VEGF Trap in Treating Patients With Metastatic Breast Cancer

Metastatic Breast Cancer Clinical Trial

Official title: Phase II Trial of VEGF Trap in Patients With Metastatic Breast Cancer Previously Treated With Anthracycline and/or Taxane

Status Completed

Clinical Trial Summary

This phase II trial is studying how well VEGF Trap works in treating patients with metastatic breast cancer. VEGF Trap may stop the growth of tumor cells by blocking blood flow to the tumor

Clinical Trial Description

PRIMARY OBJECTIVES:

I. Assess the antitumor activity of VEGF Trap, in terms of tumor response rate, in patients with metastatic breast cancer who have received =< 2 prior chemotherapy regimens for metastatic disease, including a taxane and/or anthracycline.

II. Assess the 6-month progression-free survival rate in patients treated with VEGF Trap.

SECONDARY OBJECTIVES:

I. Describe the adverse event profile (grade using the NCI CTCAE version 3.0) of VEGF Trap in these patients.

II. Describe the progression-free survival times in patients treated with VEGF Trap.

III. Describe the overall survival of patients treated with VEGF Trap. IV. Describe the duration of response in patients treated with VEGF Trap.

OUTLINE: This is a multicenter study.

Patients receive VEGF Trap IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3-6 months for up to 5 years. ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer
• Recurrent Breast Cancer
• Stage IV Breast Cancer

• NCT number: NCT00369655
• Study type: Interventional
• Source: National Cancer Institute (NCI)
• Status: Completed
• Phase: Phase 2
• Start date: January 2007
• Completion date: January 2011