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An Open-label Randomized Parallel Two-arm Multicenter Study of Eribulin Versus Vinorelbine in Female Subjects With Locally Recurrent or Metastatic Breast Cancer, Previously Treated With At Least Two and a Maximum of Five Prior Chemotherapy Regimens, Including an Anthracycline and a Taxane

Trial Profile

An Open-label Randomized Parallel Two-arm Multicenter Study of Eribulin Versus Vinorelbine in Female Subjects With Locally Recurrent or Metastatic Breast Cancer, Previously Treated With At Least Two and a Maximum of Five Prior Chemotherapy Regimens, Including an Anthracycline and a Taxane

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 17 Jul 2019

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At a glance

  • Drugs Eribulin (Primary) ; Vinorelbine
  • Indications Advanced breast cancer; Carcinoma
  • Focus Pharmacokinetics; Registrational; Therapeutic Use
  • Sponsors Eisai Co Ltd
  • Most Recent Events

    • 17 Jul 2019 According to Eisai Co Ltd media release, that the company has received a new drug approval for eribulin mesylate (HALAVEN) for use in the treatment of patients with locally advanced or metastatic breast cancer, previously treated with at least two prior chemotherapy regimens, including an anthracycline and a taxane, from the China National Medical Products Administration (NMPA) based on the results of this study.
    • 28 Mar 2019 Results published in the European Journal of Cancer
    • 29 Nov 2017 According to Eisai Co Ltd media release, the company announced today that the China Food and Drug Administration (CFDA) has accepted for review the resubmitted New Drug Application (NDA) for Eisais anticancer agent eribulin mesylate [eribulin, product name: Halaven(R)].
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