Efficacy and Safety of the Combination of Trastuzumab Plus TUCAtinib Plus viNorelbine in Patients With HER2-positive Non-resectable Locally Advanced or Metastatic Breast Cancer

"Run-in Phase:~* Trastuzumab either IV or SC: 8 mg/kg IV loading dose (if necessary), followed by 6 mg/kg intravenous (IV) or 600 mg subcutaneous (SC) every 3 weeks.~* Oral vinorelbine: 50 mg/m2 (in the first cycle) and 60 mg/m2 (in the following cycles if no dose limiting toxicity \[DLT\] is seen) on days 1 and 8, every 3 weeks.~* Oral tucatinib 300 mg twice a day (BID) on a continuous dosing schedule.~Following patients in the phase II:~* Trastuzumab either IV or SC: 8 mg/kg IV loading dose (if necessary), followed by 6 mg/kg IV or 600 mg SC every 3 weeks.~* Oral vinorelbine: 50 mg/m2 or 60 mg/m2 (based on the run-in phase results) on days 1 and 8, every 3 weeks.~* Oral tucatinib 300 mg BID on a continuous dosing schedule."

"Run-in Phase:~* Trastuzumab either IV or SC: 8 mg/kg IV loading dose (if necessary), followed by 6 mg/kg intravenous (IV) or 600 mg subcutaneous (SC) every 3 weeks.~* Oral vinorelbine: 50 mg/m2 (in the first cycle) and 60 mg/m2 (in the following cycles if no dose limiting toxicity \[DLT\] is seen) on days 1 and 8, every 3 weeks.~* Oral tucatinib 300 mg twice a day (BID) on a continuous dosing schedule.~Following patients in the phase II:~* Trastuzumab either IV or SC: 8 mg/kg IV loading dose (if necessary), followed by 6 mg/kg IV or 600 mg SC every 3 weeks.~* Oral vinorelbine: 50 mg/m2 or 60 mg/m2 (based on the run-in phase results) on days 1 and 8, every 3 weeks.~* Oral tucatinib 300 mg BID on a continuous dosing schedule."

"Run-in Phase:~* Trastuzumab either IV or SC: 8 mg/kg IV loading dose (if necessary), followed by 6 mg/kg intravenous (IV) or 600 mg subcutaneous (SC) every 3 weeks.~* Oral vinorelbine: 50 mg/m2 (in the first cycle) and 60 mg/m2 (in the following cycles if no dose limiting toxicity \[DLT\] is seen) on days 1 and 8, every 3 weeks.~* Oral tucatinib 300 mg twice a day (BID) on a continuous dosing schedule.~Following patients in the phase II:~* Trastuzumab either IV or SC: 8 mg/kg IV loading dose (if necessary), followed by 6 mg/kg IV or 600 mg SC every 3 weeks.~* Oral vinorelbine: 50 mg/m2 or 60 mg/m2 (based on the run-in phase results) on days 1 and 8, every 3 weeks.~* Oral tucatinib 300 mg BID on a continuous dosing schedule."