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NCT00574587 · ClinicalTrials.gov registry record · Phase 1
Trial for Locally Advanced Breast Cancer Using Vorinostat Plus Chemotherapy
A Phase 1 study, sponsored by Albert Einstein College of Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 55
- Enrollment target
NCT00574587: Completed Phase 1 study, sponsored by Albert Einstein College of Medicine.
NCT00574587 is a Phase 1 study that has completed, run by Albert Einstein College of Medicine. The registered enrollment target is 55 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00574587, a Phase 1 study, has completed, sponsored by Albert Einstein College of Medicine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 55 participants
- Enrollment target
Study Summary
Vorinostat is a histone deacetylase (HDAC) inhibitor which is approved by the U.S. Food and Drug Administration for the treatment of a rare type of cancer involving the skin (cutaneous T cell lymphoma), but not for breast cancer. HDAC inhibitors work by unsilencing tumor suppressor genes and other genes in the cancer cells that are repressed; when the genes are turned back on by the drug, it leads to death of the cancer cells. HDAC inhibitors such as vorinostat have been shown to enhance the effects of chemotherapy and trastuzumab in experimental systems. The purpose of this trial is to determine the optimal dose of vorinostat to use in combination with standard chemotherapy alone (or in combination with plus trastuzumab for HER2-positive disease), and to determine whether vorinostat enhances the effectiveness of standard chemotherapy (+/- trastuzumab) in patients with locally advanced breast cancer.
Primary Outcome
Dose limiting toxicity in cycle 1
Interventions
- DRUG Trastuzumab
- DRUG Cyclophosphamide
- DRUG Doxorubicin
- DRUG Paclitaxel
- DRUG Vorinostat
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2007-12 |
| Est. Completion | 2014-05 |
| Phase | Phase 1 |
What the finished NCT00574587 record still lists
NCT00574587 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 5 interventions - of which Trastuzumab is the first listed.
NCT00574587 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00574587 about?
NCT00574587 is a clinical study titled "Trial for Locally Advanced Breast Cancer Using Vorinostat Plus Chemotherapy". Vorinostat is a histone deacetylase (HDAC) inhibitor which is approved by the U.S. Food and Drug Administration for the treatment of a rare type of cancer involving the skin (cutaneous T cell lymphoma), but not for breast cancer. HDAC inhibitors work by unsilencing tumor suppressor genes and other g...
What is the current status of trial NCT00574587?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 55 participants. The study started on 2007-12. Estimated completion is 2014-05.
What interventions are being tested in trial NCT00574587?
The interventions under investigation include: Trastuzumab (DRUG), Cyclophosphamide (DRUG), Doxorubicin (DRUG), Paclitaxel (DRUG), Vorinostat (DRUG).
Who is sponsoring clinical trial NCT00574587?
This trial is sponsored by Albert Einstein College of Medicine, which has 175 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00574587's enrollment target sits among peer trials
55 918th of 2000 higher than 1,070 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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