Trial Information

Characterization of Circulating Tumor Cells (CTCs) to Direct Pre-Operative and Systemic Therapy in Patients With Locally Advanced or Metastatic Stage IV Breast Cancer

Up to 60 mL of blood will be collected from each patient at up to 6 time points. Samples
will be delivered to the Bruce Laboratory (Palo Alto Research Center) for immunolabeling and
FAST scanning. The FAST scanning will utilize CK+, CD45-and DAPI+ labeling as well as cell
morphology confirmed by collaborating pathologists to select for CTC with the technology
allowing for assessment of up to four additional protein expressions on the surface of
CTC's. Additional samples at the proposed time points will be placed on ice and sent over
to the Wang Laboratory for the purpose of extracting RNA/microRNA and proteins from CTC's
for profiling and further analysis. Benefits are only to society, not the individual.
Knowledge obtained from applying the two technologies may help with better selection of
therapy, early detection of progression, possibly better diagnosis and development of
targeted therapeutic agents in the future.