Comparison Trial of Letrozole to Anastrozole in the Adjuvant Treatment of Postmenopausal Women With Hormone Receptor and Node Positive Breast Cancer
Phase 3
33 Years
N/A
33 Years
N/A
Open (Enrolling)
Female
Breast Cancer
Female
Breast Cancer
Trial Information
Comparison Trial of Letrozole to Anastrozole in the Adjuvant Treatment of Postmenopausal Women With Hormone Receptor and Node Positive Breast Cancer
Inclusion Criteria:
- Recent primary surgery for breast cancer
- Early stage breast cancer
- Postmenopausal
- Hormone receptor positive
- Positive lymph node involvement
Exclusion Criteria:
- Metastatic disease
- Presence of contralateral breast cancer including DCIS
- Progression
Other protocol-defined inclusion/exclusion criteria may apply.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Compare rate of disease free survival at 5 years between letrozole and anastrozole
Outcome Time Frame:
Disease-free survival 320 events and 639 events
Safety Issue:
No
Principal Investigator
Novartis Pharmaceuticals
Investigator Role:
Study Director
Investigator Affiliation:
Novartis Pharmaceuticals
Authority:
United States: Food and Drug Administration
Study ID:
CFEM345D2411
NCT ID:
NCT00248170
Start Date:
December 2005
Completion Date:
June 2013
Related Keywords:
- Breast Cancer
- Breast cancer
- letrozole
- anastrozole
- adjuvant
- postmenopausal
- FACE
- Breast Neoplasms
Name | Location |
|---|---|
| Texas Oncology, P.A. | Dallas, Texas 75246 |
| Aultman Cancer Center | Canton, Ohio 44710 |
| Comprehensive Cancer Institute | Huntsville, Alabama 35801 |
| Florida Cancer Specialists | Fort Myers, Florida 33901 |
| Tyler Cancer Center | Tyler, Texas 75702 |
| San Antonio Tumor and Blood Clinic | San Antonio, Texas 78217 |
| Wichita Community Clinical Oncology Program | Wichita, Kansas 67214-3882 |
| Florida Cancer Institute | New Port Richey, Florida 34652 |
| Central Indiana Cancer Centers | Indianapolis, Indiana 46227 |
| Allison Cancer Center | Midland, Texas 79701 |
| Center for Cancer & Blood Disorders | Bethesda, Maryland 20817 |
| Northwest Cancer Specialists, P.C. | Vancouver, Washington |
| Longview Cancer Center | Longview, Texas 75601 |
| Kansas City Cancer Center | Kansas City, Kansas 66112 |
| Center for Oncology Research and Treatment, PA | Dallas, Texas 75230 |
| Gulfcoast Oncology Associates | St. Petersburg, Florida 33705 |
| Birmingham Hematology and Oncology Associates | Birmingham, Alabama 35235 |
| El Paso Cancer Treatment Ctr-East | El Paso, Texas 79915 |
| Sarah Cannon Research Institute | Nashville, Tennessee 37203 |
| MD Anderson Cancer Center/University of Texas | Houston, Texas 77030 |
| Oncology & Hematology Associates, PC | New London, Connecticut 06320 |
| Northeast Georgia Cancer Care | Athens, Georgia 30607 |
| Texas Cancer Center- Sherman | Sherman, Texas 75090-0504 |
| Texas Cancer Center ( Medical City Dallas Hospital) | Dallas, Texas 75230 |
| Fairfax Northern Virginia Hematology Oncology | Fairfax, Virginia |
| New York Oncology Hematology, P.C. NYOH Latham | Troy, New York 12180 |
| Northern Arizona Hematology/Oncology Associates, P.C. | Flagstaff, Arizona 86001 |
| Cancer Centers of Florida PA | Ocoee, Florida 34761 |
| St. Louis Cancer & Breast Institute | St. Louis, Missouri 63141 |
| Sarah Cannon Oncology Hematology Care, Inc | Cincinnati, Ohio 45242 |
| Oncology Associates of Oregon, PC | Eugene, Oregon 97401-8122 |
| Medical Oncology Associates of Wyorning Valley, PC | Kingston, Pennsylvania 18704 |
| Chattanooga Oncology and Hematology Assoicates, PC | Chattanooga, Tennessee 37404 |
| Texas Oncology, P.A. Presbyterian Hospital | Dallas, Texas 75246 |
| Texas Oncology, P.A. Sammons Cancer Center | Dallas, Texas 75246 |
| Texas Oncology, P.A. Texas Oncology PA | Dallas, Texas 75251 |
| Texas Cancer Center Denton | Denton, Texas 76210 |
| South Texas Cancer Center- McAllen | McAllen, Texas 78503 |
| Waco Cancer and Research Center | Waco, Texas 76712 |
