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A Multinational, Multicenter, Open-label, Phase II/III Clinical Trial to Evaluate the Efficacy and Safety of Liporaxel (Oral Paclitaxel) Compared to Taxol (IV Paclitaxel) as First-line Therapy in Patients With Recurrent or Metastatic HER2 Negative Breast Cancer

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Trial Profile

A Multinational, Multicenter, Open-label, Phase II/III Clinical Trial to Evaluate the Efficacy and Safety of Liporaxel (Oral Paclitaxel) Compared to Taxol (IV Paclitaxel) as First-line Therapy in Patients With Recurrent or Metastatic HER2 Negative Breast Cancer

Status: Active, no longer recruiting
Phase of Trial: Phase II/III

Latest Information Update: 29 Jul 2024

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At a glance

  • Drugs Paclitaxel (Primary) ; Paclitaxel
  • Indications Advanced breast cancer; HER2 negative breast cancer; Male breast cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms OPTIMAL; OPTIMAL 3
  • Sponsors Daehwa Pharmaceutical
  • Most Recent Events

    • 25 Jul 2024 Planned End Date changed from 31 Mar 2024 to 31 Dec 2025.
    • 26 Dec 2023 Planned End Date changed from 31 Mar 2022 to 31 Mar 2024.
    • 26 Dec 2023 Planned primary completion date changed from 31 Dec 2020 to 30 Jan 2024.

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