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

Trial Profile

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

Not yet recruiting
Phase of Trial: Phase III

Latest Information Update: 24 Aug 2017

At a glance

  • Drugs Trastuzumab (Primary) ; Cyclophosphamide; Docetaxel; Epirubicin
  • Indications Adenocarcinoma; Early breast cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms TROIKA
  • Sponsors Prestige BioPharma
  • Most Recent Events

    • 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.
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