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Spots Global Cancer Trial Database for 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

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Trial Identification

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

Interventions

Eribulin mesylate

Study Description

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).

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

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

Contact Details

Name: Sam Misir

Affiliation: Eisai Inc.

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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