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:||Observational Model: Case Control
Time Perspective: Prospective
|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 ]
Biospecimen Retention: Samples With DNA
Whole blood, tissue.
|Study Start Date:||November 2005|
|Estimated Study Completion Date:||May 2013|
|Estimated Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
Patients with Stage IV breast cancer.
Other: Blood draw
Blood draws before starting treatment, then monthly for two to three months. If patient is receiving chemotherapy as standard care, they will have blood drawn prior to cycles 1, 2, and 3(approximately every 3-4 weeks for 8-10 weeks, for a total of 3 blood draws). If patients are receiving hormone therapy as standard care, they will have blood drawn prior to beginning treatment, and then approximately every 6 weeks for 12 weeks (3 blood draws total).
Other: Blood draw
One tablespoon of blood will be drawn one time.
Enrollment Stage IV breast cancer patients who have measurable breast cancer metastases and are initiating a regimen of systemic therapy are eligible for enrollment.
Phlebotomy Peripheral blood will be obtained from all subjects at the time of initial enrollment, and at serial time-points during follow-up. The first specimen will be drawn prior to the initiation of systemic therapy, and subsequent specimens will be obtained approximately every 6 weeks for approximately 12 weeks depending on the type and schedule of systemic therapy. Results of molecular analyses will not be available to clinical investigators.
Systemic Therapy Subjects initiating hormone therapy, chemotherapy, and/or immunotherapy are eligible for participation.
Restaging Results of patient imaging obtained as part of standard clinical care will be collected as available.
Survival Analysis Subjects will be followed for at least one year following enrollment. All clinical and radiographic data will be reviewed in order to determine the clinical response to therapy. Kaplan-Meier survival estimates will be compared with log-rank testing.
|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|