A Phase II, Single-Arm Trial of Poziotinib as Salvage Treatment in Patients With Metastatic Breast Cancer Who Has HER2 or EGFR Mutation or Activated AR or EGFR Pathway

Inclusion Criteria

• •1. Histologically confirmed metastatic breast cancer with measurable or evaluable disease
• •2. age ≥ 20 years
• •3. HER2 mutation or EGFR mutation/gene amplification confirmed by CancerSCAN or Activated AR pathway confirmed by RNA seq \& nCounter assay, AR expression was confirmed by immunohistochemistry(IHC) or EGFR high expression (≥ IHC 2+ \& lower ER / ≥ IHC score + and HER2 2+ or SISH negative)
• •4. ECOG performance status 0 - 2
• •5. Two or more regimens for locally recurrent or metastatic breast cancer, including an anthracycline and a taxane
• •6. Life expectancy ≥ 3 months
• •7. Progression within 6 months or less of latest chemotherapy
• •8. The patients must have recovered from the acute toxic effects of the treatment prior to study enrollment. Prior radiotherapy must be completed 2 weeks before study entry.
• •9. Adequate bone marrow function (≥ ANC 1,500/ul, ≥ platelet 100,000/ul, ≥ Hemoglobin 9.0 g/dl)
• •10. Adequate renal function (serum creatinine ≤ 1.5 x upper normal limit or CCr ≥ 50 ml/min)
• •11. Adequate liver function (serum bilirubin ≤ 1.5 x upper normal limit, AST/ALT ≤ 3 x upper normal limit)
• •12. No prior history of pan-HER TKI including poziotinib for metastatic breast cancer
• •13. Written informed consent