The purpose of the study is to demonstrate equivalence
Patients will receive CT-P6 or Herceptin every 3 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
475
Administered every 3 weeks
Administered every 3 weeks
Administered every 3 weeks
Samsung Medical Center
Seoul, South Korea
Objective Response Rate
Best Overall Response (BOR) was derived from the overall response across all time points until after Cycle 8 using Independent Tumor Review Committee (ITRC) data in the FAS. Objective Response Rate (ORR) was defined as the number of patients with a BOR of complete response (CR) or partial response (PR) divided by the number of patients in the corresponding population, as assessed by Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1.
Time frame: 6 months (up to 24 weeks)
Time to Progression
Time from randomization to determined progressive disease, as assessed by RECIST version 1.1.
Time frame: Through study completion, approximately 40 months
Time to Response
Time from randomization to observed tumor response (Complete Response or Partial Response), as assessed by RECIST 1.1
Time frame: Through study completion, approximately 40 months
Progression Free Survival
Time from randomization to radiological progression or death from any cause, as assessed by RECIST 1.1
Time frame: Through study completion, approximately 40 months
Overall Survival
The number of days between the date of randomization and the date of death from any cause.
Time frame: Through study completion, approximately 40 months
Safety Endpoints; Cardiotoxicity
Mean change from baseline to endpoint assessment in left ventricular ejection fraction (LVEF) (%)
Time frame: Through study completion, approximately 40 months
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Safety Endpoints; Immunogenicity
Assessed by the proportion of patients with development of antibodies to study drug (positive anti-drug antibody \[ADA\] results after the first study drug infusion)
Time frame: During treatment, median of 13 cycles (every cycle is 3 weeks)
Pharmacokinetic Endpoints; Ctroughss
Trough concentration at steady state
Time frame: predose and at 1.5 hours (end of infusion) of each cycle