CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 168 enrolled
Drug / intervention
Ixabepilone +1 moredrug
Likely dose
Ixabepilone 40 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/NCT00866905
NCT00866905Phase 2Completed
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Phase II Study of Ixabepilone and Cyclophosphamide as Neoadjuvant Therapy in HER2-Negative Breast Cancer

SCRI Development Innovations, LLC·interventional·Posted Mar 23, 2009·Updated Nov 22, 2021

In Brief

A Phase 2 clinical trial evaluating Ixabepilone and Cyclophosphamide for Breast Cancer. Completed, enrolled 168 participants across 20 sites.

Detailed Summary

We propose to evaluate ixabepilone in combination with cyclophosphamide for the neoadjuvant treatment of locally advanced breast cancer. In this regimen, ixabepilone is substituted for docetaxel, since preclinical and clinical studies suggest that ixabepilone is more active than either docetaxel or paclitaxel. The combination of ixabepilone and cyclophosphamide could further improve the efficacy of non-anthracycline neoadjuvant therapy.

Study Details

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

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 23, 2009
Enrollment StartApr 1, 2009
Primary CompletionJul 1, 2014
Study CompletionOct 1, 2014
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 17.3 years ago

Interventions

Ixabepilonedrug

40 mg/m2 IV infusion over 3 hours on day 1 of a 21 day cycle for 6 cycles

Cyclophosphamidedrug

600 mg/m2 IV infusion per institutional guidelines on day 1 of a 21 day cycle for 6 cycles