QUANTIFICATION OF CIRCULATING ENDOTHELIAL CELLS (CEC) AND PLASMA ANGIOGENIC FACTORS IN PATIENTS WITH BREAST CANCER

Trial Information

QUANTIFICATION OF CIRCULATING ENDOTHELIAL CELLS (CEC) AND PLASMA ANGIOGENIC FACTORS IN PATIENTS WITH BREAST CANCER

OBJECTIVES:

Primary

- To compare peripheral blood (PB) concentrations of circulating endothelial cells (CEC)
in women with measurable, active breast cancer to PB concentrations of CEC in a control
population of women with a history of breast cancer who are currently without evidence
of active disease.

Secondary

- To compare in women with measurable breast cancer the relationship between PB
concentrations of CEC prior to and at 3 and 6 weeks following initiation of a new
chemotherapy or hormonal therapy, and correlate these values with clinical response to
treatment to determine if CEC can be used as a tumor marker or indicator of disease
burden.

- To compare PB concentrations of CEC to levels of plasma proteins associated with
angiogenesis, including vascular endothelial growth factor, in women with active or a
prior history of breast cancer.

OUTLINE: Peripheral blood and plasma samples are collected for analysis of circulating
endothelial cells (CEC) and angiogenic growth factor levels. Blood samples from patients
initiating a new chemotherapy or hormonal therapy for breast cancer are collected at
baseline and at 3 and 6 weeks following the start of treatment. CEC are quantified via flow
cytometry and plasma angiogenic markers are assessed via ELISA.

PROJECTED ACCRUAL: A total of 100 patients with active, measurable breast cancer and 100
patients with a prior history of breast cancer will be accrued for this study.