Ixabepilone + Carboplatin Metastatic Breast Cancer
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).
|Study Design:||Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Ixabepilone Plus Carboplatin in Patients With Metastatic Breast Cancer: The ECLIPSE Study|
- 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). [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Clinical benefit rate (CBR) defined as overall response rate (ORR) [complete response + partial response (CR + PR)] + SD > 6 months [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Progression-free survival (PFS) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Overall survival (OS) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Duration of responses, duration of stable disease, time to response and drug toxicity [ Time Frame: 24 months ] [ Designated as safety issue: No ]Toxicities will be graded according to the NCI Common Terminology Criteria for Adverse Events (version 4.0). Subjects enrolled in this study will be carefully monitored during the entire treatment phase and will be followed as is appropriate. Incidence and type of adverse events, including serious adverse events, will be tabulated and summarized using descriptive statistics. Adverse events that are unrelated to treatment and that occur >30 days after the administration of treatment will not be reported or analyzed.
|Study Start Date:||January 2010|
|Estimated Study Completion Date:||January 2014|
|Estimated Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
Experimental: Weekly Ixabepilone +carboplatin for metastatic breast cancer
Subjects will receive ixabepilone and carboplatin on Days 1 and 8 of each 21-day cycle.
20 mg/m2 on Days 1 and 8Drug: Carboplatin
carboplatin AUC=2.5 on Days 1 and 8
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.
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|Principal Investigator:||Cynthia R Osborne, MD||US Oncology|