A Phase I/II Exploratory Study of Ribavirin in Metastatic Breast Cancer Expressing Elevated eIF4E
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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall response rate to therapy with daily oral ribavirin
2 years
No
Wilson Miller, MD, PhD
Principal Investigator
Jewish General Hospital
Canada: Health Canada
Ribavirin-003
NCT01056757
December 2009
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