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NCT07492641PHASE3Recruiting

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

BeOne Medicines

Start Date

5/22/2026

Completion Date

8/7/2037

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 Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

BGB-43395

DRUG

Letrozole

DRUG

Abemaciclib

DRUG

Palbociclib

DRUG

Ribociclib

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Conditions

HR+/HER2- Breast Cancer

Locations

Alabama Oncology Princeton

Birmingham, Alabama 35211

United States

Alaska Oncology and Hematology, Llc

Anchorage, Alaska 99508-2974

United States

Ironwood Cancer and Research Centers Chandler Ii

Chandler, Arizona 85224-5665

United States

Helios Clinical Research the Oncology Institute Fountain Valley

Fountain Valley, California 92708

United States

Brcr Coral Springs

Coral Springs, Florida 33065

United States

Florida Clinical Trials Group Plantation

Plantation, Florida 33322

United States

Hematology Oncology Associates of the Treasure Coast

Port Saint Lucie, Florida 34952-7596

United States

Florida Clinical Trials Group Tamarac

Tamarac, Florida 33321

United States

Hope and Healing Cancer Services

Hinsdale, Illinois 60521-0509

United States

Cancer Care Specialists For Illinois

O'Fallon, Illinois 62269

United States

Fort Wayne Medical Oncology and Hematology

Fort Wayne, Indiana 46804

United States

Owensboro Health Mitchell Memorial Cancer Center

Owensboro, Kentucky 42303

United States

Nebraska Cancer Specialists St Francis Grand Island

Grand Island, Nebraska 68803

United States

Cancer Partners of Nebraska April Sampson Cancer Center

Lincoln, Nebraska 68516

United States

Nebraska Cancer Specialists

Omaha, Nebraska 68130-2042

United States

Astera Cancer Care East Brunswick

East Brunswick, New Jersey 08816-4096

United States

Summit Medical Group

Florham Park, New Jersey 07932-1049

United States

Pardee Cancer Center

Hendersonville, North Carolina 28739

United States

Carolina Cancer Research Center

Wilson, North Carolina 27896

United States

Gabrail Cancer Center Research

Canton, Ohio 44718-2566

United States

Dayton Physicians Network

Dayton, Ohio 45409

United States

Oregon Oncology Specialists

Salem, Oregon 97301

United States

McGlinn Cancer Institute

West Reading, Pennsylvania 19611-2143

United States

Virginia Cancer Institute

Richmond, Virginia 23229-8605

United States

Northwest Medical Specialties

Tacoma, Washington 98405

United States

Blacktown Cancer and Haematology Centre

Blacktown, New South Wales NSW 2148

Australia

Wollongong Hospital

Wollongong, New South Wales NSW 2500

Australia

Sunshine Coast University Private Hospital

Birtinya, Queensland QLD 4575

Australia

Townsville University Hospital

Douglas, Queensland QLD 4814

Australia

Peter Maccallum Cancer Centre

Melbourne, Victoria VIC 3000

Australia

Fiona Stanley Hospital

Murdoch, Western Australia WA 6150

Australia

One Clinical Research

Nedlands, Western Australia WA 6009

Australia

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality 200000

China

National Hospital Organization Hokkaido Cancer Center

Sapporo, Hokkaido 003-0804

Japan

Social Medical Corporation Hakuaikai Sagara Hospital

Kagoshima, Kagoshima-ken 892-0833

Japan

Tokai University Hospital

Iseharashi, Kanagawa 259-1193

Japan

Nippon Medical School Musashi Kosugi Hospital

Kawasakishi, Kanagawa 211-8533

Japan

Mie University Hospital

Tsu, Mie-ken 514-8507

Japan

Cancer Institute Hospital of Jfcr

Kotoku, Tokyo 135-8550

Japan

Showa Medical University Hospital

Shinagawaku, Tokyo 142-8666

Japan

Tokyo Womens Medical University Hospital

Shinjukuku, Tokyo 162-8666

Japan

Pulau Pinang Hospital

George Town, 10450

Malaysia

Hospital Wanita Dan Kanak Kanak Sabah (Hospital Likas)

Kota Kinabalu Sabah, 88996

Malaysia

Hospital Kuala Lumpur

Kuala Lumpur, 50586

Malaysia

University Malaya Medical Centre

Kuala Lumpur, 59100

Malaysia

Sarawak General Hospital

Kuching, 93586

Malaysia

Hospital Picaso

Petaling Jaya, 46300

Malaysia

National Cancer Institute (Institut Kanser Negara)

Putrajaya, 62250

Malaysia

Brcr Global Puerto Rico Hato Rey

San Juan, 00917

Puerto Rico

Inje University Haeundae Paik Hospital

HaeundaeGu, Busan Gwang'yeogsi 48108

South Korea

Dong A University Hospital

Seogu, Busan Gwang'yeogsi 49201

South Korea

Chungbuk National University Hospital

Cheongju-si, Chungcheongbukdo 28644

South Korea

Soon Chun Hyang University Cheonan Hospital

Cheonansi, Chungcheongnam-do 31151

South Korea

Keimyung University Dongsan Hospital

Dalseogu, Daegu Gwang'yeogsi 42601

South Korea

Cha Bundang Medical Center, Cha University

BundangGu SeongnamSi, Gyeonggi-do 13496

South Korea

Korea University Ansan Hospital

DanwonGu AnsanSi, Gyeonggi-do 15355

South Korea

National Cancer Center (Korea)

IlsandongGu GoyangSi, Gyeonggi-do 10408

South Korea

The Catholic University of Korea, St Vincents Hospital

PaldalGu SuwonSi, Gyeonggi-do 16247

South Korea

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do 13620

South Korea

Inha University Hospital

Jemulpogu, Incheon Gwang'yeogsi 22332

South Korea

Gachon University Gil Medical Center

NamdongGu, Incheon Gwang'yeogsi 21565

South Korea

Chonnam National University Hwasun Hospital

HwasunGun, Jeollanam-do 58128

South Korea

Chung Ang University Hospital

DongjakGu, Seoul Teugbyeolsi 06973

South Korea

Samsung Medical Center

GangnamGu, Seoul Teugbyeolsi 06351

South Korea

Korea University Guro Hospital

GuroGu, Seoul Teugbyeolsi 08308

South Korea

The Catholic University of Korea, Seoul St Marys Hospital

SeochoGu, Seoul Teugbyeolsi 06591

South Korea

Severance Hospital Yonsei University Health System

SeodaemunGu, Seoul Teugbyeolsi 03722

South Korea

Korea University Anam Hospital

SeongbukGu, Seoul Teugbyeolsi 02841

South Korea

Seoul National University Hospital

Seoul, Seoul Teugbyeolsi 03080

South Korea

Gangnam Severance Hospital, Yonsei University Health System

Seoul, Seoul Teugbyeolsi 06273

South Korea

Ehwa Womans University Mokdong Hospital

Seoul, Seoul Teugbyeolsi 07985

South Korea

Asan Medical Center

SongpaGu, Seoul Teugbyeolsi 05505

South Korea

Ulsan University Hospital

Ulsan, Ulsan Gwang'yeogsi 44033

South Korea

Ajou University Hospital

Suwon, 16499

South Korea