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

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.

Study Overview

• Status: Completed
• Conditions: Breast Neoplasms
• Intervention / Treatment: Drug: exemestane (Aromasin); Drug: tamoxifen + exemestane

• Study Type: Interventional
• Enrollment (Actual): 9779
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Bessemer, Alabama, United States, 35022
      • Pfizer Investigational Site
    • Birmingham, Alabama, United States, 35209
      • Pfizer Investigational Site
    • Birmingham, Alabama, United States, 35205
      • Pfizer Investigational Site
    • Birmingham, Alabama, United States, 35213
      • Pfizer Investigational Site
    • Birmingham, Alabama, United States, 35211
      • Pfizer Investigational Site
    • Birmingham, Alabama, United States, 35235
      • Pfizer Investigational Site
  • Arizona
    • Flagstaff, Arizona, United States, 86001
      • Pfizer Investigational Site
    • Green Valley, Arizona, United States, 85614
      • Pfizer Investigational Site
    • Oro Valley, Arizona, United States, 85737
      • Pfizer Investigational Site
    • Phoenix, Arizona, United States, 85012
      • Pfizer Investigational Site
    • Safford, Arizona, United States, 85546
      • Pfizer Investigational Site
    • Scottsdale, Arizona, United States, 85258
      • Pfizer Investigational Site
    • Sedona, Arizona, United States, 86336
      • Pfizer Investigational Site
    • Tucson, Arizona, United States, 85712
      • Pfizer Investigational Site
    • Tucson, Arizona, United States, 85710
      • Pfizer Investigational Site
    • Tucson, Arizona, United States, 85745
      • Pfizer Investigational Site
    • Tuscon, Arizona, United States, 85704
      • Pfizer Investigational Site
  • Arkansas
    • North Little Rock, Arkansas, United States, 72117
      • Pfizer Investigational Site
  • Colorado
    • Aurora, Colorado, United States, 80012
      • Pfizer Investigational Site
    • Boulder, Colorado, United States, 80303
      • Pfizer Investigational Site
    • Colorado Springs, Colorado, United States, 80909
      • Pfizer Investigational Site
    • Denver, Colorado, United States, 80220
      • Pfizer Investigational Site
    • Denver, Colorado, United States, 80218
      • Pfizer Investigational Site
    • Fort Collins, Colorado, United States, *0524
      • Pfizer Investigational Site
    • Lakewood, Colorado, United States, 80228
      • Pfizer Investigational Site
    • Lone Tree, Colorado, United States, 80124
      • Pfizer Investigational Site
    • Longmont,, Colorado, United States, 80501
      • Pfizer Investigational Site
    • Pueblo, Colorado, United States, 81008
      • Pfizer Investigational Site
    • Thornton, Colorado, United States, 80260-
      • Pfizer Investigational Site
  • Florida
    • Clearwater, Florida, United States, 33761
      • Pfizer Investigational Site
    • Hudson,, Florida, United States, 34667
      • Pfizer Investigational Site
    • Jacksonville, Florida, United States, 32207
      • Pfizer Investigational Site
    • Jacksonville, Florida, United States, 32204
      • Pfizer Investigational Site
    • Lauderhill, Florida, United States, 33319
      • Pfizer Investigational Site
    • Melbourne, Florida, United States, 32901
      • Pfizer Investigational Site
    • New Port Richey, Florida, United States, 34655
      • Pfizer Investigational Site
    • Ocala, Florida, United States, 34474
      • Pfizer Investigational Site
    • Orange Park, Florida, United States, 32073
      • Pfizer Investigational Site
    • Palatka, Florida, United States, 32177
      • Pfizer Investigational Site
    • Plantation, Florida, United States, 33324
      • Pfizer Investigational Site
    • St Augustine, Florida, United States, 32086
      • Pfizer Investigational Site
  • Illinois
    • Alton,, Illinois, United States, 62002
      • Pfizer Investigational Site
    • Arlington Heights, Illinois, United States, �60005
      • Pfizer Investigational Site
    • Niles, Illinois, United States, 60714
      • Pfizer Investigational Site
    • Winfield, Illinois, United States, 60190
      • Pfizer Investigational Site
  • Indiana
    • Carmel, Indiana, United States, 46032
      • Pfizer Investigational Site
    • Fishers, Indiana, United States, 46037
      • Pfizer Investigational Site
    • Greenfield, Indiana, United States, 46140
      • Pfizer Investigational Site
    • Indianapolis, Indiana, United States, 46219
      • Pfizer Investigational Site
    • Indianapolis,, Indiana, United States, 46227
      • Pfizer Investigational Site
    • Shelbyville, Indiana, United States, 46176
      • Pfizer Investigational Site
    • Terre Haute, Indiana, United States, 47802
      • Pfizer Investigational Site
  • Iowa
    • Cedar Rapids, Iowa, United States, 52403
      • Pfizer Investigational Site
  • Kansas
    • Kansas City, Kansas, United States, 66112
      • Pfizer Investigational Site
    • Shawnee Mission, Kansas, United States, 66204
      • Pfizer Investigational Site
  • Maryland
    • Westminster, Maryland, United States, 21157
      • Pfizer Investigational Site
  • Massachusetts
    • North Adams, Massachusetts, United States, 01247
      • Pfizer Investigational Site
    • Pittsfield, Massachusetts, United States, 01201
      • Pfizer Investigational Site
  • Minnesota
    • Burnsville, Minnesota, United States, 55337
      • Pfizer Investigational Site
    • Edina, Minnesota, United States, 55435-2150
      • Pfizer Investigational Site
    • Maplewood, Minnesota, United States, 55109
      • Pfizer Investigational Site
    • St. Paul, Minnesota, United States, 55102-2389
      • Pfizer Investigational Site
    • Woodbury,, Minnesota, United States, 55125
      • Pfizer Investigational Site
  • Missouri
    • Columbia, Missouri, United States, 65201
      • Pfizer Investigational Site
    • Kansas City, Missouri, United States, 64111
      • Pfizer Investigational Site
    • Kansas City, Missouri, United States, 64131
      • Pfizer Investigational Site
    • Kansas City, Missouri, United States, 64154
      • Pfizer Investigational Site
    • Lee's Summit, Missouri, United States, 64064
      • Pfizer Investigational Site
    • Lee's summit, Missouri, United States, 29307
      • Pfizer Investigational Site
    • St. Louis, Missouri, United States, 63136
      • Pfizer Investigational Site
  • Nevada
    • Las Vegas, Nevada, United States, 89128
      • Pfizer Investigational Site
  • New Mexico
    • Santa Fe, New Mexico, United States, 87505
      • Pfizer Investigational Site
  • New York
    • Albany, New York, United States, 12206
      • Pfizer Investigational Site
    • Albany,, New York, United States, 12208
      • Pfizer Investigational Site
    • Amsterdam,, New York, United States, 12010
      • Pfizer Investigational Site
    • Brockport, New York, United States, 14420
      • Pfizer Investigational Site
    • Canandaigua, New York, United States, 14424
      • Pfizer Investigational Site
    • Geneva, New York, United States, 14456
      • Pfizer Investigational Site
    • Hudson, New York, United States, 12534
      • Pfizer Investigational Site
    • Latham, New York, United States, 12110-0610
      • Pfizer Investigational Site
    • Rexford,, New York, United States, 12148
      • Pfizer Investigational Site
    • Troy,, New York, United States, 12180
      • Pfizer Investigational Site
  • North Carolina
    • Asheville, North Carolina, United States, 28801
      • Pfizer Investigational Site
    • Cary, North Carolina, United States, 27518
      • Pfizer Investigational Site
    • Durham, North Carolina, United States, 27704
      • Pfizer Investigational Site
    • Elizabeth City, North Carolina, United States, 27909
      • Pfizer Investigational Site
    • Hickory, North Carolina, United States, 28602
      • Pfizer Investigational Site
    • Kernersville, North Carolina, United States, 27284
      • Pfizer Investigational Site
    • Lexington, North Carolina, United States, 27295
      • Pfizer Investigational Site
    • Raleigh, North Carolina, United States, 27607
      • Pfizer Investigational Site
    • Raleigh, North Carolina, United States, 27614
      • Pfizer Investigational Site
    • Seneca, North Carolina, United States, 29672
      • Pfizer Investigational Site
    • Winston-salem, North Carolina, United States, 27103
      • Pfizer Investigational Site
  • Ohio
    • Kettering, Ohio, United States, 45409
      • Pfizer Investigational Site
  • Oklahoma
    • Bartlesville, Oklahoma, United States, 74006
      • Pfizer Investigational Site
    • Noman, Oklahoma, United States, 73071
      • Pfizer Investigational Site
    • Oklahoma City, Oklahoma, United States, 73102
      • Pfizer Investigational Site
    • Oklahoma City, Oklahoma, United States, 73104-5020
      • Pfizer Investigational Site
    • Oklahoma City, Oklahoma, United States, 73112-4416
      • Pfizer Investigational Site
    • Oklahoma city, Oklahoma, United States, 73109
      • Pfizer Investigational Site
    • Tulsa, Oklahoma, United States, 74133
      • Pfizer Investigational Site
    • Tulsa, Oklahoma, United States, 74136
      • Pfizer Investigational Site
    • Tulsa, Oklahoma, United States, 74104
      • Pfizer Investigational Site
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Pfizer Investigational Site
    • Portland, Oregon, United States, 97210
      • Pfizer Investigational Site
    • Portland, Oregon, United States, 97216
      • Pfizer Investigational Site
    • Portland, Oregon, United States, 97225
      • Pfizer Investigational Site
    • Portland, Oregon, United States, 97213-2996
      • Pfizer Investigational Site
    • Springfield, Oregon, United States, 97477
      • Pfizer Investigational Site
    • Tualatin, Oregon, United States, 97062
      • Pfizer Investigational Site
  • Pennsylvania
    • Kingston, Pennsylvania, United States, 18704-5535
      • Pfizer Investigational Site
  • South Carolina
    • Easley,, South Carolina, United States, 29640
      • Pfizer Investigational Site
    • Greenville, South Carolina, United States, 29615
      • Pfizer Investigational Site
    • Greenville, South Carolina, United States, 29605
      • Pfizer Investigational Site
    • Spartanburg, South Carolina, United States, 29307
      • Pfizer Investigational Site
  • Texas
    • Abilene, Texas, United States, 79606-5208
      • Pfizer Investigational Site
    • Arlington, Texas, United States, 76012
      • Pfizer Investigational Site
    • Arlington, Texas, United States, 76014
      • Pfizer Investigational Site
    • Austin, Texas, United States, 78745
      • Pfizer Investigational Site
    • Austin, Texas, United States, 78731
      • Pfizer Investigational Site
    • Beaumont, Texas, United States, 77702-1449
      • Pfizer Investigational Site
    • Bedford, Texas, United States, 76022'
      • Pfizer Investigational Site
    • Dallas, Texas, United States, 75230-2510
      • Pfizer Investigational Site
    • Dallas, Texas, United States, 75246
      • Pfizer Investigational Site
    • Dallas, Texas, United States, 75237
      • Pfizer Investigational Site
    • Dallas, Texas, United States, 75231-4400
      • Pfizer Investigational Site
    • Denton, Texas, United States, 76210
      • Pfizer Investigational Site
    • El Paso, Texas, United States, 79902
      • Pfizer Investigational Site
    • El Paso, Texas, United States, 79915
      • Pfizer Investigational Site
    • Fort Worth, Texas, United States, 76104
      • Pfizer Investigational Site
    • Fredericksburg, Texas, United States, 78624
      • Pfizer Investigational Site
    • Garland, Texas, United States, 75042
      • Pfizer Investigational Site
    • Houston, Texas, United States, 77024
      • Pfizer Investigational Site
    • Irving, Texas, United States, 75061-224
      • Pfizer Investigational Site
    • Kerrville,, Texas, United States, 78028
      • Pfizer Investigational Site
    • Lewisville, Texas, United States, 75067
      • Pfizer Investigational Site
    • Longview, Texas, United States, 75601
      • Pfizer Investigational Site
    • McAllen, Texas, United States, 78503
      • Pfizer Investigational Site
    • Mesquite, Texas, United States, 75150
      • Pfizer Investigational Site
    • Midland, Texas, United States, 79701
      • Pfizer Investigational Site
    • New Braunfels, Texas, United States, 78130
      • Pfizer Investigational Site
    • Odessa, Texas, United States, 79761
      • Pfizer Investigational Site
    • Paris, Texas, United States, 75460-5004
      • Pfizer Investigational Site
    • Plano, Texas, United States, 75075-7787
      • Pfizer Investigational Site
    • Round Rock, Texas, United States, 78681
      • Pfizer Investigational Site
    • San Antonio, Texas, United States, 78229
      • Pfizer Investigational Site
    • San Antonio, Texas, United States, 78217
      • Pfizer Investigational Site
    • San Antonio, Texas, United States, 78258-3912
      • Pfizer Investigational Site
    • San Antonio,, Texas, United States, 78212
      • Pfizer Investigational Site
    • Sherman, Texas, United States, TX 75090-0504
      • Pfizer Investigational Site
    • Tyler, Texas, United States, 75702
      • Pfizer Investigational Site
    • Waco, Texas, United States, 76712
      • Pfizer Investigational Site
    • Webster, Texas, United States, 77598
      • Pfizer Investigational Site
    • Weslaco, Texas, United States, 78596
      • Pfizer Investigational Site
    • Wichita Falls, Texas, United States, 76310
      • Pfizer Investigational Site
  • Virginia
    • Chesapeake, Virginia, United States, 23320
      • Pfizer Investigational Site
    • Christianburg, Virginia, United States, 24073
      • Pfizer Investigational Site
    • Christianburg,, Virginia, United States, 24073
      • Pfizer Investigational Site
    • Fairfax, Virginia, United States, 22031
      • Pfizer Investigational Site
    • Gainesville, Virginia, United States, 20155
      • Pfizer Investigational Site
    • Hampton,, Virginia, United States, 23666
      • Pfizer Investigational Site
    • Newport News, Virginia, United States, 23606
      • Pfizer Investigational Site
    • Norfolk, Virginia, United States, 23502
      • Pfizer Investigational Site
    • Pulaski, Virginia, United States, 24301
      • Pfizer Investigational Site
    • Roanoke, Virginia, United States, 24101
      • Pfizer Investigational Site
    • Salem, Virginia, United States, 24153
      • Pfizer Investigational Site
    • Williamsburg,, Virginia, United States, 23188
      • Pfizer Investigational Site
    • Woodbridge, Virginia, United States, 22191
      • Pfizer Investigational Site
    • Wytheville, Virginia, United States, 24382
      • Pfizer Investigational Site
  • Washington
    • Burien,, Washington, United States, 98166
      • Pfizer Investigational Site
    • Edmonds, Washington, United States, 98026
      • Pfizer Investigational Site
    • Seattle, Washington, United States, 98133
      • Pfizer Investigational Site
    • Seattle, Washington, United States, 98133-8414
      • Pfizer Investigational Site
    • Spokane, Washington, United States, 99202
      • Pfizer Investigational Site
    • Spokane, Washington, United States, 99216
      • Pfizer Investigational Site
    • Spokane, Washington, United States, 99218
      • Pfizer Investigational Site
    • Vancouver, Washington, United States, 98684
      • Pfizer Investigational Site
    • Vancouver, Washington, United States, 98686
      • Pfizer Investigational Site
    • Vancouver, Washington, United States, 98684-6930
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: exemestane	Drug: exemestane (Aromasin); exemestane, orally, 25 mg, for 5 years; Other Names: aromasin
Experimental: tamoxifen + exemestane	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

General Publications

• 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.
• Derks 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.
• 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.
• Noordhoek 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.
• 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.

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: August 1, 2001
• Primary Completion (Actual): October 1, 2008
• Study Completion (Actual): February 1, 2011

Study Registration Dates

• First Submitted: May 8, 2002
• First Submitted That Met QC Criteria: May 8, 2002
• First Posted (Estimate): May 9, 2002

Study Record Updates

• Last Update Posted (Estimate): October 28, 2015
• Last Update Submitted That Met QC Criteria: October 6, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Hormone Antagonists; Bone Density Conservation Agents; Aromatase Inhibitors; Steroid Synthesis Inhibitors; Estrogen Antagonists; Selective Estrogen Receptor Modulators; Estrogen Receptor Modulators; Tamoxifen; Exemestane
• Other Study ID Numbers: 971-ONC-0028-081; A5991026