Comparison Trial of Letrozole to Anastrozole in the Adjuvant Treatment of Postmenopausal Women With Hormone Receptor and Node Positive Breast Cancer
Completed · Phase 3
Conditions studied: Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT00248170
- Run by
- Novartis Pharmaceuticals
- People needed
- 4172
- Starts
- 2005-12-01
- Expected to finish
- 2014-09-01
- Last updated by the study team
- 2016-04-19
Who can join
Age: 33 and older, up to 96. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Recent primary surgery for breast cancer
- Early stage breast cancer
- Postmenopausal
- Hormone receptor positive
- Positive lymph node involvement
You may not qualify if…
- Metastatic disease
- Presence of contralateral breast cancer including DCIS
- Progression
- Other protocol-defined inclusion/exclusion criteria may apply.
Where it is running
- Comprehensive Cancer Institute — Huntsville, Alabama, United States
- Northern Arizona Hematology/Oncology Associates, P.C. — Flagstaff, Arizona, United States
- Oncology & Hematology Associates, PC — New London, Connecticut, United States
- Florida Cancer Specialists — Fort Meyers, Florida, United States
- Sarah Cannon Research Institute — Jacksonville, Florida, United States
- Cancer Centers of Florida PA — Ocoee, Florida, United States
- Florida Cancer Institute — Orlando, Florida, United States
- Gulfcoast Oncology Associates — St. Petersburg, Florida, United States
- University Cancer & Blood Center, LLC — Athens, Georgia, United States
- Central Indiana Cancer Centers — Indianapolis, Indiana, United States
- Kansas City Cancer Center — Overland Park, Kansas, United States
- Wichita Community Clinical Oncology Program — Wichita, Kansas, United States
- Center for Cancer & Blood Disorders — Bethesda, Maryland, United States
- St. Louis Cancer & Breast Institute — St Louis, Missouri, United States
- New York Oncology Hematology, P.C. NYOH Latham — Troy, New York, United States
- Raleigh Hematology Oncology Associates — Cary, North Carolina, United States
- Aultman Cancer Center — Canton, Ohio, United States
- Sarah Cannon Oncology Hematology Care, Inc — Cincinnati, Ohio, United States
- Oncology Associates of Oregon, PC — Eugene, Oregon, United States
- Medical Oncology Associates of Wyorning Valley, PC — Kingston, Pennsylvania, United States
- Chattanooga Oncology and Hematology Assoicates, PC — Chattanooga, Tennessee, United States
- Sarah Cannon Research Institute — Nashville, Tennessee, United States
- Texas Oncology, P.A. — Bedford, Texas, United States
- Center for Oncology Research and Treatment, PA — Dallas, Texas, United States
- Birmingham Hematology and Oncology Associates — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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