Ignite Creation Date:
2024-05-05 @ 10:50 PM
Last Modification Date:
2024-10-26 @ 10:24 AM
Study NCT ID:
NCT01194908
Status:
TERMINATED
Last Update Posted:
2015-01-26
First Post:
2010-09-01
Brief Title:
Re-expression of ER in Triple Negative Breast Cancers
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
Phase III Trial of Tamoxifen Following Epigenetic Regeneration of Estrogen Receptor Using Decitabine and LBH 589 in Patients With Triple Negative Metastatic Breast Cancer
Status:
TERMINATED
Status Verified Date:
2015-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 patients 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| WCI1696-09 | OTHER | Other | None |