CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 42 enrolled
Drug / intervention
Omeprazoledrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02595372
NCT02595372Phase 2Completed

Inhibiting Fatty Acid Synthase to Improve Efficacy of Neoadjuvant Chemotherapy

Kathy Miller·interventional·Posted Nov 3, 2015·Updated Dec 15, 2021

In Brief

A Phase 2 clinical trial evaluating Omeprazole for Cancer of the Breast. Completed, enrolled 42 participants across 9 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedNov 3, 2015
Enrollment StartNov 12, 2015
Primary CompletionNov 21, 2019
Study CompletionMar 1, 2021
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 10.7 years ago

Interventions

Omeprazoledrug