Trial Using CTCs to Make Therapy Decisions

HUNTINGDON VALLEY, Pennsylvania—Immunicon Corporation has announced that a major clinical trial using the CellSearch Assay has opened to enrollment. The randomized phase III trial (S0500), conducted by the Southwest Oncology Group (SWOG), is testing the strategy of changing therapy vs maintaining therapy for metastatic breast cancer patients who have elevated circulating tumors cells (CTCs) at first follow-up assessment. Immunicon will perform CTC testing for participating sites.

Eligible patients are those with confirmed breast cancer and clinical evidence of metastatic disease who are entering their first line of chemotherapy for their metastatic disease. Prior use of hormonal therapy, bisphosphonate, trastuzumab (Herceptin), and/or bevacizumab (Avastin) in the metastatic setting is allowed.

Jeffrey B. Smerage, MD, PhD, of the University of Michigan Comprehensive Cancer Center, and PI for the study, commented, "The SWOG study is a natural extension of the pivotal trial that Immunicon conducted for FDA clearance [of the CellSearch Assay]. The original study demonstrated that CTCs can be used to predict survival at multiple time points during therapy. The data suggest that effective therapy that eliminates CTCs does indeed positively impact survival."