Comparison Trial of Letrozole to Anastrozole in the Adjuvant Treatment of Postmenopausal Women With Hormone Receptor and Node Positive Breast Cancer
- Registration Number
- NCT00248170
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
Eligible patients will be post-menopausal hormone receptor- and lymph node-positive females who recently underwent primary surgery for breast cancer. Patients will be randomized to letrozole (2.5 mg per day for 5 years) vs anastrozole (1 mg per day for 5 years). Follow up will occur for 5 years after the completion of enrollment for survival and disease status updates.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 4172
- Recent primary surgery for breast cancer
- Early stage breast cancer
- Postmenopausal
- Hormone receptor positive
- Positive lymph node involvement
- Metastatic disease
- Presence of contralateral breast cancer including DCIS
- Progression
Other protocol-defined inclusion/exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Letrozole Letrozole 2.5 mg by mouth (p.o.) once daily Anastrozole Anastrozole 1 mg p.o. once daily
- Primary Outcome Measures
Name Time Method Disease Free Survival 84 months Disease-free survival was defined as the time from the date of randomization to the date of the first documentation of re-occurrence of invasive breast cancer in local, regional or distant sites, new invasive breast cancer in the contra-lateral breast, or death from any cause.
- Secondary Outcome Measures
Name Time Method Distant Disease-free Survival 84 months Distant disease-free survival was defined as the time from date of randomization to the date of the first development of any relapse at a distant site or death from any cause.
Percentage of Participants Who Experienced Clinical Fracture Events 84 months The incidence of clinical fractures was analyzed.
Time to Development of Distant Metastases 84 months Time to development of distant metastases was defined as the time from date of randomization to the date of the first development of any recurrent or metastatic disease in sites other than the local mastectomy scar, the ipsilateral breast in case of breast conservation or the contra lateral breast.
Overall Survival 84 months Overall survival was defined as the time from the date of randomization to the date of death from any cause.
Time to Development of Contra Lateral Breast Cancer 84 months Time to development of contra lateral breast cancer was defined as the time from the date of randomization to the date of the first development of any disease in the contra lateral breast.
Percentage of Participants Who Experienced Cardiovascular Events 84 months The incidence of ischemic heart disease, cardiac failures, cerebrovascular accidents and thromboembolic events was analyzed.
Change From Baseline in Serum Lipid Profiles baseline, 6, 12, 24, 36, 48 and 60 months Total cholesterol was analyzed to assess the impact on serum lipids profiles. The adjusted means was calculated.
Trial Locations
- Locations (41)
Chattanooga Oncology and Hematology Assoicates, PC
🇺🇸Chattanooga, Tennessee, United States
Texas Cancer Center ( Medical City Dallas Hospital)
🇺🇸Dallas, Texas, United States
El Paso Cancer Treatment Ctr-East
🇺🇸El Paso, Texas, United States
Raleigh Hematology Oncology Associates
🇺🇸Cary, North Carolina, United States
Texas Oncology Presbyterian Hospital
🇺🇸Dallas, Texas, United States
Northern Arizona Hematology/Oncology Associates, P.C.
🇺🇸Flagstaff, Arizona, United States
Center for Oncology Research and Treatment, PA
🇺🇸Dallas, Texas, United States
Novartis Investigative Site
🇬🇧Surrey, United Kingdom
Texas Oncology Texas Oncology PA
🇺🇸Dallas, Texas, United States
New York Oncology Hematology, P.C. NYOH Latham
🇺🇸Troy, New York, United States
Longview Cancer Center
🇺🇸Longview, Texas, United States
Allison Cancer Center
🇺🇸Midland, Texas, United States
Texas Cancer Center Denton
🇺🇸Denton, Texas, United States
Medical Oncology Associates of Wyorning Valley, PC
🇺🇸Kingston, Pennsylvania, United States
Texas Oncology Sammons Cancer Center
🇺🇸Dallas, Texas, United States
San Antonio Tumor and Blood Clinic
🇺🇸Fredericksburg, Texas, United States
Virginia Cancer Specialists, PC
🇺🇸Fairfax, Virginia, United States
South Texas Cancer Center- McAllen
🇺🇸McAllen, Texas, United States
Texas Cancer Center- Sherman
🇺🇸Sherman, Texas, United States
MD Anderson Cancer Center/University of Texas
🇺🇸Houston, Texas, United States
Wichita Community Clinical Oncology Program
🇺🇸Wichita, Kansas, United States
Kansas City Cancer Center
🇺🇸Overland Park, Kansas, United States
Sarah Cannon Oncology Hematology Care, Inc
🇺🇸Cincinnati, Ohio, United States
Sarah Cannon Research Institute
🇺🇸Nashville, Tennessee, United States
Central Indiana Cancer Centers
🇺🇸Indianapolis, Indiana, United States
Tyler Cancer Center
🇺🇸Tyler, Texas, United States
Waco Cancer and Research Center
🇺🇸Waco, Texas, United States
Northwest Cancer Specialists, P.C.
🇺🇸Vancover, Washington, United States
Comprehensive Cancer Institute
🇺🇸Huntsville, Alabama, United States
Florida Cancer Specialists
🇺🇸Fort Meyers, Florida, United States
Gulfcoast Oncology Associates
🇺🇸St. Petersburg, Florida, United States
St. Louis Cancer & Breast Institute
🇺🇸St. Louis, Missouri, United States
Texas Oncology, P.A.
🇺🇸Fort Worth, Texas, United States
Oncology Associates of Oregon, PC
🇺🇸Eugene, Oregon, United States
Aultman Cancer Center
🇺🇸Canton, Ohio, United States
Florida Cancer Institute
🇺🇸Orlando, Florida, United States
Birmingham Hematology and Oncology Associates
🇺🇸Birmingham, Alabama, United States
Center for Cancer & Blood Disorders
🇺🇸Bethesda, Maryland, United States
Oncology & Hematology Associates, PC
🇺🇸New London, Connecticut, United States
Cancer Centers of Florida PA
🇺🇸Ocoee, Florida, United States
University Cancer & Blood Center, LLC
🇺🇸Athens, Georgia, United States