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
OBJECTIVES:
Primary
- 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.
Secondary
- 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
days 1-28.
- Arm II: Patients receive oral anastrozole once daily and oral placebo twice daily on
days 1-28.
In both arms courses repeat every 28 days in the absence of disease progression or
unacceptable toxicity.
Patients are followed every 4 weeks until disease progression and then every 12 weeks
thereafter.
PROJECTED ACCRUAL: A maximum of 110 patients (55 per treatment arm) will be accrued for this
study.
Interventional
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
Progression-free survival
No
John A. Glaspy, MD, MPH
Principal Investigator
Jonsson Comprehensive Cancer Center
United States: Federal Government
CDR0000396775
NCT00098904
September 2004
Name | Location |
---|---|
Jonsson Comprehensive Cancer Center at UCLA | Los Angeles, California 90095-1781 |