Eribulin in Combination With Capecitabine for Adjuvant Treatment in Estrogen Receptor-Positive Early Stage Breast Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

77

Participants

Timeline

Start Date

August 31, 2011

Primary Completion Date

November 30, 2012

Study Completion Date

May 31, 2014

Conditions
Estrogen Receptor Positive TumorBreast Cancer
Interventions
DRUG

eribulin mesylate

Cohort I \& II: eribulin mesylate (E7389) 1.4 mg/m2 intravenously over 2 - 5 minutes on Day 1 and Day 8 for 4 cycles

DRUG

capecitabine

Cohort 1: capecitabine 900 mg/m2 orally twice daily on Days 1 - 14 of a 21-day cycle for 4 cycles Cohort II: fixed dose of 1500 mg oral capecitabine twice daily, 7 days on then 7 days off for 4 cycles

Trial Locations (23)

10469

Sciode Medical Associates, PLLC, d.b.a. Eastchester Center, The Bronx

12206

New York Oncology Hematology, P.C., Albany

23502

Virginia Oncology Associates, Norfolk

29605

Cancer Centers of the Carolinas, Greenville

30060

Northwest Georgia Oncology Centers, P.C., Marietta

32806

Cancer Centers of Florida, Orlando

75067

Texas Oncology-Lewisville, Lewisville

75230

Texas Oncology-Medical City Dallas, Dallas

75231

Texas Oncology-Dallas Presbyterian Hospital, Dallas

75237

Texas Oncology-Methodist Charlton Cancer Center, Dallas

75246

Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas

75460

Texas Oncology-Paris, Paris

75702

Texas Oncology-Tyler, Tyler

76104

Texas Oncology-Fort Worth 12th Ave., Fort Worth

76210

Texas Oncology- Denton South, Denton

77024

Texas Oncology-Memorial City, Houston

78217

Cancer Care Centers of South Texas, San Antonio

78731

Texas Oncology-Austin Central, Austin

85704

Arizona Oncology Associates, PC - HOPE, Tucson

85715

Arizona Oncology Associates, PC - CASA, Tucson

98684

Northwest Cancer Specialists, P.C., Vancouver

98902

Yakima Valley Memorial Hospital/North Star Lodge, Yakima

99218

Evergreen Hematology and Oncology, Spokane

All Listed Sponsors
lead

Eisai Inc.

INDUSTRY

NCT01439282 - Eribulin in Combination With Capecitabine for Adjuvant Treatment in Estrogen Receptor-Positive Early Stage Breast Cancer | Biotech Hunter | Biotech Hunter