Breast Cancer Clinical Trial
Official title:
A Phase II Evaluation Of The Efficacy And Safety Of R115777 (NSC702818) A Non-Peptidomimetic Farnesyl Transferase Inhibitor, And Trastuzumab In Patients With Advanced Breast Cancer
RATIONALE: Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary
for tumor cell growth. Monoclonal antibodies such as trastuzumab can locate tumor cells and
either kill them or deliver tumor-killing substances to them without harming normal cells.
Combining tipifarnib with trastuzumab may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining tipifarnib with trastuzumab
in treating patients who have metastatic breast cancer.
OBJECTIVES:
- Determine the antitumor activity of tipifarnib and trastuzumab (Herceptin) in patients
with metastatic breast cancer.
- Determine the safety and tolerability of this regimen in these patients.
OUTLINE: This is an open-label, multicenter study.
Patients receive oral tipifarnib twice daily on days 1-21 and trastuzumab (Herceptin) IV
over 30-90 minutes on day 1. Courses repeat every 4 weeks in the absence of disease
progression or unacceptable toxicity.
Patients are followed every 2 months.
PROJECTED ACCRUAL: A total of 18-40 patients will be accrued for this study within 9-20
months.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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