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Brief Title: A Study of Single-Agent Eribulin Mesylate as First-Line Therapy for Locally Recurrent or Metastatic Human Epidermal Growth Factor Receptor Two (HER2) Negative Breast Cancer
Official Title: A Phase 2, Multicenter, Single-Arm Study of Single-Agent Eribulin Mesylate as First-Line Therapy for Locally Recurrent or Metastatic Human Epidermal Growth Factor Receptor Two (HER2) Negative Breast Cancer
Study ID: NCT01268150
Brief Summary: The purpose of this study is to assess the efficacy and safety of single-agent eribulin mesylate for first-line treatment of subjects with locally recurrent or metastatic breast cancer.
Detailed Description: This is a multicenter, single-arm, Phase 2 trial to assess the efficacy and safety of single-agent eribulin mesylate for first-line treatment of subjects with locally recurrent or metastatic human epidermal growth factor receptor (HER2)-negative breast cancer. A total of 52 adult female subjects will be enrolled and treated with eribulin mesylate (1.4 mg/m2 as an intravenous \[i.v.\] infusion over 2 to 5 minutes on Days 1 and 8 of each 3-week cycle).
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
University of Miami, Miami, Florida, United States
Augusta Oncology Associates, Augusta, Georgia, United States
Central Georgia Cancer Care, Macon, Georgia, United States
Northwest Georgia Oncology Centers, P.C., Marietta, Georgia, United States
Central Indiana Cancer Centers, Indianapolis, Indiana, United States
Missouri Cancer Associates, Columbia, Missouri, United States
Hematology Oncology Centers of Northern Rockies, Billings, Montana, United States
New York Oncology Hematology, P.C., Albany, New York, United States
Weill Cornell Medical Center, New York, New York, United States
Northwest Cancer Specialists, P.C., Portland, Oregon, United States
The West Clinic, Memphis, Tennessee, United States
Texas Oncology- Bedford, Bedford, Texas, United States
Texas Oncology - Medical City Dallas, Dallas, Texas, United States
Texas Oncology-Dallas Presbyterian Hospital, Dallas, Texas, United States
Cancer Care Centers of South Texas, San Antonio, Texas, United States
Texas Oncology- Tyler, Tyler, Texas, United States
Columbia Basin Hematology and Oncology, Kennewick, Washington, United States
Name: Sam Misir
Affiliation: Eisai Inc.
Role: STUDY_DIRECTOR