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NCT03473639 · ClinicalTrials.gov registry record · Phase 1
A Pilot Study of the Combination of Entinostat With Capecitabine in High Risk Breast Cancer After Neo-adjuvant Therapy
A Phase 1 study, sponsored by University of Virginia.
- Completed
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
NCT03473639: Completed Phase 1 study, sponsored by University of Virginia.
NCT03473639 is a Phase 1 study that has completed, run by University of Virginia. The registered enrollment target is 13 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03473639, a Phase 1 study, has completed, sponsored by University of Virginia.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
Study Summary
The purpose of this study is to learn about the safety and side effects of combining entinostat, an investigational drug, with capecitabine, a drug commonly used in breast cancer (BC), in both participants with metastatic breast cancer (MBC) and then participants with high-risk breast cancer after neo-adjuvant therapy.
Primary Outcome
This will be defined based on the number of "dose limiting toxicities" in participants at each dose level.
Interventions
- DRUG Capecitabine
- DRUG Entinostat
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2019-01-29 |
| Est. Completion | 2022-11-01 |
| Phase | Phase 1 |
What the finished NCT03473639 record still lists
NCT03473639 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 2 interventions - of which Capecitabine is the first listed.
NCT03473639 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03473639 about?
NCT03473639 is a clinical study titled "A Pilot Study of the Combination of Entinostat With Capecitabine in High Risk Breast Cancer After Neo-adjuvant Therapy". The purpose of this study is to learn about the safety and side effects of combining entinostat, an investigational drug, with capecitabine, a drug commonly used in breast cancer (BC), in both participants with metastatic breast cancer (MBC) and then participants with high-risk breast cancer after n...
What is the current status of trial NCT03473639?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2019-01-29. Estimated completion is 2022-11-01.
What interventions are being tested in trial NCT03473639?
The interventions under investigation include: Capecitabine (DRUG), Entinostat (DRUG).
Who is sponsoring clinical trial NCT03473639?
This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03473639's enrollment target sits among peer trials
13 1847th of 2000 higher than 149 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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