ImmunoGuide® Enzyme immunoassay (ELISA) for the determination of free Trastuzumab (Herceptin®, Herclon®) in serum and plasma.<br><br>
The drug Trastuzumab (trade names Herceptin®, Herclone®) is a recombinant DNA-derived humanized monoclonal antibody that selectively targets the extracellular domain of the human epidermal growth factor receptor 2 protein (HER2). The antibody is an IgG1 kappa that contains human framework regions with the complementarity-determining regions of a murine anti p185 HER2 antibody that binds to HER2. Trastuzumab blood concentrations throughout the dosing interval expected to be remaining above those considered necessary for anticancer activity. Furthermore, in a separate analysis, patients with the lowest Trastuzumab serum trough concentrations had the highest rate of disease progression and shortest overall survival.<br><br>
According to the prescribing information, the steady-state mean trough (Cmin) and maximum serum concentrations of Trastuzumab were reported to be 47.4 (5-115) µg/mL and 179 (107-309) µg/mL for the patients with primary tumor type of either breast cancer or metastatic breast cancer dosing 8mg/kg +6mg/kg q3w, 66.1 (14.9-142) µg/mL and 109 (51.0-209) µg/mL for the patients with breast cancer dosing 4mg/kg +2mg/kg qw.<br><br>
In this context, identification of biomarkers for (non-)response and risk factors for adverse drug reactions that might be related to serum concentrations and maintaining the effective concentration of Trastuzumab in order to potentially avoid some side effects with a reliable method might be beneficial. For research use only, not for use in diagnostic procedures.