A Phase I/II Study of ABI-007 (Abraxane®, Nab®-Paclitaxel)and Vinorelbine in Patients With Stage IV (Metastatic) Breast Cancer

Stage IV (Metastatic) Breast Cancer Clinical Trial

Official title: An Open-Label Phase I/II Study of Weekly ABI-007 and Vinorelbine With or Without G-CSF in Patients With Stage IV (Metastatic) Breast Cancer

Status Terminated

Clinical Trial Summary

The purpose of this study is to: 1) determine the optimal tolerated dose of ABI-007 and vinorelbine, given concurrently on a weekly basis, in the absence of planned growth factor support with granulocyte colony-stimulating factor (G-CSF) (Patients with HER-2/neu positive disease may receive Herceptin, and 2) determine the optimal tolerated dose of ABI-007 and vinorelbine, given concurrently on a weekly basis, in the presence of planned growth factor support with G-CSF.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Breast Neoplasms
• Stage IV (Metastatic) Breast Cancer

• NCT number: NCT00140140
• Study type: Interventional
• Source: Celgene
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: August 2005
• Completion date: February 2008