Ixabepilone + Carboplatin Metastatic Breast Cancer



Status:Archived
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:January 2010

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Phase II Trial of Ixabepilone Plus Carboplatin in Patients With Metastatic Breast Cancer: The ECLIPSE Study


Ixabepilone adds significantly to the antitumor effectiveness of capecitabine in both ER+
and triple negative breast cancer. Ixabepilone has substantial antitumor activity in
taxane-refractory patients and novel combinations are needed in this poor prognosis
population. Carboplatin in combination with gemcitabine or paclitaxel has activity in
metastatic breast cancer (MBC); there is also demonstrated activity of the
gemcitabine/carboplatin combination in the ER+ versus triple negative subsets. A Phase I
study of ixabepilone plus carboplatin in solid tumor patients demonstrated the safety of
this combination at the doses and schedule proposed for this Phase II trial (BMS data on
file).


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.


We found this trial at
50
sites
Dallas, Texas 75237
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900 West Faris Road
Greenville, South Carolina 29605
(864) 679-3900
Cancer Centers of the Carolinas - Faris Road Cancer Centers of the Carolinas is now...
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Greenville, SC
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Hudson, Florida 34667
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Hudson, FL
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Abilene, Texas 79606
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Abilene, TX
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Amarillo, Texas 79106
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Amarillo, TX
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Austin, Texas 78705
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Austin, TX
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Beaumont, TX
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Beckley, West Virginia 25801
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Bedford, Texas 76022
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Burien, Washington 98166
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Burien, WA
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Carmel, Indiana 46032
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Carmel, IN
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Columbia, Maryland 21044
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Columbia, Missouri 65201
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Columbia, MO
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Dallas, TX
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Dallas, Texas 75246
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Dallas, TX
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Dayton, Ohio 45406
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Denton, Texas 76210
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Denver, Colorado 80218
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Edmonds, Washington 98026
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Escondido, California 92025
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Escondido, CA
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Henderson, NV
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7360 W. Deschutes
Kennewick, Washington 99336
509-783-0144
Columbia Basin Hematology and Oncology Our collaboration with Seattle Cancer Care Alliance gives you convenient...
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Kennewick, WA
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Kingston, Pennsylvania 18704
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Melbourne, Florida 32901
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Minneapolis, Minnesota 55404
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Morristown, New Jersey 07960
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New York, New York 10016
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Niles, IL
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Norfolk, Virginia 23502
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Ocoee, FL
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Overland Park, Kansas 66210
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Phoenix, Arizona 85012
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Raleigh, North Carolina 27607
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Rochester, New York 14623
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100 NE Loop 410; Suite 600
San Antonio, Texas 78216
210-424-1600
Cancer Care Centers of South Texas At Cancer Care Centers of South Texas, we are...
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San Antonio, TX
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Sedona, AZ
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Sherman, Texas 75090
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Spokane, Washington 99218
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Spokane, WA
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Spokane, Washington 99218
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St. Joseph, Missouri 64507
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Sugar Land, TX
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Tucson, AZ
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Tyler, Texas 75702
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Vancouver, Washington 98686
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Waco, Texas 76712
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Westminister, Maryland 21157
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Westminister, MD
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Wichita Falls, TX
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Yakima, Washington 98902
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Yakima, WA
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