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

Completed · Phase 3

Conditions studied: Breast Neoplasms

In brief

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.

Key facts

Study ID

NCT00036270

Run by

Pfizer

People needed

9779

Starts

2001-08-01

Expected to finish

2011-02-01

Last updated by the study team

2015-10-28

Who can join

Age: 50 and older. Sex: female. Healthy volunteers: not accepted.

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.

Where it is running

• 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 — Flagstaff, Arizona, United States
• Pfizer Investigational Site — Green Valley, Arizona, United States
• Pfizer Investigational Site — Oro Valley, Arizona, United States
• Pfizer Investigational Site — Phoenix, Arizona, United States
• Pfizer Investigational Site — Safford, Arizona, United States
• Pfizer Investigational Site — Scottsdale, Arizona, United States
• Pfizer Investigational Site — Sedona, Arizona, 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 — Tuscon, Arizona, United States
• Pfizer Investigational Site — North Little Rock, Arkansas, United States
• Pfizer Investigational Site — Aurora, Colorado, United States
• Pfizer Investigational Site — Boulder, Colorado, United States
• Pfizer Investigational Site — Colorado Springs, Colorado, United States
• Pfizer Investigational Site — Denver, Colorado, United States
• Pfizer Investigational Site — Denver, Colorado, United States
• Pfizer Investigational Site — Fort Collins, Colorado, United States
• Pfizer Investigational Site — Lakewood, Colorado, United States
• Pfizer Investigational Site — Bessemer, Alabama, United States

Full record on ClinicalTrials.gov

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