A Phase II Trial of Short-Term Everolimus (RAD001) to Predict Response in Women With Operable Breast Cancer
- Determine whether the administration of everolimus results in a decrease of total
choline, a surrogate marker of response, in at least 30% of women with resectable
- Determine whether tumors with activated mTOR signaling, as measured by phosphorylation
of 4E-BP1 and activity of cap dependent translational complex, will identify those
women responsive to everolimus.
OUTLINE: Patients receive oral everolimus once daily on days 1-7 in the absence of disease
progression or unacceptable toxicity. Within 24 hours after completing everolimus, patients
Tumor tissue samples are collected at baseline and during surgery for the analysis of mTOR
targets (i.e., 4E-BP1, p70S6 kinase phosphorylation), Ki67, cleaved caspase 3, and activity
of cap dependent translational complex by immunohistochemical assays. Patients also undergo
MRI/MRS before and after everolimus therapy for total choline and glucose levels
After completion of study therapy, patients are followed for 30 days.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Decrease of total choline in at least 30% of patients
Choline is measured by magnetic resonance imaging (MRI/MRS) scan.
Pre-Treatment Compared to Post-Treatment (Day 7)
Douglas Yee, MD
Masonic Cancer Center, University of Minnesota
United States: Food and Drug Administration
|University of Minnesota Children's Hospital - Fairview||Minneapolis, Minnesota 55455|