Breast NeoplasmsNCT00071383
Analysis of Brain Metastasis in Patients With Breast Cancer, With and Without Over-Expression of HER-2
An observational study of Breast Neoplasms, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Neoplasms
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2003to Nov 2004
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- A woman with a known or with radiographic evidence of a breast neoplasm metastatic to the brain.
- Medically-indicated (diagnostic and/or therapeutic) brain tumor resection.
- Informed consent from female patient, age 18 or older. In general, patients less than 18 years of age rarely have breast cancer metastatic to the brain.
Who cannot join
- Inability to provide informed consent prior to surgery.
- Medical conditions that cannot be corrected prior to surgery that would be standard contraindications for craniotomy (brain tumor patients).
- Men.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, Maryland, 20892
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Breast Neoplasms
- Keywords
- Herceptin, Trastuzumab, Microdissection, Proteomics, Microarrays, Metastatic Brain Tumor, Breast Cancer, Brain, Carcinoma, Genomics, Metastatic Breast Cancer, Metastatic Breast Tumor
- Medical subject headings
- Breast Neoplasms, Brain Neoplasms, Carcinoma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2003 (estimated)
- Study startOct 2003
- Study completionNov 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 78 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00071383
- Sponsor's protocol ID
- 040005
- Other IDs
- 04-N-0005
- Status last verified
- Nov 2004
- First submitted
- 20 Oct 2003
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Sorlie T, Tibshirani R, Parker J, Hastie T, Marron JS, Nobel A, Deng S, Johnsen H, Pesich R, Geisler S, Demeter J, Perou CM, Lonning PE, Brown PO, Borresen-Dale AL, Botstein D. Repeated observation of breast tumor subtypes in independent gene expression data sets. Proc Natl Acad Sci U S A. 2003 Jul 8;100(14):8418-23. doi: 10.1073/pnas.0932692100. Epub 2003 Jun 26.
PubMed 12829800Pollack JR, Sorlie T, Perou CM, Rees CA, Jeffrey SS, Lonning PE, Tibshirani R, Botstein D, Borresen-Dale AL, Brown PO. Microarray analysis reveals a major direct role of DNA copy number alteration in the transcriptional program of human breast tumors. Proc Natl Acad Sci U S A. 2002 Oct 1;99(20):12963-8. doi: 10.1073/pnas.162471999. Epub 2002 Sep 24.
PubMed 12297621Sorlie T, Perou CM, Tibshirani R, Aas T, Geisler S, Johnsen H, Hastie T, Eisen MB, van de Rijn M, Jeffrey SS, Thorsen T, Quist H, Matese JC, Brown PO, Botstein D, Lonning PE, Borresen-Dale AL. Gene expression patterns of breast carcinomas distinguish tumor subclasses with clinical implications. Proc Natl Acad Sci U S A. 2001 Sep 11;98(19):10869-74. doi: 10.1073/pnas.191367098.
PubMed 11553815
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Brain Metastasis in Patients With Breast Cancer, With and Without Over-Expression of HER-2
- ClinicalTrials.gov ID
- NCT00071383
- Acronym / sponsor ID
- 040005
- Conditions
- Breast Neoplasms
- Keywords
- Herceptin, Trastuzumab, Microdissection, Proteomics, Microarrays, Metastatic Brain Tumor, Breast Cancer, Brain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- Oct 2003
- Study completion
- Nov 2004
- First posted
- 13 Oct 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- A woman with a known or with radiographic evidence of a breast neoplasm metastatic to the brain.
- Medically-indicated (diagnostic and/or therapeutic) brain tumor resection.
- Informed consent from female patient, age 18 or older. In general, patients less than 18 years of age rarely have breast cancer metastatic to the brain.
Key exclusion criteria (3 listed)
- Inability to provide informed consent prior to surgery.
- Medical conditions that cannot be corrected prior to surgery that would be standard contraindications for craniotomy (brain tumor patients).
- Men.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 12829800Sorlie T, Tibshirani R, Parker J, Hastie T, Marron JS, Nobel A, Deng S, Johnsen H, Pesich R, Geisler S, Demeter J, Perou CM, Lonning PE, Brown PO, Borresen-Dale AL, Botstein D. Repeated observation of breast tumor subtypes in independent gene expression data sets. Proc Natl Acad Sci U S A. 2003 Jul 8;100(14):8418-23. doi: 10.1073/pnas.0932692100. Epub 2003 Jun 26.
- Background: PubMed 12297621Pollack JR, Sorlie T, Perou CM, Rees CA, Jeffrey SS, Lonning PE, Tibshirani R, Botstein D, Borresen-Dale AL, Brown PO. Microarray analysis reveals a major direct role of DNA copy number alteration in the transcriptional program of human breast tumors. Proc Natl Acad Sci U S A. 2002 Oct 1;99(20):12963-8. doi: 10.1073/pnas.162471999. Epub 2002 Sep 24.
- Background: PubMed 11553815Sorlie T, Perou CM, Tibshirani R, Aas T, Geisler S, Johnsen H, Hastie T, Eisen MB, van de Rijn M, Jeffrey SS, Thorsen T, Quist H, Matese JC, Brown PO, Botstein D, Lonning PE, Borresen-Dale AL. Gene expression patterns of breast carcinomas distinguish tumor subclasses with clinical implications. Proc Natl Acad Sci U S A. 2001 Sep 11;98(19):10869-74. doi: 10.1073/pnas.191367098.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Neoplasms, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00071383, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2008.