Everolimus in Treating Patients WIth Recurrent or Metastatic Breast Cancer
- Registration Number
- NCT00255788
- Lead Sponsor
- NCIC Clinical Trials Group
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 49
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A everolimus Everolimus - 28 days q 4 wk Arm B everolimus Everolimus - days 1, 8, 15 and 22 q 4wks
- Primary Outcome Measures
Name Time Method Early progression rate by clinical evaluation every 4 weeks and radiologic reevaluation every 8 weeks Response rate by clinical evaluation every 4 weeks and radiologic reevaluation every 8 weeks
- Secondary Outcome Measures
Name Time Method 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 Adverse event rates 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
Trial Locations
- Locations (5)
Toronto Sunnybrook Regional Cancer Centre at Sunnybrook and Women's College Health Sciences Centre
🇨🇦Toronto, Ontario, Canada
Margaret and Charles Juravinski Cancer Centre
🇨🇦Hamilton, Ontario, Canada
British Columbia Cancer Agency - Vancouver Cancer Centre
🇨🇦Vancouver, British Columbia, Canada
Fraser Valley Cancer Centre at British Columbia Cancer Agency
🇨🇦Surrey, British Columbia, Canada
British Columbia Cancer Agency - Centre for the Southern Interior
🇨🇦Kelowna, British Columbia, Canada