Spots Global Cancer Trial Database for Letrozole in Treating Postmenopausal Women With Metastatic Breast Cancer
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Trial Identification
Brief Title: Letrozole in Treating Postmenopausal Women With Metastatic Breast Cancer
Official Title: 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
Study ID: NCT00014638
Conditions
Interventions
Study Description
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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Alta Bates Comprehensive Cancer Center, Berkeley, California, United States
Long Beach Memorial Breast Center, Long Beach, California, United States
Cancer Research Network, Inc., Hollywood, Florida, United States
Oncology-Hematology Group of South Florida, Miami, Florida, United States
Pharm Research, Pinecrest, Florida, United States
Cancer Research Network Inc., Plantation, Florida, United States
Good Samaritan Medical Center, West Palm Beach, Florida, United States
Illinois Oncology, Ltd., Belleville, Illinois, United States
Joliet Oncology/Hematology Associates, Ltd., Joliet, Illinois, United States
Memorial Medical Center, Springfield, Illinois, United States
Carle Cancer Center, Urbana, Illinois, United States
Southwest Oncology Association, Lafayette, Louisiana, United States
New Mexico Oncology-Hematology, Albuquerque, New Mexico, United States
Albert Einstein Comprehensive Cancer Center, Bronx, New York, United States
Oncology Partnership Network, Cincinnati, Ohio, United States
Memphis Cancer Center, Memphis, Tennessee, United States
Dial Research Associates, Inc., Nashville, Tennessee, United States
Center for Oncology Research and Treatment, Medical City Hospital, Dallas, Texas, United States
Intermountain Hematology/Oncology Associates, Inc., Salt Lake City, Utah, United States
Cascade Cancer Center, Kirkland, Washington, United States
Contact Details
Name: Stephanie Petrone, SCRS
Affiliation: Novartis Pharmaceuticals
Role: STUDY_CHAIR
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