Phase II Trial of Ixabepilone Plus Carboplatin in Patients With Metastatic Breast Cancer: The ECLIPSE Study
This is a Phase II, open label, nonrandomized, parallel, noncomparative, study of 2 groups
(as stratified below). All patients will receive ixabepilone 20 mg/m2 on Days 1 and 8 and
carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle. Patients will be stratified by
either hormone receptor positive [ER+/PR+/HER2-, ER+/PR-/HER2-, ER-/PR+/HER2-]- (n=50) or
triples negative ER-/PR-/HER2- (n=53). If one group fulfills their accrual goal first,
registration into that strata will be stopped and only patients meeting stratification
requirements for the other group will be registered.
Interventional
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Evaluate the objective response rate calculated as CR+ PR in the population evaluable for response, as well as the 2 subgroups (hormone receptor positive [ER+/PR+/HER2-, ER+/PR-/HER2-, ER-/PR+/HER2-]) and ER-/PR-HER2-, separately).
24 months
No
Cynthia R Osborne, MD
Principal Investigator
US Oncology
United States: Institutional Review Board
08007
NCT01075100
January 2010
January 2014
Name | Location |
---|---|
Virginia Oncology Associates | Newport News, Virginia 23606 |
Cancer Centers of the Carolinas | Greenville, South Carolina 29605 |
Missouri Cancer Associates | Columbia, Missouri 65201 |
Rocky Mountain Cancer Centers | Thornton, Colorado 80260 |
Southwest Cancer Care | Poway, California 92064 |
Cancer Care Northwest | Spokane, Washington 99202 |
St. Joseph Oncology, Inc. | Saint Joseph, Missouri 64506 |
Texas Oncology | Dallas, Texas |
Central Indiana Cancer Centers | Indianapolis, Indiana 46227 |
Minnesota Oncology Hematology, P.A. | Minneapolis, Minnesota 55407 |
Medical Oncology Associates of Wyoming Valley, PC | Kingston, Pennsylvania 18704 |
Highline Medical Oncology | Burien, Washington 98166 |
Hematology Oncology Associates | Phoenix, Arizona 85012 |
Raleigh Hematology Oncology Associates | Cary, North Carolina 27511 |
Puget Sound Cancer Centers | Edmonds, Washington 98026 |
Paris Regional Cancer Center | Paris, Texas 75460 |
Texas Cancer Center - Sherman | Sherman, Texas 75090-0504 |
Cancer Care Centers of South Texas | San Antonio, Texas 78229 |
Cancer Care & Hematology Specialists of Chicagoland | Niles, Illinois 60714 |
Yakima Valley Memorial Hospital/North Star Lodge | Yakima, Washington 98902 |
Melbourne Internal Medicine Associates | Melbourne, Florida 32901 |
Ruth Oratz MD | New York, New York 10016 |
Florida Cancer Institute - New Hope | New Port Richey, Florida 34655 |
Northwest Cancer Specialists, PC | Portland, Oregon 97225 |
Cancer Care Centers of South Texas-HOAST | San Antonio, Texas 78229 |
Texas Oncology - Amarillo | Amarillo, Texas 79106 |
Kansas City Cancer Center, LLC | Kansas City, Missouri 64131 |
Evergreen Hematology & Oncology | Spokane, Washington 99218 |
Columbia Basin Hematology & Oncology | Kennewicke, Washington 99336 |
Texas Oncology-Tyler | Tyler, Texas 75702 |
Texas Oncology - Bedford | Bedford, Texas 76022 |
Arizona Oncology Associates, PC - NAHOA | Sedona, Arizona 86336 |
Arizona Oncology Associates, PC - HOPE | Tucson, Arizona 85704 |
Florida Institute of Research, Medicine & Surgery | Ocoee, Florida 34761 |
Alliance Hematology Oncology, P.A. | Westminster, Maryland 21157 |
Maryland Oncology Hematology, PA The Medical Pavillion at Howard County | Columbia, Missouri 21044 |
Comprehensive Cancer Care Centers of Nevada | Henderson, Nevada 89074 |
Hematology-Oncology Associates of Northern NJ, PA Carol G. Simon Cancer Center | Morristown, New Jersey 07962 |
Interlakes Oncology & Hematology, P.C | Rochester, New York 14623 |
Dayton Oncology & Hematology, P.A. Greater Dayton Cancer Center | Kettering, Ohio 45409 |
Texas Oncology - Abilene | Abilene, Texas 79606 |
Texas Oncology - Austin Midtown | Austin, Texas 78705 |
Texas Oncology Medical City Dallas | Dallas, Texas 75230 |
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-Fort Worth 12 Ave | Fort Worth, Texas 76104 |
Texas Oncology-Memorial City | Houston, Texas 77024 |
Texas Oncology- Lewisville | Lewisville, Texas 75067 |
Texas Oncology-Longview Cancer Center | Longview, Texas 75601 |
Texas Oncology-McAllen South Second Street | McAllen, Texas 78509 |
Texas Oncology-Mesquite | Mesquite, Texas 75150 |
Texas Oncology-Midland Allison Cancer Center | Midland, Texas 79701 |
Texas Oncology- Odessa West Texas Cancer Center | Odessa, Texas 79761 |
Texas Oncology - Sugar Land | Sugar Land, Texas 77479 |
Texas Oncology-Waco | Waco, Texas 76712 |
Texas Oncology Wichita Falls Texoma Cancer Center | Wichita Falls, Texas 76310 |
Raleigh Regional Cancer Center dba Beckley Oncology Associates Inc. | Beckley, West Virginia 25801 |