At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-blind, Parallel Group, Phase III Trial to Compare the Efficacy, Safety, and Immunogenicity of TX05 With Herceptin® in Subjects With HER2 Positive Early Breast Cancer
In Brief
A Phase 3 clinical trial evaluating TX05 (trastuzumab), Herceptin®, and 3 other interventions for Breast Cancer and 4 related conditions. Completed, enrolled 809 participants across 146 sites in 10 countries.
Detailed Summary
This is a Phase III, double-blind, randomized, multicenter study to compare the efficacy and to evaluate the safety and immunogenicity of TX05 (trastuzumab) with Herceptin® in subjects with HER2 positive early breast cancer.
Study Details
Timeline
Interventions
8 mg/kg, 90 min IV infusion (Cycle 5), followed by 6 mg/kg, 60 min IV infusion (Cycles 6 - 8)
8 mg/kg, 90 min IV infusion (Cycle 5), followed by 6 mg/kg, 60 min IV infusion (Cycles 6 - 8)
175 mg/m\^2, 60 min IV infusion, every 3 weeks (Cycles 5-8)
75 mg/m\^2, IV bolus infusion, every 3 weeks (Cycles 1-4)
600 mg/m\^2, 30 min IV infusion, every 3 weeks (Cycles 1-4)