An Open-Label, Randomized, Multicenter Phase III Study Investigating the Efficacy and Safety of BGB-43395 Plus Letrozole Versus CDK4/6 Inhibitors (Abemaciclib, Palbociclib, Ribociclib) Plus Letrozole in Patients with Advanced or Metastatic HR+/HER2- Breast Cancer Who Have Not Received Prior Systemic Anticancer Treatment for Advanced or Metastatic Disease
Categories (click each to see list of all clinical trials associated with that category): Breast (ONC), FPBCC CTO Studies
Current Status: Open
Phase: III
Principal Investigator: Asif, Samia
Contact Information:
Abbie Escalera
aescalera@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT07492641?term=NCT07492641&viewType=Card&rank=1#participation-criteria
Summary
PRIMARY OBJECTIVES
I. To evaluate the progression-free survival (PFS) for treatment with BGB-43395 plus letrozole (Arm A) compared with cyclin-dependent kinase (CDK) 4/6i plus letrozole (Arm B) in patients with advanced or metastatic HR+/HER2 breast cancer (BC) who have not received prior systemic treatment for advanced or metastatic disease.
SECONDARY OBJECTIVES
I. To compare the overall survival (OS) in Arm A versus Arm B.
II. To further evaluate the anticancer activity of Arm A compared with Arm B.
III. To evaluate the safety of treatment in Arm A compared with Arm B.
IV. To evaluate patient-reported disease and treatment-related symptoms in patients in Arm A compared with Arm B.
EXPLORATORY OBJECTIVES
I. To characterize the pharmacokinetics of BGB-43395.
II. To evaluate the potential association of biomarkers with patient prognosis, response, or resistance to Arm A compared with Arm B.
III. To evaluate health status and symptom severity in patients in Arm A compared with Arm B.
IV. To evaluate treatment-related side effect burden (TSEB) and compare between Arm A and Arm B.
V. To characterize the healthcare resource utilization associated with the study treatments and provide data to support health economic evaluation.
VI. To evaluate the Time to First Subsequent Chemotherapy or Death (TFSC) in patients in Arm A compared with Arm B.
VII. To evaluate the time to definitive deterioration of the ECOG performance status in patients in Arm A compared with Arm B.