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A Randomised, Open-label, Multicentre Phase III Clinical Study to Evaluate the Efficacy and Safety of JS105 Combined With Dalpiciclib and Fulvestrant Compared With Dalpiciclib and Fulvestrant in Patients With PIK3CA-mutated, HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer.

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Trial Profile

A Randomised, Open-label, Multicentre Phase III Clinical Study to Evaluate the Efficacy and Safety of JS105 Combined With Dalpiciclib and Fulvestrant Compared With Dalpiciclib and Fulvestrant in Patients With PIK3CA-mutated, HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer.

Status: Not yet recruiting
Phase of Trial: Phase III

Latest Information Update: 10 Oct 2025

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At a glance

  • Drugs Dalpiciclib (Primary) ; Fulvestrant (Primary) ; JS 105 (Primary)
  • Indications Advanced breast cancer; HER2 negative breast cancer
  • Focus Registrational; Therapeutic Use
  • Sponsors Risen Pharma

Most Recent Events

  • 10 Oct 2025 New trial record

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