Status: Closed
Activation Date: 1998AUG24
Closing Date: 2002SEP04
Phase: III
Description: A Phase III Randomized Double Blind Study of Letrozole versus Placebo in Women with Primary Breast Cancer Completing Five or More Years of Adjuvant Tamoxifen
Eligibility: Post-menopausal women who had receptor-positive breast cancer, or unknown receptor status breast cancer, and have completed at least five years of adjuvant tamoxifen therapy.
Objective: To compare disease-free survival and overall survival. To compare incidence of contralateral breast cancer, and long-term clinical and laboratory safety. To evaluate overall quality of life.
Participation: Open to centres in participating cooperative groups.
Lay Description: The purpose of this study is to find out whether it is better to receive letrozole or no further treatment after stopping tamoxifen. To do this, half of the patients in the study will receive letrozole and the other half will receive a placebo (a preparation with no active substance of medicinal value). Treatment with letrozole or placebo will begin within three months of tamoxifen being stopped.
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Inventory
Hide Tissue Samples
| Disease Site | Trial Code | Patients Accrued | Patients - Blocks | Patients - Slides | Patients - Blocks and/or Slides |
| BREAST | MA17 | 5187 | 873 | 564 | 1081 |
(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 | MA17 | 5187 | 1 | 23 |
| 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 | MA17 | 5187 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |