A multicentre, double-blind, randomized, parallel-group, Phase III study of the efficacy and safety of Hercules plus taxane versus Herceptin plus taxane as first line therapy in HER2-positive metastatic breast cancer

Trial Profile

A multicentre, double-blind, randomized, parallel-group, Phase III study of the efficacy and safety of Hercules plus taxane versus Herceptin plus taxane as first line therapy in HER2-positive metastatic breast cancer

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 01 Dec 2017

At a glance

  • Drugs Trastuzumab (Primary) ; Docetaxel; Paclitaxel
  • Indications Advanced breast cancer; Male breast cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms HERITAGE
  • Sponsors Mylan
  • 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.
    • 11 Jan 2017 According to a Mylan media release, the U.S. Food and Drug Administration (FDA) has accepted Mylan's biologics license application (BLA) for MYL-1401O, a proposed biosimilar trastuzumab, for filing through the 351(k) pathway. The anticipated FDA goal date set under the Biosimilar User Fee Act (BsUFA) is Sept. 3, 2017.
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