Last updated: 11/03/2018 14:51:57
Breast cancer with over-expression of erbB2-BRAINSTORM
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Breast cancer with over-expression of erbB2 study of the treatment paradigm in metastasis to BRAIN (BRAINSTORM)
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
To describe the treatment pattern of brain metastasis in ErbB2 over-expressing breast cancer in Asia Pacific countries.
Timeframe: Time (in months) from date of first diagnosis of brain metastasis through to death or end of study period
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.
Timeframe: 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
Timeframe: Time (in month) between the date of diagnosis of erbB2+ breast cancer and date of first diagnosis of brain metastasis
Interventions:
Enrollment:
144
Primary completion date:
Not applicable
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Yap YS, Cornelio GH, Devi BCR, Khorprasert C, Kim SB, Kim, TY, Lee SC, Park YH, Sohn JH, Sutandyo N, Wai D, Wong DWY, Kobayashi M, Landis SH, Yeo 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;107(7):1075-82.
Medical condition
Cancer
Product
lapatinib
Collaborators
Not applicable
Study date(s)
May 2009 to June 2011
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female
Age
Not applicable
Accepts healthy volunteers
No
- 1. 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.
- 2. Brain metastasis diagnosis made between January 2006 - December 2008.
- 1. Women who have another primary cancer diagnosed between the time of breast cancer diagnosis and brain metastasis..
- 2. Patient has leptomeningeal metastases only without parenchymal brain involvement (since this pattern of the disease requires a different treatment approach.)
Inclusion and exclusion criteria
Inclusion criteria:
- 1. 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. 2. Brain metastasis diagnosis made between January 2006
- December 2008.
Exclusion criteria:
- 1. Women who have another primary cancer diagnosed between the time of breast cancer diagnosis and brain metastasis.. 2. Patient has leptomeningeal metastases only without parenchymal brain involvement (since this pattern of the disease requires a different treatment approach.)
Trial location(s)
Showing 1 - 6 of 9 Results
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2011-03-06
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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