A Randomized, Open-label, Multicenter, Phase 1b/2 Study of Eribulin Mesylate in Combination With PEGylated Recombinant Human Hyaluronidase (PEGPH20) Versus Eribulin Mesylate Alone in Subjects With Human Epidermal Growth Factor Receptor 2 (HER2)-Negative, High-Hyaluronan (HA) Metastatic Breast Cancer (MBC)

Trial Profile

A Randomized, Open-label, Multicenter, Phase 1b/2 Study of Eribulin Mesylate in Combination With PEGylated Recombinant Human Hyaluronidase (PEGPH20) Versus Eribulin Mesylate Alone in Subjects With Human Epidermal Growth Factor Receptor 2 (HER2)-Negative, High-Hyaluronan (HA) Metastatic Breast Cancer (MBC)

Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 04 Jul 2017

At a glance

  • Drugs Eribulin (Primary) ; Hyaluronidase (Primary)
  • Indications Advanced breast cancer
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors Eisai Co Ltd
  • Most Recent Events

    • 01 Feb 2017 Planned End Date changed from 1 Sep 2019 to 1 Oct 2018.
    • 01 Feb 2017 Planned primary completion date changed from 1 Mar 2019 to 1 Aug 2018.
    • 14 Dec 2016 Planned number of patients changed from 96 to 114.
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