Open Label, Multicenter Trial Of Femera (Letrozole) 2.5 mg As First-line Therapy In Postmenopausal Women With Metastatic Breast Cancer Relapsing Following Adjuvant Tamoxifen Therapy
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.
Interventional
Primary Purpose: Treatment
Stephanie Petrone, SCRS
Study Chair
Novartis Pharmaceuticals
United States: Federal Government
CDR0000068583
NCT00014638
January 2001
March 2002
Name | Location |
---|---|
Albert Einstein Comprehensive Cancer Center | Bronx, New York 10461 |
Good Samaritan Medical Center | West Palm Beach, Florida 33401 |
Oncology-Hematology Group of South Florida | Miami, Florida 33176 |
Long Beach Memorial Breast Center | Long Beach, California 90806 |
Alta Bates Comprehensive Cancer Center | Berkeley, California 94704 |
New Mexico Oncology-Hematology | Albuquerque, New Mexico 87102 |
Joliet Oncology/Hematology Associates, Ltd. | Joliet, Illinois 60435 |
Carle Cancer Center | Urbana, Illinois 61801 |
Cancer Research Network Inc. | Plantation, Florida 33324 |
Memorial Medical Center | Springfield, Illinois 62781 |
Cancer Research Network, Inc. | Plantation, Florida 33324 |
Dial Research Associates, Inc. | Nashville, Tennessee 37205 |
Center for Oncology Research and Treatment, Medical City Hospital | Dallas, Texas 75230 |
Memphis Cancer Center | Memphis, Tennessee 38119 |
Intermountain Hematology/Oncology Associates, Inc. | Salt Lake City, Utah 84124 |
Pharm Research | Pinecrest, Florida 33156 |
Illinois Oncology, Ltd. | Belleville, Illinois 62221 |
Southwest Oncology Association | Lafayette, Louisiana 70503 |
Oncology Partnership Network | Cincinnati, Ohio 45238 |
Cascade Cancer Center | Kirkland, Washington 98034-3013 |