Phase III Study of Doxorubicin/Cyclophosphamide (AC) Followed by Ixabepilone vs. AC Followed by Paclitaxel in Patients With Triple-Negative Early-Stage Breast Cancer
Patients will be randomized in a 1:1 ratio to receive one of two different treatment arms.
Patients in treatment arm 1 will receive AC followed by ixabepilone. Patients in treatment
arm 2 will receive AC followed by weekly paclitaxel.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To compare the disease-free survival (DFS) of women with triple-negative early-stage breast cancer following adjuvant treatment with AC followed by every-3-week ixabepilone vs. AC followed by weekly paclitaxel.
5 years
No
Denise A Yardley, M.D.
Study Chair
Sarah Cannon Research Institute
United States: Food and Drug Administration
SCRI BRE 145
NCT00789581
January 2009
January 2016
Name | Location |
---|---|
Medical University of South Carolina | Charleston, South Carolina 29425-0721 |
Northeast Alabama Regional Medical Center | Anniston, Alabama 36207 |
Northeast Arkansas Clinic | Jonesboro, Arkansas 72401-3125 |
South Texas Oncology and Hematology | San Antonio, Texas 78229 |
Memorial Regional Cancer Center | Hollywood, Florida 33021 |
Florida Cancer Specialists | Fort Myers, Florida 33901 |
University of Pittsburgh Medical Center | Pittsburgh, Pennsylvania 15213 |
Northeast Georgia Medical Center | Gainesville, Georgia 30501 |
Spartanburg Regional Medical Center | Spartanburg, South Carolina 29303 |
Research Medical Center | Kansas City, Missouri 64132 |
Consultants in Blood Disorders and Cancer | Louisville, Kentucky 40207 |
Baton Rouge General Medical Center | Baton Rouge, Louisiana 70821-2511 |
Integrated Community Oncology Network | Jacksonville Beach, Florida 32250 |
South Carolina Oncology Associates, PA | Columbia, South Carolina 29210 |
Family Cancer Center | Collierville, Tennessee 38017 |
Holy Cross Hospital | Fort Lauderdale, Florida 33308 |
Coastal Cancer Center | Myrtle Beach, South Carolina 29572 |
New Mexico Oncology Hematology Consultants | Albuquerque, New Mexico 87102 |
Augusta Oncology Associates | Augusta, Georgia 30901 |
Virginia Cancer Institute | Richmond, Virginia 23230 |
Wilshire Oncology Medical Group | Glendora, California 91741 |
Methodist Cancer Center | Omaha, Nebraska 68114 |
Medical Oncology Associates of Augusta | Augusta, Georgia 30901 |
Peninsula Cancer Institute | Newport News, Virginia 23601 |
Center for Cancer and Blood Disorders | Bethesda, Maryland 20817 |
Clearview Cancer Institute | Huntsville, Alabama 35805 |
Mercy Hospital | Portland, Maine 04101 |
Grand Rapids Clinical Oncology Program | Grand Rapids, Michigan 49503 |
Alamance Regional Medical Center | Burlington, North Carolina 27216 |
Space Coast Medical Associates | Cocoa Beach, Florida 32931 |
Kansas City Cancer Centers | Lenexa, Kansas |
St. Louis Cancer Care | Chesterfield, Missouri 63017 |
Tennessee Oncology, PLLC | Clarksville, Tennessee 37043 |
Fallon Clinic | Worcester, Massachusetts 01605 |
Coastal Bend Cancer Center | Corpus Christi, Texas 78404 |
Oncology Hematology Care | Cincinnati, Ohio 45242 |
Watson Clinic Center for Cancer Care and Research | Lakeland, Florida 33805 |
Oncology Hematology Associates of SW Indiana | Evansville, Indiana 47714 |
Providence Medical Group | Terre Haute, Indiana 47802 |
Hematology Oncology Associates of Northern NJ | Morristown, New Jersey 07960 |
Chattanooga Oncology Hematology Associates | Chattanooga, Tennessee 37404 |
Hematology Oncology of Indiana | Indianapolis, Indiana 46260 |
Associates in Hematology Oncology | Chattanooga, Tennessee 37404 |
Medical College of Georgia Cancer Specialists | Augusta, Georgia 30912 |
Florida Cancer Care | Davie, Florida 33328 |
Mid Ohio Oncology/Hematology, Inc./ The Mark H. Zangmeister Center | Columbus, Ohio 43219 |
Lynn Cancer Institute | Boca Raton, Florida 33428 |
Center for Cancer and Blood Disorders | Ft. Worth, Texas 76104 |
Weinberg Cancer Institute at Franklin Square | Baltimore, Maryland 21237 |
Cancer Center of Huntsville | Huntsville, Alabama 35801 |
University of Southern Alabama | Mobile, Alabama 36604 |
New Hope Cancer and Research Institute | Pomona, California 91767 |
Eastern Connecticut Hematology Oncology | Norwich, Connecticut 06360 |
Aventura Medical Center | Aventura, Florida 33180 |
Piedmont Healthcare | Atlanta, Georgia 30309 |
Emory/Winship Cancer Institute | Atlanta, Georgia 30322 |
Suburban Hem Onc | Lawrenceville, Georgia 30045 |
Mid-Illinois Hematology & Oncology | Normal, Illinois 61761 |
Hematology Oncology of the North Shore | Skokie, Illinois 60076 |
Cotton O'Neil Cancer Center | Topeka, Kansas 66606 |
Fairview Medical Oncology Clinic | Edina, Minnesota 55436 |
St. John's Clinic | Springfield, Missouri 65804 |
St. Clare's Hospital Oncology and Hematology | Denville, New Jersey 07834 |
Southern Oncology and Hematology South Jersey Healthcare - RMC | Vineland, New Jersey 08360 |
Southern Oncology and Hematology | Vineland, New Jersey 08360 |
Hematology/Oncology Inc | Elyria, Ohio 44035 |
Hickman Cancer Center (Flower Hospital) | Sylvania, Ohio 43560 |
Bux-Mont Oncology, Fox Chase Cancer Center | Rockledge, Pennsylvania 18960 |
Lowcountry Hematology Oncology | Mt. Pleasant, South Carolina 29464 |
Medical Oncology Methodist Hospital | Houston, Texas 77030 |