CancerNCT01064349
Breast Cancer With Over-expression of erbB2-BRAINSTORM
An observational study of Cancer, run by GlaxoSmithKline at 10 sites in 3 countries.
Trial summary
This retrospective cohort study aims to improve our understanding of the current paradigm for treatment of brain metastases in erbB2+ breast cancer patients in the Asia Pacific region. We aim to identify approximately 300 erbB2+ breast cancer patients with brain metastases diagnosed between 2006-2008 in 6 countries. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Cancer
- What is being tested?
- Anti-erbB2 therapy as part of a treatment regimen for either brain metastases or primary breast cancer
- How many people
- 144 participants
- Where
- 10 sitesin 3 countries
- Study dates
- 6 May 2009to 3 Jun 2011
- 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
Study population: This study aims to enrol approximately 300 Erb2+ breast cancer cases with brain metastases in 6 Asian countries (Indonesia, Korea, Malaysia, Philippines, Singapore, and Thailand).
Who may be able to join
- Female patients diagnosed with erbB2+ breast cancer. ErbB2 positivity will be as determined by respective institutional standards, and will be based on medical history only.
- Brain metastasis diagnosis made between January 2006 - December 2008.
Who cannot join
- Women who have another primary cancer diagnosed between the time of breast cancer diagnosis and brain metastasis..
- Patient has leptomeningeal metastases only without parenchymal brain involvement (since this pattern of the disease requires a different treatment approach.)
Trial locations and contacts
10 sites in 3 countries.
10 sites in 3 countries
Thailand6 sites
GSK Investigational Site
Bangkok, 10110
GSK Investigational Site
Bangkok, 10310
GSK Investigational Site
Bangkok, 10330
GSK Investigational Site
Bangkok, 10400
GSK Investigational Site
Bangkok, 10700
GSK Investigational Site
Chiang Mai, 50200
Philippines3 sites
GSK Investigational Site
Pasay, 1300
GSK Investigational Site
Quezon City, 1101
GSK Investigational Site
Quezon City, 1102
About this study
Official title: Breast Cancer With Over-expression of erbB2 Study of the Treatment Paradigm in Metastasis to BRAIN (BRAINSTORM)
This retrospective cohort study aims to improve our understanding of the current paradigm for treatment of brain metastases in erbB2+ breast cancer patients in the Asia Pacific region. We aim to identify approximately 300 erbB2+ breast cancer patients with brain metastases diagnosed between 2006-2008 in 6 countries. Medical records will be analyzed to determine the treatment pattern for brain metastases, including anti-erbB2 therapy. Additional objectives are to understand the impact of anti-erbB2 therapy on survival after brain metastases and to investigate the relationship between anti-erbB2 therapy for brain metastases and: 1) the time interval between diagnosis of erb2+ breast cancer and brain metastasis, and 2) the occurrence of brain metastasis as the first site of disease progression.
- Conditions
- Cancer
- Being tested
- Anti-erbB2 therapy as part of a treatment regimen for either brain metastases or primary breast cancer
- Keywords
- ErbB2+ breast cancer, ErbB2 treatment, brain metastases
- Medical subject headings
- Neoplasms, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-erbB2 therapy as part of a treatment regimen for either brain metastases or primary breast cancerDrug
Trastuzumab or Lapatinib
| Study group | Role | What they receive |
|---|---|---|
| Breast cancer patients with brain metastases | Female Erb2+ breast cancer patients with brain metastases diagnosed between January 2006 and December 2008 in 6 Asian countries (Indonesia, Korea, Malaysia, Philippines, Singapore, and Thailand). Receives: Drug: Anti-erbB2 therapy as part of a treatment regimen for either brain metastases or primary breast cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
To describe the treatment pattern of brain metastasis in ErbB2 over-expressing breast cancer in Asia Pacific countries.
Measured: Time (in months) from date of first diagnosis of brain metastasis through to death or end of study period
Secondary outcomes (2)
To describe the survival of ErbB2 over-expressing breast cancer patients with brain metastasis after diagnosis of brain metastasis in relation to the receipt of anti-erbB2 therapy.
Measured: Time (in months) from date of first diagnosis of brain metastasis through to death or end of study period
Describe association between usage of anti-erbB2 therapy (before brain metastasis) & 1) time interval from diagnosis of erbB2+ breast cancer to occurrence of brain metastasis and 2) occurrence of brain metastasis as the first site of disease progression
Measured: Time (in month) between the date of diagnosis of erbB2+ breast cancer and date of first diagnosis of brain metastasis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2010 (estimated)
- Study start6 May 2009
- Primary completion3 Jun 2011
- Study completion3 Jun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 144 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
- NCT01064349
- Sponsor's protocol ID
- 113349
- Status last verified
- May 2018
- First submitted
- 21 Jan 2010
- Last updated
- 14 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Yap YS, Cornelio GH, Devi BC, Khorprasert C, Kim SB, Kim TY, Lee SC, Park YH, Sohn JH, Sutandyo N, Wong DW, Kobayashi M, Landis SH, Yeoh EM, Moon H, Ro J. Brain metastases in Asian HER2-positive breast cancer patients: anti-HER2 treatments and their impact on survival. Br J Cancer. 2012 Sep 25;107(7):1075-82. doi: 10.1038/bjc.2012.346. Epub 2012 Aug 23.
PubMed 22918394
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breast Cancer With Over-expression of erbB2 Study of the Treatment Paradigm in Metastasis to BRAIN (BRAINSTORM)
- ClinicalTrials.gov ID
- NCT01064349
- Acronym / sponsor ID
- 113349
- Conditions
- Cancer
- Keywords
- ErbB2+ breast cancer, ErbB2 treatment, brain metastases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 6 May 2009
- Primary completion
- 3 Jun 2011 (actual)
- Study completion
- 3 Jun 2011 (actual)
- First posted
- 8 Feb 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.
This retrospective cohort study aims to improve our understanding of the current paradigm for treatment of brain metastases in erbB2+ breast cancer patients in the Asia Pacific region. We aim to identify approximately 300 erbB2+ breast cancer patients with brain metastases diagnosed between 2006-2008 in 6 countries. Medical records will be analyzed to determine the treatment pattern for brain metastases, including anti-erbB2 therapy. Additional objectives are to understand the impact of anti-erbB2 therapy on survival after brain metastases and to investigate the relationship between anti-erbB2 therapy for brain metastases and: 1) the time interval between diagnosis of erb2+ breast cancer and brain metastasis, and 2) the occurrence of brain metastasis as the first site of disease progression.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast cancer patients with brain metastases | – | Drug: Anti-erbB2 therapy as part of a treatment regimen for either brain metastases or primary breast cancerFemale Erb2+ breast cancer patients with brain metastases diagnosed between January 2006 and December 2008 in 6 Asian countries (Indonesia, Korea, Malaysia, Philippines, Singapore, and Thailand). |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study aims to enrol approximately 300 Erb2+ breast cancer cases with brain metastases in 6 Asian countries (Indonesia, Korea, Malaysia, Philippines, Singapore, and Thailand).
Key inclusion criteria (2 listed)
- Female patients diagnosed with erbB2+ breast cancer. ErbB2 positivity will be as determined by respective institutional standards, and will be based on medical history only.
- Brain metastasis diagnosis made between January 2006 - December 2008.
Key exclusion criteria (2 listed)
- Women who have another primary cancer diagnosed between the time of breast cancer diagnosis and brain metastasis..
- Patient has leptomeningeal metastases only without parenchymal brain involvement (since this pattern of the disease requires a different treatment approach.)
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 |
|---|---|---|
| Anti-erbB2 therapy as part of a treatment regimen for either brain metastases or primary breast cancerTrastuzumab or Lapatinib | Drug | Breast cancer patients with brain metastases |
Primary outcome
To describe the treatment pattern of brain metastasis in ErbB2 over-expressing breast cancer in Asia Pacific countries.
Time frame: Time (in months) from date of first diagnosis of brain metastasis through to death or end of study period
2 secondary outcomes
To describe the survival of ErbB2 over-expressing breast cancer patients with brain metastasis after diagnosis of brain metastasis in relation to the receipt of anti-erbB2 therapy.
Time frame: Time (in months) from date of first diagnosis of brain metastasis through to death or end of study period
Describe association between usage of anti-erbB2 therapy (before brain metastasis) & 1) time interval from diagnosis of erbB2+ breast cancer to occurrence of brain metastasis and 2) occurrence of brain metastasis as the first site of disease progression
Time frame: Time (in month) between the date of diagnosis of erbB2+ breast cancer and date of first diagnosis of brain metastasis
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 14 Sep 2018.
- Background: PubMed 22918394Yap YS, Cornelio GH, Devi BC, Khorprasert C, Kim SB, Kim TY, Lee SC, Park YH, Sohn JH, Sutandyo N, Wong DW, Kobayashi M, Landis SH, Yeoh EM, Moon H, Ro J. Brain metastases in Asian HER2-positive breast cancer patients: anti-HER2 treatments and their impact on survival. Br J Cancer. 2012 Sep 25;107(7):1075-82. doi: 10.1038/bjc.2012.346. Epub 2012 Aug 23.
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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
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by GlaxoSmithKline at 10 sites in 3 countries.
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 2 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 14 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Thailand, Philippines, Singapore. 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.
What does the primary outcome measure?
To describe the treatment pattern of brain metastasis in ErbB2 over-expressing breast cancer in Asia Pacific countries. (time frame: Time (in months) from date of first diagnosis of brain metastasis through to death or end of study period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01064349, which also lists 1 linked publication.
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 14 Sep 2018.