Recruiting

Phase 3

BGB-43395 & LetrozoleBGB-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

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

Sep, 2026

Completion date

Aug 7, 2037

Anticipated

Primary completion date

Apr, 2029

Anticipated

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

877-828-5568 clinicaltrials@beonemed.com

Locations

Alabama Oncology Princeton

Recruiting

Birmingham, Alabama, United States, 35211

Alaska Oncology and Hematology, Llc

Recruiting

Anchorage, Alaska, United States, 99508-2974

Fairbanks Cancer Care Physicians Pc

Recruiting

Fairbanks, Alaska, United States, 99701

Pioneer Research Center

Recruiting

Bullhead City, Arizona, United States, 86442

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

California Research Institute

Recruiting

Los Angeles, California, United States, 90027

Ventura County Hematology Oncology Specialists

Recruiting

Oxnard, California, United States, 93030

Kaiser Permanente San Marcos Medical Offices

Recruiting

San Marcos, California, United States, 92078

Rocky Mountain Cancer Centers, Llp(Us Oncology Research)

Recruiting

Lone Tree, Colorado, United States, 80124-5641

Brcr Coral Springs

Recruiting

Coral Springs, Florida, United States, 33065

Mid Florida Hematology and Oncology Center

Recruiting

Orange City, Florida, United States, 32763-8316

Cancer Care Centers of Brevard Palm Bay

Recruiting

Palm Bay, Florida, United States, 32901

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

The Oncology Institute of Hope and Innovation South Miami

Recruiting

South Miami, Florida, United States, 33143

Florida Clinical Trials Group Tamarac

Recruiting

Tamarac, Florida, United States, 33321

Moffitt Cancer Center McKinley Campus Richard M Shulze Family Foundation Outpatient Center

Recruiting

Tampa, Florida, United States, 33612

University Cancer and Blood Center Athens Comprehensive Cancer Center

Recruiting

Athens, Georgia, United States, 30607

Central Georgia Cancer Care Macon Office

Recruiting

Macon, Georgia, United States, 31210

Hawaii Cancer Care

Recruiting

Honolulu, Hawaii, United States, 96813

Hope and Healing Cancer Services

Recruiting

Hinsdale, Illinois, United States, 60521-0509

Cancer Care Specialists For Illinois

Recruiting

O'Fallon, Illinois, United States, 62269

Fort Wayne Medical Oncology and Hematology

Recruiting

Fort Wayne, Indiana, United States, 46804

Hematology Oncology of Indiana

Recruiting

Indianapolis, Indiana, United States, 46260

Mercy Medical Center

Recruiting

Cedar Rapids, Iowa, United States, 52403

Owensboro Health Mitchell Memorial Cancer Center

Recruiting

Owensboro, Kentucky, United States, 42303

Karmanos Cancer Institute

Recruiting

Detroit, Michigan, United States, 48201-2013

Aspirus St Lukes Hospital

Recruiting

Duluth, Minnesota, United States, 55805

Metro Minnesota Community Oncology Research Consortium (Mmcorc)

Recruiting

Saint Paul, Minnesota, United States, 55101-2502

Hattiesburg Hematology and Oncology Clinic

Recruiting

Hattiesburg, Mississippi, United States, 39401-7233

Missouri Cancer Associates Columbia, Mo

Recruiting

Columbia, Missouri, United States, 65201

Oncology Hematology Associates

Recruiting

Springfield, Missouri, United States, 65807-5288

Nebraska Cancer Specialists St Francis Grand Island

Recruiting

Grand Island, Nebraska, United States, 68803

Nebraska Hematology Oncology

Recruiting

Lincoln, Nebraska, United States, 68506-7548

Cancer Partners of Nebraska April Sampson Cancer Center

Recruiting

Lincoln, Nebraska, United States, 68516

Nebraska Cancer Specialists

Recruiting

Omaha, Nebraska, United States, 68130-2042

Comprehensive Cancer Centers of Nevada

Recruiting

Las Vegas, Nevada, United States, 89169-3321

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

Rutgers Cancer Institute of New Jersey

Recruiting

New Brunswick, New Jersey, United States, 08901-1914

Nyu Langone Health Perlmutter Cancer Center Sunset Park

Recruiting

Brooklyn, New York, United States, 11220

Nyu Langone Health Perlmutter Cancer Center At Nyu Langone Hospital Long Island

Recruiting

Mineola, New York, United States, 11501

Nyu Langone Health Perlmutter Cancer Center 34Th Street

Recruiting

New York, New York, United States, 10016

University of Rochester

Recruiting

Rochester, New York, United States, 14642-0001

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

Oncology Associates of Oregon Willamette Valley Cancer Center

Recruiting

Eugene, Oregon, United States, 97401

Oregon Oncology Specialists

Recruiting

Salem, Oregon, United States, 97301

Consultants in Medical Oncology and Hematology Cancer Center At Broomall

Recruiting

Broomall, Pennsylvania, United States, 19008

McGlinn Cancer Institute

Recruiting

West Reading, Pennsylvania, United States, 19611-2143

Ballad Health Cancer Center Kingsport

Recruiting

Kingsport, Tennessee, United States, 37660

Texas Oncology Austin Central

Recruiting

Austin, Texas, United States, 78731-4214

Texas Oncology Baylor Charles A Sammons Cancer Center

Recruiting

Dallas, Texas, United States, 75246-2003

Utah Cancer Specialists Cancer Center

Recruiting

Salt Lake City, Utah, United States, 84107

Oncology and Hematology Associates of Southwest Virginia, Inc (Us Oncology Research)

Recruiting

Blacksburg, Virginia, United States, 24060-6325

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22908-0817

Virginia Cancer Specialists

Recruiting

Fairfax, Virginia, United States, 22031-2171

Virginia Oncology Associates

Recruiting

Norfolk, Virginia, United States, 23502-2800

Virginia Cancer Institute

Recruiting

Richmond, Virginia, United States, 23229-8605

Vista Oncology East Olympia

Recruiting

Olympia, Washington, United States, 98506

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

Gundersen Health System

Recruiting

La Crosse, Wisconsin, United States, 54601-5467

More Information

Sponsor

BeOne Medicines

Last update posted

Oct 16, 2026

Last verified

Sep, 2026

Keywords

CDK4 inhibitor
CDK4/6 inhibitor

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by BeOne Medicines on 2026-10-16. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.