Paclitaxel Followed by FEC Versus Paclitaxel and RAD001 Followed by FEC In Women With Breast Cancer
Status:
Unknown status
Trial end date:
2017-04-01
Target enrollment:
Participant gender:
Summary
The goal of this clinical research is to learn if RAD001 given in combination with
chemotherapy will turn off the signaling pathway (a chain of information that tells cancer
cells to grow quickly) and make the chemotherapies given on this study more effective.
Primary Objective
ยท To determine if the addition of an mTOR inhibitor to standard neoadjuvant chemotherapy in
patients with triple receptor-negative breast cancer causes molecular changes
(inhibition/activation) of the PI3K/PTEN/AKT pathway.
Secondary Objectives
- To evaluate pathologic complete response (pCR) rates for each treatment group.
- To evaluate the relationship between pCR and the molecular changes
(inhibition/activation) of the PI13K/PTEN/AKT pathway in each treatment group.
- To evaluate overall response rates (ORR) for each treatment group.
- To assess the toxicity of both regimens and to evaluate the relationship of toxicities
with PI3K/PTEN/AKT pathway status.