Randomized Phase III Study Of Exemestane (Aromasin) For 5 Years Versus Tamoxifen for 2.5 to 3 Years Followed By Exemestane
TEAM
2 other identifiers
interventional
9,779
1 country
179
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2001
Longer than P75 for phase_3
179 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2001
CompletedFirst Submitted
Initial submission to the registry
May 8, 2002
CompletedFirst Posted
Study publicly available on registry
May 9, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedResults Posted
Study results publicly available
December 4, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2011
CompletedOctober 28, 2015
October 1, 2015
7.2 years
May 8, 2002
October 30, 2009
October 6, 2015
Conditions
Outcome Measures
Primary Outcomes (2)
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
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
Secondary Outcomes (4)
Number of Events for Overall Survival (OS)
Baseline (Month 0) up to 5 years
Time to New Primary Breast Cancers
Baseline (Month 0) up to 5 years
Number of Events for Time to Relapse
Baseline (Month 0) up to 5 years
Number of Participants With New Primary Non-breast Cancers
Baseline (Month 0) up to 5 years
Study Arms (2)
exemestane
EXPERIMENTALtamoxifen + exemestane
EXPERIMENTALInterventions
tamoxifen, 20 mg, orally, daily, 2-3 years; followed by exemestane, orally, 25 mg, for a total of 5 years of therapy
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (179)
Pfizer Investigational Site
Bessemer, Alabama, 35022, United States
Pfizer Investigational Site
Birmingham, Alabama, 35205, United States
Pfizer Investigational Site
Birmingham, Alabama, 35209, United States
Pfizer Investigational Site
Birmingham, Alabama, 35211, United States
Pfizer Investigational Site
Birmingham, Alabama, 35213, United States
Pfizer Investigational Site
Birmingham, Alabama, 35235, United States
Pfizer Investigational Site
Flagstaff, Arizona, 86001, United States
Pfizer Investigational Site
Green Valley, Arizona, 85614, United States
Pfizer Investigational Site
Oro Valley, Arizona, 85737, United States
Pfizer Investigational Site
Phoenix, Arizona, 85012, United States
Pfizer Investigational Site
Safford, Arizona, 85546, United States
Pfizer Investigational Site
Scottsdale, Arizona, 85258, United States
Pfizer Investigational Site
Sedona, Arizona, 86336, United States
Pfizer Investigational Site
Tucson, Arizona, 85710, United States
Pfizer Investigational Site
Tucson, Arizona, 85712, United States
Pfizer Investigational Site
Tucson, Arizona, 85745, United States
Pfizer Investigational Site
Tuscon, Arizona, 85704, United States
Pfizer Investigational Site
North Little Rock, Arkansas, 72117, United States
Pfizer Investigational Site
Aurora, Colorado, 80012, United States
Pfizer Investigational Site
Boulder, Colorado, 80303, United States
Pfizer Investigational Site
Colorado Springs, Colorado, 80909, United States
Pfizer Investigational Site
Denver, Colorado, 80218, United States
Pfizer Investigational Site
Denver, Colorado, 80220, United States
Pfizer Investigational Site
Fort Collins, Colorado, *0524, United States
Pfizer Investigational Site
Lakewood, Colorado, 80228, United States
Pfizer Investigational Site
Lone Tree, Colorado, 80124, United States
Pfizer Investigational Site
Longmont, Colorado, 80501, United States
Pfizer Investigational Site
Pueblo, Colorado, 81008, United States
Pfizer Investigational Site
Thornton, Colorado, 80260-, United States
Pfizer Investigational Site
Clearwater, Florida, 33761, United States
Pfizer Investigational Site
Hudson, Florida, 34667, United States
Pfizer Investigational Site
Jacksonville, Florida, 32204, United States
Pfizer Investigational Site
Jacksonville, Florida, 32207, United States
Pfizer Investigational Site
Lauderhill, Florida, 33319, United States
Pfizer Investigational Site
Melbourne, Florida, 32901, United States
Pfizer Investigational Site
New Port Richey, Florida, 34655, United States
Pfizer Investigational Site
Ocala, Florida, 34474, United States
Pfizer Investigational Site
Orange Park, Florida, 32073, United States
Pfizer Investigational Site
Palatka, Florida, 32177, United States
Pfizer Investigational Site
Plantation, Florida, 33324, United States
Pfizer Investigational Site
Saint Augustine, Florida, 32086, United States
Pfizer Investigational Site
Alton, Illinois, 62002, United States
Pfizer Investigational Site
Arlington Heights, Illinois, �60005, United States
Pfizer Investigational Site
Niles, Illinois, 60714, United States
Pfizer Investigational Site
Winfield, Illinois, 60190, United States
Pfizer Investigational Site
Carmel, Indiana, 46032, United States
Pfizer Investigational Site
Fishers, Indiana, 46037, United States
Pfizer Investigational Site
Greenfield, Indiana, 46140, United States
Pfizer Investigational Site
Indianapolis, Indiana, 46219, United States
Pfizer Investigational Site
Indianapolis, Indiana, 46227, United States
Pfizer Investigational Site
Shelbyville, Indiana, 46176, United States
Pfizer Investigational Site
Terre Haute, Indiana, 47802, United States
Pfizer Investigational Site
Cedar Rapids, Iowa, 52403, United States
Pfizer Investigational Site
Kansas City, Kansas, 66112, United States
Pfizer Investigational Site
Shawnee Mission, Kansas, 66204, United States
Pfizer Investigational Site
Westminster, Maryland, 21157, United States
Pfizer Investigational Site
North Adams, Massachusetts, 01247, United States
Pfizer Investigational Site
Pittsfield, Massachusetts, 01201, United States
Pfizer Investigational Site
Burnsville, Minnesota, 55337, United States
Pfizer Investigational Site
Edina, Minnesota, 55435-2150, United States
Pfizer Investigational Site
Maplewood, Minnesota, 55109, United States
Pfizer Investigational Site
Saint Paul, Minnesota, 55102-2389, United States
Pfizer Investigational Site
Woodbury, Minnesota, 55125, United States
Pfizer Investigational Site
Columbia, Missouri, 65201, United States
Pfizer Investigational Site
Kansas City, Missouri, 64111, United States
Pfizer Investigational Site
Kansas City, Missouri, 64131, United States
Pfizer Investigational Site
Kansas City, Missouri, 64154, United States
Pfizer Investigational Site
Lee's Summit, Missouri, 29307, United States
Pfizer Investigational Site
Lee's Summit, Missouri, 64064, United States
Pfizer Investigational Site
St Louis, Missouri, 63136, United States
Pfizer Investigational Site
Las Vegas, Nevada, 89128, United States
Pfizer Investigational Site
Santa Fe, New Mexico, 87505, United States
Pfizer Investigational Site
Albany, New York, 12206, United States
Pfizer Investigational Site
Albany, New York, 12208, United States
Pfizer Investigational Site
Amsterdam, New York, 12010, United States
Pfizer Investigational Site
Brockport, New York, 14420, United States
Pfizer Investigational Site
Canandaigua, New York, 14424, United States
Pfizer Investigational Site
Geneva, New York, 14456, United States
Pfizer Investigational Site
Hudson, New York, 12534, United States
Pfizer Investigational Site
Latham, New York, 12110-0610, United States
Pfizer Investigational Site
Rexford, New York, 12148, United States
Pfizer Investigational Site
Troy, New York, 12180, United States
Pfizer Investigational Site
Asheville, North Carolina, 28801, United States
Pfizer Investigational Site
Cary, North Carolina, 27518, United States
Pfizer Investigational Site
Durham, North Carolina, 27704, United States
Pfizer Investigational Site
Elizabeth City, North Carolina, 27909, United States
Pfizer Investigational Site
Hickory, North Carolina, 28602, United States
Pfizer Investigational Site
Kernersville, North Carolina, 27284, United States
Pfizer Investigational Site
Lexington, North Carolina, 27295, United States
Pfizer Investigational Site
Raleigh, North Carolina, 27607, United States
Pfizer Investigational Site
Raleigh, North Carolina, 27614, United States
Pfizer Investigational Site
Seneca, North Carolina, 29672, United States
Pfizer Investigational Site
Winston-Salem, North Carolina, 27103, United States
Pfizer Investigational Site
Kettering, Ohio, 45409, United States
Pfizer Investigational Site
Bartlesville, Oklahoma, 74006, United States
Pfizer Investigational Site
Norman, Oklahoma, 73071, United States
Pfizer Investigational Site
Oklahoma City, Oklahoma, 73102, United States
Pfizer Investigational Site
Oklahoma City, Oklahoma, 73104-5020, United States
Pfizer Investigational Site
Oklahoma City, Oklahoma, 73109, United States
Pfizer Investigational Site
Oklahoma City, Oklahoma, 73112-4416, United States
Pfizer Investigational Site
Tulsa, Oklahoma, 74104, United States
Pfizer Investigational Site
Tulsa, Oklahoma, 74133, United States
Pfizer Investigational Site
Tulsa, Oklahoma, 74136, United States
Pfizer Investigational Site
Eugene, Oregon, 97401, United States
Pfizer Investigational Site
Portland, Oregon, 97210, United States
Pfizer Investigational Site
Portland, Oregon, 97213-2996, United States
Pfizer Investigational Site
Portland, Oregon, 97216, United States
Pfizer Investigational Site
Portland, Oregon, 97225, United States
Pfizer Investigational Site
Springfield, Oregon, 97477, United States
Pfizer Investigational Site
Tualatin, Oregon, 97062, United States
Pfizer Investigational Site
Kingston, Pennsylvania, 18704-5535, United States
Pfizer Investigational Site
Easley, South Carolina, 29640, United States
Pfizer Investigational Site
Greenville, South Carolina, 29605, United States
Pfizer Investigational Site
Greenville, South Carolina, 29615, United States
Pfizer Investigational Site
Spartanburg, South Carolina, 29307, United States
Pfizer Investigational Site
Abilene, Texas, 79606-5208, United States
Pfizer Investigational Site
Arlington, Texas, 76012, United States
Pfizer Investigational Site
Arlington, Texas, 76014, United States
Pfizer Investigational Site
Austin, Texas, 78731, United States
Pfizer Investigational Site
Austin, Texas, 78745, United States
Pfizer Investigational Site
Beaumont, Texas, 77702-1449, United States
Pfizer Investigational Site
Bedford, Texas, 76022', United States
Pfizer Investigational Site
Dallas, Texas, 75230-2510, United States
Pfizer Investigational Site
Dallas, Texas, 75231-4400, United States
Pfizer Investigational Site
Dallas, Texas, 75237, United States
Pfizer Investigational Site
Dallas, Texas, 75246, United States
Pfizer Investigational Site
Denton, Texas, 76210, United States
Pfizer Investigational Site
El Paso, Texas, 79902, United States
Pfizer Investigational Site
El Paso, Texas, 79915, United States
Pfizer Investigational Site
Fort Worth, Texas, 76104, United States
Pfizer Investigational Site
Fredericksburg, Texas, 78624, United States
Pfizer Investigational Site
Garland, Texas, 75042, United States
Pfizer Investigational Site
Houston, Texas, 77024, United States
Pfizer Investigational Site
Irving, Texas, 75061-224, United States
Pfizer Investigational Site
Kerrville, Texas, 78028, United States
Pfizer Investigational Site
Lewisville, Texas, 75067, United States
Pfizer Investigational Site
Longview, Texas, 75601, United States
Pfizer Investigational Site
McAllen, Texas, 78503, United States
Pfizer Investigational Site
Mesquite, Texas, 75150, United States
Pfizer Investigational Site
Midland, Texas, 79701, United States
Pfizer Investigational Site
New Braunfels, Texas, 78130, United States
Pfizer Investigational Site
Odessa, Texas, 79761, United States
Pfizer Investigational Site
Paris, Texas, 75460-5004, United States
Pfizer Investigational Site
Plano, Texas, 75075-7787, United States
Pfizer Investigational Site
Round Rock, Texas, 78681, United States
Pfizer Investigational Site
San Antonio, Texas, 78212, United States
Pfizer Investigational Site
San Antonio, Texas, 78217, United States
Pfizer Investigational Site
San Antonio, Texas, 78229, United States
Pfizer Investigational Site
San Antonio, Texas, 78258-3912, United States
Pfizer Investigational Site
Sherman, Texas, TX 75090-0504, United States
Pfizer Investigational Site
Tyler, Texas, 75702, United States
Pfizer Investigational Site
Waco, Texas, 76712, United States
Pfizer Investigational Site
Webster, Texas, 77598, United States
Pfizer Investigational Site
Weslaco, Texas, 78596, United States
Pfizer Investigational Site
Wichita Falls, Texas, 76310, United States
Pfizer Investigational Site
Chesapeake, Virginia, 23320, United States
Pfizer Investigational Site
Christianburg,, Virginia, 24073, United States
Pfizer Investigational Site
Christianburg, Virginia, 24073, United States
Pfizer Investigational Site
Fairfax, Virginia, 22031, United States
Pfizer Investigational Site
Gainesville, Virginia, 20155, United States
Pfizer Investigational Site
Hampton, Virginia, 23666, United States
Pfizer Investigational Site
Newport News, Virginia, 23606, United States
Pfizer Investigational Site
Norfolk, Virginia, 23502, United States
Pfizer Investigational Site
Pulaski, Virginia, 24301, United States
Pfizer Investigational Site
Roanoke, Virginia, 24101, United States
Pfizer Investigational Site
Salem, Virginia, 24153, United States
Pfizer Investigational Site
Williamsburg, Virginia, 23188, United States
Pfizer Investigational Site
Woodbridge, Virginia, 22191, United States
Pfizer Investigational Site
Wytheville, Virginia, 24382, United States
Pfizer Investigational Site
Burien, Washington, 98166, United States
Pfizer Investigational Site
Edmonds, Washington, 98026, United States
Pfizer Investigational Site
Seattle, Washington, 98133-8414, United States
Pfizer Investigational Site
Seattle, Washington, 98133, United States
Pfizer Investigational Site
Spokane, Washington, 99202, United States
Pfizer Investigational Site
Spokane, Washington, 99216, United States
Pfizer Investigational Site
Spokane, Washington, 99218, United States
Pfizer Investigational Site
Vancouver, Washington, 98684-6930, United States
Pfizer Investigational Site
Vancouver, Washington, 98684, United States
Pfizer Investigational Site
Vancouver, Washington, 98686, United States
Related Publications (5)
Bayani J, Kornaga EN, Crozier C, Jang GH, Bathurst L, Kalatskaya I, Trinh QM, Yao CQ, Livingstone J, Boutros PC, Spears M, McPherson JD, Stein LD, Rea D, Bartlett JMS. Identification of Distinct Prognostic Groups: Implications for Patient Selection to Targeted Therapies Among Anti-Endocrine Therapy-Resistant Early Breast Cancers. JCO Precis Oncol. 2019 Dec;3:1-13. doi: 10.1200/PO.18.00373.
PMID: 35100692DERIVEDNoordhoek I, Blok EJ, Meershoek-Klein Kranenbarg E, Putter H, Duijm-de Carpentier M, Rutgers EJT, Seynaeve C, Bartlett JMS, Vannetzel JM, Rea DW, Hasenburg A, Paridaens R, Markopoulos CJ, Hozumi Y, Portielje JEA, Kroep JR, van de Velde CJH, Liefers GJ. Overestimation of Late Distant Recurrences in High-Risk Patients With ER-Positive Breast Cancer: Validity and Accuracy of the CTS5 Risk Score in the TEAM and IDEAL Trials. J Clin Oncol. 2020 Oct 1;38(28):3273-3281. doi: 10.1200/JCO.19.02427. Epub 2020 Jul 24.
PMID: 32706636DERIVEDDerks MGM, Bastiaannet E, van de Water W, de Glas NA, Seynaeve C, Putter H, Nortier JWR, Rea D, Hasenburg A, Markopoulos C, Dirix LY, Portielje JEA, van de Velde CJH, Liefers GJ. Impact of age on breast cancer mortality and competing causes of death at 10 years follow-up in the adjuvant TEAM trial. Eur J Cancer. 2018 Aug;99:1-8. doi: 10.1016/j.ejca.2018.04.009. Epub 2018 Jun 6.
PMID: 29885375DERIVEDBartlett 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.
PMID: 24091623DERIVEDvan 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.
PMID: 21247627DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Overall Survival was reported as number of events which otherwise reported as time.
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 8, 2002
First Posted
May 9, 2002
Study Start
August 1, 2001
Primary Completion
October 1, 2008
Study Completion
February 1, 2011
Last Updated
October 28, 2015
Results First Posted
December 4, 2009
Record last verified: 2015-10