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Brief Title: Treatment of Breast Cancer With Trastuzumab + HS627/ Pertuzumab + Docetaxel
Official Title: A Phase III Study to Compare HS627 vs. Pertuzumab on the Efficacy, Safety and Immunogenicity in Combination With Trastuzumab and Docetaxel as Neoadjuvant Therapy in Patients With Early-stage or Locally Advanced HER2 Positive Breast Cancer
Study ID: NCT04514419
Brief Summary: The trial included screening period (4 weeks) and treatment period (4 treatment cycles, at least 12 weeks).
Detailed Description: A multicenter, randomized, double-blind, positive drug parallel control design was used. The trial included screening period (4 weeks) and treatment period (4 treatment cycles, at least 12 weeks). All eligible subjects were randomly divided into experimental group (hs627 treatment group) and control group (pertuzumab) treatment group. After 4 treatment cycles, the subjects arranged surgical treatment, and then conducted the last visit.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
The Affiliated Hospital of Qingdao University, Qingdao, Shandong, China
Name: Zefei Jiang, M.D
Affiliation: The Affiliated Hospital of Qingdao University
Role: PRINCIPAL_INVESTIGATOR
Name: Haibo Wang, M.D
Affiliation: The Affiliated Hospital of Qingdao University
Role: PRINCIPAL_INVESTIGATOR