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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

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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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 03 Jul 2019

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At a glance

  • Drugs Trastuzumab (Primary) ; Docetaxel
  • Indications Advanced breast cancer; HER2 positive breast cancer
  • Focus Pharmacokinetics; Registrational
  • Sponsors Biocon

Most Recent Events

  • 01 Dec 2017 According to a Mylan media release, the U.S. Food and Drug Administration approved Ogivri (trastuzumab-dkst) as a biosimilar to Herceptin (trastuzumab) for the treatment of patients with breast or metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma) whose tumors overexpress the HER2 gene (HER2+).
  • 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.

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