A Randomised, Double-blind, Parallel Group, Equivalence, Multicentre Phase III Trial to Compare the Efficacy, Safety and Pharmacokinetics of HD201 to Herceptin® in Patients With HER2+ Early Breast Cancer
Phase of Trial: Phase III
Latest Information Update: 27 Nov 2017
At a glance
- Drugs Trastuzumab (Primary) ; Cyclophosphamide; Docetaxel; Epirubicin
- Indications Adenocarcinoma; Early breast cancer
- Focus Registrational; Therapeutic Use
- Acronyms TROIKA
- Sponsors Prestige BioPharma
- 17 Nov 2017 Status changed from not yet recruiting to recruiting.
- 02 Aug 2017 Treatment has been changed. Cyclophosphamide and epirubicin drugs were added. Indication changed from metastatic breast cancer to early breast cancer.
- 02 Aug 2017 Planned number of patients changed from 560 to 500.