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

NCT07492641 · tracked via the Priya Life Science UK tracker

Sponsor

BeOne Medicines

Phase

Phase 3

Started

2026-05-22

Last updated

2026-09-15

Condition(s) studied

HR+/HER2- Breast Cancer

Investigational drug(s) / intervention(s)

BGB-43395LetrozoleAbemaciclibPalbociclibRibociclib

BGB-43395: Administered orally.

Letrozole: Administered orally.

Abemaciclib: Administered orally.

Palbociclib: Administered orally.

Ribociclib: Administered orally.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Progression-Free Survival (PFS) Determined by Blinded Independent Central Review (BICR) — Up to approximately 4 years
PFS is defined as the time from first dose until first documentation of progression or death, whichever comes first, as assessed by BICR per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

Trial sites (162)

Facility	City	Region	Status
Alabama Oncology Princeton	Birmingham	Alabama	Recruiting
Alaska Oncology and Hematology, Llc	Anchorage	Alaska	Recruiting
Fairbanks Cancer Care Physicians Pc	Fairbanks	Alaska	Recruiting
Pioneer Research Center	Bullhead City	Arizona	Recruiting
Ironwood Cancer and Research Centers Chandler Ii	Chandler	Arizona	Recruiting
Genesis Cancer and Blood Institute Hot Springs (Harmony Park)	Hot Springs	Arkansas	Recruiting
Helios Clinical Research the Oncology Institute Fountain Valley	Fountain Valley	California	Recruiting
California Research Institute	Los Angeles	California	Recruiting
Ventura County Hematology Oncology Specialists	Oxnard	California	Recruiting
Brcr Coral Springs	Coral Springs	Florida	Recruiting
Mid Florida Hematology and Oncology Center	Orange City	Florida	Recruiting
Cancer Care Centers of Brevard Palm Bay	Palm Bay	Florida	Recruiting
Florida Clinical Trials Group Plantation	Plantation	Florida	Recruiting
Hematology Oncology Associates of the Treasure Coast	Port Saint Lucie	Florida	Recruiting
The Oncology Institute of Hope and Innovation South Miami	South Miami	Florida	Recruiting
Florida Clinical Trials Group Tamarac	Tamarac	Florida	Recruiting
Moffitt Cancer Center McKinley Campus Richard M Shulze Family Foundation Outpatient Center	Tampa	Florida	Recruiting
University Cancer and Blood Center Athens Comprehensive Cancer Center	Athens	Georgia	Recruiting
Central Georgia Cancer Care Macon Office	Macon	Georgia	Recruiting
Hope and Healing Cancer Services	Hinsdale	Illinois	Recruiting
Cancer Care Specialists For Illinois	OFallon	Illinois	Recruiting
Fort Wayne Medical Oncology and Hematology	Fort Wayne	Indiana	Recruiting
Hematology Oncology of Indiana	Indianapolis	Indiana	Recruiting
Mercy Medical Center	Cedar Rapids	Iowa	Recruiting
Owensboro Health Mitchell Memorial Cancer Center	Owensboro	Kentucky	Recruiting
Aspirus St Lukes Hospital	Duluth	Minnesota	Recruiting
Metro Minnesota Community Oncology Research Consortium (Mmcorc)	Saint Paul	Minnesota	Recruiting
Oncology Hematology Associates	Springfield	Missouri	Recruiting
Nebraska Cancer Specialists St Francis Grand Island	Grand Island	Nebraska	Recruiting
Cancer Partners of Nebraska April Sampson Cancer Center	Lincoln	Nebraska	Recruiting
Nebraska Cancer Specialists	Omaha	Nebraska	Recruiting
Renown Regional Medical Center	Reno	Nevada	Recruiting
Astera Cancer Care East Brunswick	East Brunswick	New Jersey	Recruiting
Summit Medical Group	Florham Park	New Jersey	Recruiting
Nyu Langone Health Perlmutter Cancer Center Sunset Park	Brooklyn	New York	Recruiting
Nyu Langone Health Perlmutter Cancer Center At Nyu Langone Hospital Long Island	Mineola	New York	Recruiting
Nyu Langone Health Perlmutter Cancer Center 34Th Street	New York	New York	Recruiting
University of Rochester	Rochester	New York	Recruiting
New York Cancer and Blood Specialists	Shirley	New York	Recruiting
Pardee Cancer Center	Hendersonville	North Carolina	Recruiting

+ 122 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07492641 on ClinicalTrials.gov ↗ ← All trials in the UK