A Phase 1/2 Study Of HKI-272 In Combination With Vinorelbine In Subjects With Solid Tumors And Metastatic Breast Cancer

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 female subjects for which vinorelbine plus HKI-272 is a reasonable
treatment option (part 2 only).

- At least 1 prior antineoplastic 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 or subject relapsing under adjuvant treatment (part 2
only).

- At least 1 measurable lesion as defined by Response Evaluation Criteria in Solid
Tumors (RECIST).

Exclusion Criteria:

- More than 2 prior antineoplastic treatment regimens (excluding hormonotherapy) for
metastatic disease. Subjects who relapsed under adjuvant treatment shouldn't have
received more than one line of chemotherapy 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).