Prospective Validation Trial of Circulating Tumor Cells (CTCs) in Women With Metastatic Breast Cancer
- To validate the prognostic significance of circulating tumor cells (CTCs) in patients with newly diagnosed metastatic breast cancer (MBC).
- To prospectively determine if assessment of CTCs can be used to stratify patients with MBC into two prognostic groups independent of existing methods i.e. hormone-receptor status, site of metastasis (e.g. visceral vs. non visceral) and treatment administered (e.g. chemotherapy vs. hormonal therapy).
- To incorporate this information into the current TNM staging system by sub-classifying stage IV disease into two prognostic groups, Stage IVA and Stage IVB.
1. To perform global gene profiling on selected specimens and correlate the profiles with clinical outcomes.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||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|
- To detect and count cancer cells in the blood of patients who have recently been diagnosed with a recurrent breast cancer. [ Time Frame: 26 Months ] [ Designated as safety issue: No ]
- To learn if the detection of circulating cancer cells is a predictor for a worse disease prognosis. [ Time Frame: 26 Months ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Blood collected prior to the initiation of chemotherapy as follows: 1 x 4 ml (serum tube), 2x10 ml (CellSave Tube), and 1x10 ml EDTA (selected centers); To perform global gene profiling on selected specimens and correlate the profiles with clinical outcomes.
|Study Start Date:||October 2005|
|Study Completion Date:||December 2007|
|Primary Completion Date:||December 2007 (Final data collection date for primary outcome measure)|
Patients with newly diagnosed stage IV breast cancer scheduled to start systemic therapy.
Procedure: Blood Sample
1x4 ml (Serum Tube); 2x10 ml (CellSave Tube); 1x10 ml EDTA (Selected Centers)
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00493350
|United States, Texas|
|U.T.M.D. Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Massimo Cristofanilli, MD||M.D. Anderson Cancer Center|