An Evaluation of the Safety and Efficacy of Lapatinib Plus Trastuzumab Plus Paclitaxel in First-Line HER2+ Metastatic Breast Cancer.

Abstract:

Background: Trastuzumab given concomitantly with paclitaxel is an established first-line metastatic breast cancer (MBC) treatment; however, approximately 30% to 40% of patients show no response as defined by RECIST to this combination. Lapatinib is an oral dual tyrosine kinase inhibitor of EGFR and HER2 and approved, in combination with capecitabine, after trastuzumab-based therapy for HER2+ MBC. The differing mechanisms of action may allow synergy between lapatinib and trastuzumab when given concurrently with paclitaxel for MBC.Methods: This is an open-label phase I safety study. The primary objective of the study was to assess the safety and tolerability of lapatinib when administered with concurrent paclitaxel and trastuzumab. Patients were enrolled into 1 of 3 cohorts. Cohort 1 received lapatinib (1000 mg/d), paclitaxel (80 mg/m2 weekly for 3 weeks of a 4-week cycle), and the standard …

Año de publicación:

2009

Keywords:

Fuente:

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