32
Participants
Start Date
November 21, 2016
Primary Completion Date
November 14, 2019
Study Completion Date
March 27, 2020
paclitaxel
80 mg/m2 (or nab-paclitaxel 80-100 mg/m2) weekly
Trastuzumab
Either every 3 weeks (8 mg/kg cycle 1 then 6 mg/kg cycles 2-4) or weekly (4 mg/kg week 1 then 2 mg/kg weeks 2-12)
Pertuzumab
every 3 weeks (840 mg cycle 1 then 420 mg cycles 2-4) or weeks 1 and 2 cycle 1 (420 mg each dose) during the first 3-6 weeks of treatment, then 420 mg day 1 of cycles 2-4.
carboplatin
AUC 2 administered weekly with no planned treatment breaks
Breast surgery
breast conserving or mastectomy
AC
"doxorubicin and cyclophosphamide (AC) every 2 or 3 weeks for 4 cycles~Dose-dense AC: Doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 IV day 1 every 2 weeks x 4 cycles~Standard AC: Doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 IV day 1 r every 3 weeks x 4 cycles"
Rhode Island Hospital and The Miriam Hospital, Providence
Women and Infants hospital of RI, Providence
Lead Sponsor
Women and Infants Hospital of Rhode Island
OTHER
Rhode Island Hospital
OTHER
The Miriam Hospital
OTHER
Brown University
OTHER