At a glance
ClinicalIndex Comparison Record- ✓Histologically or cytologically confirmed breast adenocarcinoma
- ✓Adequate surgical resection and/or radiotherapy and/or adjuvant chemotherapy as indicated
- ✓Stage T1–3 N0–2 M0 (or any TNM stage for which adjuvant hormonal therapy is being considered)
- ✓Postmenopausal status
- ✕Inflammatory breast cancer
- ✕Histologically positive supraclavicular nodes
- ✕Ulceration or infiltration of skin by local metastasis
- ✕Neoadjuvant chemotherapy prior to enrollment
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating exemestane (Aromasin) and tamoxifen + exemestane for Breast Neoplasms. Completed, enrolled 9,779 participants across 179 sites.
Detailed 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.
Study Details
Timeline
Interventions
exemestane, orally, 25 mg, for 5 years
tamoxifen, 20 mg, orally, daily, 2-3 years; followed by exemestane, orally, 25 mg, for a total of 5 years of therapy