RATIONALE: Everolimus may stop the growth of tumor cells by blocking blood flow to the tumor. PURPOSE: This randomized phase II trial is studying two different schedules of everolimus to see how well they work in treating patients with recurrent or metastatic breast cancer.
OBJECTIVES: Primary * 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. Secondary * Determine the time to progression and response duration in patients treated with these regimens. * 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 toxicity. 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 study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
49
British Columbia Cancer Agency - Centre for the Southern Interior
Kelowna, British Columbia, Canada
Fraser Valley Cancer Centre at British Columbia Cancer Agency
Surrey, British Columbia, Canada
British Columbia Cancer Agency - Vancouver Cancer Centre
Vancouver, British Columbia, Canada
Margaret and Charles Juravinski Cancer Centre
Hamilton, Ontario, Canada
Response rate by clinical evaluation every 4 weeks and radiologic reevaluation every 8 weeks
Early progression rate by clinical evaluation every 4 weeks and radiologic reevaluation every 8 weeks
Adverse event rates
Time to progression by clinical evaluation every 4 weeks and radiologic reevaluation every 8 weeks
Response duration by evaluation 4 weeks after response and then every 8 weeks
Correlative assessment of response with molecular markers of mTor activity on archival tissue
Optional correlative assessment of response with molecular markers of mTor activity on fresh tissue
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Toronto Sunnybrook Regional Cancer Centre at Sunnybrook and Women's College Health Sciences Centre
Toronto, Ontario, Canada