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| Sponsor: | NCIC Clinical Trials Group |
|---|---|
| Collaborators: |
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 |
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.
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 Other: placebo |
Phase III |
| 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 |
| Estimated Primary Completion Date: | September 2002 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Arm I: Experimental
Patients receive oral letrozole once daily.
|
Drug: letrozole
Given orally
|
|
Arm II: Placebo Comparator
Patients receive oral placebo once daily.
|
Other: placebo
Given orally
|
Show Detailed Description
Eligibility| 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:
Contacts and Locations
Show 542 Study Locations| 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 | University of Vermont |
| Study Chair: | Martine J. Piccart-Gebhart, MD, PhD | Institut Jules Bordet |
More Information
| 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 |
| Study First Received: | November 1, 1999 |
| Last Updated: | September 11, 2009 |
| ClinicalTrials.gov Identifier: | NCT00003140 History of Changes |
| Health Authority: | Unspecified |
|
stage I breast cancer stage II breast cancer stage IIIA breast cancer |
|
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Skin Diseases Antineoplastic Agents Therapeutic Uses |
Breast Neoplasms Enzyme Inhibitors Letrozole Aromatase Inhibitors Pharmacologic Actions Breast Diseases |