Randomized Phase III Study Of Exemestane (Aromasin) For 5 Years Versus Tamoxifen for 2.5 to 3 Years Followed By Exemestane
| Status: | Completed |
|---|---|
| Conditions: | Breast Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 50 - Any |
| Updated: | 4/21/2016 |
| Start Date: | August 2001 |
| End Date: | February 2011 |
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
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.
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.
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.
We found this trial at
141
sites
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