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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by AHS Cancer Control Alberta.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
AHS Cancer Control Alberta
ClinicalTrials.gov Identifier:
NCT00530569
First received: September 13, 2007
Last updated: January 24, 2013
Last verified: January 2012
  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:


Further study details as provided by AHS Cancer Control Alberta:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
AHS Cancer Control Alberta
Investigators
Principal Investigator: Bill Kangerloo, M.D. AHS Cancer Control Alberta
  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 AHS Cancer Control Alberta:
Breast Cancer
Herceptin Therapy

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

ClinicalTrials.gov processed this record on October 23, 2014