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

• Status: Completed
• Trial end date: 2011-02-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Exemestane; Tamoxifen

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.