Conditions: Neoplasms, Breast
Keywords: lapatinib GW572016 ErbB2 EGFR ErbB1 MBC FISH amplification Metastatic Breast Cancer dual tyrosine kinase inhibitor Her-2/neu
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 296
Healthy volunteers: no

Brief summary:
This study will evaluate and compare the safety and efficacy of lapatinib in combination with trastuzumab versus lapatinib monotherapy in subjects with HER2-positive metastatic breast cancer.

Detailed description:

Arms:
arm 1: Lapatinib 1000mg once daily in combination with trastuzumab 4mg/kg loading dose followed by 2mg/kg weekly arm 2: Lapatinib 1500mg once daily

Interventions: intervention 1: Lapatinib intervention 2: Trastuzumab
Intervention descriptions: intervention 1: oral lapatinib once daily intervention 2: IV trastuzumab 2mg/kg weekly after 4mg/kg loading dose

Protocol document: