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Sponsored by: |
Novartis |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00014638 |
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.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer |
Drug: letrozole |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment |
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 Start Date: | January 2001 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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
United States, California | |
Alta Bates Comprehensive Cancer Center | |
Berkeley, California, United States, 94704 | |
Long Beach Memorial Breast Center | |
Long Beach, California, United States, 90806 | |
United States, Florida | |
Cancer Research Network Inc. | |
Plantation, Florida, United States, 33324 | |
Cancer Research Network, Inc. | |
Hollywood, Florida, United States, 33020 | |
Good Samaritan Medical Center | |
West Palm Beach, Florida, United States, 33401 | |
Oncology-Hematology Group of South Florida | |
Miami, Florida, United States, 33176 | |
Pharm Research | |
Pinecrest, Florida, United States, 33156 | |
United States, Illinois | |
Carle Cancer Center | |
Urbana, Illinois, United States, 61801 | |
Illinois Oncology, Ltd. | |
Belleville, Illinois, United States, 62221 | |
Joliet Oncology/Hematology Associates, Ltd. | |
Joliet, Illinois, United States, 60435 | |
Memorial Medical Center | |
Springfield, Illinois, United States, 62781 | |
United States, Louisiana | |
Southwest Oncology Association | |
Lafayette, Louisiana, United States, 70503 | |
United States, New Mexico | |
New Mexico Oncology-Hematology | |
Albuquerque, New Mexico, United States, 87109 | |
United States, New York | |
Albert Einstein Comprehensive Cancer Center | |
Bronx, New York, United States, 10461 | |
United States, Ohio | |
Oncology Partnership Network | |
Cincinnati, Ohio, United States, 45238 | |
United States, Tennessee | |
Dial Research Associates, Inc. | |
Nashville, Tennessee, United States, 37205 | |
Memphis Cancer Center | |
Memphis, Tennessee, United States, 38119 | |
United States, Texas | |
Center for Oncology Research and Treatment, Medical City Hospital | |
Dallas, Texas, United States, 75230 | |
United States, Utah | |
Intermountain Hematology/Oncology Associates, Inc. | |
Salt Lake City, Utah, United States, 84124 | |
United States, Washington | |
Cascade Cancer Center | |
Kirkland, Washington, United States, 98034-3013 |
Study Chair: | Stephanie Petrone, SCRS | Novartis Pharmaceuticals |
Study ID Numbers: | CDR0000068583, NOVARTIS-CFEM345A-US10 |
Study First Received: | April 10, 2001 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00014638 History of Changes |
Health Authority: | United States: Federal Government |
stage IV breast cancer recurrent breast cancer |
Skin Diseases Adjuvants, Immunologic Breast Neoplasms Letrozole |
Aromatase Inhibitors Tamoxifen Breast Diseases Recurrence |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Skin Diseases Antineoplastic Agents Therapeutic Uses |
Breast Neoplasms Enzyme Inhibitors Letrozole Aromatase Inhibitors Pharmacologic Actions Breast Diseases |