Woman Man
- | Country : -
- | organs : -
- | Specialty : -
Extract
Primary objectives: Part 1: To assess the safety and tolerability, and to define the MTD of orally administered HKI-272 in combination with trastuzumab in subjects with advanced breast cancer. Part 2: To determine the 16 week progression free survival (PFS) rate for subjects with advanced breast cancer treated at the MTD with HKI-272 and trastuzumab.
Inclusion criteria
- Advanced HER2 breast cancer. HER2 is a member of the epidermal growth factor (EGFR) family of receptors involved in cell proliferation, tumorigenesis, and metastasis and abnormally expressed in multiple tumor types. EGFR may also be over-expressed in breast cancer, play a role in tumorigenesis, and also confers a worse prognosis. Coexpression of EGFR family (HER1, 2 and 3) has been associated with a negative synergistic effect on 15-year disease specific survival of breast cancer patients