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A Randomized, Double-blind, Placebo-controlled, Phase III Clinical Trial of GB491 Combined With Fulvestrant in Subjects With HR+, HER2- Locally Advanced or Metastatic Breast Cancer Who Have Progressed on Prior Endocrine Therapy

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Trial Profile

A Randomized, Double-blind, Placebo-controlled, Phase III Clinical Trial of GB491 Combined With Fulvestrant in Subjects With HR+, HER2- Locally Advanced or Metastatic Breast Cancer Who Have Progressed on Prior Endocrine Therapy

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

Latest Information Update: 07 Feb 2024

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At a glance

  • Drugs Lerociclib (Primary) ; Fulvestrant
  • Indications Advanced breast cancer; HER2 negative breast cancer; Male breast cancer
  • Focus Therapeutic Use
  • Acronyms LEONARDA-1
  • Sponsors Genor Biopharma
  • Most Recent Events

    • 06 Jun 2023 Results (data cutoff: 2 Dec 2022) reporting safety and efficacy data presented at the 59th Annual Meeting of the American Society of Clinical Oncology
    • 05 Jun 2023 Results presented in a Genor Biopharma Media Release.
    • 29 May 2023 Primary endpoint (PFS by BICR.) has been met, according to a Genor Biopharma Media Release.
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