Study Evaluating HKI-272 (Neratinib) In Subjects With Advanced Breast Cancer

Phase 2 Study of HKI-272 In Subjects With Advanced Breast Cancer

The purpose of this study is to learn whether neratinib is safe and effective in treating women with advanced human epidermal growth factor receptor 2 (HER2) positive breast cancer.

Arm A: HER2 gene amplification and disease progression following at least 6 weeks of standard doses of Herceptin; Arm B: HER2 gene amplification and no prior Herceptin or HER2-targeted treatment.

Inclusion Criteria:

• Pathologic diagnosis of breast cancer and current stage IIIB, IIIC, or IV
• Progression following at least 6 weeks of standard doses of Herceptin (Arm A only)
• Over-expression of HER2
• Tumor tissue available and adequate for analysis at screening
• At least one measurable lesion

Exclusion Criteria:

• Prior treatment with Herceptin (Arm B only)
• More than 4 prior cytotoxic chemotherapy regimens
• Subjects with bone or skin as the only site of measurable disease
• Inadequate cardiac function
• Major surgery, chemotherapy, radiotherapy, investigational agents or other cancer therapy within 1 week of treatment day 1
• Active central nervous system metastases
• Pregnant or breastfeeding women
• Inability to swallow the HKI-272 capsules