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

Alabama Oncology Princeton
Birmingham, Alabama 35211

Alaska Oncology and Hematology, Llc
Anchorage, Alaska 99508-2974

Ironwood Cancer and Research Centers Chandler Ii
Chandler, Arizona 85224-5665

Genesis Cancer and Blood Institute Hot Springs (Harmony Park)
Hot Springs, Arkansas 71913

Helios Clinical Research the Oncology Institute Fountain Valley
Fountain Valley, California 92708

Ventura County Hematology Oncology Specialists
Oxnard, California 93030

Brcr Coral Springs
Coral Springs, Florida 33065

Mid Florida Hematology and Oncology Center
Orange City, Florida 32763-8316

Florida Clinical Trials Group Plantation
Plantation, Florida 33322

Hematology Oncology Associates of the Treasure Coast
Port Saint Lucie, Florida 34952-7596

Florida Clinical Trials Group Tamarac
Tamarac, Florida 33321

Hope and Healing Cancer Services
Hinsdale, Illinois 60521-0509

Cancer Care Specialists For Illinois
OFallon, Illinois 62269

Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana 46804

Mercy Medical Center
Cedar Rapids, Iowa 52403

Owensboro Health Mitchell Memorial Cancer Center
Owensboro, Kentucky 42303

Metro Minnesota Community Oncology Research Consortium (Mmcorc)
Saint Paul, Minnesota 55101-2502

Nebraska Cancer Specialists St Francis Grand Island
Grand Island, Nebraska 68803

Cancer Partners of Nebraska April Sampson Cancer Center
Lincoln, Nebraska 68516

Nebraska Cancer Specialists
Omaha, Nebraska 68130-2042

Renown Regional Medical Center
Reno, Nevada 89502

Astera Cancer Care East Brunswick
East Brunswick, New Jersey 08816-4096

Summit Medical Group
Florham Park, New Jersey 07932-1049

New York Cancer and Blood Specialists
Shirley, New York 11967

Pardee Cancer Center
Hendersonville, North Carolina 28739

Carolina Cancer Research Center
Wilson, North Carolina 27896

Gabrail Cancer Center Research
Canton, Ohio 44718-2566

Dayton Physicians Network
Dayton, Ohio 45409

Oregon Oncology Specialists
Salem, Oregon 97301

McGlinn Cancer Institute
West Reading, Pennsylvania 19611-2143

Ballad Health Cancer Center Kingsport
Kingsport, Tennessee 37660

Virginia Cancer Institute
Richmond, Virginia 23229-8605

Multicare Cancer Institute Deaconess Medical Office Building 1
Spokane, Washington 99204

Multicare Cancer Institute Tacoma General Hospital
Tacoma, Washington 98405

Northwest Medical Specialties
Tacoma, Washington 98405

Multicare Cancer Institute North Star Lodge
Yakima, Washington 98902

Brcr Global Puerto Rico Hato Rey
San Juan, Puerto Rico 00917

More Details

Status
Recruiting
Sponsor
BeOne Medicines

Study Contact

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