Spots Global Cancer Trial Database for Clinical Study of Recombinant Anti-HER2 Humanized Monoclonal Antibody (GB221) for Injection
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Trial Identification
Brief Title: Clinical Study of Recombinant Anti-HER2 Humanized Monoclonal Antibody (GB221) for Injection
Official Title: A Randomized, Double-blind, Multi-center Phase Ⅲ Clinical Study to Evaluate the Recombinant Anti-HER2 Humanized Monoclonal Antibody or Placebo in Combination With Capecitabine for the Treatment of HER-2-positive Advanced Breast Cancer
Study ID: NCT04164615
Conditions
Study Description
Brief Summary: The primary objective of this trial is to compare the progression-free survival (PFS) in two groups of combined therapy of GB221/ capecitabine tablets versus combined therapy of placebo/capecitabine tablets; the secondary objective is to evaluate the objective response rate (ORR),time to progression (TTP) from treatment period to week 12; overall survival (OS), safety, immunogenicity (anti-drug antibody), PFS of subjects during continued treatment period.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
People's Liberation Army General Hospital The Fifth Medical Center, Beijing, Beijing, China
Contact Details
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