A Randomized, Blinded, Phase 2 Study of Letrozole Plus the Farnesyl Transferase Inhibitor ZARNESTRA (R115777) and Letrozole Plus Placebo in the Treatment of Advanced Breast Cancer After Antiestrogen Therapy
- Compare the efficacy of letrozole with or without tipifarnib based on an objective
response rate in women with locally advanced, locoregionally recurrent, or metastatic
breast cancer that has progressed after antiestrogen therapy.
- Compare the time to progression, time to treatment failure, and survival in patients
treated with these regimens.
- Compare the clinical benefit rate in patients treated with these regimens.
- Compare the duration of response and duration of clinical benefit in patients treated
with these regimens.
- Compare the safety and tolerability of these regimens in these patients.
- Determine the pharmacokinetics of tipifarnib in these patients.
OUTLINE: This is a randomized, double-blind, multicenter study. Patients are randomized to 1
of 2 treatment arms.
- Arm I: Patients receive oral letrozole once daily and oral placebo twice daily on days
- Arm II: Patients receive oral letrozole once daily and oral tipifarnib twice daily on
Courses in both arms repeat every 28 days in the absence of disease progression or
Patients are followed at 30-42 days and every 6 months thereafter.
PROJECTED ACCRUAL: Approximately 120 patients (40 for arm I and 80 for arm II) will be
accrued for this study.
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
Paula Silverman, MD
Case Comprehensive Cancer Center
United States: Federal Government
|Ireland Cancer Center||Cleveland, Ohio 44106-5065|