Clinical Study of Recombinant Anti-HER2 Humanized Monoclonal Antibody (GB221) for Injection
- Registration Number
- NCT04164615
- Lead Sponsor
- Genor Biopharma Co., Ltd.
- 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
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 336
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo control + capecitabine tablets Placebo control placebo+capecitabine GB221+ Capecitabine tablets GB221 test drug+capecitabine
- Primary Outcome Measures
Name Time Method Progression-free survival, PFS through study completion, an average of 2 year To evaluate the efficacy of GB221 as defined by progression-free survival in patients with breast cancer.
- Secondary Outcome Measures
Name Time Method Objective Response Rate, ORR through study completion, an average of 2 year To evaluate the efficacy of GB221 as defined by overall response rate, in patients with breast cancer.
Antidrug antibody, ADA through study completion, an average of 2 year Antidrug antibody, ADA
Overall survival, OS through study completion, an average of 2 year To evaluate the duration from the first administration to death because of any reason in patients with breast cancer.
PFS in the extended treatment phase through study completion, an average of 2 year PFS in the extended treatment phase
Trial Locations
- Locations (1)
People's Liberation Army General Hospital The Fifth Medical Center
🇨🇳Beijing, Beijing, China