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Evaluation of Clinical Significance of Circulating Markers in Breast Cancer Patients Undergoing Herceptin Therapy (HER 2)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Alberta Health Services
ClinicalTrials.gov Identifier:
NCT00530569
First received: September 13, 2007
Last updated: January 24, 2013
Last verified: January 2012
History of Changes
  Purpose

About 30% of breast cancers have higher than normal levels of a cellular marker called HER2. The amount of HER2 is often measured in breast tissue. A higher level of this marker usually indicates a more aggressive type of breast cancer. Cytokeratin is a second cellular marker found in breast cancer cells. Detection of Circulating cytokeratin in the blood could indicate the presence of cancer. The Pathology Department of the Tom Baker Cancer Center is doing this study to see if measuring the levels of circulating HER2 and cytokeratin, through blood testing has clinical significance for patients with breast cancer.


Condition Intervention
Breast Cancer
 Procedure: Blood Test

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Evaluation of Clinical Significance of Circulating Markers in Breast Cancer Patients Undergoing Herceptin Therapy

Resource links provided by NLM:

Drug Information available for: Trastuzumab
U.S. FDA Resources

Further study details as provided by Alberta Health Services:

Estimated Enrollment: 60
Study Start Date: August 2007
Intervention Details:
    Procedure: Blood Test
    CBC and HER2 level at baseline, prior to each chemo and/or herceptin cycle, one month after chemo and/or herceptin completion, quarterly up to 12 months or a maximum of 20 blood draws.
Detailed Description:
  • 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.
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00530569

Locations
Canada, Alberta
Tom Baker Cancer Centre
Calgary, Alberta, Canada, T2N 4N2
Sponsors and Collaborators
Alberta Health Services
Investigators
Principal Investigator: Bill Kangerloo, M.D. Alberta Health Services
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00530569     History of Changes
Other Study ID Numbers: 17924
Study First Received: September 13, 2007
Last Updated: January 24, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by Alberta Health Services:
Breast Cancer
Herceptin Therapy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
 Trastuzumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013