Overview

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

Status:
Terminated

Trial end date:
2008-02-01

Target enrollment:

Participant gender:

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.

Phase:

Phase 1/Phase 2

Details

Lead Sponsor:

Celgene
Celgene Corporation

Treatments:

Albumin-Bound Paclitaxel
Lenograstim
Paclitaxel
Sargramostim
Trastuzumab
Vinblastine
Vinorelbine