NCT03556358

Trial to Compare the Safety, Efficacy and Immunogenicity of TX05 With Herceptin® in HER2+ Early Breast Cancer

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 809 (actual)
• Sponsor: Tanvex BioPharma USA, Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer
• Breast Neoplasms
• HER2-positive Breast Cancer
• Stage II Breast Cancer
• Stage IIIA Breast Cancer

Interventions

Type	Name	Description
BIOLOGICAL	TX05 (trastuzumab)	8 mg/kg, 90 min IV infusion (Cycle 5), followed by 6 mg/kg, 60 min IV infusion (Cycles 6 - 8)
BIOLOGICAL	Herceptin®	8 mg/kg, 90 min IV infusion (Cycle 5), followed by 6 mg/kg, 60 min IV infusion (Cycles 6 - 8)
DRUG	Paclitaxel	175 mg/m\^2, 60 min IV infusion, every 3 weeks (Cycles 5-8)
DRUG	Epirubicin	75 mg/m\^2, IV bolus infusion, every 3 weeks (Cycles 1-4)
DRUG	Cyclophosphamide	600 mg/m\^2, 30 min IV infusion, every 3 weeks (Cycles 1-4)

Timeline

• Start date: 2018-06-28
• Primary completion: 2020-11-27
• Completion: 2021-02-04
• First posted: 2018-06-14
• Last updated: 2022-01-14
• Results posted: 2022-01-14

Locations

146 sites across 10 countries: Belarus, Chile, Georgia, Hungary, India, Mexico, Peru, Philippines, Russia, Ukraine

Regulatory

• FDA-regulated drug study