Recruiting
Phase 3

BGB-43395 & Letrozole

Sponsor:

BeOne Medicines

Code:

NCT07492641

Conditions

HR+/HER2- Breast Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

BGB-43395

Letrozole

Abemaciclib

Palbociclib

Ribociclib

Study Details

Brief 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.

Conditions

HR+/HER2- Breast Cancer

Study ID

NCT07492641

Start date

May 22, 2026

Status verified date

Aug, 2026

Completion date

Aug 7, 2037

Anticipated

Primary completion date

Apr, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

1056 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm A: BGB-43395 + Letrozole

Participants will receive BGB-43395 in combination with letrozole.

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.

Interventions

BGB-43395

Administered orally.

Letrozole

Administered orally.

Abemaciclib

Administered orally.

Palbociclib

Administered orally.

Ribociclib

Administered orally.

Primary outcome measure

  • Progression-Free Survival (PFS) Determined by Blinded Independent Central Review (BICR) [ Time Frame: Up to approximately 4 years ]

Central Contacts and Locations

Central contacts

Study Director

877-828-5568clinicaltrials@beonemed.com

Locations

Alabama Oncology Princeton

Recruiting

Birmingham, Alabama, United States, 35211

Alaska Oncology and Hematology, Llc

Recruiting

Anchorage, Alaska, United States, 99508-2974

Ironwood Cancer and Research Centers Chandler Ii

Recruiting

Chandler, Arizona, United States, 85224-5665

Genesis Cancer and Blood Institute Hot Springs (Harmony Park)

Recruiting

Hot Springs, Arkansas, United States, 71913

Helios Clinical Research the Oncology Institute Fountain Valley

Recruiting

Fountain Valley, California, United States, 92708

Ventura County Hematology Oncology Specialists

Recruiting

Oxnard, California, United States, 93030

Brcr Coral Springs

Recruiting

Coral Springs, Florida, United States, 33065

Mid Florida Hematology and Oncology Center

Recruiting

Orange City, Florida, United States, 32763-8316

Florida Clinical Trials Group Plantation

Recruiting

Plantation, Florida, United States, 33322

Hematology Oncology Associates of the Treasure Coast

Recruiting

Port Saint Lucie, Florida, United States, 34952-7596

Florida Clinical Trials Group Tamarac

Recruiting

Tamarac, Florida, United States, 33321

Hope and Healing Cancer Services

Recruiting

Hinsdale, Illinois, United States, 60521-0509

Cancer Care Specialists For Illinois

Recruiting

OFallon, Illinois, United States, 62269

Fort Wayne Medical Oncology and Hematology

Recruiting

Fort Wayne, Indiana, United States, 46804

Mercy Medical Center

Recruiting

Cedar Rapids, Iowa, United States, 52403

Owensboro Health Mitchell Memorial Cancer Center

Recruiting

Owensboro, Kentucky, United States, 42303

Metro Minnesota Community Oncology Research Consortium (Mmcorc)

Recruiting

Saint Paul, Minnesota, United States, 55101-2502

Nebraska Cancer Specialists St Francis Grand Island

Recruiting

Grand Island, Nebraska, United States, 68803

Cancer Partners of Nebraska April Sampson Cancer Center

Recruiting

Lincoln, Nebraska, United States, 68516

Nebraska Cancer Specialists

Recruiting

Omaha, Nebraska, United States, 68130-2042

Renown Regional Medical Center

Recruiting

Reno, Nevada, United States, 89502

Astera Cancer Care East Brunswick

Recruiting

East Brunswick, New Jersey, United States, 08816-4096

Summit Medical Group

Recruiting

Florham Park, New Jersey, United States, 07932-1049

New York Cancer and Blood Specialists

Recruiting

Shirley, New York, United States, 11967

Pardee Cancer Center

Recruiting

Hendersonville, North Carolina, United States, 28739

Carolina Cancer Research Center

Recruiting

Wilson, North Carolina, United States, 27896

Gabrail Cancer Center Research

Recruiting

Canton, Ohio, United States, 44718-2566

Dayton Physicians Network

Recruiting

Dayton, Ohio, United States, 45409

Oregon Oncology Specialists

Recruiting

Salem, Oregon, United States, 97301

McGlinn Cancer Institute

Recruiting

West Reading, Pennsylvania, United States, 19611-2143

Ballad Health Cancer Center Kingsport

Recruiting

Kingsport, Tennessee, United States, 37660

Virginia Cancer Institute

Recruiting

Richmond, Virginia, United States, 23229-8605

Multicare Cancer Institute Deaconess Medical Office Building 1

Recruiting

Spokane, Washington, United States, 99204

Multicare Cancer Institute Tacoma General Hospital

Recruiting

Tacoma, Washington, United States, 98405

Northwest Medical Specialties

Recruiting

Tacoma, Washington, United States, 98405

Multicare Cancer Institute North Star Lodge

Recruiting

Yakima, Washington, United States, 98902

More Information

Sponsor

BeOne Medicines

Last update posted

Aug 19, 2026

Last verified

Aug, 2026

Keywords

  • CDK4 inhibitor
  • CDK4/6 inhibitor

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by BeOne Medicines on 2026-08-19.