Clinical trial NCT00036270: Randomized Phase III Study Of Exemestane (Aromasin) For 5 Years Versus Tamoxifen for 2.5 to 3 Years Followed By Exemestane
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Neoplasms
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2002-05-09
Enrollment: 9779
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Disease Free Survival (DFS): Number of Events (Disease Relapse or Death) From Baseline up to 2.75 Years
timeFrame: Baseline (Month 0) up to 2.75 years
measure: Disease Free Survival (DFS): Number of Events (Disease Relapse or Death) From Baseline up to 5 Years
timeFrame: Baseline (Month 0) up to 5 years
Secondary outcomes:
measure: Number of Events for Overall Survival (OS)
timeFrame: Baseline (Month 0) up to 5 years
measure: Time to New Primary Breast Cancers
timeFrame: Baseline (Month 0) up to 5 years
measure: Number of Events for Time to Relapse
timeFrame: Baseline (Month 0) up to 5 years
measure: Number of Participants With New Primary Non-breast Cancers
timeFrame: Baseline (Month 0) up to 5 years
Other outcomes:
Locations:
city: Bessemer
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Flagstaff
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Green Valley
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Oro Valley
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Safford
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Scottsdale
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Sedona
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Tucson
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Tucson
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Tucson
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Tuscon
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: North Little Rock
country: United States
facility: Pfizer Investigational Site
state: Arkansas
city: Aurora
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Boulder
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Colorado Springs
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Denver
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Denver
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Fort Collins
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Lakewood
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Lone Tree
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Longmont,
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Pueblo
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Thornton
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Clearwater
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Hudson,
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Lauderhill
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Melbourne
country: United States
facility: Pfizer Investigational Site
state: Florida
city: New Port Richey
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Ocala
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Orange Park
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Palatka
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Plantation
country: United States
facility: Pfizer Investigational Site
state: Florida
city: St Augustine
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Alton,
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Arlington Heights
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Niles
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Winfield
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Carmel
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Fishers
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Greenfield
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Indianapolis,
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Indianapolis
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Shelbyville
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Terre Haute
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Cedar Rapids
country: United States
facility: Pfizer Investigational Site
state: Iowa
city: Kansas City
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Shawnee Mission
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Westminster
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: North Adams
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Pittsfield
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Burnsville
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Edina
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Maplewood
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: St. Paul
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Woodbury,
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Columbia
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Kansas City
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Kansas City
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Kansas City
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Lee's summit
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Lee's Summit
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: St. Louis
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Las Vegas
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Santa Fe
country: United States
facility: Pfizer Investigational Site
state: New Mexico
city: Albany,
country: United States
facility: Pfizer Investigational Site
state: New York
city: Albany
country: United States
facility: Pfizer Investigational Site
state: New York
city: Amsterdam,
country: United States
facility: Pfizer Investigational Site
state: New York
city: Brockport
country: United States
facility: Pfizer Investigational Site
state: New York
city: Canandaigua
country: United States
facility: Pfizer Investigational Site
state: New York
city: Geneva
country: United States
facility: Pfizer Investigational Site
state: New York
city: Hudson
country: United States
facility: Pfizer Investigational Site
state: New York
city: Latham
country: United States
facility: Pfizer Investigational Site
state: New York
city: Rexford,
country: United States
facility: Pfizer Investigational Site
state: New York
city: Troy,
country: United States
facility: Pfizer Investigational Site
state: New York
city: Asheville
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Cary
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Durham
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Elizabeth City
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Hickory
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Kernersville
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Lexington
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Seneca
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Winston-salem
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Kettering
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Bartlesville
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Noman
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Oklahoma City
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Oklahoma City
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Oklahoma city
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Oklahoma City
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Tulsa
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Tulsa
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Tulsa
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Eugene
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Portland
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Portland
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Portland
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Portland
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Springfield
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Tualatin
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Kingston
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Easley,
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Greenville
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Greenville
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Spartanburg
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Abilene
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Arlington
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Arlington
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Austin
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Austin
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Beaumont
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Bedford
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Denton
country: United States
facility: Pfizer Investigational Site
state: Texas
city: El Paso
country: United States
facility: Pfizer Investigational Site
state: Texas
city: El Paso
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Fort Worth
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Fredericksburg
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Garland
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Irving
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Kerrville,
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Lewisville
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Longview
country: United States
facility: Pfizer Investigational Site
state: Texas
city: McAllen
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Mesquite
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Midland
country: United States
facility: Pfizer Investigational Site
state: Texas
city: New Braunfels
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Odessa
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Paris
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Plano
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Round Rock
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio,
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Sherman
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Tyler
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Waco
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Webster
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Weslaco
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Wichita Falls
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Chesapeake
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Christianburg,
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Christianburg
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Fairfax
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Gainesville
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Hampton,
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Newport News
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Norfolk
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Pulaski
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Roanoke
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Salem
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Williamsburg,
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Woodbridge
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Wytheville
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Burien,
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Edmonds
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Seattle
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Seattle
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Spokane
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Spokane
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Spokane
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Vancouver
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Vancouver
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Vancouver
country: United States
facility: Pfizer Investigational Site
state: Washington
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.