Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00071383
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2003-10-20
Brief Title:
Analysis of Brain Metastasis in Patients With Breast Cancer With and Without Over-Expression of HER-2
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Analysis of Brain Metastasis in Patients With Breast Cancer With and Without Over-Expression of HER-2
Status:
COMPLETED
Status Verified Date:
2004-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will examine two subsets of patients with breast cancer metastasis that is spreading to the brain It will identify genes and proteins that promote metastasis particularly in women who are found to over-express have more than other people do the human epidermal growth factor receptor ErbB2 also known as HER-2 The molecular and genetic events that permit tumor metastasis are not well understood There is intense investigation going on into the process in which tumor cells escape the primary local tumor spread to distant places in the body and find and create conditions that promote growth in those tissues Metastasis of tumors such as breast cancer to the brain is a common problem Tumor cells will be analyzed with the use of microarrays A microarray is a tool for analyzing gene expression consisting of a small membrane or glass slide containing samples of many genes arranged in a regular pattern The goal is to identify a potential molecular signature It is hoped that there will be discovery of why some patients are more likely than others to develop a brain metastasis which can have a major negative effect on the quality of life and survival
Female patients 18 years of age with known or evidence by radiology of a breast tumor metastatic to the brain or those who have had a removal of a brain tumor for diagnosis or treatment may be eligible for this study
Participants will undergo the following procedures and tests
Craniotomy that is surgical opening of the skull and removal of the brain tumor
Blood specimens taken from a central vein or artery before the operation throughout as needed and for several days afterward to measure blood chemistries blood count and so forth
Physical examination and imaging of the central nervous system before and after surgery
Urine or serum or both pregnancy test of women of childbearing potential
Patients will also undergo blood tests at 3-month intervals after surgery for up to 5 years The purpose is to determine if there are tumor cells in the blood which may explain how they reached the brain
Female patients 18 years of age with known or evidence by radiology of a breast tumor metastatic to the brain or those who have had a removal of a brain tumor for diagnosis or treatment may be eligible for this study
Participants will undergo the following procedures and tests
Craniotomy that is surgical opening of the skull and removal of the brain tumor
Blood specimens taken from a central vein or artery before the operation throughout as needed and for several days afterward to measure blood chemistries blood count and so forth
Physical examination and imaging of the central nervous system before and after surgery
Urine or serum or both pregnancy test of women of childbearing potential
Patients will also undergo blood tests at 3-month intervals after surgery for up to 5 years The purpose is to determine if there are tumor cells in the blood which may explain how they reached the brain
Detailed Description:
Introduction The molecular and genetic events that permit tumor metastasis are not well understood The process whereby tumor cells escape the primary local tumor spread to distant sites in the body and find and create conditions conducive to growth in these disparate tissues remains an area of intense investigation Metastasis of epithelial tumors such as breast cancer to the brain is a common problem with significant consequences with respect to neurological dysfunction and shortening of survival
Objective To study two subset of patients with breast cancer metastatic to the brain to identify genes and proteins that facilitate metastasis particularly in women who over-express the growth factor receptor HER2 in which an increased risk of brain metastasis has recently been identified
Study Population 78 patients with breast cancer metastatic to the brain 39 women whose tumors are HER2-- and 39 women whose tumors are HER2- to compare with published microarray studies of non-metastatic breast cancer patients with these tumor types as well as with one another to help explain the differential trend toward metastasis in patients treated with Herceptin a new therapy directed at HER-2 over-expressing tumors
Anticipated Risks and Benefits Less than minimal risk to the patients to sample tissue already removed from the brain as part of medically-necessary surgery and to sample blood No direct benefit to the patient is expected
Outcome Estimate and Potential Meaning for the Field That this very detailed investigation of the genes and proteins expressed differentially between the non-metastatic and metastatic breast cancers as well as between HER2-- and HER2- subtypes will identify new or previously-unsuspected targets for new therapies to either prevent the development of brain metastasis or to treat these brain metastases more effectively
Objective To study two subset of patients with breast cancer metastatic to the brain to identify genes and proteins that facilitate metastasis particularly in women who over-express the growth factor receptor HER2 in which an increased risk of brain metastasis has recently been identified
Study Population 78 patients with breast cancer metastatic to the brain 39 women whose tumors are HER2-- and 39 women whose tumors are HER2- to compare with published microarray studies of non-metastatic breast cancer patients with these tumor types as well as with one another to help explain the differential trend toward metastasis in patients treated with Herceptin a new therapy directed at HER-2 over-expressing tumors
Anticipated Risks and Benefits Less than minimal risk to the patients to sample tissue already removed from the brain as part of medically-necessary surgery and to sample blood No direct benefit to the patient is expected
Outcome Estimate and Potential Meaning for the Field That this very detailed investigation of the genes and proteins expressed differentially between the non-metastatic and metastatic breast cancers as well as between HER2-- and HER2- subtypes will identify new or previously-unsuspected targets for new therapies to either prevent the development of brain metastasis or to treat these brain metastases more effectively
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 |
|---|---|---|---|
| 04-N-0005 | None | None | None |