Conditions: Neoplasms, Breast
Keywords: GW786034 Quality of Life GW572016 Lapatinib Pazopanib Metastatic Breast cancer Genetics FISH Advanced
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 189
Healthy volunteers: no

Brief summary:
This study is being conducted to compare the efficacy and safety of pazopanib in combination with lapatinib with that of lapatinib alone in subjects with locally advanced or metastatic breast cancer whose tumors overexpress the ErbB2 protein.

Detailed description:

Arms:
arm 1: 1500 mg (6 x 250 mg tablets) oral lapatinib once daily arm 2: 1000 mg (4 x 250 mg tablets) of oral lapatinib and 400 mg (4 x 100 mg tablets) of oral pazopanib taken together once daily arm 3: 1500 mg (6 x 250 mg tablets) of oral lapatinib and 800 mg (1 x 500 mg tablets plus 3 x 100 mg tablets) of oral pazopanib taken together once daily

Interventions: intervention 1: pazopanib (GW786034) 400 mg intervention 2: lapatinib (GW572016) 1500 mg intervention 3: lapatinib (GW572016) 1000 mg intervention 4: pazopanib (GW786034) 800 mg
Intervention descriptions: intervention 1: 400 mg administered orally once daily intervention 2: 1500 mg administered orally once daily. intervention 3: 1000 mg administered orally once daily intervention 4: 800 mg administered orally once daily

Protocol document: