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

Purpose

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.

Condition

  • HR+/HER2- Breast Cancer

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion 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 signing the informed consent. - 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.

Exclusion Criteria

  • Participants who have received prior systemic treatment in the advanced or metastatic setting. - Participants who have received prior treatment with any selective cyclin-dependent kinase 4 (CDK4) or cyclin-dependent kinase 2 (CDK2) targeting agent, or any other investigational anticancer drug in any disease setting, except for prior investigational or approved SERDs in the adjuvant setting, provided that disease recurrence occurred more than 12 months after the last dose of endocrine-based therapy. - Participants with active leptomeningeal disease or uncontrolled, untreated brain metastasis. Note: Other protocol-defined inclusion/exclusion criteria may apply.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm A: BGB-43395 + Letrozole 		Participants will receive BGB-43395 in combination with letrozole.
  • Drug: BGB-43395
    Administered orally.
  • Drug: Letrozole
    Administered orally.
Active Comparator
Arm B: Cyclin-Dependent Kinase 4/6 Inhibitor + Letrozole 		Participants will receive either abemaciclib, palbociclib, or ribociclib based on the Investigator's choice in combination with letrozole.
  • Drug: Letrozole
    Administered orally.
  • Drug: Abemaciclib
    Administered orally.
  • Drug: Palbociclib
    Administered orally.
  • Drug: Ribociclib
    Administered orally.

Recruiting Locations

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

More Details

Status
Recruiting
Sponsor
BeOne Medicines

Study Contact

Study Director
877-828-5568
clinicaltrials@beonemed.com