Abstract
1130 Background: RAD001 (everolimus) is an oral inhibitor of the mTOR serine-threonine kinase, implicated in regulation of protein synthesis and ultimately cell growth, proliferation, and angiogenesis. Preclinical results have shown that RAD001 enhances the efficacy of several chemotherapy agents. It is being developed in combination with different agents across various indications, including breast cancer. Primary objective of this phase 1b methodology is to determine feasibility of combining different regimens (doses/schedules) of RAD001 with trastuzumab (T) plus a chemotherapy agent, in patients with metastatic breast cancer with documented resistance to trastuzumab. Methods: Design is tailored towards optimizing regimen selection in combination setting using an adaptive Bayesian dose-escalation scheme. Model is based on occurrence of dose-limiting toxicities (DLT) at any time during study. Primary endpoint is rate of DLT in cycle 1, i.e. estimate of risk that a patient experiences a DLT in cycle 1. As...
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