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| Sponsors and Collaborators: |
International Breast Cancer Study Group Federation Nationale des Centres de Lutte Contre le Cancer Danish Breast Cancer Cooperative Group |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00004205 |
Purpose
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by reducing the production of estrogen. Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen by the tumor cells. If is not yet known which treatment regimen is most effective for breast cancer.
PURPOSE: Randomized double-blind phase III trial to compare the effectiveness of letrozole with that of tamoxifen in treating postmenopausal women who have breast cancer that has been surgically removed.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: letrozole Drug: tamoxifen citrate |
Phase III |
OBJECTIVES:
OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified according to adjuvant chemotherapy (prior therapy vs no prior or concurrent therapy vs concurrent therapy), prior surgery (modified radical mastectomy vs a lesser surgical procedure), and participating center. Patients are randomized to one of four treatment arms.
Patients may receive concurrent radiotherapy. Some patients receive concurrent adjuvant chemotherapy beginning within 8 weeks after surgery and continuing for no more than 6 months.
Patients are followed annually.
PROJECTED ACCRUAL: A total of 5,180 patients (1,295 per treatment arm) will be accrued for this study within 6 years.
Eligibility
DISEASE CHARACTERISTICS:
Histologically confirmed resectable adenocarcinoma of the breast
pN0, pN1, pN2, or M0
Negative nodal status
Unknown nodal status
Positive nodal status
Must have had total mastectomy, lumpectomy, or quadrantectomy
Postmenopausal
Regardless of prior hormonal replacement therapy (HRT) or hysterectomy:
No prior HRT:
No prior HRT or hysterectomy:
Prior HRT regardless of hysterectomy:
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| Denmark | |
| Rigshospitalet | |
| Copenhagen, Denmark, 2100 | |
| France | |
| Institut Bergonie | |
| Bordeaux, France, 33076 | |
| Switzerland | |
| Kantonsspital - St. Gallen | |
| St. Gallen, Switzerland, CH-9007 | |
| Study Chair: | Beat Thurlimann, MD | Kantonsspital - St. Gallen |
| Study Chair: | Louis Mauriac, MD | Institut Bergonie |
| Study Chair: | Henning T. Mouridsen, MD, PhD | Rigshospitalet, Denmark |
More Information