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A Phase III Study to Evaluate Efficacy and Safety of SHR6390 in Combination With Letrozole or Anastrozole Versus Placebo in Combination With Letrozole or Anastrozole in Patients With HR Positive and HER2 Negative Recurrent/Metastatic Breast Cancer

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Trial Profile

A Phase III Study to Evaluate Efficacy and Safety of SHR6390 in Combination With Letrozole or Anastrozole Versus Placebo in Combination With Letrozole or Anastrozole 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: 14 Mar 2025

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At a glance

  • Drugs Dalpiciclib (Primary) ; Anastrozole; Letrozole
  • Indications Advanced breast cancer; HER2 negative breast cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms DAWNA-2
  • Sponsors Jiangsu Hengrui Medicine Co.

Most Recent Events

  • 11 May 2023 Results of the preplanned interim analysis (At data cutoff June 1, 2022) assessing the efficacy and safety of dalpiciclib plus letrozole or anastrozole in patients with hormone receptor-positive, HER2-negative advanced breast cancer who had no previous systemic therapy in the advanced setting, published in the Lancet Oncology.
  • 13 Sep 2022 Results assessing efficacy of dalpiciclib plus letrozole or anastrozole as first-line treatment for HR+/HER2- advanced breast cancer patients, presented at the 47th European Society for Medical Oncology Congress.
  • 29 Aug 2022 Primary endpoint (Investigator-assessed PFS) has been met, according to Jiangsu Hengrui Pharmaceuticals Media Release.

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