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

Genor Biopharma Co., Ltd.1 site in 1 country336 target enrollmentNovember 24, 2016

ConditionsHER-2-positive Advanced Breast Cancer

InterventionsGB221 Placebo control

DrugsGB221 Placebo control

Overview

Phase: Phase 3
Intervention: GB221
Conditions: HER-2-positive Advanced Breast Cancer
Sponsor: Genor Biopharma Co., Ltd.
Enrollment: 336
Locations: 1
Primary Endpoint: Progression-free survival, PFS
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 24, 2016

End Date

November 2020

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Genor Biopharma Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arms & Interventions

GB221+ Capecitabine tablets

test drug+capecitabine

Intervention: GB221

Placebo control + capecitabine tablets

placebo+capecitabine

Intervention: Placebo control

Outcomes

Primary Outcomes

Progression-free survival, PFS

Time Frame: 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 Outcomes

Objective Response Rate, ORR(through study completion, an average of 2 year)
Antidrug antibody, ADA(through study completion, an average of 2 year)
Overall survival, OS(through study completion, an average of 2 year)
PFS in the extended treatment phase(through study completion, an average of 2 year)