Conditions: Breast Neoplasms
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 9779
Healthy volunteers: no

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.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: exemestane (Aromasin) intervention 2: tamoxifen + exemestane
Intervention descriptions: intervention 1: exemestane, orally, 25 mg, for 5 years intervention 2: tamoxifen, 20 mg, orally, daily, 2-3 years; followed by exemestane, orally, 25 mg, for a total of 5 years of therapy

Protocol document: