CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 384 enrolled
Drug / intervention
Ixabepilone +3 moredrug
Likely dose
Ixabepilone 40mgfrom 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/NCT00455533
NCT00455533Phase 2Completed

A Randomized Phase II Biomarker Neoadjuvant Study of Sequential AC Followed by Ixabepilone Compared to Sequential AC Followed by Paclitaxel in Women With Early Stage Breast Cancer

Bristol-Myers Squibb·interventional·Posted Apr 3, 2007·Updated Feb 24, 2016

In Brief

A Phase 2 clinical trial evaluating Ixabepilone, Paclitaxel, and 2 other interventions for Breast Cancer. Completed, enrolled 384 participants across 49 sites in 15 countries.

Detailed Summary

The study will evaluate the effectiveness of ixabepilone when given after doxorubicin plus cyclophosphamide (AC) compared to standard treatment of paclitaxel given after doxorubicin plus cyclophosphamide in patients with early stage breast cancer. In addition the study will verify predefined biomarkers as well as discover new biomarkers that could identify patients who are more likely to respond to ixabepilone than standard paclitaxel based therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesArgentina, Austria, France, Germany, India, Italy, Peru, Philippines, Russia, Singapore, South Korea, Spain, Taiwan, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 3, 2007
Enrollment StartOct 1, 2007
Primary CompletionDec 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 19.2 years ago

Interventions

Ixabepilonedrug

Intravenous Solution, intravenous (IV), 40mg/m², Day 1 every 21 days, 12 Weeks

Paclitaxeldrug

Intravenous Solution, IV, 80mg/m², Weekly, 12 Weeks

Cyclophosphamidedrug

Intravenous Solution, IV, 600mg/m², Day 1 every 21 days, 12 Weeks

Doxorubicindrug

Intravenous Solution, IV, 60mg/m², Day 1 every 21 days, 12 Weeks