Clinical Trials | 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 University of Virginia seeks adults age 18 years and older for a clinical trial. You may be eligible for this trial if you have confirmed locally advanced or metastatic HR+ HER2- breast cancer. This study aims to learn more about how well people tolerate a medication called BGB-43395 when taken by mouth twice daily in combination with a medication called letrozole, compared with standard treatment using a CDK 4/6 inhibitor. Standard treatment will combine letrozole with one of the following medications chosen by the study doctor: abemaciclib, palbociclib, or ribociclib. If you participate in this study, you will be randomized (assigned by chance) to one of two groups: Arm A: You will receive the study drug BGB-43395 in combination with letrozole. Arm B: You will receive a CDK 4/6 inhibitor in combination with letrozole. This study will include: blood draws, tumor imaging assessments, tumor tissue collection, and physical examinations. Study-related procedures that are being done beyond your standard of care will be provided at no cost to you or your insurance. More information can be found here: https://clinicaltrials.gov/study/NCT07492641