Letrozole With or Without Tipifarnib in Treating Women With Locally Advanced, Locally Recurrent, or Metastatic Breast Cancer
Recruitment status was Active, not recruiting
RATIONALE: Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by reducing the production of estrogen. Combining tipifarnib with letrozole may kill more tumor cells.
PURPOSE: Randomized phase II trial to compare the effectiveness of letrozole with or without tipifarnib in treating women with locally advanced, locally recurrent, or metastatic breast cancer that has progressed after antiestrogen therapy.
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||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|
|Study Start Date:||January 2003|
- 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 1-21.
- Arm II: Patients receive oral letrozole once daily and oral tipifarnib twice daily on days 1-21.
Courses in both arms repeat every 28 days in the absence of disease progression or unacceptable toxicity.
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.
|United States, Ohio|
|Ireland Cancer Center|
|Cleveland, Ohio, United States, 44106-5065|
|Study Chair:||Paula Silverman, MD||Case Comprehensive Cancer Center|