A Randomized, Open-Label, Two-Arm Study Of Neratinib Plus Paclitaxel Versus Trastuzumab Plus Paclitaxel As First-Line Treatment For ErbB-2-Positive Locally Recurrent Or Metastatic Breast Cancer

Inclusion Criteria:

- ErbB-2 positive locally recurrent or metastatic breast cancer

- Eastern Cooperative Oncology Group (ECOG) 0-2

- Measurable disease

- Availability of tumor tissue for HER2 status confirmation

Exclusion Criteria:

- Prior systemic anti-cancer therapy other than endocrine therapy for locally recurrent
or metastatic disease

- Prior erbB-2 inhibitor other than trastuzumab or lapatinib in the neoadjuvant or
adjuvant setting

- Progression/recurrence within 12 months after completion of adjuvant or neoadjuvant
therapy

- history of heart disease

- history of gastrointestinal disease