200
Participants
Start Date
February 5, 2020
Primary Completion Date
December 13, 2021
Study Completion Date
February 8, 2026
Pertuzumab IV
Pertuzumab will be administered as a fixed non-weight-based loading dose of 840-milligrams (mg) IV and then a 420-mg IV maintenance dose Q3W.
Trastuzumab IV
Trastuzumab will be administered as an 8-milligram per kilogram of body weight (mg/kg) IV loading dose and then 6 mg/kg IV maintenance dose Q3W.
Pertuzumab and Trastuzumab FDC SC
The pertuzumab and trastuzumab fixed-dose combination for subcutaneous administration (PH FDC SC) will be administered SC at a fixed non-weight-based dose. A loading dose of 1200 mg SC pertuzumab and 600 mg SC trastuzumab is then followed by a maintenance dose of 600 mg SC pertuzumab and 600 mg SC trastuzumab Q3W.
Doxorubicin
Doxorubicin 60 milligrams per meter squared of body surface area (mg/m\^2) will be administered IV on Day 1 of each cycle of treatment (as part of AC Q3W) for Cycles 1-4.
Cyclophosphamide
Cyclophosphamide 600 mg/m\^2 will be administered IV on Day 1 of each cycle of treatment (as part of AC Q3W) for Cycles 1-4.
Docetaxel
Docetaxel 75 mg/m\^2 will be administered IV on Day 1 of Cycle 5. At the investigator's discretion the dose may be escalated to 100 mg/m\^2 IV for Cycles 6-8 (Q3W) provided no dose-limiting toxicity occurs.
Surgery
Participants in both cohorts are scheduled to undergo surgery after 8 cycles of neoadjuvant therapy. Participants may undergo breast-conserving surgery or mastectomy according to routine clinical practice.
Post-Operative Radiotherapy
If indicated, radiotherapy is given after chemotherapy and surgery, during adjuvant HER2-targeted therapy and hormone therapy (for hormone-receptor positive disease).
Hormone Therapy
For hormone receptor positive breast cancer, tamoxifen or aromatase inhibitors will be allowed as adjuvant hormone therapy for postmenopausal participants and with ovarian suppression or ablation for premenopausal participants in countries where it has been registered for this indication. Its use must be consistent with the registered label. Hormone therapy is given after chemotherapy and surgery during adjuvant HER2-targeted therapy.
Peking University People's Hospital, Beijing
Beijing Cancer Hospital, Beijing
The 900th Hospital of PLA joint service support force, Fuzhou
Jilin Cancer Hospital, Changchun
The First Hospital of Jilin University, Changchun
Harbin Medical University Cancer Hospital, Harbin
Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai
Fudan University Shanghai Cancer Center, Shanghai
Jiangsu Province Hospital, Nanjing
Shandong Cancer Hospital, Jinan
The Affiliated Hospital of Medical College Qingdao University, Qingdao
Zhejiang Cancer Hospital, Hangzhou
Union Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan
Hubei Cancer Hospital, Wuhan
Sun Yet-sen University Cancer Center, Guangzhou
West China Hospital, Sichuan University, Chengdu
The First Affiliated Hospital of Xian Jiao Tong University, Xi'an
Hebei Medical University Fourth Hospital, Shijiazhuang
Hoffmann-La Roche
INDUSTRY