The purpose of this study is to evaluate the anti-tumor activity of the combination of experimental drug (larotaxel) when combined with Herceptin® in patients with advanced breast cancer. Anti-tumor activity will be determined by looking at changes in tumor size on CT or MRI scans. Additional goals of this study are to look at patient safety, to determine how long the study drugs (larotaxel and Herceptin®) stay in the patient's body and what effects the study medications may have on each other, and to find out how long patients remain cancer free on this study treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
administered as a 1-hour IV infusion on Day 1 of every 3 weeks (q3w)
administered as a 90-minute IV infusion on Day 1 of every week (qw)
Sanofi-Aventis Administrative Office
Malvern, Pennsylvania, United States
Tumor response measured
Time frame: every 2 cycles during treatment phase
Progression Free Survival and Overall Survival
Time frame: measured every 3 weeks during study treatment, then every 6 weeks after a patient has stopped the study treatment until the patient's cancer worsens, then every 3 months
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