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NCT01194908 · ClinicalTrials.gov registry record · Phase 1
Re-expression of ER in Triple Negative Breast Cancers
A Phase 1 study, sponsored by Emory University.
- Terminated
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
NCT01194908 is a Phase 1 study that was terminated before completion, run by Emory University. The registered enrollment target is 5 participants.
The verdict
NCT01194908, a Phase 1 study, was terminated before completion, sponsored by Emory University.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 5 participants
- Enrollment target
Study Summary
Patients are being asked to take part in this study because they have metastatic breast cancer that is triple negative (does not express estrogen receptor (ER), progesterone receptor (PR) or HER2). This means that agents such as trastuzumab (Herceptin®) and tamoxifen are not currently treatment options for their cancer. Another option for treating the patient's cancer at this point is with chemotherapy. The patient should discuss this and other options with their doctor prior to entering this study. Laboratory studies have demonstrated that ER is actually present in some triple negative breast cancers but is "silenced" (does not function properly) because methyl and histone groups are attached to it and inactivate it. Special drugs called demethylating inhibitors (such as decitabine) and histone deacetylase inhibitors (such as LBH589) can remove these methyl and histone groups and reactivate ER. This reactivated ER can then be targeted with agents like tamoxifen. The patient is being asked to join this clinical research study to find out if ER can be reactivated in their cancer using decitabine in combination with LBH589. If ER is reactivated in their cancer, we will then determine if tamoxifen can decrease the growth of the cancer.
Interventions
- DRUG Decitabine, LBH589, Tamoxifen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2010-07 |
| Est. Completion | 2014-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01194908
The ClinicalTrials.gov registry entry for NCT01194908 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Decitabine, LBH589, Tamoxifen is the first listed.
NCT01194908 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01194908 about?
NCT01194908 is a clinical study titled "Re-expression of ER in Triple Negative Breast Cancers". Patients are being asked to take part in this study because they have metastatic breast cancer that is triple negative (does not express estrogen receptor (ER), progesterone receptor (PR) or HER2). This means that agents such as trastuzumab (Herceptin®) and tamoxifen are not currently treatment opti...
What is the current status of trial NCT01194908?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2010-07. Estimated completion is 2014-01.
What interventions are being tested in trial NCT01194908?
The interventions under investigation include: Decitabine, LBH589, Tamoxifen (DRUG).
Who is sponsoring clinical trial NCT01194908?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
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