185
Participants
Start Date
April 18, 2023
Primary Completion Date
August 31, 2027
Study Completion Date
November 30, 2029
Paclitaxel
80 mg/m2 IV administered on Days 1, 8, 15 of each 21-day cycle
Carboplatin
Carboplatin AUC 1.5 IV administered on Days 1, 8, 15 of each 21-day cycle
Trastuzumab
Trastuzumab 8 mg/kg loading dose, followed by 6 mg/kg maintenance dose, administered on Day 1 of each 21-day cycle
Pertuzumab
Pertuzumab 840 mg loading dose, followed by 420 mg maintenance dose, administered on Day 1 of each 21-day cycle
Doxorubicin
60 mg/m2 IV administered on Day 1 of each 14-day cycle
Cyclophosphamide
600 mg/m2 IV administered on Day 1 of each 14-day cycle
Pembrolizumab
"Either 200 mg IV administered on Day 1 of Cycles 1-4, or 400 mg IV administered on Day 1 of Cycles 1 and 3 of the paclitaxel/carboplatin regimen.~400 mg on Day 1 of Cycles 1 and 4 of the dose-dense AC regimen."
Pertuzumab/Trastuzumab/Hyaluronidase-zzxf
Can be used in place of separate IV formulations of pertuzumab and trastuzumab. 1200 mg pertuzumab/600 mg trastuzumab/30,000 U hyaluronidase administered subcutaneously on Day 1 of the first cycle, followed by a maintenance dose of 600 mg pertuzumab/600 mg trastuzumab/20,000 U hyaluronidase administered subcutaneously every 3 weeks.
RECRUITING
Harris Health System - Smith Clinic, Houston
RECRUITING
O'Quinn Medical Tower - McNair Campus - Dan L Duncan Comprehensive Cancer Center, Houston
Baylor Breast Care Center
OTHER