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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 | Clinical Trials | Clareo Health

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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

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

NCT00036270•Pfizer

View on ClinicalTrials.gov

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

Age

50 - No limit years

Sex

FEMALE

Healthy Volunteers

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.

Locations (179)

Pfizer Investigational Site

Bessemer, Alabama, United States

Pfizer Investigational Site