IXTEND: A Randomized Phase 2 Study to Evaluate the Combination of Ixabepilone Plus Capecitabine or Capecitabine Plus Docetaxel in the Treatment of Metastatic Breast Cancer
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Participants With Best Tumor Response as Assessed With Response Evaluation Criteria in Solid Tumors (RECIST)
RECIST definitions: Complete reponse (CR)=disappearance of all nontarget lesions; partial response (PR)=at least 30% reduction in the sum of the longest diameter (LD) of all target lesions in reference to the baseline sum LD; stable disease (SD)=neither PR nor progressive disease (PD) criteria were met; PD=at least 20% increase in the sum of the LD of all target lesions, taking as reference the smallest sum LD recorded at or following baseline. Tumor status assessed by investigator.
Baseline to 6 weeks (end of Cycle 2)
No
Bristol-Myers Squibb
Study Director
Bristol-Myers Squibb
United States: Food and Drug Administration
CA163-131
NCT00546364
February 2008
March 2010
Name | Location |
---|---|
Sinai Hospital of Baltimore | Baltimore, Maryland 21225 |
Mary Bird Perkins Cancer Center | Baton Rouge, Louisiana 70809 |
Akron General Medical Center | Akron, Ohio 44302 |
Albert Einstein Cancer Center | Philadelphia, Pennsylvania 19141 |
Midwestern Regional Medical Center | Zion, Illinois 60099 |
DCH Cancer Treatment Center | Tuscaloosa, Alabama 35401 |
Summa Health System | Akron, Ohio 44312 |
Center for Cancer Care at Goshen Health System | Goshen, Indiana 46526 |
Jackson Oncology Associates, PLLC | Jackson, Mississippi 39202 |
Gaston Hematology and Oncology | Gastonia, North Carolina 28054 |
Doylestown Hospital | Doylestown, Pennsylvania 18901 |
Scripps Cancer Center | La Jolla, California 92037 |
Charleston Cancer Center | Charleston, South Carolina 29406 |
The Center for Cancer and Hematologic Disease | Cherry Hill, New Jersey 08003 |
Local Institution | Cincinnati, Ohio |
Georgetown University Medical Center | Washington, District of Columbia 20007 |
University of Kentucky | Lexington, Kentucky 40536-0098 |
Local Institution | Fort Lauderdale, Florida |
Local Institution | New Brunswick, New Jersey |
Local Institution | Duncansville, Pennsylvania |
Cancer Specialists of South Texas | Corpus Christi, Texas 78412 |
Santee Hematology/Oncology | Sumter, South Carolina 29150 |
Northwestern University Feinberg School of Medicine | Chicago, Illinois 60611 |
Peninsula Cancer Institute | Newport News, Virginia 23601 |
Hematology & Oncology Associates of NEPA | Dunmore, Pennsylvania 18512 |
Marion L Shepard Cancer Center | Washington, North Carolina 27889 |
Local Institution | Providence, Rhode Island |
The Cancer Center at Hackensack University Medical Center | Hackensack, New Jersey 07601 |
Cancer Center of Kansas | Wichita, Kansas 67214 |
Hematology/Oncology Clinic | Baton Rouge, Louisiana 70808 |
Howell Office Plaza | Howell, New Jersey 07731 |
Coastal Bend Cancer Center | Corpus Christi, Texas 78404 |
Local Institution | Honolulu, Hawaii |
Local Institution | Newark, Delaware |
Cancer Center of Central Connecticut | Southington, Connecticut |
Arena Oncology Associates, PC | Great Neck, New York 11021 |
Lowcountry Hematology & Oncology, Pa | Mt. Pleasant, South Carolina 29464 |
Hematology Oncology Associates of Rockland | Nyack, New York 10960 |
Kingsport Hematology Oncology | Kingsport, Tennessee 37660 |
University Medical Center, Inc | Louisville, Kentucky 40202 |
Providence Cancer Center | Spokane, Washington 99204 |
Monroe Medical Associates | Munster, Indiana 46321 |
Medical Oncology Associates of Augusta, PC | Augusta, Georgia 30901 |
John W Kugler, MD | Peoria, Illinois 61615 |
Center for Cancer & Blood Disorders, PC | Bethesda, Maryland 20817 |
Cooper Hospital, Division of Hematology/Oncology | Voorhees, New Jersey 08043 |
UNM Cancer Center | Albuquerque, New Mexico 87106 |
New Mexico Cancer Care Associates (NMCCA) | Santa Fe, New Mexico 87505 |
Mid Ohio Oncology/Hematology, Inc, dba The Mark H Zangmeister Center | Columbus, Ohio 43219 |
St Mary Medical Center | Langhorne, Pennsylvania 19047 |
Regional Hematology Oncology, PC | Langhorne, Pennsylvania 19047 |
Sanford Cancer Center Oncology Clinic | Sioux Falls, South Dakota 57104 |
The University of Tennessee Medical Center | Knoxville, Tennessee 37920 |
Austin Cancer Centers | Austin, Texas 78759 |
Edward L Middleman, MD | Duncanville, Texas 75137 |
Section Chief Medical Oncology | Houston, Texas 77030 |
Jose A Figueroa, MD | Lubbock, Texas 79410 |
Southlake Oncology | Southlake, Texas 76092 |
Leah L Dietrich, MD | La Crosse, Wisconsin 54601 |