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

ClinicalTrials.gov ID: NCT07492641

Public ClinicalTrials.gov record NCT07492641. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Oct 30, 2026, 6:39 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID: NCT07492641
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 3
Lead sponsor: BeOne Medicines; Industry
Enrollment: 1,056 participants

Conditions and interventions

Conditions

HR+/HER2- Breast Cancer

Interventions

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: May 22, 2026 (Actual)
Primary completion: Apr 2029 (Estimated)
Completion: Aug 7, 2037 (Estimated)
Last update posted: Oct 26, 2026

2026 – 2037

United States locations

U.S. sites: 84
U.S. states: 33
U.S. cities: 82

Facility	City	State	ZIP	Site status
Alabama Oncology Princeton	Birmingham	Alabama	35211	Recruiting
Alaska Oncology and Hematology, Llc	Anchorage	Alaska	99508-2974	Recruiting
Fairbanks Cancer Care Physicians Pc	Fairbanks	Alaska	99701	Recruiting
Pioneer Research Center	Bullhead City	Arizona	86442	Recruiting
Ironwood Cancer and Research Centers Chandler Ii	Chandler	Arizona	85224-5665	Recruiting
City of Hope Phoenix Cancer Center	Goodyear	Arizona	85338	Recruiting
Genesis Cancer and Blood Institute Hot Springs (Harmony Park)	Hot Springs	Arkansas	71913	Recruiting
City of Hope National Medical Center	Duarte	California	91010-3012	Recruiting
Helios Clinical Research the Oncology Institute Fountain Valley	Fountain Valley	California	92708	Recruiting
California Research Institute	Los Angeles	California	90027	Recruiting
Ventura County Hematology Oncology Specialists	Oxnard	California	93030	Recruiting
Kaiser Permanente San Marcos Medical Offices	San Marcos	California	92078	Recruiting
Providence Saint Johns Health Center	Santa Monica	California	90404-2303	Recruiting
Wellness Oncology and Hematology	West Hills	California	91307	Recruiting
Rocky Mountain Cancer Centers, Llp(Us Oncology Research)	Lone Tree	Colorado	80124-5641	Recruiting
Danbury Hospital	Danbury	Connecticut	06810	Recruiting
Brcr Coral Springs	Coral Springs	Florida	33065	Recruiting
Mid Florida Hematology and Oncology Center	Orange City	Florida	32763-8316	Recruiting
Cancer Care Centers of Brevard Palm Bay	Palm Bay	Florida	32901	Recruiting
Florida Clinical Trials Group Plantation	Plantation	Florida	33322	Recruiting
Hematology Oncology Associates of the Treasure Coast	Port Saint Lucie	Florida	34952-7596	Recruiting
The Oncology Institute of Hope and Innovation South Miami	South Miami	Florida	33143	Recruiting
Florida Clinical Trials Group Tamarac	Tamarac	Florida	33321	Recruiting
Moffitt Cancer Center McKinley Campus Richard M Shulze Family Foundation Outpatient Center	Tampa	Florida	33612	Recruiting
University Cancer and Blood Center Athens Comprehensive Cancer Center	Athens	Georgia	30607	Recruiting
Central Georgia Cancer Care Macon Office	Macon	Georgia	31210	Recruiting
Hawaii Cancer Care	Honolulu	Hawaii	96813	Recruiting
Hope and Healing Cancer Services	Hinsdale	Illinois	60521-0509	Recruiting
Cancer Care Specialists For Illinois	O'Fallon	Illinois	62269	Recruiting
City of Hope Chicago Cancer Center	Zion	Illinois	60099	Recruiting
Fort Wayne Medical Oncology and Hematology	Fort Wayne	Indiana	46804	Recruiting
Hematology Oncology of Indiana	Indianapolis	Indiana	46260	Recruiting
Mercy Medical Center	Cedar Rapids	Iowa	52403	Recruiting
Owensboro Health Mitchell Memorial Cancer Center	Owensboro	Kentucky	42303	Recruiting
Karmanos Cancer Institute	Detroit	Michigan	48201-2013	Recruiting
Aspirus St Lukes Hospital	Duluth	Minnesota	55805	Recruiting
Allina Health Cancer Institute Minneapolis	Minneapolis	Minnesota	55407	Recruiting
Metro Minnesota Community Oncology Research Consortium (Mmcorc)	Saint Paul	Minnesota	55101-2502	Recruiting
Hattiesburg Hematology and Oncology Clinic	Hattiesburg	Mississippi	39401-7233	Recruiting
Missouri Cancer Associates Columbia, Mo	Columbia	Missouri	65201	Recruiting
Oncology Hematology Associates	Springfield	Missouri	65807-5288	Recruiting
Nebraska Cancer Specialists St Francis Grand Island	Grand Island	Nebraska	68803	Recruiting
Nebraska Hematology Oncology	Lincoln	Nebraska	68506-7548	Recruiting
Cancer Partners of Nebraska April Sampson Cancer Center	Lincoln	Nebraska	68516	Recruiting
Nebraska Cancer Specialists	Omaha	Nebraska	68130-2042	Recruiting
Comprehensive Cancer Centers of Nevada	Las Vegas	Nevada	89169-3321	Recruiting
Renown Regional Medical Center	Reno	Nevada	89502	Recruiting
Astera Cancer Care East Brunswick	East Brunswick	New Jersey	08816-4096	Recruiting
Summit Medical Group	Florham Park	New Jersey	07932-1049	Recruiting
Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey	08901-1914	Recruiting
Nyu Langone Health Perlmutter Cancer Center Sunset Park	Brooklyn	New York	11220	Recruiting
Nyu Langone Health Perlmutter Cancer Center At Nyu Langone Hospital Long Island	Mineola	New York	11501	Recruiting
Nyu Langone Health Perlmutter Cancer Center 34Th Street	New York	New York	10016	Recruiting
University of Rochester	Rochester	New York	14642-0001	Recruiting
New York Cancer and Blood Specialists	Shirley	New York	11967	Recruiting
Stony Brook Cancer Center	Stony Brook	New York	11794	Recruiting
University of North Carolina At Chapel Hill	Chapel Hill	North Carolina	27514-4220	Recruiting
Pardee Cancer Center	Hendersonville	North Carolina	28739	Recruiting
Carolina Cancer Research Center	Wilson	North Carolina	27896	Recruiting
Gabrail Cancer Center Research	Canton	Ohio	44718-2566	Recruiting
Dayton Physicians Network	Dayton	Ohio	45409	Recruiting
Oncology Associates of Oregon Willamette Valley Cancer Center	Eugene	Oregon	97401	Recruiting
Oregon Oncology Specialists	Salem	Oregon	97301	Recruiting
Consultants in Medical Oncology and Hematology Cancer Center At Broomall	Broomall	Pennsylvania	19008	Recruiting
McGlinn Cancer Institute	West Reading	Pennsylvania	19611-2143	Recruiting
Avera Cancer Institute	Sioux Falls	South Dakota	57105-2108	Recruiting
Ballad Health Cancer Center Kingsport	Kingsport	Tennessee	37660	Recruiting
Vanderbilt Ingram Cancer Center Nashville Vanderbilt Breast Center	Nashville	Tennessee	37204	Recruiting
Texas Oncology Austin Central	Austin	Texas	78731-4214	Recruiting
Texas Oncology Baylor Charles A Sammons Cancer Center	Dallas	Texas	75246-2003	Recruiting
Baylor Scott and White Medical Center Round Rock	Round Rock	Texas	78665	Recruiting
Utah Cancer Specialists Cancer Center	Salt Lake City	Utah	84107	Recruiting
Oncology and Hematology Associates of Southwest Virginia, Inc (Us Oncology Research)	Blacksburg	Virginia	24060-6325	Recruiting
University of Virginia	Charlottesville	Virginia	22908-0817	Recruiting
Virginia Cancer Specialists	Fairfax	Virginia	22031-2171	Recruiting
Virginia Oncology Associates	Norfolk	Virginia	23502-2800	Recruiting
Virginia Cancer Institute	Richmond	Virginia	23229-8605	Recruiting
Vista Oncology East Olympia	Olympia	Washington	98506	Recruiting
Multicare Cancer Institute Deaconess Medical Office Building 1	Spokane	Washington	99204	Recruiting
Multicare Cancer Institute Tacoma General Hospital	Tacoma	Washington	98405	Recruiting
Northwest Medical Specialties	Tacoma	Washington	98405	Recruiting
Multicare Cancer Institute North Star Lodge	Yakima	Washington	98902	Recruiting
Gundersen Health System	La Crosse	Wisconsin	54601-5467	Recruiting
Medical College of Wisconsin	Milwaukee	Wisconsin	53226-3522	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 157 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT07492641, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Oct 26, 2026 · Synced Oct 30, 2026

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT07492641 live on ClinicalTrials.gov.

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