Inhibiting Fatty Acid Synthase to Improve Efficacy of Neoadjuvant Chemotherapy
Public ClinicalTrials.gov record NCT02595372. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT02595372
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 42 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 12, 2015 (Actual)
- Primary completion
- Nov 21, 2019 (Actual)
- Completion
- Mar 1, 2021 (Actual)
- Last update posted
- Dec 15, 2021
2015 – 2021
United States locations
- U.S. sites
- 9
- U.S. states
- 5
- U.S. cities
- 6
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Georgetown University | Washington D.C. | District of Columbia | 20007 | — |
| Washington Hospital | Washington D.C. | District of Columbia | 20010 | — |
| Indiana University Health North Hospital | Carmel | Indiana | 46032 | — |
| Indiana University Health Hospital | Indianapolis | Indiana | 46202 | — |
| Indiana University Health Melvin and Bren Simon Cancer Center | Indianapolis | Indiana | 46202 | — |
| Spring Mill Medical Center | Indianapolis | Indiana | 46290 | — |
| Franklin Square Medical Center | Baltimore | Maryland | 21237 | — |
| Wake Forest Baptist Health | Winston-Salem | North Carolina | 27157 | — |
| Ohio State University | Columbus | Ohio | 43210 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02595372, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 15, 2021 · Synced Oct 28, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02595372 live on ClinicalTrials.gov.