drugset / Trial / NCT02595372

Inhibiting Fatty Acid Synthase to Improve Efficacy of Neoadjuvant Chemotherapy

NCT02595372

Phase 2 Completed 42 enrolled Kathy Miller
NaSingle-groupOpen-labelTreatment

Summary

In preliminary laboratory science studies, the investigators show that proton pump inhibitors (PPIs) effectively inhibit human fatty acid synthase (FASN) and breast cancer cell survival. A preliminary retrospective study shows that PPI usage in breast cancer patients during chemotherapy significantly improved overall survival. The impact was most striking in patients with triple negative breast cancer (TNBC). Thus, PPIs may be repositioned as safe and effective breast cancer drugs to enhance the effect of chemotherapy. Many of the hurdles that slow progress from target, to lead compound, to investigational agent, to standard therapy are not barriers for the PPIs. The PPIs are FDA-approved, chronically used, and well tolerated so the investigators can move quickly from the laboratory to a proof of concept clinical trial. Incorporating the PPIs into standard care will require more than the investigators propose here, but the investigators have already plotted the additional steps needed to truly impact patient care. If successful, the data gathered in this proposal will lend support to and guide development of a definitive randomized trial.

Timeline

Start
2015-11-12
Primary completion
2019-11-21
Completion
2021-03-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Omeprazole Other / unclassified 80 mg Oral

Indications