CancerNCT01077648
Brain Metastasis in Breast Cancer Patients
An observational study of Cancer, run by GlaxoSmithKline.
Trial summary
The purpose of this epidemiologic study is to establish a population-based cohort of women with advanced stage breast cancer which can be used to quantify the frequency and timing of brain metastases, and other distant metastases, in this patient population. Read more about this study
- Who is it for?
- Ages 30 years and older, women only
- Conditions the study is for
- Cancer
- What is being tested?
- Trastuzumab or Lapatinib
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- Feb 2010to Aug 2013
- 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 30 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: This study aims to retrospectively collect data on nearly 4,000 advanced breast cancer cases treated within the Henry Ford Health System
Who may be able to join
- Initially diagnosed with American Joint Commission on Cancer (AJCC) stage III or stage IV breast cancer between January 1, 1995 through December 31, 2007 -OR- diagnosed with AJCC stage I or II breast cancer and progressed to stage III or IV disease between January 1, 1995 through December 31, 2007;
- At least one year of follow-up after initial diagnosis (among patients who did not die before one year of follow-up); and
- Age 30 years or older at diagnosis.
Who cannot join
- Does not have at least one year of follow-up after initial diagnosis (among patients who did not die before one year of follow-up); and
- Age less than 30 years or older at diagnosis.
About this study
Official title: Occurrence of Brain Metastasis in Breast Cancer Patients Diagnosed at Advanced Stages of the Disease
The purpose of this epidemiologic study is to establish a population-based cohort of women with advanced stage breast cancer which can be used to quantify the frequency and timing of brain metastases, and other distant metastases, in this patient population.
Read the detailed description
A retrospective cohort study will be conducted in the Henry Ford Health System (HFHS). Using medical record review, we will identify all women diagnosed with advanced stage (stage III and IV) breast cancer between January 1, 1995- December 31, 2007. For each case included in the study, we will obtain data on demographics, tumor information, treatment related medical encounters and procedures, and occurrence and timing of brain and/or other distant metastases. The main outcome for this study is the development of distant metastases. Each patient in the cohort will be classified as to the occurrence and date of distant metastases. Metastases will be classified as Brain, Distant lymph node, Lung/pleural effusion, Liver, Bone, Other visceral, Other non-visceral.
Other secondary outcomes to be explored include:
- Survival after advanced breast cancer-time in months from the date of advanced stage breast cancer diagnosis until death or end of study period
- Time to brain metastases-time in month from the date of advanced stage breast cancer diagnosis until brain metastases diagnosis
- Survival after brain metastases-time in months from the date of diagnosis of brain metastases until death or end of study period
- Conditions
- Cancer
- Being tested
- Trastuzumab or Lapatinib
- Keywords
- Breast Cancer, Treatment, Brain metastases, ErbB2 expression
- Medical subject headings
- Neoplasms, Breast Neoplasms, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trastuzumab or LapatinibDrug
Anti-erbB2 therapy for breast cancer treatment will be analyzed as a class level variable; individual drugs including trastuzumab and lapatinib will also be explored as exposures if sufficient numbers of patients exist.
| Study group | Role | What they receive |
|---|---|---|
| Women diagnosed with advanced breast cancer | Women diagnosed with advanced breast cancer during January 1, 1995-December 31, 2007 and treated as part of the Henry Ford Health System Receives: Drug: Trastuzumab or Lapatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of advanced stage breast cancer patients that develop brain metastases, overall and stratified by anti-HER2 therapy (for HER2+ patients only).
Measured: Time from breast cancer diagnosis until death or end of study periods (September 1, 2009)
Secondary outcomes (3)
Overall survival from advanced stage breast cancer, overall and stratified by tumor characteristics and anti-HER2 therapy (for HER2+ patients only).
Measured: Time from diagnosis of advanced stage breast cancer until death or end of study period (September 1, 2009)
Time to brain metastases stratified by key tumor characteristics and anti-HER2 therapy (for HER2+ patients only).
Measured: Time from diagnosis of advanced stage breast cancer until brain metastases diagnosis
Survival after brain metastases diagnosis, overall and stratified by key tumor characteristics and anti-HER2 therapy (for HER2+ patients only)
Measured: Time from diagnosis of brain metastases until death or end of study period (September 1, 2009)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2010 (estimated)
- Study startFeb 2010
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01077648
- Sponsor's protocol ID
- 112951
- Status last verified
- May 2014
- First submitted
- 25 Feb 2010
- Last updated
- 26 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Occurrence of Brain Metastasis in Breast Cancer Patients Diagnosed at Advanced Stages of the Disease
- ClinicalTrials.gov ID
- NCT01077648
- Acronym / sponsor ID
- 112951
- Conditions
- Cancer
- Keywords
- Breast Cancer, Treatment, Brain metastases, ErbB2 expression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 1 Mar 2010 (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.
The purpose of this epidemiologic study is to establish a population-based cohort of women with advanced stage breast cancer which can be used to quantify the frequency and timing of brain metastases, and other distant metastases, in this patient population.
Detailed description
A retrospective cohort study will be conducted in the Henry Ford Health System (HFHS). Using medical record review, we will identify all women diagnosed with advanced stage (stage III and IV) breast cancer between January 1, 1995- December 31, 2007. For each case included in the study, we will obtain data on demographics, tumor information, treatment related medical encounters and procedures, and occurrence and timing of brain and/or other distant metastases. The main outcome for this study is the development of distant metastases. Each patient in the cohort will be classified as to the occurrence and date of distant metastases. Metastases will be classified as Brain, Distant lymph node, Lung/pleural effusion, Liver, Bone, Other visceral, Other non-visceral.
Other secondary outcomes to be explored include:
- Survival after advanced breast cancer-time in months from the date of advanced stage breast cancer diagnosis until death or end of study period
- Time to brain metastases-time in month from the date of advanced stage breast cancer diagnosis until brain metastases diagnosis
- Survival after brain metastases-time in months from the date of diagnosis of brain metastases until death or end of study period
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women diagnosed with advanced breast cancer | – | Drug: Trastuzumab or LapatinibWomen diagnosed with advanced breast cancer during January 1, 1995-December 31, 2007 and treated as part of the Henry Ford Health System |
Who may qualify
- Ages
- 30 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study aims to retrospectively collect data on nearly 4,000 advanced breast cancer cases treated within the Henry Ford Health System
Key inclusion criteria (3 listed)
- Initially diagnosed with American Joint Commission on Cancer (AJCC) stage III or stage IV breast cancer between January 1, 1995 through December 31, 2007 -OR- diagnosed with AJCC stage I or II breast cancer and progressed to stage III or IV disease between January 1, 1995 through December 31, 2007;
- At least one year of follow-up after initial diagnosis (among patients who did not die before one year of follow-up); and
- Age 30 years or older at diagnosis.
Key exclusion criteria (2 listed)
- Does not have at least one year of follow-up after initial diagnosis (among patients who did not die before one year of follow-up); and
- Age less than 30 years or older at diagnosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trastuzumab or LapatinibAnti-erbB2 therapy for breast cancer treatment will be analyzed as a class level variable; individual drugs including trastuzumab and lapatinib will also be explored as exposures if sufficient numbers of patients exist. | Drug | Women diagnosed with advanced breast cancer |
Primary outcome
Proportion of advanced stage breast cancer patients that develop brain metastases, overall and stratified by anti-HER2 therapy (for HER2+ patients only).
Time frame: Time from breast cancer diagnosis until death or end of study periods (September 1, 2009)
3 secondary outcomes
Overall survival from advanced stage breast cancer, overall and stratified by tumor characteristics and anti-HER2 therapy (for HER2+ patients only).
Time frame: Time from diagnosis of advanced stage breast cancer until death or end of study period (September 1, 2009)
Time to brain metastases stratified by key tumor characteristics and anti-HER2 therapy (for HER2+ patients only).
Time frame: Time from diagnosis of advanced stage breast cancer until brain metastases diagnosis
Survival after brain metastases diagnosis, overall and stratified by key tumor characteristics and anti-HER2 therapy (for HER2+ patients only)
Time frame: Time from diagnosis of brain metastases until death or end of study period (September 1, 2009)
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 26 May 2014.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by GlaxoSmithKline.
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 2 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 26 May 2014. Status can change between updates, so confirm with the study contact before making plans.
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.
What does the primary outcome measure?
Proportion of advanced stage breast cancer patients that develop brain metastases, overall and stratified by anti-HER2 therapy (for HER2+ patients only). (time frame: Time from breast cancer diagnosis until death or end of study periods (September 1, 2009)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 May 2014.