A Phase 2 Study Of Perifosine In Metastatic Or Advanced Breast Cancer
- Determine the objective tumor response rate in patients with recurrent or refractory,
locally advanced or metastatic breast cancer treated with perifosine.
- Determine the toxicity of this drug in these patients.
- Determine the stable disease rate, time to disease progression, objective response
duration, and duration of stable disease in patients treated with this drug.
- Correlate potential endpoints, including phosphorylated ERK, PKB, and SAPK,
phosphorylated PKC alpha, beta, and gamma isoforms, p21 ^WAF1; and activated capase-3
in tumor biopsies, with clinical outcome in patients treated with this drug.
OUTLINE: This is an open-label, multicenter study.
Patients receive a loading dose of oral perifosine on days 1 and 2 and once daily on days
3-21 during course 1. Patients receive oral perifosine once daily on days 1-21 in each
subsequent course. Courses repeat every 28 days in the absence of disease progression or
unacceptable toxicity. Patients achieving a complete response (CR) may receive 2 additional
courses beyond the CR.
PROJECTED ACCRUAL: A total of 18-35 patients will be accrued for this study within 6-12
Masking: Open Label, Primary Purpose: Treatment
Natasha Leighl, MD, FRCPC
Princess Margaret Hospital, Canada
United States: Federal Government