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Omeprazole in Treating Patients with Stage I-III Triple Negative Breast Cancer Undergoing Chemotherapy

Trial Status: Closed to Accrual and Intervention

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.

Inclusion Criteria

  • Newly diagnosed triple negative breast cancer (TNBC) clinical stage I (must be T1c), II, or III * Estrogen receptor (ER) and progesterone receptor (PR) < 10% * HER2 negative based on one of the following: ** Immunohistochemistry (IHC) 0 or 1+ ** IHC 2+ and fluorescence in situ hybridization (FISH) negative ** IHC 2+ and FISH equivocal and no indication for HER2 targeted therapy based on the treating investigators discretion (i.e., HER2: CEP17 ratio < 2.0 or HER2 total copy number < 6)
  • Planned neoadjuvant treatment with anthracycline and taxane containing chemotherapy
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Ability to provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization
  • Women of childbearing potential definition must have a negative pregnancy test within 14 days of registration; all women (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) are considered to have childbearing potential unless they meet one of the following criteria: * Prior hysterectomy or bilateral oophorectomy; * Has not had menses at any time in the preceding 24 consecutive months
  • Left ventricular ejection fraction (LVEF) > lower limit of normal (LLN) based on cardiac echocardiography (ECHO) or multi-gated acquisition (MUGA)
  • Hemoglobin (Hgb) >= 8.5
  • Absolute neutrophil count (ANC) > 1,000
  • Platelets >= 100,000
  • Creatinine =< 1.5
  • Total bilirubin (T. bili) =< 1.3
  • Aspartate aminotransferase (AST) =< 2.5 x upper limit of normal (ULN)

Exclusion Criteria

  • Use of prescription proton pump inhibitors (PPIs) within 12 months prior to study entry * Dexlansoprazole (Dexilant) * Pantoprazole (Protonix) * Rabeprazole (AcipHex) * Esomeprazole (Nexium) * Lansoprazole (Prevacid) * Omeprazole (Prilosec, Zegerid)
  • Use of over the counter (OTC) PPIs within 6 months prior to study entry * Esomeprazole (Nexium) * Lansoprazole (Prevacid) * Omeprazole (Prilosec, Zegerid)
  • Use of orlistat or any other known FASN inhibitor within 6 months prior to study entry
  • Nursing mothers are excluded
  • Known hypersensitivity to any component of the formulation or substituted benzimidazoles
  • Prior osteoporotic fracture

District of Columbia

Washington
MedStar Georgetown University Hospital
Status: CLOSED_TO_ACCRUAL_AND_INTERVENTION
Contact: Antonella N. Novielli
Phone: 202-784-3923
MedStar Washington Hospital Center
Status: CLOSED_TO_ACCRUAL_AND_INTERVENTION
Contact: Gouled Ahmed
Phone: 202-877-9374

Indiana

Indianapolis
Indiana University / Melvin and Bren Simon Cancer Center
Status: CLOSED_TO_ACCRUAL_AND_INTERVENTION
Contact: Kathy Durham Miller
Phone: 317-948-3855

Maryland

Baltimore
MedStar Franklin Square Medical Center / Weinberg Cancer Institute
Status: CLOSED_TO_ACCRUAL_AND_INTERVENTION
Contact: Jean Flack

North Carolina

Winston-Salem
Wake Forest University Health Sciences
Status: CLOSED_TO_ACCRUAL_AND_INTERVENTION
Contact: Stacey G. Lewis
Phone: 336-716-6927

Ohio

Columbus
Ohio State University Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL_AND_INTERVENTION
Contact: Lynette Anne Mesi
Phone: 614-685-6046

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.

Trial Phase Phase II

Trial Type Treatment

Lead Organization
Indiana University / Melvin and Bren Simon Cancer Center

Principal Investigator
Kathy Durham Miller

  • Primary ID IUSCC-0555
  • Secondary IDs NCI-2016-02013
  • Clinicaltrials.gov ID NCT02595372