329
Participants
Start Date
March 14, 2016
Primary Completion Date
October 23, 2017
Study Completion Date
March 14, 2022
FEC Chemotherapy
Fluorouracil 500-600 milligrams per square meter (mg/m2), epirubicin 90-120 mg/m2, and cyclophosphamide 500-600 mg/m2 by intravenous (IV) infusion every 3 weeks for three cycles (Cycles 5-7). FEC chemotherapeutic agents will be administered following surgery on Day 1 of each specified cycle.
Surgery
All participants who are eligible for surgery will undergo surgery and have their pathologic response evaluated.
Docetaxel
Docetaxel IV infusion in 3-week cycles. Neoadjuvant treatment: 75 mg/m2 for Cycles 1-4.
Pertuzumab
Pertuzumab IV infusion in 3-week cycles. Prior to surgery (neoadjuvant treatment): 840 milligrams (mg) loading dose for Cycle 1, followed by 420 mg for Cycles 2-4. After surgery and 3 cycles of FEC chemotherapy (adjuvant treatment): 840 mg loading dose for Cycle 8, followed by 420 mg for Cycles 9-20)
Placebo
Placebo by IV infusion in 3-week cycles as neoadjuvant treatment (Cycles 1-4)and as adjuvant treatment (Cycles 8-20)
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 for Cycle 8, followed by 6 mg/kg for Cycles 9-20.
Mackay Memorial Hospital; Dept of Surgery, Taipei
Taipei Medical University Hospital, Taipei
China Medical University Hospital; Surgery, Taichung
Bhumibol Adulyadej Hospital; Medicine, Bangkok
Ajou University Medical Center, Gyeonggi-do
Taipei Medical University ?Shuang Ho Hospital, New Taipei City
Srinagarind Hospital, Khon Kaen University; Surgery, Khon Kaen
Kyungpook National University Medical Center, Daegu
Songklanagarind Hospital; Department of Surgery, Songkhla
The Affiliated Hospital of Military Medical Sciences(The 307th Hospital of Chinese PLA), Beijing
the First Hospital of Jilin University, Changchun
Jilin Cancer Hospital, Changchun
Harbin Medical University Cancer Hospital, Harbin
Shanghai Jiao Tong University School of Medicine (SJTUSM) - Ruijin Hospital (GuangCi Hospital), Shanghai
Fudan University Shanghai Cancer Center, Shanghai
Jiangsu Province Hospital, Nanjing
Shandong Cancer Hospital, Jinan
Zhejiang Cancer Hospital, Zhejiang
Fujian Medical University Union Hospital, Fuzhou
Henan Cancer Hospital, Zhengzhou
Guangdong General Hospital, Guangzhou
Sun Yet-sen University Cancer Center, Guangzhou
Korea University Guro Hospital, Seoul
Hoffmann-La Roche
INDUSTRY