Letrozole in Treating Postmenopausal Women With Metastatic Breast Cancer
- Conditions
- Breast Cancer
- Registration Number
- NCT00014638
- Lead Sponsor
- Novartis
- Brief Summary
RATIONALE: Estrogen can stimulate the growth of cancer cells. Letrozole may fight breast cancer by reducing the production of estrogen.
PURPOSE: Phase IV trial to study the effectiveness of letrozole in treating postmenopausal women who have metastatic breast cancer that has been previously treated with tamoxifen.
- Detailed Description
OBJECTIVES: I. Determine the time to progression of postmenopausal women with metastatic breast cancer treated with letrozole (Femara) as first-line therapy. II. Determine the objective response rate, time to treatment failure, survival rate, and changes in symptom distress in patients treated with this regimen.
OUTLINE: This is a multicenter study. Patients are stratified according to time to diagnosis of metastatic disease. Patients receive oral letrozole (Femara) daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 590 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (20)
Cancer Research Network, Inc.
🇺🇸Hollywood, Florida, United States
Good Samaritan Medical Center
🇺🇸West Palm Beach, Florida, United States
Carle Cancer Center
🇺🇸Urbana, Illinois, United States
Center for Oncology Research and Treatment, Medical City Hospital
🇺🇸Dallas, Texas, United States
Oncology Partnership Network
🇺🇸Cincinnati, Ohio, United States
Dial Research Associates, Inc.
🇺🇸Nashville, Tennessee, United States
Intermountain Hematology/Oncology Associates, Inc.
🇺🇸Salt Lake City, Utah, United States
Long Beach Memorial Breast Center
🇺🇸Long Beach, California, United States
Alta Bates Comprehensive Cancer Center
🇺🇸Berkeley, California, United States
Oncology-Hematology Group of South Florida
🇺🇸Miami, Florida, United States
Pharm Research
🇺🇸Pinecrest, Florida, United States
Joliet Oncology/Hematology Associates, Ltd.
🇺🇸Joliet, Illinois, United States
Illinois Oncology, Ltd.
🇺🇸Belleville, Illinois, United States
Memorial Medical Center
🇺🇸Springfield, Illinois, United States
Southwest Oncology Association
🇺🇸Lafayette, Louisiana, United States
New Mexico Oncology-Hematology
🇺🇸Albuquerque, New Mexico, United States
Memphis Cancer Center
🇺🇸Memphis, Tennessee, United States
Cascade Cancer Center
🇺🇸Kirkland, Washington, United States
Cancer Research Network Inc.
🇺🇸Plantation, Florida, United States
Albert Einstein Comprehensive Cancer Center
🇺🇸Bronx, New York, United States