A Randomized Phase II Study of Two Different Schedules of RAD001C in Patients With Recurrent/Metastatic Breast Cancer
- Determine the efficacy of 2 different treatment schedules of everolimus, in terms of
clinical/radiological response and early progression, in patients with recurrent or
metastatic breast cancer.
- Determine the time to progression and response duration in patients treated with these
- Determine the toxic effects of these regimens in these patients.
- Correlate molecular markers of mTOR activity in tumor tissue with objective tumor
response in patients treated with these regimens.
OUTLINE: This is a randomized, open label, multicenter study. Patients are stratified
according to presence of visceral metastases (yes vs no) and prior chemotherapy regimens for
recurrent disease (0 vs 1). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral everolimus once daily on days 1-28.
- Arm II: Patients receive oral everolimus on days 1, 8, 15, and 22. In both arms,
courses repeat every 28 days in the absence of disease progression or unacceptable
After completion of study treatment, patients are followed at 4 weeks and then periodically
until disease progression.
PROJECTED ACCRUAL: A total of 60 patients (30 per treatment arm) will be accrued for this
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Response rate by clinical evaluation every 4 weeks and radiologic reevaluation every 8 weeks
Susan Ellard, MD
British Columbia Cancer Agency - Centre for the Southern Interior
United States: Federal Government