This phase II trial is studying how well giving capecitabine together with tipifarnib works in treating women with taxane-resistant metastatic breast cancer. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Giving capecitabine together with tipifarnib may kill more tumor cells
PRIMARY OBJECTIVES: I. The primary objective of this study is to determine the response rate in patients with taxane-resistant metastatic breast cancer treated with capecitabine plus tipifarnib. SECONDARY OBJECTIVES: I. To evaluate toxicity in patients with taxane-resistant metastatic breast cancer treated with capecitabine plus tipifarnib. II. To evaluate progression free survival, time to treatment failure, and overall survival in patients with taxane-resistant metastatic breast cancer treated with capecitabine plus tipifarnib. OUTLINE: This is a multicenter study. Patients receive oral tipifarnib twice daily and oral capecitabine twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 4 additional courses beyond documentation of CR. Patients are followed every 3 months for 2 years and then every 6 months for 1 year.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
70
Given PO
Given PO
Eastern Cooperative Oncology Group
Boston, Massachusetts, United States
Objective response rate (PR+CR)
Time frame: Up to 5 years
Progression-free survival (PFS)
The Kaplan-Meier method will be used to estimate distributions.
Time frame: From registration to progression or to death from any cause without documentation of progression, assessed up to 5 years
Time to treatment failure (TTF)
The Kaplan-Meier method will be used to estimate distributions.
Time frame: From registration to disease progression, permanent discontinuation of treatment due to toxicity, or death, whichever occurs first, assessed up to 5 years
Overall survival (OS)
The Kaplan-Meier method will be used to estimate distributions.
Time frame: Up to 5 years
Incidence of toxicities
Time frame: Up to 5 years
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