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Evaluation of Clinical Significance of Circulating Markers in Breast Cancer Patients Undergoing Herceptin Therapy


N/A
18 Years
80 Years
Open (Enrolling)
Female
Breast Cancer

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Trial Information

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.


Inclusion Criteria:



- Albertan women with breast cancer who will undergo Herceptin therapy as part of their
treatment at some point during a one-year period.

Exclusion Criteria:

- Greater than 80 years of age

- Previous cancer diagnosis - (other than skin cancer)

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Principal Investigator

Bill Kangerloo, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Alberta Health Services

Authority:

Canada: Ethics Review Committee

Study ID:

17924

NCT ID:

NCT00530569

Start Date:

August 2007

Completion Date:

Related Keywords:

  • Breast Cancer
  • Breast Cancer
  • Herceptin Therapy
  • Breast Neoplasms

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