Conditions: Breast Cancer
Keywords: ErbB-2 positive advanced breast cancer HKI-272 Neratinib Nerlynx HER2 PB-272 metastatic breast cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 479
Healthy volunteers: no

Brief summary:
This study is investigating the effects of an experimental drug (neratinib) in combination with paclitaxel versus trastuzumab in combination with paclitaxel for the treatment of women who have not received previous treatment for erbB-2-positive locally recurrent or metastatic breast cancer. The study will compare the effectiveness of each regimen in shrinking tumors and extending the lives of women with erbB-2 (HER2) positive breast cancer. The study will also compare the safety of the two regimens and as well as the quality of life of subjects receiving either regimen.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Neratinib intervention 2: Trastuzumab intervention 3: Paclitaxel
Intervention descriptions: intervention 1: Neratinib - 240 mg orally daily, administered once daily. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent. intervention 2: Trastuzumab - 4 mg/kg IV initial loading dose followed by subsequent once weekly doses of 2mg/kg IV. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent. intervention 3: Paclitaxel - 80 mg/m² IV administered on days 1, 8, and 15 of a 28-day cycle. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.

Protocol document: