A Randomized Double-Blind Phase-2 Study of Anastrozole Plus Lonafarnib (SCH 66336) or Anastrozole Plus Placebo for the Treatment of Subjects With Advanced Breast Cancer
- Compare progression-free survival of postmenopausal women with hormone
receptor-positive stage IIIB, IIIC, or IV breast cancer treated with anastrozole in
combination with lonafarnib vs placebo.
- Compare the objective response rate in patients treated with these regimens.
- Compare duration of response in patients treated with these regimens.
- Compare overall survival of patients treated with these regimens.
- Determine exposure to these regimens in these patients.
- Compare the safety of these regimens in these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled, parallel-group, multicenter
study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral anastrozole once daily and oral lonafarnib twice daily on
- Arm II: Patients receive oral anastrozole once daily and oral placebo twice daily on
In both arms courses repeat every 28 days in the absence of disease progression or
Patients are followed every 4 weeks until disease progression and then every 12 weeks
PROJECTED ACCRUAL: A maximum of 110 patients (55 per treatment arm) will be accrued for this
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
John A. Glaspy, MD, MPH
Jonsson Comprehensive Cancer Center
United States: Federal Government
|Jonsson Comprehensive Cancer Center at UCLA||Los Angeles, California 90095-1781|