RAD001 Plus Docetaxel in Patients With Metastatic Breast Cancer
Status:
Terminated
Trial end date:
2012-04-01
Target enrollment:
Participant gender:
Summary
Primary:
- To assess the safety and tolerability and to find the maximum tolerated dose of the
combination administration of RAD001 plus docetaxel when given to patients with
metastatic breast cancer who are being considered for standard docetaxel treatment
(phase I).
- To characterize the pharmacokinetics of RAD001 and docetaxel when co-administered (phase
I).
Secondary:
- To determine the phosphorylation status of the components of the mTOR signaling pathway
and the expression of modifiers of apoptosis in the primary breast tumors, in order to
determine whether these markers can be used as predictors of sensitivity to the
combination of RAD001 and docetaxel
- To determine the effect of the combination of RAD001 and docetaxel on the expression and
phosphorylation of mTOR's targets in the accessible tumor tissue, in order to identify
potential pharmacodynamics markers of response to this drug combination