Conditions: Neoplasms, Breast
Keywords: metastatic breast cancer ErbB1 kinase inhibitor ErbB2 EGFR lapatinib Her2-neu
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 580
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine the efficacy and safety of an oral dual tyrosine kinase inhibitor (GW572016) in combination with paclitaxel compared to paclitaxel alone in first line advanced or metastatic breast cancer.

Detailed description:

Arms:
arm 1: Lapatinib 1500 mg, once daily and Paclitaxel 175 mg/m Intravenously over 3 hours ever 3 weeks arm 2: Paclitaxel 175 mg/m Intravenously over 3 hours ever 3 weeks and Placebo

Interventions: intervention 1: Paclitaxel intervention 2: GW572016 (Lapatinib)
Intervention descriptions: intervention 1: Active Comparator intervention 2: Oral GW572016 Lapatinib

Protocol document: