Evaluation of Clinical Significance of Circulating Markers in Breast Cancer Patients Undergoing Herceptin Therapy
- Single Variate analysis will be performed to correlate variables such as tumour size,
grade, stage, ER status, PR status and biopsy HER2 status with soluble HER2 levels.
- Soluble HER2 levels will be analyzed as both a continuous and categorized variable.
- The analysis will attempt to discern the relationship between soluble HER2 levels, HER2
positive circulating epithelial cell level and treatment response.
- This will provide evidence of the effect various treatments have on HER2 levels. HER2
levels both in patients treated with Herceptin and those on other treatment protocols,
will be related to clinical disease measures such as time to progression, time to
failure, duration of response and duration of survival.
- An initial model of the relationship between these factors and soluble HER2 as a marker
will be established from the data.
Observational
Time Perspective: Prospective
Bill Kangerloo, M.D.
Principal Investigator
Alberta Health Services
Canada: Ethics Review Committee
17924
NCT00530569
August 2007
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