A Phase II Open Label Single-Arm Study of E7389 in Patients With Locally Advanced or Metastatic Breast Cancer, Previously Treated With Anthracycline, Taxane, and Capecitabine Therapy, Refractory to the Last Prior Therapy for Their Disease
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective Response Rate
Based on Response Evaluation Criteria in Solid Tumors (RECIST), consisting of complete response (CR) plus partial response (PR). Defined as the best response from the start of treatment until disease progression or recurrence. Lesions measured by computed tomography (CT) scan and magnetic resonance imaging (MRI). Objective response rate: complete response (CR-disappearance of all lesions)+ partial response (PR-30% decrease in lesion diameter), Progressive Disease (PD-20% increase in lesion diameter), stable disease (SD-neither shrinkage nor increase of lesions).
Every two cycles
No
Dale Shuster, Ph.D.
Study Director
Eisai Inc.
United States: Food and Drug Administration
E7389-G000-211
NCT00246090
October 2005
September 2007
Name | Location |
---|---|
Harrington Cancer Center | Amarillo, Texas 79106 |
Yakima Valley Memorial Hospital | Yakima, Washington 98902 |
University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
Comprehensive Cancer Centers of Nevada | Las Vegas, Nevada 89109 |
Rocky Mountain Cancer Center | Denver, Colorado 80218 |
Wilshire Oncology Medical Group, Inc. | Rancho Cucamonga, California 91730 |
Missouri Cancer Associates | Columbia, Missouri 65201 |
Tyler Cancer Center | Tyler, Texas 75702 |
Cancer Care Northwest | Spokane, Washington 99202 |
Cancer Care Associates | Tulsa, Oklahoma 74136 |
Willamette Valley Cancer Center | Eugene, Oregon 97401-8122 |
SUNY Upstate Medical University | Syracuse, New York 13210 |
Arkansas Cancer Research Center | Little Rock, Arkansas 72205 |
University of Chicago | Chicago, Illinois 60637 |
Charleston Hematology Oncology | Charleston, South Carolina 29403 |
North Texas Regional Cancer Center | Plano, Texas 75075 |
Rocky Mountain Cancer Center-Midtown | Denver, Colorado 80218 |
Utah Cancer Specialists | Salt Lake City, Utah 84106 |
Decatur Memorial Hospital | Decatur, Illinois 62526 |
Montana Cancer Specialists | Missoula, Montana 59807-7877 |
Northern Indiana Cancer Research Consortium | South Bend, Indiana |
North Shore Hematology Oncology Associates | East Setauket, New York 11733 |
Birmingham Hematology and Oncology | Birmingham, Alabama 35235 |
El Paso Cancer Treatment Center | El Paso, Texas 79915 |
Central indiana Cancer Center | Indianapolis, Indiana 46227 |
Raleigh Hematology Oncology Associates | Cary, North Carolina 27511 |
Center for Oncology Research and Treatment, PA | Dallas, Texas 75230 |
Hematology-Oncology Associates | Pensacola, Florida 32501 |
Park Nicollet Institute | St Louis Park, Minnesota 55416 |
University of Tennessee Medical Center | Knoxville, Tennessee 37920 |
Mercy Cancer Center | Hot Springs, Arkansas 71913 |
Rocky Mountain Cancer Center-Rose | Denver, Colorado 80220 |
Cancer Research Network | Plantation, Florida 33324 |
Dr. Elizabeth Tan-Chiu, PA | Tamarac, Florida 33321 |
Peachtree Hematology And Oncology Consultants | Atlanta, Georgia 30309 |
Cancer Care and Hematology Specialist of Chicagoland | Niles, Illinois 60714 |
Monroe Medical Center | Munster, Indiana 46321 |
Frederick Memorial Hospital, Regional Cancer Therapy Center | Frederick, Maryland 21701 |
New York Oncology Hematology, P.C | Albany, New York 12208 |
Huntington Medical Group, PC | Huntington Station, New York 11746 |
Weill Cornell Breast Cancer Center | New York, New York 10021 |
Northwestern Carolina Oncology And Hematology, PA | Hudson, North Carolina 28602 |
'Signal Point Hematology/Oncology, Inc. | Middletown, Ohio 45042 |
Medical University of Ohio | Toledo, Ohio 43614 |
Kaiser Permanente, Central Interstate Clinic, Hematology Oncology | Portland, Oregon 97227 |
Northwest Cancer Specialist Hoyt | Portland, Oregon 97227 |
Northwest Cancer Specialist Rose Qtr | Portland, Oregon 97225 |
Texas Oncology, P.A. Bedford | Bedford, Texas 76022 |
Sammons Cancer Center-Dallas | Dallas, Texas 75246 |
Texas Oncology PA | Dallas, Texas 75231 |
El Paso Cancer Treatment Center West | El Paso, Texas 79902 |
Baylor College of Medicine, Breast Cancer Clinic | Houston, Texas 77030 |
Valley Oncology PA | Weslaco, Texas 78596 |
Fairfax Northern VA Hematology Oncology PC | Fairfax, Virginia 22031 |
Oncology and Hematology Associates | Salem, Virginia 24153 |
Northwest Cancer Specialist | Vancouver, Washington 98684 |