216
Participants
Start Date
May 30, 2020
Primary Completion Date
December 30, 2022
Study Completion Date
December 30, 2027
Pyrotinib
Pyrotinib 400 mg taken orally everyday, every 3 weeks, for 4 cycles.
Trastuzumab
"Trastuzumab IV infusion in 3-week cycles.~Neoadjuvant treatment: 8 milligrams per kilogram (mg/kg) loading dose for Cycle 1, followed by 6 mg/kg for Cycles 2-4.~Adjuvant treatment: 8 mg/kg loading dose, followed by 6 mg/kg for remaining cycles till completion of 1 year trastuzumab"
Pertuzumab
"Pertuzumab IV infusion in 3-week cycles.~Neoadjuvant treatment: 840 milligrams (mg) loading dose for Cycle 1, followed by 420 mg for Cycles 2-4.~Adjuvant treatment: 840 mg loading dose, followed by 420mg for remaining cycles till completion of 1 year pertuzumab"
Nab-paclitaxel
Nab-paclitaxel 100mg/m2 by intravenous (IV) infusion on day1, day8 and day15, every 3 weeks, for 4 cycles.
EC chemotherapy
Epirubicin 90 mg/m2, and cyclophosphamide 600 mg/m2 by intravenous (IV) infusion every 3 weeks for 4 cycles (Cycles 5-8)
Physician's choice
Physician decided chemotherapy for 0-4 cycles.
T-DM1
T-DM1 IV infusion in 3-week cycles. 3.6 mg/kg by intravenous (IV) infusion every 3 weeks for 14 cycles
Surgery
All participants who are eligible for surgery will undergo surgery and have their pathologic response evaluated.
Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai
Jiangsu HengRui Medicine Co., Ltd.
INDUSTRY
Shanghai Jiao Tong University School of Medicine
OTHER