Breast Neoplasms Clinical Trial
— TEAMOfficial title:
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
| Verified date | October 2015 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 9779 |
| Est. completion date | February 2011 |
| Est. primary completion date | October 2008 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 50 Years and older |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Pfizer Investigational Site | Abilene | Texas |
| United States | Pfizer Investigational Site | Albany | New York |
| United States | Pfizer Investigational Site | Albany, | New York |
| United States | Pfizer Investigational Site | Alton, | Illinois |
| United States | Pfizer Investigational Site | Amsterdam, | New York |
| United States | Pfizer Investigational Site | Arlington | Texas |
| United States | Pfizer Investigational Site | Arlington | Texas |
| United States | Pfizer Investigational Site | Arlington Heights | Illinois |
| United States | Pfizer Investigational Site | Asheville | North Carolina |
| United States | Pfizer Investigational Site | Aurora | Colorado |
| United States | Pfizer Investigational Site | Austin | Texas |
| United States | Pfizer Investigational Site | Austin | Texas |
| United States | Pfizer Investigational Site | Bartlesville | Oklahoma |
| United States | Pfizer Investigational Site | Beaumont | Texas |
| United States | Pfizer Investigational Site | Bedford | Texas |
| United States | Pfizer Investigational Site | Bessemer | Alabama |
| United States | Pfizer Investigational Site | Birmingham | Alabama |
| United States | Pfizer Investigational Site | Birmingham | Alabama |
| United States | Pfizer Investigational Site | Birmingham | Alabama |
| United States | Pfizer Investigational Site | Birmingham | Alabama |
| United States | Pfizer Investigational Site | Birmingham | Alabama |
| United States | Pfizer Investigational Site | Boulder | Colorado |
| United States | Pfizer Investigational Site | Brockport | New York |
| United States | Pfizer Investigational Site | Burien, | Washington |
| United States | Pfizer Investigational Site | Burnsville | Minnesota |
| United States | Pfizer Investigational Site | Canandaigua | New York |
| United States | Pfizer Investigational Site | Carmel | Indiana |
| United States | Pfizer Investigational Site | Cary | North Carolina |
| United States | Pfizer Investigational Site | Cedar Rapids | Iowa |
| United States | Pfizer Investigational Site | Chesapeake | Virginia |
| United States | Pfizer Investigational Site | Christianburg | Virginia |
| United States | Pfizer Investigational Site | Christianburg, | Virginia |
| United States | Pfizer Investigational Site | Clearwater | Florida |
| United States | Pfizer Investigational Site | Colorado Springs | Colorado |
| United States | Pfizer Investigational Site | Columbia | Missouri |
| United States | Pfizer Investigational Site | Dallas | Texas |
| United States | Pfizer Investigational Site | Dallas | Texas |
| United States | Pfizer Investigational Site | Dallas | Texas |
| United States | Pfizer Investigational Site | Dallas | Texas |
| United States | Pfizer Investigational Site | Denton | Texas |
| United States | Pfizer Investigational Site | Denver | Colorado |
| United States | Pfizer Investigational Site | Denver | Colorado |
| United States | Pfizer Investigational Site | Durham | North Carolina |
| United States | Pfizer Investigational Site | Easley, | South Carolina |
| United States | Pfizer Investigational Site | Edina | Minnesota |
| United States | Pfizer Investigational Site | Edmonds | Washington |
| United States | Pfizer Investigational Site | El Paso | Texas |
| United States | Pfizer Investigational Site | El Paso | Texas |
| United States | Pfizer Investigational Site | Elizabeth City | North Carolina |
| United States | Pfizer Investigational Site | Eugene | Oregon |
| United States | Pfizer Investigational Site | Fairfax | Virginia |
| United States | Pfizer Investigational Site | Fishers | Indiana |
| United States | Pfizer Investigational Site | Flagstaff | Arizona |
| United States | Pfizer Investigational Site | Fort Collins | Colorado |
| United States | Pfizer Investigational Site | Fort Worth | Texas |
| United States | Pfizer Investigational Site | Fredericksburg | Texas |
| United States | Pfizer Investigational Site | Gainesville | Virginia |
| United States | Pfizer Investigational Site | Garland | Texas |
| United States | Pfizer Investigational Site | Geneva | New York |
| United States | Pfizer Investigational Site | Green Valley | Arizona |
| United States | Pfizer Investigational Site | Greenfield | Indiana |
| United States | Pfizer Investigational Site | Greenville | South Carolina |
| United States | Pfizer Investigational Site | Greenville | South Carolina |
| United States | Pfizer Investigational Site | Hampton, | Virginia |
| United States | Pfizer Investigational Site | Hickory | North Carolina |
| United States | Pfizer Investigational Site | Houston | Texas |
| United States | Pfizer Investigational Site | Hudson | New York |
| United States | Pfizer Investigational Site | Hudson, | Florida |
| United States | Pfizer Investigational Site | Indianapolis | Indiana |
| United States | Pfizer Investigational Site | Indianapolis, | Indiana |
| United States | Pfizer Investigational Site | Irving | Texas |
| United States | Pfizer Investigational Site | Jacksonville | Florida |
| United States | Pfizer Investigational Site | Jacksonville | Florida |
| United States | Pfizer Investigational Site | Kansas City | Kansas |
| United States | Pfizer Investigational Site | Kansas City | Missouri |
| United States | Pfizer Investigational Site | Kansas City | Missouri |
| United States | Pfizer Investigational Site | Kansas City | Missouri |
| United States | Pfizer Investigational Site | Kernersville | North Carolina |
| United States | Pfizer Investigational Site | Kerrville, | Texas |
| United States | Pfizer Investigational Site | Kettering | Ohio |
| United States | Pfizer Investigational Site | Kingston | Pennsylvania |
| United States | Pfizer Investigational Site | Lakewood | Colorado |
| United States | Pfizer Investigational Site | Las Vegas | Nevada |
| United States | Pfizer Investigational Site | Latham | New York |
| United States | Pfizer Investigational Site | Lauderhill | Florida |
| United States | Pfizer Investigational Site | Lee's summit | Missouri |
| United States | Pfizer Investigational Site | Lee's Summit | Missouri |
| United States | Pfizer Investigational Site | Lewisville | Texas |
| United States | Pfizer Investigational Site | Lexington | North Carolina |
| United States | Pfizer Investigational Site | Lone Tree | Colorado |
| United States | Pfizer Investigational Site | Longmont, | Colorado |
| United States | Pfizer Investigational Site | Longview | Texas |
| United States | Pfizer Investigational Site | Maplewood | Minnesota |
| United States | Pfizer Investigational Site | McAllen | Texas |
| United States | Pfizer Investigational Site | Melbourne | Florida |
| United States | Pfizer Investigational Site | Mesquite | Texas |
| United States | Pfizer Investigational Site | Midland | Texas |
| United States | Pfizer Investigational Site | New Braunfels | Texas |
| United States | Pfizer Investigational Site | New Port Richey | Florida |
| United States | Pfizer Investigational Site | Newport News | Virginia |
| United States | Pfizer Investigational Site | Niles | Illinois |
| United States | Pfizer Investigational Site | Noman | Oklahoma |
| United States | Pfizer Investigational Site | Norfolk | Virginia |
| United States | Pfizer Investigational Site | North Adams | Massachusetts |
| United States | Pfizer Investigational Site | North Little Rock | Arkansas |
| United States | Pfizer Investigational Site | Ocala | Florida |
| United States | Pfizer Investigational Site | Odessa | Texas |
| United States | Pfizer Investigational Site | Oklahoma City | Oklahoma |
| United States | Pfizer Investigational Site | Oklahoma City | Oklahoma |
| United States | Pfizer Investigational Site | Oklahoma city | Oklahoma |
| United States | Pfizer Investigational Site | Oklahoma City | Oklahoma |
| United States | Pfizer Investigational Site | Orange Park | Florida |
| United States | Pfizer Investigational Site | Oro Valley | Arizona |
| United States | Pfizer Investigational Site | Palatka | Florida |
| United States | Pfizer Investigational Site | Paris | Texas |
| United States | Pfizer Investigational Site | Phoenix | Arizona |
| United States | Pfizer Investigational Site | Pittsfield | Massachusetts |
| United States | Pfizer Investigational Site | Plano | Texas |
| United States | Pfizer Investigational Site | Plantation | Florida |
| United States | Pfizer Investigational Site | Portland | Oregon |
| United States | Pfizer Investigational Site | Portland | Oregon |
| United States | Pfizer Investigational Site | Portland | Oregon |
| United States | Pfizer Investigational Site | Portland | Oregon |
| United States | Pfizer Investigational Site | Pueblo | Colorado |
| United States | Pfizer Investigational Site | Pulaski | Virginia |
| United States | Pfizer Investigational Site | Raleigh | North Carolina |
| United States | Pfizer Investigational Site | Raleigh | North Carolina |
| United States | Pfizer Investigational Site | Rexford, | New York |
| United States | Pfizer Investigational Site | Roanoke | Virginia |
| United States | Pfizer Investigational Site | Round Rock | Texas |
| United States | Pfizer Investigational Site | Safford | Arizona |
| United States | Pfizer Investigational Site | Salem | Virginia |
| United States | Pfizer Investigational Site | San Antonio | Texas |
| United States | Pfizer Investigational Site | San Antonio | Texas |
| United States | Pfizer Investigational Site | San Antonio | Texas |
| United States | Pfizer Investigational Site | San Antonio, | Texas |
| United States | Pfizer Investigational Site | Santa Fe | New Mexico |
| United States | Pfizer Investigational Site | Scottsdale | Arizona |
| United States | Pfizer Investigational Site | Seattle | Washington |
| United States | Pfizer Investigational Site | Seattle | Washington |
| United States | Pfizer Investigational Site | Sedona | Arizona |
| United States | Pfizer Investigational Site | Seneca | North Carolina |
| United States | Pfizer Investigational Site | Shawnee Mission | Kansas |
| United States | Pfizer Investigational Site | Shelbyville | Indiana |
| United States | Pfizer Investigational Site | Sherman | Texas |
| United States | Pfizer Investigational Site | Spartanburg | South Carolina |
| United States | Pfizer Investigational Site | Spokane | Washington |
| United States | Pfizer Investigational Site | Spokane | Washington |
| United States | Pfizer Investigational Site | Spokane | Washington |
| United States | Pfizer Investigational Site | Springfield | Oregon |
| United States | Pfizer Investigational Site | St Augustine | Florida |
| United States | Pfizer Investigational Site | St. Louis | Missouri |
| United States | Pfizer Investigational Site | St. Paul | Minnesota |
| United States | Pfizer Investigational Site | Terre Haute | Indiana |
| United States | Pfizer Investigational Site | Thornton | Colorado |
| United States | Pfizer Investigational Site | Troy, | New York |
| United States | Pfizer Investigational Site | Tualatin | Oregon |
| United States | Pfizer Investigational Site | Tucson | Arizona |
| United States | Pfizer Investigational Site | Tucson | Arizona |
| United States | Pfizer Investigational Site | Tucson | Arizona |
| United States | Pfizer Investigational Site | Tulsa | Oklahoma |
| United States | Pfizer Investigational Site | Tulsa | Oklahoma |
| United States | Pfizer Investigational Site | Tulsa | Oklahoma |
| United States | Pfizer Investigational Site | Tuscon | Arizona |
| United States | Pfizer Investigational Site | Tyler | Texas |
| United States | Pfizer Investigational Site | Vancouver | Washington |
| United States | Pfizer Investigational Site | Vancouver | Washington |
| United States | Pfizer Investigational Site | Vancouver | Washington |
| United States | Pfizer Investigational Site | Waco | Texas |
| United States | Pfizer Investigational Site | Webster | Texas |
| United States | Pfizer Investigational Site | Weslaco | Texas |
| United States | Pfizer Investigational Site | Westminster | Maryland |
| United States | Pfizer Investigational Site | Wichita Falls | Texas |
| United States | Pfizer Investigational Site | Williamsburg, | Virginia |
| United States | Pfizer Investigational Site | Winfield | Illinois |
| United States | Pfizer Investigational Site | Winston-salem | North Carolina |
| United States | Pfizer Investigational Site | Woodbridge | Virginia |
| United States | Pfizer Investigational Site | Woodbury, | Minnesota |
| United States | Pfizer Investigational Site | Wytheville | Virginia |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Disease Free Survival (DFS): Number of Events (Disease Relapse or Death) From Baseline 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. | Baseline (Month 0) up to 2.75 years | No |
| Primary | Disease Free Survival (DFS): Number of Events (Disease Relapse or Death) From Baseline 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. | Baseline (Month 0) up to 5 years | No |
| Secondary | Number of Events for Overall Survival (OS) | 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. | Baseline (Month 0) up to 5 years | No |
| Secondary | Time to New Primary Breast Cancers | New primary breast cancers were defined as events of ipsilateral/contralateral breast cancer (CBC). | Baseline (Month 0) up to 5 years | No |
| Secondary | Number of Events for Time to Relapse | 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. | Baseline (Month 0) up to 5 years | No |
| Secondary | Number of Participants With New Primary Non-breast Cancers | 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. | Baseline (Month 0) up to 5 years | No |
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