RAD001 Plus Docetaxel in Patients With Metastatic Breast Cancer

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

Timeline

Start

2005-11-01

Primary completion

2012-04

Completion

2012-04

Outcome

Outcome not reported

Stopped: “Toxicity and Lack of Efficacy”

Drugs

Indications