Overview

A Study of Epothilone D in Combination With Herceptin (Trastuzumab) in Patients With HER-2 Positive Advanced or Metastatic Breast Cancer.

Status:
Completed

Trial end date:
2008-04-01

Target enrollment:

Participant gender:

Summary

This single arm study will determine the efficacy and safety of an epothilone D and Herceptin combination regimen in patients with HER-2 positive locally advanced or metastatic breast cancer. Epothilone D will be administered intravenously on days 1, 8 and 15 every 4 weeks at a dose not exceeding 100mg/m2. Herceptin will be administered intravenously on a weekly schedule; a 4mg/kg loading dose will be followed by a weekly maintenance dose of 2mg/kg. The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.

Phase:

Phase 2

Details

Lead Sponsor:

Hoffmann-La Roche

Treatments:

Desoxyepothilone B
Epothilones
Trastuzumab