The goal of this phase I-II clinical research study is to find the highest safe dose of XRP9881 and capecitabine that can be given in combination in the treatment of metastatic breast cancer in patients who have been previously treated by taxanes and anthracyclines. The safety and effectiveness of this combination will also be studied. Patients participating in the study will be asked to give additional blood samples to look at the level of study drugs in the blood.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
34
IV infusion on Day 1 of a 21-day cycle
oral, twice daily, Day 1-Day 14 of a 21-day cycle
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States
Sanofi-Aventis Administrative Office
Paris, France
Safety, tolerability, and maximum tolerated dose (MTD) of XRP9881 when given in combination with capecitabine
Time frame: study period
Response in patients with measurable disease
Time frame: study period
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