Treatment With Ribavirin for Patients With Metastatic Breast Cancer

Metastatic Breast Cancer Clinical Trial

Official title: A Phase I/II Exploratory Study of Ribavirin in Metastatic Breast Cancer Expressing Elevated eIF4E

Status Terminated

Clinical Trial Summary

The purpose of this study is to learn whether oral Ribavirin is safe and effective in treating patients with metastatic breast cancer, that have high levels of eIF4E.

Clinical Trial Description

Overexpression of eIF4E occurs in greater than 50% of BC, where it has been associated with clinical progression, angiogenesis and chemoresistance. eIF4E protein expression is not elevated in stroma or in benign tissue. A major focus in the future management of BC is to develop novel targeted therapeutics, with associated biomarkers of clinical value. It is possible that targeting a central regulator that can control multiple pathways might be more effective than targeting a single downstream molecule. In our preclinical studies, we have demonstrated that ribavirin inhibits proliferation of BC cell lines at clinically achievable concentrations by inhibiting its target, eIF4E. This trial addresses the important clinical issue of the lack of treatment for poor prognosis BC, characterized by overexpression of eIF4E. We will explore the use of eIF4E as therapeutic target and a predictive marker. We will determine whether targeting eIF4E with ribavirin, a commercially approved, inexpensive, oral therapeutic compound with a favourable toxicity profile, may present a novel treatment option for patients with aggressive, metastatic disease. ;

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

• NCT number: NCT01056757
• Study type: Interventional
• Source: Jewish General Hospital
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: December 2009
• Completion date: November 2010