Phase I Oral mTOR Inhibitor RAD001 in Combo w/ Capecitabine for Metastatic Breast
Status:
Terminated
Trial end date:
2011-12-01
Target enrollment:
Participant gender:
Summary
In order to improve the survival of metastatic breast patients, it is important to
investigate the use of novel therapeutic agents combined with known active agents in the
treatment of breast cancer. This is a phase I study evaluating the maximum tolerated doses
and toxicities of RAD001 in combination with capecitabine for the treatment of metastatic
breast cancer. RAD001 (INN: everolimus) is a novel macrolide, which is being developed as an
antiproliferative drug with applications as an immunosuppressant and anticancer agent. Phase
I trials in patients with solid tumors have shown that treatment with RAD001 is
well-tolerated with a minimal side effect profile. Capecitabine (Xeloda, Roche) is an oral
fluoropyrimidine that was approved in 1998 for the treatment of patients with metastatic
breast cancer. The all-oral regimen of RAD001 with capecitabine is an attractive approach as
the treatment of metastatic breast cancer has not yet proven to be curative. We also want to
find out what possible benefit this combination of drugs might have on treating your cancer.