CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 103 enrolled
Drug / intervention
Ixabepilone +1 moredrug
Likely dose
Ixabepilone 20 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01075100
NCT01075100Phase 2Completed
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Phase II Trial of Ixabepilone Plus Carboplatin in Patients With Metastatic Breast Cancer: The ECLIPSE Study

US Oncology Research·interventional·Posted Feb 24, 2010·Updated Dec 7, 2016

In Brief

A Phase 2 clinical trial evaluating Ixabepilone and Carboplatin for Metastatic Breast Cancer. Completed, enrolled 103 participants across 59 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Breast Cancer
CountriesUnited States
CollaboratorsBristol-Myers Squibb

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 24, 2010
Enrollment StartJan 1, 2010
Primary CompletionJun 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 16.4 years ago

Interventions

Ixabepilonedrug

20 mg/m2 on Days 1 and 8

Carboplatindrug

carboplatin AUC=2.5 on Days 1 and 8