Phase 2 Study of Standard Chemotherapy With Trastuzumab, Plus or Minus Pertuzumab, for Pre-treated Metastatic Breast Cancer

"Treatment for all patients will consist of trastuzumab, given as a loading dose of 8 mg/kg IV on Day 1 followed by 6 mg/kg IV every 3 weeks thereafter.~Patients randomized to the chemotherapy plus trastuzumab arm (without pertuzumab) can receive trastuzumab 6 mg/kg IV every 3 weeks if they are receiving docetaxel or capecitabine on a 3-week cycle, or 4 mg/kg IV every 2 weeks if they are receiving vinorelbine, paclitaxel, or nab-paclitaxel on a 4-week cycle. The loading dose for all patients remains 8 mg/kg.~For patients randomized to the chemotherapy plus trastuzumab plus pertuzumab arm, both trastuzumab and pertuzumab need to be administered every 3 weeks regardless of which chemotherapy agent they are receiving."

pertuzumab given as a loading dose of 840 mg IV on Day 1 followed by 420 mg IV every 3 weeks.

"physician's choice of chemotherapy:~* Vinorelbine 25 mg/m2 IV weekly times 3 with 1 week off; OR~* Paclitaxel 80 mg/m2 IV weekly times 3 with 1 week off; OR~* Nab-Paclitaxel 100 mg/m2 IV weekly times 3 with 1 week off; OR~* Docetaxel 75 mg/m2 IV every 3 weeks; OR~* Capecitabine 1500 mg by mouth twice a day (PO BID) 14 days on and then 7 days off."