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Sponsors and Collaborators: |
National Cancer Institute of Canada National Cancer Institute (NCI) North Central Cancer Treatment Group International Breast Cancer Study Group Eastern Cooperative Oncology Group Southwest Oncology Group Cancer and Leukemia Group B European Organization for Research and Treatment of Cancer |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003140 |
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by reducing the production of estrogen.
PURPOSE: This randomized phase III trial is studying letrozole to see how well it works in treating women with breast cancer who have received tamoxifen for at least 5 years.
Condition | Intervention | Phase |
Breast Cancer |
Drug: letrozole |
Phase III |
Genetics Home Reference related topics: | breast cancer |
MedlinePlus related topics: | Breast Cancer Cancer |
ChemIDplus related topics: | Tamoxifen Tamoxifen citrate Letrozole |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control |
Official Title: | A Phase III Randomized Double Blind Study of Vorozole Versus Placebo in Women With Primary Breast Cancer Completing Five or More Years of Adjuvant Tamoxifen |
Estimated Enrollment: | 4700 |
Study Start Date: | August 1998 |
Primary Completion Date: | September 2002 (Final data collection date for primary outcome measure) |
Show Detailed Description |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed primary invasive breast carcinoma resected at time of original diagnosis
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Postmenopausal defined by one of the following:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Show 547 Study Locations |
National Cancer Institute of Canada |
National Cancer Institute (NCI) |
North Central Cancer Treatment Group |
International Breast Cancer Study Group |
Eastern Cooperative Oncology Group |
Southwest Oncology Group |
Cancer and Leukemia Group B |
European Organization for Research and Treatment of Cancer |
Study Chair: | Paul E. Goss, MD, PhD | Massachusetts General Hospital |
Study Chair: | James N. Ingle, MD | Mayo Clinic |
Study Chair: | Monica Castiglione-Gertsch, MD | University Hospital Inselspital, Berne |
Study Chair: | Nicholas J. Robert, MD | Fairfax Northern Virginia Hematology Oncology, PC - Fairfax |
Study Chair: | Silvana Martino, DO | John Wayne Cancer Institute at Saint John's Health Center |
Study Chair: | Hyman B. Muss, MD | Vermont Cancer Center at University of Vermont |
Study Chair: | Martine J. Piccart-Gebhart, MD, PhD | Institut Jules Bordet |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000065921, CAN-NCIC-MA17, CALGB-49805, E-JMA17, EORTC-10983, IBCSG-BIG97-01, NCCTG-JMA17, SWOG-JMA17, JRF-Vor-Int-10, NCCTG-CAN-MA17, SWOG-CAN-MA17 |
First Received: | November 1, 1999 |
Last Updated: | September 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00003140 |
Health Authority: | Unspecified |
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