Conditions: Metastatic Breast Cancer Neoplasms, Breast
Keywords: dual kinase inhibitor, EGFR/ErbB1, ErbB2-overexpressing, GW572016, advanced/metastatic breast cancer, Lapatinib, HER-2/new, pharmacokinetics
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 51
Healthy volunteers: no

Brief summary:
This study is to evaluate the safety and efficacy of lapatinib taken together with capecitabine in Japanese patients. The study will proceed in two phases; the first phase(Part1) will lead to an evaluation of the mainly tolerability as well as PK parameters. If there are no major safety concerns in Part 1, the study will move into the second phase (Part 2) to further evaluate the safety and clinical activity.

Detailed description:

Arms:
arm 1: Lapatinib 1250mg once daily +capecitabine 2000mg/m\^2 twice daily (14 days out of 21 days)

Interventions: intervention 1: Lapatinib intervention 2: capecitabine
Intervention descriptions: intervention 1: 1250mg once daily intervention 2: 2000mg/m\^2 twice daily (14 days out of 21 days)

Protocol document: