At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III, Randomized, Two-armed, Parallel, Triple-blind, Active-controlled, Equivalency Clinical Trial of Efficacy and Safety Pertuzumab® (CinnaGen Co.) Compared With Perjeta® (Originator Pertuzumab) in Neoadjuvant Treatment of HER2+ Breast Cancer
In Brief
A Phase 3 clinical trial evaluating Trastuzumab, Pertuzumab, and 2 other interventions for HER2-positive Breast Cancer. Completed, enrolled 214 participants across 44 sites.
Detailed Summary
This study was a phase III, multicenter, triple-blind, equivalency clinical trial to determine the therapeutic efficacy and safety between Pertuzumab® (CinnaGen Co.) compared to originator pertuzumab in HER2-positive early breast cancer patients. Patients were stratified dynamically for random assignment to treatment with either Pertuzumab® (CinnaGen Co.) or originator pertuzumab, and received neoadjuvant TCHP regimen every 3- weeks.
Study Details
Timeline
Interventions
An initial dose of 8 mg/kg, followed by 6 mg/kg every 3-weeks
An initial dose of 840 mg, followed by 420 mg every 3-weeks
A dose of AUC6 (area under the plasma concentration-time curve) every 3-weeks
75 mg/m2 every 3-weeks