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A Randomized, Double-Blind, Placebo-Controlled Phase III Trial of GB491 in Combination With Letrozole in Subjects With HR Positive and HER2 Negative Locally Advanced or Metastatic Breast Cancer Who Have Not Previously Received Systemic Therapy in This Disease Setting

Trial Profile

A Randomized, Double-Blind, Placebo-Controlled Phase III Trial of GB491 in Combination With Letrozole in Subjects With HR Positive and HER2 Negative Locally Advanced or Metastatic Breast Cancer Who Have Not Previously Received Systemic Therapy in This Disease Setting

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

Latest Information Update: 20 Oct 2024

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At a glance

  • Drugs Lerociclib (Primary) ; Letrozole (Primary)
  • Indications Advanced breast cancer; HER2 negative breast cancer
  • Focus Registrational; Therapeutic Use
  • Sponsors Genor Biopharma

Most Recent Events

  • 04 Jun 2024 Results (By September 20, 2023, N=279) assessing the efficacy and safety of lerociclib and letrozole in HR+/HER2- advanced or metastatic breast cancer were presented at the 60th Annual Meeting of the American Society of Clinical Oncology.
  • 13 Mar 2024 According to a Genor Biopharma media release, the China National Medical Products Administration (NMPA) has officially accepted the new drug application for GB491 (Lerociclib, cyclin-dependent kinase 4/6 inhibitor) combined with Letrozole for the treatment of HR-positive, HER2-negative patients with advanced breast cancer who have not previously undergone systemic antitumor therapy.
  • 11 May 2023 Planned primary completion date changed to 30 Jan 2026.

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