Overview

A Phase III Trial to Compare the Efficacy, Safety and Pharmacokinetics of HD201 to Herceptin® in HER2+ Early Breast Cancer Patients

Status:
Active, not recruiting

Trial end date:
2022-03-01

Target enrollment:

Participant gender:

Summary

In the TROIKA study, the proposed biosimilar HD201 will be compared to its reference product Herceptin®. The aim of the study is to demonstrate equivalence of HD201 and Herceptin® in terms of efficacy, safety and pharmacokinetics.

Phase:

Phase 3

Details

Lead Sponsor:

Prestige Biopharma Limited
Prestige Biopharma Ltd
Prestige Biopharma Pte Ltd

Treatments:

Cyclophosphamide
Docetaxel
Epirubicin
Trastuzumab