Home
Search
Study Topics
Glossary
|
|
|
|
|
|
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 |
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 |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control |
Official Title: | A Phase III Study to Evaluate Letrozole as Adjuvant Endocrine Therapy for Postmenopausal Women With Receptor (ER and/or PgR) Positive Tumors |
Study Start Date: | March 1998 |
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.
Ages Eligible for Study: | 30 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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:
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 |
Study ID Numbers: | CDR0000067451, IBCSG-1-98, DAN-DBCG-IBCSG-1-98, FRE-FNCLCC-IBCSG-1-98, EU-99022, IBCSG-18-98, NOVARTIS-2026703019, BIG-I-98 |
Study First Received: | January 21, 2000 |
Last Updated: | January 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00004205 |
Health Authority: | United States: Federal Government |
stage I breast cancer stage II breast cancer stage IIIA breast cancer breast cancer in situ |
recurrent breast cancer ductal breast carcinoma lobular breast carcinoma in situ |
Carcinoma, Lobular Skin Diseases Carcinoma in Situ Citric Acid Breast Neoplasms Letrozole |
Carcinoma, Ductal, Breast Tamoxifen Breast Diseases Recurrence Carcinoma |
Estrogen Antagonists Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Hormonal Antineoplastic Agents Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Enzyme Inhibitors |
Bone Density Conservation Agents Selective Estrogen Receptor Modulators Pharmacologic Actions Estrogen Receptor Modulators Neoplasms Neoplasms by Site Therapeutic Uses Aromatase Inhibitors |