Sorafenib in Treating Patients With Metastatic Breast Cancer

Stage IV Breast Cancer Clinical Trial

Official title: Phase II Trial of Raf Kinase Inhibitor BAY 43-9006 as Single Oral Agent in Patients With Metastatic Breast Cancer Previously Exposed to Anthracycline and/or Taxane

Status Completed

Clinical Trial Summary

This phase II trial is studying how well sorafenib works in treating patients with metastatic breast cancer. Sorafenib may stop the growth of tumor cells by blocking the enzymes necessary for their growth and by stopping blood flow to the tumor.

Clinical Trial Description

OBJECTIVES:

I. Determine the tumor response rate in patients with metastatic breast cancer previously treated with an anthracycline- and/or taxane-containing regimen receiving sorafenib.

II. Assess the toxicity profile of this drug in these patients. III. Determine time to disease progression and survival time of patients treated with this drug.

IV. Correlate pre-treatment levels of activated ERK1/2 with tumor response in patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 6 months until disease progression and then every 3 months for up to 5 years. ;

Related Conditions & MeSH terms

• Breast Neoplasms
• Breast Neoplasms, Male
• Male Breast Cancer
• Recurrent Breast Cancer
• Stage IV Breast Cancer

• NCT number: NCT00096434
• Study type: Interventional
• Source: National Cancer Institute (NCI)
• Status: Completed
• Phase: Phase 2
• Start date: September 2004