Ignite Creation Date:
2024-05-05 @ 9:08 PM
Last Modification Date:
2024-10-26 @ 9:59 AM
Study NCT ID:
NCT00810017
Status:
TERMINATED
Last Update Posted:
2022-05-19
First Post:
2008-12-16
Brief Title:
Phase 2 Study of Trastuzumab and Etoposide for Her2 Positive Breast Cancer
Sponsor:
Medstar Health Research Institute
Organization:
Medstar Health Research Institute
Study Overview
Official Title:
Phase II Clinical Study Combining Trastuzumab With Etoposide in Treatment of HER2-Positive Metastatic Breast Cancer
Status:
TERMINATED
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Terminated due to difficulty in accruing patients
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is for women and men who have previously treated metastatic has spread to other parts in the body Her2- positive breast cancer The purpose of this study is to find out what effects good and bad the FDA-approved drugs etoposide and trastuzumab have on this type of breast cancer and to determine if these drugs are safe to use together This research is being done to find more effective treatment for this type of condition
In this study trastuzumab and etoposide will be given by intravenous infusion IV through a vein on the first 3 days of every 3-week cycle This is repeated for 6 cycles After 6 cycles only trastuzumab will be given until worsening of disease In this study a small amount of your tissue that was collected when you had surgery will be evaluated in the lab to look at genetic differences among people and how those differences may affect a response to a specific drug or medicine This testing will look for a gene called Top2A Previous studies suggest that people who have both the Top2A and Her2 genes respond to certain chemotherapies anti-cancer drugs differently from those who only have the Her2 gene
In this study trastuzumab and etoposide will be given by intravenous infusion IV through a vein on the first 3 days of every 3-week cycle This is repeated for 6 cycles After 6 cycles only trastuzumab will be given until worsening of disease In this study a small amount of your tissue that was collected when you had surgery will be evaluated in the lab to look at genetic differences among people and how those differences may affect a response to a specific drug or medicine This testing will look for a gene called Top2A Previous studies suggest that people who have both the Top2A and Her2 genes respond to certain chemotherapies anti-cancer drugs differently from those who only have the Her2 gene
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None