This phase II trial studies how well omeprazole works in treating patients with stage I-III triple negative breast cancer who are undergoing chemotherapy. Omeprazole may help inhibit the ability of breast cancer cells to use fatty acid synthase to fuel their growth and may improve the results of chemotherapy.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02595372.
PRIMARY OBJECTIVE:
I. Estimate the rate of pathologic complete response (pCR) in patients with triple negative breast cancer and FASN expression treated with standard neoadjuvant chemotherapy in combination with high dose omeprazole.
SECONDARY OBJECTIVES:
I. Quantify the number of patients with newly diagnosed triple negative breast cancer (TNBC) with tumors that express FASN.
II. Estimate the rate of pCR in patients with triple negative breast cancer (irrespective of FASN status) treated with standard neoadjuvant chemotherapy in combination with high dose omeprazole.
III. Describe the safety of incorporating high dose omeprazole with standard neoadjuvant chemotherapy.
IV. Estimate the biologic activity of high dose omeprazole in modulating FASN expression and activity.
TERTIARY/EXPLORATORY/CORRELATIVE OBJECTIVES:
I. Describe omeprazole exposure.
II. Compare peak omeprazole concentration to level associated activity based on preclinical testing (~5.6 uM based on half maximal inhibitory concentration [IC50]).
III. Using pharmacokinetics (PK)-pharmacodynamics (PD) models, use omeprazole concentration and change in lipid levels to predict clinical outcome.
IV. Explore changes in lipid profile over time.
OUTLINE:
Patients receive omeprazole orally (PO) twice daily (BID) beginning 4-7 days prior to standard of care chemotherapy and continuing for up to 8 months in the absence of disease progression or unexpected toxicity.
Lead OrganizationIndiana University/Melvin and Bren Simon Cancer Center
Principal InvestigatorKathy Durham Miller
