Everolimus in Treating Patients WIth Recurrent or Metastatic Breast Cancer
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.
|Study Design:||Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized Phase II Study of Two Different Schedules of RAD001C in Patients With Recurrent/Metastatic Breast Cancer|
- 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
|Study Start Date:||January 2005|
|Study Completion Date:||January 2011|
|Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
- 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 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00255788
|Canada, British Columbia|
|British Columbia Cancer Agency - Centre for the Southern Interior|
|Kelowna, British Columbia, Canada, V1Y 5L3|
|Fraser Valley Cancer Centre at British Columbia Cancer Agency|
|Surrey, British Columbia, Canada, V3V 1Z2|
|British Columbia Cancer Agency - Vancouver Cancer Centre|
|Vancouver, British Columbia, Canada, V5Z 4E6|
|Margaret and Charles Juravinski Cancer Centre|
|Hamilton, Ontario, Canada, L8V 5C2|
|Toronto Sunnybrook Regional Cancer Centre at Sunnybrook and Women's College Health Sciences Centre|
|Toronto, Ontario, Canada, M4N 3M5|
|Study Chair:||Susan Ellard, MD||British Columbia Cancer Agency - Centre for the Southern Interior|
|Study Chair:||Karen A. Gelmon, MD||British Columbia Cancer Agency|