Spots Global Cancer Trial Database for A Two-Arm Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Combination With Chemotherapy in Chinese Participants With HER2-Positive Early Breast Cancer
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Trial Identification
Brief Title: A Two-Arm Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Combination With Chemotherapy in Chinese Participants With HER2-Positive Early Breast Cancer
Official Title: A Phase III, Randomized, Multicenter, Open-Label, Two-Arm Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Combination With Chemotherapy in Chinese Patients With HER2-Positive Early Breast Cancer
Study ID: NCT04024462
Conditions
Study Description
Brief Summary: This study will evaluate the pharmacokinetics, efficacy, and safety of the pertuzumab and trastuzumab fixed-dose combination for subcutaneous administration (PH FDC SC) as compared with those of the pertuzumab intravenous (IV) and trastuzumab IV formulations in Chinese participants with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Peking University People's Hospital, Beijing, , China
Beijing Cancer Hospital, Beijing, , China
The First Hospital of Jilin University, Changchun City, , China
Jilin Cancer Hospital, Changchun, , China
West China Hospital, Sichuan University, Chengdu, , China
The 900th Hospital of PLA joint service support force, Fuzhou, , China
Sun Yet-sen University Cancer Center, Guangzhou City, , China
Zhejiang Cancer Hospital; Breast Surgery, Hangzhou City, , China
Harbin Medical University Cancer Hospital, Harbin, , China
Shandong Cancer Hospital, Jinan, , China
Jiangsu Province Hospital, Nanjing, , China
The Affiliated Hospital of Medical College Qingdao University, Qingdao, , China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai City, , China
Fudan University Shanghai Cancer Center, Shanghai City, , China
Hebei Medical University Fourth Hospital;(Tumor Hospital of Hebei Province), Shijiazhuang, , China
Union Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan City, , China
Hubei Cancer Hospital, Wuhan, , China
The First Affiliated Hospital of Xian Jiao Tong University, Xi'an City, , China
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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