At a glance
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A Randomized, Open-Label, Phase III Study of Taxane Based Chemotherapy With Lapatinib or Trastuzumab as First-Line Therapy for Women With HER2/Neu Positive Metastatic Breast Cancer
In Brief
A Phase 3 clinical trial evaluating trastuzumab, docetaxel, and 2 other interventions for Breast Cancer. Completed, enrolled 652 participants across 257 sites in 21 countries.
Detailed Summary
This was a multi-center, multinational, randomized, open-label, Phase III study comparing combination taxane-based chemotherapy plus lapatinib to combination taxane-based chemotherapy plus trastuzumab in women with documented evidence of human epidermal growth factor receptor 2 (HER2) positive metastatic breast cancer (MBC) (by local or central laboratory testing) who had received no prior chemotherapy or HER2 targeted therapy in the metastatic setting.
Study Details
Timeline
Interventions
IV q weekly (loading dose 4mg/kg; subsequent doses 2mg/kg) or IV q 3 weekly (loading dose 8mg/kg, subsequent doses 6mg/kg).
75mg/m2 IV q 3 weekly, day 1 of a 3 week cycle for 8 cycles plus G-CSF (when given together with lapatinib).
1250 mg once daily (while given with taxane). 1500mg once daily (when given alone after taxane completion).
80mg/m2 IV q weekly days 1, 8 and 15 of a 4-week cycle for 6 cycles.