Status: Closed
Activation Date: 2003JUN02
Closing Date: 2008JUL31
Phase: III
Description: A Randomized Phase III Trial of Exemestane Versus Anastrozole in Postmenopausal Women with Receptor Positive Primary Breast Cancer
Eligibility: Post-menopausal women who have histologically or cytologically confirmed, receptor-positive, adequately excised, primary breast cancer are eligible for this trial. Adjuvant chemotherapy and radiation are allowable. Chemotherapy must be completed before randomization. Radiotherapy may be given prior to or concurrently with protocol therapy.
Objective: To compare event free survival (EFS) between women treated with Exemestane or Anastrozole as adjuvant therapy. To compare the incidence of contralateral breast cancer, the time to distant recurrence, survival & safety among treatment groups.
Participation: NCIC CTG, CTSU sites, IBCSG
Lay Description: The purpose of this study is to compare the ability of Exemestane and Anasrozole to prevent the recurrence of breast cancer and to compare their side effects. Every patient will receive one of these two drugs. This research is being done because there is still a risk of breast cancer returning after surgery. While current chemotherapy and hormone therapy (eg Tamoxifen) are useful, we want to improve the chance that the cancer will not return and we do not know which of the drugs is better.
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Hide Tissue Samples
| Disease Site | Trial Code | Patients Accrued | Patients - Blocks | Patients - Slides | Patients - Blocks and/or Slides |
| BREAST | MA27 | 7576 | 3920 | 4029 | 4354 |
(Core size is 0.6 mm)
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Fluid Samples| Disease Site | Trial Code | Patients Accrued | TMA Blocks | Patients on TMA Blocks |
| BREAST | MA27 | 7576 | 79 | 3610 |
| Disease Site | Trial Code | Patients Accrued | Patients - Whole Blood | Patients - Cellular Component of Blood | Patients - DNA extracted from Blood | Patients - RNA extracted from Blood | Patients - Plasma | Patients - Serum | Patients - Urine | Patients - Buccal |
| BREAST | MA27 | 7576 | 3592 | 0 | 5038 | 0 | 5423 | 7 | 0 | 0 |