drugset / Trial / NCT01075100

Ixabepilone + Carboplatin Metastatic Breast Cancer

NCT01075100

Phase 2 Completed 103 enrolled US Oncology Research Bristol-Myers Squibb · collab
NaSingle-groupOpen-labelTreatment

Summary

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).

Timeline

Start
2010-01
Primary completion
2013-06
Completion
2013-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Carboplatin Small molecule 2.5 unknown
Subject Ixabepilone Small molecule 20 mg/m2

Indications