At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Open Label Randomized Clinical Trial of Standard Neoadjuvant Chemotherapy (Paclitaxel Followed by FEC) Versus the Combination of Paclitaxel and RAD001 Followed by FEC in Women With Triple Receptor-Negative Breast Cancer (CRAD001C24101)
In Brief
A Phase 2 clinical trial evaluating Paclitaxel, 5-Fluorouracil, and 3 other interventions for Breast Cancer. Targeting 62 participants across 1 site.
Detailed 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 · 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.
Study Details
Timeline
Interventions
80 mg/m\^2 by vein once weekly over 1 hour on day 1(+/- 2 days) each week for 3 weeks and for 12 cycles.
500 mg/m\^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.
100 mg/m\^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.
500 mg/m\^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.
30 mg by mouth weekly on Days 1, 8, \& 15 for 12 cycles.