Comparative PK, Efficacy, Safety and Immunogenicity evaluation of Bmab-200 versus Herceptin, both in combination with Docetaxel in patients with Her2+ Metastatic Breast Cancer: A Double Blind, Randomised, Active Control, Parallel assignment, Comparative Phase III, Clinical Trial

Trial Profile

Comparative PK, Efficacy, Safety and Immunogenicity evaluation of Bmab-200 versus Herceptin, both in combination with Docetaxel in patients with Her2+ Metastatic Breast Cancer: A Double Blind, Randomised, Active Control, Parallel assignment, Comparative Phase III, Clinical Trial

Completed
Phase of Trial: Phase III

Latest Information Update: 13 Jul 2017

At a glance

  • Drugs Trastuzumab (Primary) ; Docetaxel
  • Indications Advanced breast cancer
  • Focus Pharmacokinetics; Registrational
  • Most Recent Events

    • 13 Jul 2017 According to a Mylan media release, the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) recommended approval of the companies proposed biosimilar trastuzumab. The committee voted 16-0 in support of eligible indications of the reference product, Herceptin, which include HER2-positive breast cancer in the metastatic and adjuvant settings.
    • 18 Jan 2012 Status changed from not yet recruiting to recruiting as reported by Clinical Trials Registry - India.
    • 04 Nov 2011 New trial record
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