A Randomised, Double-blind, Parallel Group, Equivalence, Multicentre Phase III Trial to Compare the Efficacy, Safety and Pharmacokinetics of HD201 in Combination With Docetaxel to Herceptin® in Combination With Docetaxel in Patients With HER2+ Early Breast Cancer
Not yet recruiting
Phase of Trial: Phase III
Latest Information Update: 09 Aug 2017
At a glance
- Drugs Trastuzumab (Primary) ; Cyclophosphamide; Docetaxel; Epirubicin
- Indications Adenocarcinoma; Breast cancer
- Focus Registrational; Therapeutic Use
- Acronyms TROIKA
- Sponsors Prestige BioPharma
- 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.
- 02 Aug 2017 Planned initiation date changed from 1 Jun 2017 to 1 Sep 2017.