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A Randomized Phase III Clinical Study of Entinostat/Placebo in Combination With Exemestane in Chinese Patients With Hormone Receptor-positive Advanced Breast Cancer

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A Randomized Phase III Clinical Study of Entinostat/Placebo in Combination With Exemestane in Chinese Patients With Hormone Receptor-positive Advanced Breast Cancer

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

Latest Information Update: 02 Jul 2024

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At a glance

  • Drugs Entinostat (Primary) ; Exemestane (Primary)
  • Indications Advanced breast cancer; HER2 negative breast cancer
  • Focus Registrational; Therapeutic Use
  • Sponsors Eddingpharm; EOC Pharma

    • Most Recent Events

    • 04 Jun 2024 Results of of overall survival (OS) and long-term safety, presented at the 60th Annual Meeting of the American Society of Clinical Oncology
    • 16 May 2024 According to an EOC Pharma media release , announced that the New Drug Application (NDA) of Entinostat in combination with AI for the treatment of hormone receptor (HR) positive and human epidermal growth factor receptor 2 (HER-2) negative patients with locally advanced or metastatic breast cancer relapsed or progressed after endocrine therapy was officially accepted by the National Medical Products Administration (NMPA).This NDA submission is based on the results of a Phase III clinical study
    • 07 Jul 2021 Planned End Date changed from 1 Aug 2021 to 1 Mar 2023.

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