BGB-43395 Plus Letrozole Versus CDK4/6i Plus Letrozole for Patients With Advanced or Metastatic HR+/HER2- Breast Cancer Who Have Not Received Prior Treatment for Advanced or Metastatic Disease

The purpose of this study is to investigate the efficacy and safety of BGB-43395 in combination with letrozole compared with investigator's choice of cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) in combination with letrozole in patients with advanced or metastatic hormone receptor positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer (BC) who have not received prior systemic treatment for advanced or metastatic disease.

Trial Details

NCT ID
NCT07492641
Phase
PHASE3
Sponsor
BeOne Medicines
Status
RECRUITING
Cancer Type
Breast Cancer
Interventions
  • BGB-43395
  • Letrozole
  • Abemaciclib
  • Palbociclib
  • Ribociclib
Locations (sample)
  • Birmingham, Alabama, United States|33.52066,-86.80249
  • Anchorage, Alaska, United States|61.21806,-149.90028
  • Chandler, Arizona, United States|33.30616,-111.84125
  • Hot Springs, Arkansas, United States|34.5037,-93.05518
  • Fountain Valley, California, United States|33.70918,-117.95367

Key Eligibility Criteria

  • Participants must be at least 18 years of age or the legal age of consent in the jurisdiction in which the study is taking place at the time of sig…
  • Participants with histologically confirmed locally advanced or metastatic HR+ HER2- breast cancer.
  • Participants must have a stable Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1.
  • Adequate organ function.

For full eligibility, visit ClinicalTrials.gov.

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