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 |
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
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900 West Faris Road
Greenville, South Carolina 29605
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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Columbia Basin Hematology and Oncology Our collaboration with Seattle Cancer Care Alliance gives you convenient...
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Cancer Care Centers of South Texas At Cancer Care Centers of South Texas, we are...
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