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

• 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.

• 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.

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.

• 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

• Bartlett JM, Brookes CL, Piper T, van de Velde CJ, Stocken D, Lyttle N, Hasenburg A, Quintayo MA, Kieback DG, Putter H, Markopoulos C, Kranenbarg EM, Mallon EA, Dirix LY, Seynaeve C, Rea DW. Do type 1 receptor tyrosine kinases inform treatment choice? A prospectively planned analysis of the TEAM trial. Br J Cancer. 2013 Oct 29;109(9):2453-61. doi: 10.1038/bjc.2013.609. Epub 2013 Oct 3.
• van de Velde CJ, Rea D, Seynaeve C, Putter H, Hasenburg A, Vannetzel JM, Paridaens R, Markopoulos C, Hozumi Y, Hille ET, Kieback DG, Asmar L, Smeets J, Nortier JW, Hadji P, Bartlett JM, Jones SE. Adjuvant tamoxifen and exemestane in early breast cancer (TEAM): a randomised phase 3 trial. Lancet. 2011 Jan 22;377(9762):321-31. doi: 10.1016/S0140-6736(10)62312-4.

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.