy For Postmenopausal, Receptor Positive, Node Negative or Node Positive Breast Cancer Patients
Brief Summary

To compare the effects of exemestane for 5 years versus tamoxifen and exemestane given sequentially over 5 years in the adjuvant treatment of postmenopausal women with early breast cancer.

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.

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 (Aromasin)
    exemestane, orally, 25 mg, for 5 years
    Other Name: aromasin
  • Drug: tamoxifen + exemestane
    tamoxifen, 20 mg, orally, daily, 2-3 years; followed by exemestane, orally, 25 mg, for a total of 5 years of therapy
Study Arms  ICMJE
  • Experimental: exemestane
    Intervention: Drug: exemestane (Aromasin)
  • Experimental: tamoxifen + exemestane
    Intervention: Drug: tamoxifen + exemestane
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: June 29, 2011)
9779
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE February 2011
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically/cytologically confirmed adenocarcinoma of the breast, followed by adequate surgical resection and/or radiotherapy, and/or adjuvant chemotherapy, if indicated.
  • Stage T1-3 N0-2 Mo, Any TNM stage BC for whom adjuvant hormonal therapy is being considered.

Exclusion Criteria:

  • Those patients not deemed to have had potentially curative primary surgical treatment or one of the following criteria:
  • Inflammatory breast cancer
  • Histologically positive supraclavicular nodes
  • Ulceration/infiltration of local skin metastasis
  • Neoadjuvant chemotherapy
  • Ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS) without invasion
  • ER and PR negative primary tumor or ER/PR unknown status.
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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00036270
Other Study ID Numbers  ICMJE 971-ONC-0028-081
A5991026
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 October 2015

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