Last updated: 03/04/2020 20:50:20
The burden of illness among patients with stage I-IIIA HER2+ breast cancer who undergo surgical resection and adjuvant therapy
GSK study ID
201203
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Other
Other
Trial overview
Official title: The burden of illness among patients with stage I-IIIA HER2+ breast cancer who undergo surgical resection and adjuvant therapy
Trial description: This protocol describes a retrospective chart review study to characterize the current burden of illness, treatment patterns, and demographic and clinical characteristics of persons with early stage HER2+ breast cancer in Canada. Burden of illness will be characterized by healthcare resource utilization and associated costs. This study will provide a better understanding of this patient population and their unmet medical needs, as well as identify areas where lapatinib will provide the greatest clinical and economic benefit.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Demographic Characteristics
Timeframe: 2008-2013
Drug(s) that received as adjuvant therapy
Timeframe: 2008-2013
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
0
Primary completion date:
Not applicable
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Breast Cancer, Neoplasms
Product
lapatinib
Collaborators
Not applicable
Study date(s)
January 2015 to February 2015
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female
Age
18 - 50 Year
Accepts healthy volunteers
none
- 18 years of age or older, having undergone surgical and adjuvant treatment for stage I-IIIA HER2+ breast cancer, and free of distant metastases.
- Patient charts will be excluded if surgical or adjuvant treatment for stage I-IIIA HER2+ breast cancer was received as part of a clinical trial.
Inclusion and exclusion criteria
Inclusion criteria:
- 18 years of age or older, having undergone surgical and adjuvant treatment for stage I-IIIA HER2+ breast cancer, and free of distant metastases.
Exclusion criteria:
- Patient charts will be excluded if surgical or adjuvant treatment for stage I-IIIA HER2+ breast cancer was received as part of a clinical trial.
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
Other
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
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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