Last updated: 11/03/2018 13:54:42
Brain metastasis in breast cancer patients
GSK study ID
112951
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Occurrence of brain metastasis in breast cancer patients diagnosed at advanced stages of the disease
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Proportion of advanced stage breast cancer patients that develop brain metastases, overall and stratified by anti-HER2 therapy (for HER2+ patients only).
Timeframe: Time from breast cancer diagnosis until death or end of study periods (September 1, 2009)
Secondary outcomes:
Overall survival from advanced stage breast cancer, overall and stratified by tumor characteristics and anti-HER2 therapy (for HER2+ patients only).
Timeframe: 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).
Timeframe: 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)
Timeframe: Time from diagnosis of brain metastases until death or end of study period (September 1, 2009)
Interventions:
Enrollment:
1
Primary completion date:
Not applicable
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Cancer
Product
lapatinib, trastuzumab
Collaborators
Not applicable
Study date(s)
February 2010 to August 2013
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female
Age
30+ years
Accepts healthy volunteers
No
- 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
- 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.
Inclusion and exclusion criteria
Inclusion criteria:
- 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.
Exclusion criteria:
- 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.
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2013-10-08
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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