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
Information provided by:
AHS Cancer Control Alberta
First received: September 13, 2007
Last updated: January 24, 2013
Last verified: January 2012
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.
Procedure: Blood Test
||Time Perspective: Prospective
||Evaluation of Clinical Significance of Circulating Markers in Breast Cancer Patients Undergoing Herceptin Therapy
| Estimated Enrollment:
| Study Start Date:
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.
- 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.
|Ages Eligible for Study:
||18 Years to 80 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Albertan women with breast cancer who will undergo Herceptin therapy as part of their treatment at some point during a one-year period.
- Albertan women with breast cancer who will undergo Herceptin therapy as part of their treatment at some point during a one-year period.
- Greater than 80 years of age
- Previous cancer diagnosis - (other than skin cancer)
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
|Tom Baker Cancer Centre
|Calgary, Alberta, Canada, T2N 4N2 |
Alberta Health Services
||Bill Kangerloo, M.D.
||Alberta Health Services
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 13, 2007
||January 24, 2013
||Canada: Ethics Review Committee
Keywords provided by AHS Cancer Control Alberta:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 31, 2015
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