Breast Cancer Clinical Trial

Letrozole in Treating Postmenopausal Women With Metastatic Breast Cancer

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.

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Full 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.

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Eligibility Criteria

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 is for people with:

Breast Cancer

Phase:

Phase 4

Study ID:

NCT00014638

Recruitment Status:

Completed

Sponsor:

Novartis

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There are 20 Locations for this study

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Alta Bates Comprehensive Cancer Center
Berkeley California, 94704, United States
Long Beach Memorial Breast Center
Long Beach California, 90806, United States
Cancer Research Network, Inc.
Hollywood Florida, 33020, United States
Oncology-Hematology Group of South Florida
Miami Florida, 33176, United States
Pharm Research
Pinecrest Florida, 33156, United States
Cancer Research Network Inc.
Plantation Florida, 33324, United States
Good Samaritan Medical Center
West Palm Beach Florida, 33401, United States
Illinois Oncology, Ltd.
Belleville Illinois, 62221, United States
Joliet Oncology/Hematology Associates, Ltd.
Joliet Illinois, 60435, United States
Memorial Medical Center
Springfield Illinois, 62781, United States
Carle Cancer Center
Urbana Illinois, 61801, United States
Southwest Oncology Association
Lafayette Louisiana, 70503, United States
New Mexico Oncology-Hematology
Albuquerque New Mexico, 87109, United States
Albert Einstein Comprehensive Cancer Center
Bronx New York, 10461, United States
Oncology Partnership Network
Cincinnati Ohio, 45238, United States
Memphis Cancer Center
Memphis Tennessee, 38119, United States
Dial Research Associates, Inc.
Nashville Tennessee, 37205, United States
Center for Oncology Research and Treatment, Medical City Hospital
Dallas Texas, 75230, United States
Intermountain Hematology/Oncology Associates, Inc.
Salt Lake City Utah, 84124, United States
Cascade Cancer Center
Kirkland Washington, 98034, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 4

Study ID:

NCT00014638

Recruitment Status:

Completed

Sponsor:


Novartis

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