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A Phase III Study to Evaluate the Efficacy and Safety of SHR6390 in Combination With Fulvestrant Versus Placebo Combined With Fulvesrant in Patients With HR Positive and HER2 Negative Recurrent/Metastatic Breast Cancer

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Trial Profile

A Phase III Study to Evaluate the Efficacy and Safety of SHR6390 in Combination With Fulvestrant Versus Placebo Combined With Fulvesrant in Patients With HR Positive and HER2 Negative Recurrent/Metastatic Breast Cancer

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

Latest Information Update: 05 Jan 2023

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At a glance

  • Drugs Dalpiciclib (Primary) ; Fulvestrant (Primary)
  • Indications Advanced breast cancer; HER2 negative breast cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms DAWNA-1
  • Sponsors Jiangsu Hengrui Medicine Co.

    • Most Recent Events

    • 13 Sep 2022 Updated results after >1 year of additional follow-up assessing (data cutoff date Mar. 25, 2022) efficacy and safety of dalpiciclib plus fulvestrant in HR positive/HER2 negative advanced breast cancer, presented at the 47th European Society for Medical Oncology Congress.
    • 01 Jul 2021 Results published in the Oncologist
    • 08 Jun 2021 Primary endpoint (Investigator-assessed PFS) has been met according to the results presented at the 57th Annual Meeting of the American Society of Clinical Oncology

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