NCT00274456

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

A Randomized Phase II Study of Weekly or Every 3 Weeks ABI-007 Versus Every 3 Weeks Taxotere as First Line Therapy of Stage IV (Metastatic) Breast Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 302 (actual)
• Sponsor: Celgene · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This was an open-label study conducted comparing the toxicity and antitumor activity of ABI-007 (Abraxane®, nab®-paclitaxel) to docetaxel (Taxotere).

Detailed description

This was an open-label, randomized study to compare the following regimens with respect to toxicity and antitumor activity: * the maximum tolerated dose (MTD) of ABI-007 300 mg/m\^2 every 3 weeks; * ABI-007 100 mg/m\^2 administered weekly for 3 weeks with a 1 week rest; * ABI-007 150 mg/m\^2 administered weekly for 3 weeks with a 1 week rest; * the standard dose and schedule of Taxotere (100 mg/m\^2 every 3 weeks).

Conditions

• Metastatic Breast Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2005-11-01
• Primary completion: 2008-03-01
• Completion: 2011-07-01
• First posted: 2006-01-11
• Last updated: 2019-11-21
• Results posted: 2013-07-02

Locations

1 site across 1 country: Ukraine