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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00036270
First received: May 8, 2002
Last updated: March 27, 2012
Last verified: March 2012

May 8, 2002
March 27, 2012
August 2001
October 2008   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
Not Provided
Complete list of historical versions of study NCT00036270 on ClinicalTrials.gov Archive Site
  • Number of Events for Overall Survival (OS) [ Time Frame: Baseline (Month 0) up to 5 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
Not Provided
Not Provided
Not Provided
 
Randomized Phase III Study Of Exemestane (Aromasin) For 5 Years Versus Tamoxifen for 2.5 to 3 Years Followed By Exemestane
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

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.

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 (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
  • Experimental: exemestane
    Intervention: Drug: exemestane (Aromasin)
  • Experimental: tamoxifen + exemestane
    Intervention: Drug: tamoxifen + exemestane

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
9779
February 2011
October 2008   (final data collection date for primary outcome measure)

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.
Female
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00036270
971-ONC-0028-081, A5991026
Yes
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2012

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