- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00014638
Letrozole in Treating Postmenopausal Women With Metastatic Breast Cancer
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
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.
Study Overview
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.
Study Type
Phase
- Phase 4
Contacts and Locations
Study Locations
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California
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Berkeley, California, United States, 94704
- Alta Bates Comprehensive Cancer Center
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Long Beach, California, United States, 90806
- Long Beach Memorial Breast Center
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Florida
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Hollywood, Florida, United States, 33020
- Cancer Research Network, Inc.
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Miami, Florida, United States, 33176
- Oncology-Hematology Group of South Florida
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Pinecrest, Florida, United States, 33156
- Pharm Research
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Plantation, Florida, United States, 33324
- Cancer Research Network Inc.
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West Palm Beach, Florida, United States, 33401
- Good Samaritan Medical Center
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Illinois
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Belleville, Illinois, United States, 62221
- Illinois Oncology, Ltd.
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Joliet, Illinois, United States, 60435
- Joliet Oncology/Hematology Associates, Ltd.
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Springfield, Illinois, United States, 62781
- Memorial Medical Center
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Urbana, Illinois, United States, 61801
- Carle Cancer Center
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Louisiana
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Lafayette, Louisiana, United States, 70503
- Southwest Oncology Association
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New Mexico
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Albuquerque, New Mexico, United States, 87109
- New Mexico Oncology-Hematology
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New York
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Bronx, New York, United States, 10461
- Albert Einstein Comprehensive Cancer Center
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Ohio
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Cincinnati, Ohio, United States, 45238
- Oncology Partnership Network
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Tennessee
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Memphis, Tennessee, United States, 38119
- Memphis Cancer Center
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Nashville, Tennessee, United States, 37205
- Dial Research Associates, Inc.
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Texas
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Dallas, Texas, United States, 75230
- Center for Oncology Research and Treatment, Medical City Hospital
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Utah
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Salt Lake City, Utah, United States, 84124
- Intermountain Hematology/Oncology Associates, Inc.
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Washington
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Kirkland, Washington, United States, 98034-3013
- Cascade Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS: Diagnosis of metastatic breast cancer Measurable or evaluable disease Postmenopausal No spontaneous menses for at least 5 years (including chemotherapy-induced amenorrhea) Spontaneous menses within the past 5 years allowed if amenorrheic for at least 12 months and LH and FSH in postmenopausal normal range (including chemotherapy-induced amenorrhea) Bilateral oophorectomy Radiotherapy castration and amenorrheic for at least 3 months Hormone receptor status: Estrogen-receptor (ER) and/or progesterone-receptor (PR) positive No ER and PR negative or unknown tumors
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Stephanie Petrone, SCRS, Novartis Pharmaceuticals
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Hormone Antagonists
- Aromatase Inhibitors
- Steroid Synthesis Inhibitors
- Estrogen Antagonists
- Letrozole
Other Study ID Numbers
- CDR0000068583
- NOVARTIS-CFEM345A-US10
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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