A Phase II, Multicenter, Single-Arm, Feasibility Study of Eribulin in Combination With Capecitabine for Adjuvant Treatment in Estrogen Receptor-Positive Early Stage Breast Cancer
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate the feasibility of adjuvant treatment eribulin plus capecitabine for each individual subject the regimen is considered feasible if that subject is able to achieve relative dose intensity (RDI) of at least 85% of the 4 cycles of treatment.
Relative dose intensity for each subject will be calculated as follows: (1) based on each subject's body surface area (BSA), a total planned dose for both eribulin (Dep) and capecitabine (Dcp) calculated for a full 4-cycle regimen; (2) actual total dose of eribulin (Dea) and capecitabine (Dca) for the full 4-cycle regimen as collected on the case report form; (3) overall RDI = (Dea/Dep + Dca/Dcp)/2.
12 wks
No
David Cox
Study Director
Eisai Inc.
United States: Food and Drug Administration
E7389-A001-212
NCT01439282
August 2011
Name | Location |
---|---|
Virginia Oncology Associates | Newport News, Virginia 23606 |
Cancer Centers of the Carolinas | Greenville, South Carolina 29605 |
New York Oncology Hematology, P.C. | Albany, New York 12208 |
Cancer Centers of Florida | Orlando, Florida 32806 |
Northwest Georgia Oncology Centers, P.C. | Marietta, Georgia 30060 |
Northwest Cancer Specialists, P.C. | Vancouver, Washington |
Cancer Care Centers of South Texas | San Antonio, Texas 78229 |
Yakima Valley Memorial Hospital/North Star Lodge | Yakima, Washington 98902 |
Evergreen Hematology & Oncology | Spokane, Washington 99218 |
Texas Oncology-Austin Central | Austin, Texas 78731 |
Texas Oncology-Tyler | Tyler, Texas 75702 |
Arizona Oncology Associates, PC - HOPE | Tucson, Arizona 85704 |
Texas Oncology-Methodist Charlton Cancer Center | Dallas, Texas 75237 |
Texas Oncology-Dallas Presbyterian Hospital | Dallas, Texas 75231 |
Texas Oncology- Denton South | Denton, Texas 76210 |
Texas Oncology-Memorial City | Houston, Texas 77024 |
Texas Oncology-Baylor Charles A. Sammons Cancer Center | Dallas, Texas 75246 |
Texas Oncology-Medical City Dallas | Dallas, Texas 75230-2510 |
Arizona Oncology Associates, PC - CASA | Tucson, Arizona 85715 |
Sciode Medical Associates, PLLC, d.b.a. Eastchester Center | Bronx, New York 10469 |
Texas Oncology-Fort Worth 12th Ave. | Fort Worth, Texas ??76104 |
Texas Oncology-Lewisville | Lewisville, Texas ??75067 |
Texas Oncology-Paris | Paris, Texas 75460 |