NCT07492641From ClinicalTrials.govRecruiting

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

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

HR+/HER2- Breast Cancer

At a glance

Phase: Phase 3
Study type: Interventional
Sponsor: BeOne Medicines
Enrolment target: 1,056
Started: 22 May 2026
Main results due: April 2029
Study sites: 189
Registry updated: 28 September 2026

Can you take part?

Aged 18 years and over.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria

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.

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(189)

Alabama Oncology Princeton
Birmingham, Alabama, United States
Recruiting
Alaska Oncology and Hematology, Llc
Anchorage, Alaska, United States
Recruiting
Fairbanks Cancer Care Physicians Pc
Fairbanks, Alaska, United States
Recruiting
Pioneer Research Center
Bullhead City, Arizona, United States
Recruiting
Ironwood Cancer and Research Centers Chandler Ii
Chandler, Arizona, United States
Recruiting
Genesis Cancer and Blood Institute Hot Springs (Harmony Park)
Hot Springs, Arkansas, United States
Recruiting
Helios Clinical Research the Oncology Institute Fountain Valley
Fountain Valley, California, United States
Recruiting
California Research Institute
Los Angeles, California, United States
Recruiting
Ventura County Hematology Oncology Specialists
Oxnard, California, United States
Recruiting
Brcr Coral Springs
Coral Springs, Florida, United States
Recruiting
Mid Florida Hematology and Oncology Center
Orange City, Florida, United States
Recruiting
Cancer Care Centers of Brevard Palm Bay
Palm Bay, Florida, United States
Recruiting
Florida Clinical Trials Group Plantation
Plantation, Florida, United States
Recruiting
Hematology Oncology Associates of the Treasure Coast
Port Saint Lucie, Florida, United States
Recruiting
The Oncology Institute of Hope and Innovation South Miami
South Miami, Florida, United States
Recruiting
Florida Clinical Trials Group Tamarac
Tamarac, Florida, United States
Recruiting
Moffitt Cancer Center McKinley Campus Richard M Shulze Family Foundation Outpatient Center
Tampa, Florida, United States
Recruiting
University Cancer and Blood Center Athens Comprehensive Cancer Center
Athens, Georgia, United States
Recruiting
Central Georgia Cancer Care Macon Office
Macon, Georgia, United States
Recruiting
Hawaii Cancer Care
Honolulu, Hawaii, United States
Recruiting
Hope and Healing Cancer Services
Hinsdale, Illinois, United States
Recruiting
Cancer Care Specialists For Illinois
OFallon, Illinois, United States
Recruiting
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, United States
Recruiting
Hematology Oncology of Indiana
Indianapolis, Indiana, United States
Recruiting
Mercy Medical Center
Cedar Rapids, Iowa, United States
Recruiting
Owensboro Health Mitchell Memorial Cancer Center
Owensboro, Kentucky, United States
Recruiting
Karmanos Cancer Institute
Detroit, Michigan, United States
Recruiting
Aspirus St Lukes Hospital
Duluth, Minnesota, United States
Recruiting
Metro Minnesota Community Oncology Research Consortium (Mmcorc)
Saint Paul, Minnesota, United States
Recruiting
Oncology Hematology Associates
Springfield, Missouri, United States
Recruiting
Nebraska Cancer Specialists St Francis Grand Island
Grand Island, Nebraska, United States
Recruiting
Cancer Partners of Nebraska April Sampson Cancer Center
Lincoln, Nebraska, United States
Recruiting
Nebraska Cancer Specialists
Omaha, Nebraska, United States
Recruiting
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
Recruiting
Renown Regional Medical Center
Reno, Nevada, United States
Recruiting
Astera Cancer Care East Brunswick
East Brunswick, New Jersey, United States
Recruiting
Summit Medical Group
Florham Park, New Jersey, United States
Recruiting
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Recruiting
Nyu Langone Health Perlmutter Cancer Center Sunset Park
Brooklyn, New York, United States
Recruiting
Nyu Langone Health Perlmutter Cancer Center At Nyu Langone Hospital Long Island
Mineola, New York, United States
Recruiting
Nyu Langone Health Perlmutter Cancer Center 34Th Street
New York, New York, United States
Recruiting
University of Rochester
Rochester, New York, United States
Recruiting
New York Cancer and Blood Specialists
Shirley, New York, United States
Recruiting
Pardee Cancer Center
Hendersonville, North Carolina, United States
Recruiting
Carolina Cancer Research Center
Wilson, North Carolina, United States
Recruiting
Gabrail Cancer Center Research
Canton, Ohio, United States
Recruiting
Dayton Physicians Network
Dayton, Ohio, United States
Recruiting
Oncology Associates of Oregon Willamette Valley Cancer Center
Eugene, Oregon, United States
Recruiting
Oregon Oncology Specialists
Salem, Oregon, United States
Recruiting
Consultants in Medical Oncology and Hematology Cancer Center At Broomall
Broomall, Pennsylvania, United States
Recruiting
McGlinn Cancer Institute
West Reading, Pennsylvania, United States
Recruiting
Ballad Health Cancer Center Kingsport
Kingsport, Tennessee, United States
Recruiting
Texas Oncology Austin Central
Austin, Texas, United States
Recruiting
Utah Cancer Specialists Cancer Center
Salt Lake City, Utah, United States
Recruiting
Oncology and Hematology Associates of Southwest Virginia, Inc (Us Oncology Research)
Blacksburg, Virginia, United States
Recruiting
Virginia Cancer Specialists
Fairfax, Virginia, United States
Recruiting
Virginia Cancer Institute
Richmond, Virginia, United States
Recruiting
Vista Oncology East Olympia
Olympia, Washington, United States
Recruiting
Multicare Cancer Institute Deaconess Medical Office Building 1
Spokane, Washington, United States
Recruiting
Multicare Cancer Institute Tacoma General Hospital
Tacoma, Washington, United States
Recruiting

Showing 60 of 189 sites — filter to narrow it down. 189 of the 189 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07492641. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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