International Stage IV Stratification Study (ISSS): Prospective Validation Trial of Circulating Tumor Cells (CTCs) as Prognostic and Predictive Markers in Women With Metastatic Breast Cancer About to Start First-Line Treatment
Patients with tumors that have spread to other parts of the body and who are about to start
systemic treatment will be eligible to take part in this study.
As is standard of care, you will have an evaluation of your disease through CT scans, bone
scans, and PET scans. Before you begin your routine treatment, participants in this study
will have 3 teaspoons of blood drawn at an M. D. Anderson clinic. This will be the only
blood draw required for this study. You will then begin receiving standard therapy for your
disease as decided by your treating physician.
You will have follow-ups with either your physician or through the research personnel (by
phone calls by the research nurse) at 3, 6, 12, 18, and 36 months. After 36 months,
follow-up will continue indefinitely at your doctor's discretion. At these follow-ups, your
medical record will be reviewed to gather information for this study.
One of the blood samples will be preserved and used for research and development purposes
specifically related to this study. This research includes also analysis of the tumor gene
profiling. This study will be done to better understand the biology of metastatic breast
cancer. Neither participants nor the doctors taking care of them will be told about the
results of the research.
This is an investigational study. CellSearch (the technology used to count circulating
tumor cells) is approved by the FDA for breast cancer prognosis. About 660 patients will
take part in this multicenter study. About 100 patients will be enrolled at M. D. Anderson.
Observational Model: Case-Only, Time Perspective: Prospective
To detect and count cancer cells in the blood of patients who have recently been diagnosed with a recurrent breast cancer.
Massimo Cristofanilli, MD
M.D. Anderson Cancer Center
United States: Institutional Review Board
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