Letrozole in Treating Postmenopausal Women With Metastatic Breast Cancer

Phase 4

Completed

• Conditions: Breast Cancer

• Registration Number: NCT00014638
• Lead Sponsor: Novartis

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.

Study Timeline

• Study Start: 2001-01
• Study First Submitted: 2001-04-10
• Primary Completion: 2002-03
• Study Completion: 2002-03
• Study First Submitted QC: 2003-11-12
• Study First Posted: 2003-11-13
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-20
• Last Update Posted: 2013-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (20)

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

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