NCT01075100

Ixabepilone + Carboplatin Metastatic Breast Cancer

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 103 (actual)
• Sponsor: US Oncology Research · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

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.

Conditions

• Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	Ixabepilone	20 mg/m2 on Days 1 and 8
DRUG	Carboplatin	carboplatin AUC=2.5 on Days 1 and 8

Timeline

• Start date: 2010-01-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2010-02-24
• Last updated: 2016-12-07
• Results posted: 2016-12-07

Locations

59 sites across 1 country: United States