A Phase 1/2 Study Of HKI-272 (Neratinib) in Combination With Trastuzumab (Herceptin) In Subjects With Advanced Breast Cancer

Exclusion Criteria

• •More than 3 prior cytotoxic chemotherapy regimens for locally advanced or metastatic disease
• •Major surgery, chemotherapy, radiotherapy, investigational agents, Herceptin or other cancer therapy within 2 weeks of treatment day 1
• •Prior treatment with anthracyclines with cumulative dose of \>400 mg/m\^2
• •Extensive visceral disease
• •Active central nervous system metastases
• •Pregnant or breast feeding women
• •Significant chronic or recent acute gastrointestinal disorder with diarrhea as a major symptom
• •Prior exposure to HKI-272 or other HER2 targeted agents (except Herceptin and Tykerb)
• •Significant cardiac disease or dysfunction
• •History of life-threatening hypersensitivity to Herceptin
• •Inability or unwillingness to swallow HKI-272 capsules
• •Any other cancer within 5 years with the exception of contralateral breast cancer, adequately treated cervical carcinoma in situ, or adequately treated basal or squamous cell carcinoma of the skin