Letrozole in Treating Postmenopausal Women With Metastatic Breast Cancer
NCT ID: NCT00014638
Last Updated: 2013-02-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
INTERVENTIONAL
2001-01-31
2002-03-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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TREATMENT
Interventions
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letrozole
Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS: Age: 18 and over Sex: Female Menopausal status: See Disease Characteristics Performance status: Karnofsky 50-100% WHO 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Corrected serum calcium less than 11.6 mg/dL Other: No known hypersensitivity to any of the constituents of the study drug No history of noncompliance to medical regimens No unreliability Not pregnant or nursing Fertile patients must use effective contraception HIV negative
PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent anticancer immunotherapy or biological response modifiers Chemotherapy: See Disease Characteristics Prior adjuvant or neoadjuvant chemotherapy with adjuvant tamoxifen allowed No concurrent anticancer chemotherapy Endocrine therapy: See Chemotherapy No other concurrent anticancer endocrine therapy (including steroids) Radiotherapy: See Disease Characteristics No concurrent radiotherapy to sole site of disease Concurrent radiotherapy to a limited area (e.g., for painful disease) allowed Surgery: See Disease Characteristics No prior adrenalectomy or hypophysectomy Other: At least 30 days since prior systemic investigational drugs At least 7 days since prior topical investigational drugs No other concurrent investigational drugs Concurrent bisphosphonates (e.g., zoledronic acid) for bone metastasis allowed
18 Years
FEMALE
No
Sponsors
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Novartis
INDUSTRY
Responsible Party
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Principal Investigators
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Stephanie Petrone, SCRS
Role: STUDY_CHAIR
Novartis Pharmaceuticals
Locations
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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
The 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
Countries
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Other Identifiers
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NOVARTIS-CFEM345A-US10
Identifier Type: -
Identifier Source: secondary_id
CDR0000068583
Identifier Type: -
Identifier Source: org_study_id
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