Phase II Trial Comparing ABI-007 (Abraxane®, Nab®-Paclitaxel) to Taxotere in First Line Therapy of Patients With Stage IV Breast Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

302

Participants

Timeline

Start Date

November 1, 2005

Primary Completion Date

March 1, 2008

Study Completion Date

July 1, 2011

Conditions
Metastatic Breast Cancer
Interventions
DRUG

ABI-007

ABI-007 administered by intravenous infusion over 30 minutes at one of three different dosing levels (100, 150 or 300 mg/m\^2) with a treatment cycle length of either 3 or 4 weeks depending upon treatment arm assignment.

DRUG

Docetaxel

Docetaxel dosed q3w at 100 mg/m\^2

Trial Locations (1)

01021

Study Sites in Russia and the Ukraine, Kiev

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Celgene

INDUSTRY