Conditions: Advanced Breast Cancer Breast Cancer
Keywords: HER2 ErbB2 metastatic neratinib lapatinib capecitabine HKI-272 Nerlynx PB-272
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 233
Healthy volunteers: no

Brief summary:
This is a study of an experimental drug (neratinib) versus a combination of drugs (lapatinib and capecitabine) in women who have erbB-2 (HER-2) positive metastatic or locally advanced breast cancer. The goal of this study is to compare the two regimens in shrinking tumors and extending the lives of women with erbB2 (HER2) positive breast cancer. The study will also compare the safety of the two regimens and to compare quality of life of patients taking the two regimens.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Neratinib intervention 2: Lapatinib intervention 3: Capecitabine
Intervention descriptions: intervention 1: Tablets 240 mg orally once per day until disease progression or unacceptable toxicity intervention 2: Tablets 1250 mg orally once per day until disease progression or unacceptable toxicity. intervention 3: Tablets 2000 mg/m² given orally in two evenly divided daily doses for first 14 days of each 21 day cycle. Given until disease progression or unacceptable toxicity.

Protocol document: