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A Phase III Study to Evaluate the Efficacy and Safety of XZP-3287 in Combination With Fulvestrant Versus Placebo Combined With Fulvestrant 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 XZP-3287 in Combination With Fulvestrant Versus Placebo Combined With Fulvestrant 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: 07 Jun 2025

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At a glance

  • Drugs Birociclib (Primary) ; Fulvestrant
  • Indications Advanced breast cancer; HER2 negative breast cancer
  • Focus Registrational; Therapeutic Use
  • Sponsors XuanZhu Pharma

Most Recent Events

  • 15 May 2025 According to Sihuan Pharmaceutical Holdings Group media release, Bireociclib tablets have been approved for 2 indications namely - HR+/HER2- breast cancer by the NMPA. They are approved in China as a monotherapy for the patients with disease progression after receiving two or more endocrine therapies and one chemotherapy in the metastatic stage. They can be combined with fulvestrant for patients with disease progression after previous endocrine therapy.
  • 04 Jun 2024 Interim results assessing the efficacy and safety of Bireociclib plus fulvestrant in HR+/HER2- advanced breast cancer (ABC) that progressed on or after previous ET. Methods: BRIGHT-2 study was a multicenter, randomized, double-blinded, phase 3 trial in patients with HR+/HER2- ABC who had progressed on or after prior ET were presented at the 60th Annual Meeting of the American Society of Clinical Oncology.
  • 22 May 2024 Status changed from recruiting to active, no longer recruiting.

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