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A Multi-national,Multi-center, Open-label, Phase 2 Clinical Trial to Evaluate the Efficacy, Safety and Pharmacokinetics of DHP107 (Liporaxel®,Oral Paclitaxel) Compared to IV Paclitaxel in Patients With Recurrent or Metastatic Breast Cancer(OPERA)

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Trial Profile

A Multi-national,Multi-center, Open-label, Phase 2 Clinical Trial to Evaluate the Efficacy, Safety and Pharmacokinetics of DHP107 (Liporaxel®,Oral Paclitaxel) Compared to IV Paclitaxel in Patients With Recurrent or Metastatic Breast Cancer(OPERA)

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 21 Feb 2024

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At a glance

  • Drugs Paclitaxel (Primary) ; Paclitaxel
  • Indications Advanced breast cancer; HER2 negative breast cancer
  • Focus Therapeutic Use
  • Acronyms OPERA
  • Sponsors Daehwa Pharmaceutical

    • Most Recent Events

    • 13 Oct 2022 Status has been changed to completed, as per results presented at the 47th European Society for Medical Oncology Congress
    • 13 Sep 2022 Results evaluating the efficacy and safety of DHP107 compared with IV paclitaxel, presented at the 47th European Society for Medical Oncology Congress
    • 11 Dec 2020 Results (n=13) of sub-study assessing pharmacokinetics and safety profiles presented at the 43rd Annual San Antonio Breast Cancer Symposium
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