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Randomized Phase III Study Of Exemestane (Aromasin) For 5 Years Versus Tamoxifen for 2.5 to 3 Years Followed By Exemestane (TEAM)
This study is ongoing, but not recruiting participants.
First Received: May 8, 2002   Last Updated: September 10, 2009   History of Changes
Sponsor: Pfizer
Information provided by: Pfizer
ClinicalTrials.gov Identifier: NCT00036270
  Purpose

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.


Condition Intervention Phase
Breast Neoplasms
 Drug: exemestane (Aromasin)
Drug: tamoxifen + exemestane
 Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official 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

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer
Drug Information available for: Tamoxifen Tamoxifen citrate Exemestane
U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • To determine whether adjuvant treatment with exemestane improves the disease-free survival of postmenopausal, receptor positive, node negative or node positive breast cancer patients compared with adjuvant tamoxifen therapy at 2.75 and 5 years. [ Time Frame: 2.75 years; 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • The incidence of new primary breast cancers of the postmenopausal women treated with 5 years of exemestane (Aromasin) versus tamoxifen therapy for 2.5- 3 years followed by 2.5- 2 years of exemestane (Aromasin). [ Time Frame: 2.75 years; 5 years ] [ Designated as safety issue: No ]
  • The relative safety profiles [ Time Frame: 2.75 years; 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 2400
Study Start Date: October 2001
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
exemestane: Experimental Drug: exemestane (Aromasin)
exemestane, orally, 25 mg, for 5 years
tamoxifen + exemestane: Experimental 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

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00036270

  Hide Study Locations
Locations
United States, Alabama
Pfizer Investigational Site
Birmingham, Alabama, United States, 35205
Pfizer Investigational Site
Birmingham, Alabama, United States, 35235
Pfizer Investigational Site
Bessemer, Alabama, United States, 35022
Pfizer Investigational Site
Birmingham, Alabama, United States, 35209
Pfizer Investigational Site
Birmingham, Alabama, United States, 35213
Pfizer Investigational Site
Birmingham, Alabama, United States, 35211
United States, Arizona
Pfizer Investigational Site
Sedona, Arizona, United States, 86336
Pfizer Investigational Site
Flagstaff, Arizona, United States, 86001
Pfizer Investigational Site
Phoenix, Arizona, United States, 85012
Pfizer Investigational Site
scottsdale, Arizona, United States, 85258
Pfizer Investigational Site
Green Valley, Arizona, United States, 85614
Pfizer Investigational Site
Tucson, Arizona, United States, 85712
Pfizer Investigational Site
Tucson, Arizona, United States, 85745
United States, Colorado
Pfizer Investigational Site
Denver, Colorado, United States, 80218
Pfizer Investigational Site
Aurora, Colorado, United States, 80012
Pfizer Investigational Site
Pueblo, Colorado, United States, 81008
Pfizer Investigational Site
Colorado Springs, Colorado, United States, 80909
Pfizer Investigational Site
Denver, Colorado, United States, 80220
Pfizer Investigational Site
Thornton, Colorado, United States, 80260-
Pfizer Investigational Site
Boulder, Colorado, United States, 80303
Pfizer Investigational Site
Lone Tree, Colorado, United States, 80124
Pfizer Investigational Site
Longmont,, Colorado, United States, 80501
Pfizer Investigational Site
Lakewood, Colorado, United States, 80228
Pfizer Investigational Site
Fort Collins, Colorado, United States, *0524
United States, Florida
Pfizer Investigational Site
Melbourne, Florida, United States, 32901
Pfizer Investigational Site
Ocala, Florida, United States, 34474
Pfizer Investigational Site
Orange Park, Florida, United States, 32073
Pfizer Investigational Site
Hudson,, Florida, United States, 34667
Pfizer Investigational Site
Lauderhill, Florida, United States, 33319
Pfizer Investigational Site
Plantation, Florida, United States, 33324
Pfizer Investigational Site
New Port Richey, Florida, United States, 34655
Pfizer Investigational Site
Palatka, Florida, United States, 32177
Pfizer Investigational Site
St Augustine, Florida, United States, 32086
United States, Illinois
Pfizer Investigational Site
Niles, Illinois, United States, 60714
Pfizer Investigational Site
Arlington Heights, Illinois, United States, �60005
Pfizer Investigational Site
Winfield, Illinois, United States, 60190
Pfizer Investigational Site
Alton,, Illinois, United States, 62002
United States, Indiana
Pfizer Investigational Site
Terre Haute, Indiana, United States, 47802
Pfizer Investigational Site
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, 46227
Pfizer Investigational Site
Indianapolis, Indiana, United States, 46219
Pfizer Investigational Site
Shelbyville, Indiana, United States, 46176
United States, Iowa
Pfizer Investigational Site
Cedar Rapids, Iowa, United States, 52403
United States, Kansas
Pfizer Investigational Site
Kansas City, Kansas, United States, 66112
United States, Maryland
Pfizer Investigational Site
Westminster, Maryland, United States, 21157
United States, Massachusetts
Pfizer Investigational Site
Pittsfield, Massachusetts, United States, 01201
Pfizer Investigational Site
North Adams, Massachusetts, United States, 01247
United States, Minnesota
Pfizer Investigational Site
Minneapolis, Minnesota, United States, 55404
Pfizer Investigational Site
Woodbury,, Minnesota, United States, 55125
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
Burnsville, Minnesota, United States, 55337
United States, Missouri
Pfizer Investigational Site
St. Louis, Missouri, United States, 63136
Pfizer Investigational Site
Columbia, Missouri, United States, 65201
Pfizer Investigational Site
Lee's summit, Missouri, United States, 29307
Pfizer Investigational Site
Kansas City, Missouri, United States, 64131
Pfizer Investigational Site
Kansas City, Missouri, United States, 64111
Pfizer Investigational Site
Lee's Summit, Missouri, United States, 64064
Pfizer Investigational Site
Kansas City, Missouri, United States, 64154
United States, Nevada
Pfizer Investigational Site
Las Vegas, Nevada, United States, 89169
Pfizer Investigational Site
Las Vegas, Nevada, United States, 89128
United States, New Mexico
Pfizer Investigational Site
Santa Fe, New Mexico, United States, 87505
United States, New York
Pfizer Investigational Site
Albany, New York, United States, 12206
Pfizer Investigational Site
Latham, New York, United States, 12110-0610
Pfizer Investigational Site
Troy,, New York, United States, 12180
Pfizer Investigational Site
Amsterdam,, New York, United States, 12010
Pfizer Investigational Site
Hudson, New York, United States, 12534
Pfizer Investigational Site
Rexford,, New York, United States, 12148
Pfizer Investigational Site
Albany,, New York, United States, 12208
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
Rochester, New York, United States, 14626
United States, North Carolina
Pfizer Investigational Site
Cary, North Carolina, United States, 27518
Pfizer Investigational Site
Seneca, North Carolina, United States, 29672
Pfizer Investigational Site
Raleigh, North Carolina, United States, 27614
Pfizer Investigational Site
Raleigh, North Carolina, United States, 27607
Pfizer Investigational Site
Elizabeth City, North Carolina, United States, 27909
Pfizer Investigational Site
Hickory, North Carolina, United States, 28602
Pfizer Investigational Site
Durham, North Carolina, United States, 27704
United States, Ohio
Pfizer Investigational Site
Kettering, Ohio, United States, 45409
United States, Oklahoma
Pfizer Investigational Site
Bartlesville, Oklahoma, United States, 74006
Pfizer Investigational Site
Tulsa, Oklahoma, United States, 74136
Pfizer Investigational Site
Noman, Oklahoma, United States, 73071
Pfizer Investigational Site
Oklahoma city, Oklahoma, United States, 73109
United States, Oregon
Pfizer Investigational Site
Eugene, Oregon, United States, 97401
Pfizer Investigational Site
portland, Oregon, United States, 97225
Pfizer Investigational Site
Portland, Oregon, United States, 97213-2996
Pfizer Investigational Site
Tualatin, Oregon, United States, 97062
Pfizer Investigational Site
springfield, Oregon, United States, 97477
Pfizer Investigational Site
Portland, Oregon, United States, 97216
Pfizer Investigational Site
Portland, Oregon, United States, 97210
United States, Pennsylvania
Pfizer Investigational Site
Kingston, Pennsylvania, United States, 18704-5535
United States, South Carolina
Pfizer Investigational Site
Greenville, South Carolina, United States, 29601
Pfizer Investigational Site
Easley,, South Carolina, United States, 29640
Pfizer Investigational Site
Greenville, South Carolina, United States, 29605
Pfizer Investigational Site
Spartanburg, South Carolina, United States, 29307
Pfizer Investigational Site
Greenville, South Carolina, United States, 29615
United States, Texas
Pfizer Investigational Site
Houston, Texas, United States, 77060
Pfizer Investigational Site
Bedford, Texas, United States, 76022`
Pfizer Investigational Site
Round Rock, Texas, United States, 78681
Pfizer Investigational Site
Arlington, Texas, United States, 76014
Pfizer Investigational Site
Dallas, Texas, United States, 75246
Pfizer Investigational Site
Mesquite, Texas, United States, 75150
Pfizer Investigational Site
Garland, Texas, United States, 75042
Pfizer Investigational Site
Austin, Texas, United States, 78731
Pfizer Investigational Site
El Paso, Texas, United States, 79902
Pfizer Investigational Site
Houston, Texas, United States, 77024
Pfizer Investigational Site
Odessa, Texas, United States, 79761
Pfizer Investigational Site
McAllen, Texas, United States, 78503
Pfizer Investigational Site
Beaumont, Texas, United States, 77702-1449
Pfizer Investigational Site
Abilene, Texas, United States, 79606-5208
Pfizer Investigational Site
Lewisville, Texas, United States, 75067
Pfizer Investigational Site
Fredericksburg, Texas, United States, 78624
Pfizer Investigational Site
Sherman, Texas, United States, TX 75090-0504
Pfizer Investigational Site
Fort Worth, Texas, United States, 76104
Pfizer Investigational Site
fort worth, Texas, United States, 76104
Pfizer Investigational Site
Dallas, Texas, United States, 75230-2510
Pfizer Investigational Site
Plano, Texas, United States, 75075-7787
Pfizer Investigational Site
Arlington, Texas, United States, 76012
Pfizer Investigational Site
Austin, Texas, United States, 78745
Pfizer Investigational Site
El Paso, Texas, United States, 79915
Pfizer Investigational Site
Longview, Texas, United States, 75601
Pfizer Investigational Site
Weslaco, Texas, United States, 78596
Pfizer Investigational Site
Dallas, Texas, United States, 75231-4400
Pfizer Investigational Site
Waco, Texas, United States, 76712
Pfizer Investigational Site
Paris, Texas, United States, 75460-5004
Pfizer Investigational Site
New Braunfels, Texas, United States, 78130
Pfizer Investigational Site
San Antonio, Texas, United States, 78229
Pfizer Investigational Site
Denton, Texas, United States, 76210
Pfizer Investigational Site
Dallas, Texas, United States, 75237
Pfizer Investigational Site
Webster, Texas, United States, 77598
Pfizer Investigational Site
Midland, Texas, United States, 79701
Pfizer Investigational Site
Kerrville,, Texas, United States, 78028
Pfizer Investigational Site
San Antonio,, Texas, United States, 78212
Pfizer Investigational Site
San Antonio, Texas, United States, 78217
Pfizer Investigational Site
San Antonio, Texas, United States, 78258-3912
Pfizer Investigational Site
Wichita Falls, Texas, United States, 76310
Pfizer Investigational Site
Tyler, Texas, United States, 75702
Pfizer Investigational Site
Irving, Texas, United States, 75061-224
United States, Virginia
Pfizer Investigational Site
Norfolk, Virginia, United States, 23502
Pfizer Investigational Site
Roanoke, Virginia, United States, 24101
Pfizer Investigational Site
Salem, Virginia, United States, 24153
Pfizer Investigational Site
wytheville, Virginia, United States, 24382
Pfizer Investigational Site
Fairfax, Virginia, United States, 22031
Pfizer Investigational Site
woodbridge, Virginia, United States, 22191
Pfizer Investigational Site
Christianburg,, Virginia, United States, 24073
Pfizer Investigational Site
Hampton,, Virginia, United States, 23666
Pfizer Investigational Site
Newport News, Virginia, United States, 23606
Pfizer Investigational Site
Williamsburg,, Virginia, United States, 23188
Pfizer Investigational Site
Gainesville, Virginia, United States, 20155
Pfizer Investigational Site
Christianburg, Virginia, United States, 24073
Pfizer Investigational Site
Pulaski, Virginia, United States, 24301
Pfizer Investigational Site
Chesapeake, Virginia, United States, 23320
United States, Washington
Pfizer Investigational Site
Spokane, Washington, United States, 99202
Pfizer Investigational Site
Edmonds, Washington, United States, 98026
Pfizer Investigational Site
Burien,, Washington, United States, 98166
Pfizer Investigational Site
Vancouver, Washington, United States, 98686
Pfizer Investigational Site
Seattle, Washington, United States, 98133
Pfizer Investigational Site
Vancouver, Washington, United States, 98684
Pfizer Investigational Site
Vancouver, Washington, United States, 98684-6930
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers: 971-ONC-0028-081, A5991026
Study First Received: May 8, 2002
Last Updated: September 10, 2009
ClinicalTrials.gov Identifier: NCT00036270     History of Changes
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Estrogen Antagonists
Molecular Mechanisms of Pharmacological Action
Skin Diseases
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Breast Neoplasms
Enzyme Inhibitors
Bone Density Conservation Agents
 Selective Estrogen Receptor Modulators
Tamoxifen
Pharmacologic Actions
Estrogen Receptor Modulators
Neoplasms
Neoplasms by Site
Therapeutic Uses
Exemestane
Aromatase Inhibitors
Breast Diseases

ClinicalTrials.gov processed this record on November 22, 2009



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