A Phase 1/2 Study of HKI-272 (Neratinib) in Combination With Paclitaxel (Taxol) in Subjects With Solid Tumors and Breast Cancer

Inclusion Criteria: Inclusion criteria for both parts of clinical trial: * Good performance status * Normal ejection fraction * Adequate cardiac, kidney, and liver function * Adequate blood counts * At least one measurable target lesion * Negative pregnancy test for female subjects Inclusion Criteria for Part 1 Only: \- Pathologically confirmed solid tumor not curable with available standard therapy Inclusion Criteria for Part 2 Only: * Pathologically confirmed breast cancer * HER2 positive tumor * Prior treatment with Herceptin Exclusion Criteria: Exclusion criteria for both parts of clinical trial: * Major surgery, radiotherapy, chemotherapy or investigational agents within two weeks of treatment day 1 * Subjects with bone or skin as the only site of disease * Active central nervous system metastases * Significant cardiac disease or dysfunction * Significant gastrointestinal disorder * Inability or unwillingness to swallow HKI-272 capsules * Prior exposure to HKI-272 or other HER2 targeted agents, except trastuzumab (Part 2 only). Prior lapatinib is permitted in arm B of part 2. * Treatment with a taxane within 3 months of treatment day 1 * Grade 2 or greater motor or sensory neuropathy * Pregnant or breast feeding women * Known hypersensitivity to paclitaxel or Cremophor EL * Prior treatment with anthracyclines with cumulative dose of \>400 mg/m\^2 * 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 Exclusion Criteria for Part 2 Only: \- More than 1 (arm A) or 3 (arm B) prior cytotoxic chemotherapy regimen for metastatic disease