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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 is a Phase 1 study that has completed, run by Albert Einstein College of Medicine. The registered enrollment target is 55 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00574587
The ClinicalTrials.gov registry entry for NCT00574587 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 55 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Albert Einstein College of Medicine, which has 175 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Trastuzumab is the first listed.
NCT00574587 reports 0 study locations.
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.
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