• Physical Exams, Adverse Event Assessment, Tumor Assessments (CT, MRI, bone scan) including independent radiologic review for Part 2 [ Time Frame: 10 months (estimated average participation) ] [ Designated as safety issue: Yes ]
  

• Electrocardiograms (ECGs), QTCLeft Ventricular Ejection Fraction, (LVEF [ Time Frame: 10 months (estimated average participation) ] [ Designated as safety issue: No ]
  

The study will be conducted in two parts. In the first part, testing will be done on up to 12 subjects to determine the highest tolerable dose of HKI-272 and vinorelbine in patients with advanced solid tumors. In the second part of the study, approximately 60 additional subjects with metastatic ErbB-2-positive breast cancer, with no prior exposure to lapatinib (Tykerb®), are planned to be added to better define the tolerability and preliminary activity of HKI-272 in combination with vinorelbine. Up to 20 additional subjects with ErbB-2-positive breast cancer with prior lapatinib (Tykerb®) exposure are also planned to be enrolled in part 2 for exploratory analyses.

Inclusion Criteria:

• Confirmed pathologic diagnosis of a solid tumor that is not curable with available therapies for which HKI-272 plus vinorelbine is a reasonable treatment option (part 1 only) or Confirmed pathologic diagnosis of ErbB-2-positive breast cancer (current stage IV) in subjects for which vinorelbine plus HKI-272 is a reasonable treatment option (part 2 only).
• At least 1 prior cytotoxic chemotherapy treatment regimen for metastatic disease and at least 1 prior treatment with a trastuzumab-containing regimen for at least 6 weeks, for metastatic disease (part 2 only).
• At least 1 measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST).

Exclusion Criteria:

• More than 2 prior cytotoxic chemotherapy treatment regimens for metastatic disease (part 2 only).
• Prior treatment with vinorelbine for metastatic setting, or prior treatment with any ErbB-2 targeted agents except trastuzumab (part 2 only). Up to 20 subjects with ErbB-2-overexpressing metastatic breast cancer who have been previously exposed to lapatinib but are not refractory to lapatinib may be enrolled in part 2.
• Prior treatment with anthracyclines with a cumulative dose of doxorubicin of greater than 400 mg/m2, or of epirubicin dose of greater than 800 mg/m2, or the equivalent dose for other anthracyclines or derivatives (part 2 only).