A Study to Determine the Clinical Significance of Molecular Detection of Breast Cancer in the Blood of Stage IV Breast Cancer Patients
This study is designed to determine whether molecular detection of breast cancer cells in the peripheral blood of Stage IV breast cancer patients is a clinically relevant predictor of progression-free and overall survival. Stage IV breast cancer patients who have measurable breast cancer metastases and are initiating a regimen of systemic therapy are eligible for enrollment. Multi-marker real-time RT-PCR analysis will be performed on peripheral blood specimens from 92 breast cancer patients and 120 healthy volunteers. Peripheral blood specimens from breast cancer patients will be obtained at the time of study entry (prior to initiation of systemic therapy) and at serial time points during follow-up. Subjects will be followed longitudinally until death, although the study has been powered so that the primary objective can be addressed after 12 months of follow-up. Healthy volunteers will be asked to provide a blood sample at time of enrollment but will not be followed.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
|Official Title:||Peripheral Blood Molecular Staging of Breast Cancer: A Prospective Cohort Study Designed to Determine the Clinical Significance of Molecular Detection of Breast Cancer in the Peripheral Blood of Stage IV Breast Cancer Patients|
- The prevalence of breast cancer cells in the peripheral blood [ Time Frame: 1 year ] [ Designated as safety issue: No ]Specifically, it is predicted that 60% of subjects with Stage IV breast cancer will have evidence of breast cancer cells in the peripheral blood by multi-marker real-time RT-PCR analysis, and that these subjects will experience a significantly decreased progression-free and overall survival.
- Evaluate the prognostic significance of molecular detection of breast cancer cells in peripheral blood after initiation of systemic therapy. [ Time Frame: Until patient death ] [ Designated as safety issue: No ]Specifically, we will determine if molecular detection of circulating breast cancer cells after the initiation of systemic therapy is associated with a significantly decreased progression-free and overall survival.
- Quantify baseline molecular marker expression levels in the peripheral blood of healthy volunteers [ Time Frame: Approximately 12 weeks ] [ Designated as safety issue: No ]Determine if baseline molecular marker expression levels are dependent on patient age, race, and/or the presence of benign breast disease.
- Compare molecular analyses to the results of the CellSeach assay [ Time Frame: Approximately 12 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||November 2005|
|Study Completion Date:||February 2013|
|Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
Experimental: Stage IV Breast Cancer
Blood draws at baseline before systemic therapy. Blood draw then every 6 weeks for approximately 12 weeks.
|Other: Blood draw|
Baseline blood draw.
|Other: Blood draw|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00355316
|United States, Missouri|
|Washington University School of Medicine|
|St. Louis, Missouri, United States, 63110|
|United States, South Carolina|
|Medical University of South Carolina|
|Charleston, South Carolina, United States, 29425|
|Principal Investigator:||William E. Gillanders, M.D.||Washington University School of Medicine|