An Open-Label, Randomized, Multicenter Phase 3 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
Summary
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.
Arms & interventions
- DrugBGB-43395
Administered orally.
- DrugLetrozole
Administered orally.
- DrugAbemaciclib
Administered orally.
- DrugPalbociclib
Administered orally.
- DrugRibociclib
Administered orally.
Outcome measures
Primary
Progression-Free Survival (PFS) Determined by Blinded Independent Central Review (BICR)
PFS is defined as the time from first dose until first documentation of progression or death, whichever comes first, as assessed by BICR per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Time frame: Up to approximately 4 years
Secondary
Overall Survival (OS)
Time frame: Up to approximately 11 years
Overall Response Rate (ORR)
Time frame: Up to approximately 4 years
Duration of Response (DOR)
Time frame: Up to approximately 4 years
PFS Determined by Investigator
Time frame: Up to approximately 4 years
Clinical Benefit Rate (CBR)
Time frame: Up to approximately 4 years
Time to Response (TTR)
Time frame: Up to approximately 4 years
Number of Participants with Adverse Events (AEs)
Time frame: From first dose of study drug up to 30 days after last dose, up to approximately 11 years
Change from Baseline in European Organisation for Research and Treatment of Cancer (EORTC)-Item Library (IL)454.
Time frame: Baseline and up to approximately 4 years
Progression-Free Survival 2 (PFS2)
Time frame: Up to approximately 4 years
Eligibility criteria
Study locations (11)
Alaska Oncology and Hematology, Llc
Anchorage, Alaska, 99508-2974
Ironwood Cancer and Research Centers Chandler Ii
Chandler, Arizona, 85224-5665
Brcr Coral Springs
Coral Springs, Florida, 33065
Florida Clinical Trials Group Tamarac
Tamarac, Florida, 33321
Cancer Care Specialists For Illinois
O'Fallon, Illinois, 62269
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, 46804
Nebraska Cancer Specialists
Omaha, Nebraska, 68130-2042
Astera Cancer Care East Brunswick
East Brunswick, New Jersey, 08816-4096
Pardee Cancer Center
Hendersonville, North Carolina, 28739
Gabrail Cancer Center Research
Canton, Ohio, 44718-2566
Northwest Medical Specialties
Tacoma, Washington, 98405