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
ER/PR Positive (Hormone Receptor Positive) 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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