RecruitingPhase 3NCT07492641

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

Sponsor

BeOne Medicines

Enrollment

1,056 participants

Start Date

May 22, 2026

Study Type

INTERVENTIONAL

Conditions

HR+/HER2- Breast Cancer

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Abemaciclib, a drug called BGB-43395, and others for people with hr+/her2- breast cancer. The study is currently recruiting participants at 4 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBGB-43395

Administered orally.

DRUGLetrozole

Administered orally.

DRUGAbemaciclib

Administered orally.

DRUGPalbociclib

Administered orally.

DRUGRibociclib

Administered orally.

Locations(74)

Alabama Oncology Princeton

Birmingham, Alabama, United States

Alaska Oncology and Hematology, Llc

Anchorage, Alaska, United States

Ironwood Cancer and Research Centers Chandler Ii

Chandler, Arizona, United States

Helios Clinical Research the Oncology Institute Fountain Valley

Fountain Valley, California, United States

Brcr Coral Springs

Coral Springs, Florida, United States

Florida Clinical Trials Group Plantation

Plantation, Florida, United States

Hematology Oncology Associates of the Treasure Coast

Port Saint Lucie, Florida, United States

Florida Clinical Trials Group Tamarac

Tamarac, Florida, United States

Hope and Healing Cancer Services

Hinsdale, Illinois, United States

Cancer Care Specialists For Illinois

O'Fallon, Illinois, United States

Fort Wayne Medical Oncology and Hematology

Fort Wayne, Indiana, United States

Owensboro Health Mitchell Memorial Cancer Center

Owensboro, Kentucky, United States

Nebraska Cancer Specialists St Francis Grand Island

Grand Island, Nebraska, United States

Cancer Partners of Nebraska April Sampson Cancer Center

Lincoln, Nebraska, United States

Nebraska Cancer Specialists

Omaha, Nebraska, United States

Astera Cancer Care East Brunswick

East Brunswick, New Jersey, United States

Summit Medical Group

Florham Park, New Jersey, United States

Pardee Cancer Center

Hendersonville, North Carolina, United States

Carolina Cancer Research Center

Wilson, North Carolina, United States

Gabrail Cancer Center Research

Canton, Ohio, United States

Dayton Physicians Network

Dayton, Ohio, United States

Oregon Oncology Specialists

Salem, Oregon, United States

McGlinn Cancer Institute

West Reading, Pennsylvania, United States

Virginia Cancer Institute

Richmond, Virginia, United States

Northwest Medical Specialties

Tacoma, Washington, United States

Blacktown Cancer and Haematology Centre

Blacktown, New South Wales, Australia

Wollongong Hospital

Wollongong, New South Wales, Australia

Sunshine Coast University Private Hospital

Birtinya, Queensland, Australia

Townsville University Hospital

Douglas, Queensland, Australia

Peter Maccallum Cancer Centre

Melbourne, Victoria, Australia

Fiona Stanley Hospital

Murdoch, Western Australia, Australia

One Clinical Research

Nedlands, Western Australia, Australia

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

National Hospital Organization Hokkaido Cancer Center

Sapporo, Hokkaido, Japan

Social Medical Corporation Hakuaikai Sagara Hospital

Kagoshima, Kagoshima-ken, Japan

Tokai University Hospital

Iseharashi, Kanagawa, Japan

Nippon Medical School Musashi Kosugi Hospital

Kawasakishi, Kanagawa, Japan

Mie University Hospital

Tsu, Mie-ken, Japan

Cancer Institute Hospital of Jfcr

Kotoku, Tokyo, Japan

Showa Medical University Hospital

Shinagawaku, Tokyo, Japan

Tokyo Womens Medical University Hospital

Shinjukuku, Tokyo, Japan

Pulau Pinang Hospital

George Town, Malaysia

Hospital Wanita Dan Kanak Kanak Sabah (Hospital Likas)

Kota Kinabalu Sabah, Malaysia

Hospital Kuala Lumpur

Kuala Lumpur, Malaysia

University Malaya Medical Centre

Kuala Lumpur, Malaysia

Sarawak General Hospital

Kuching, Malaysia

Hospital Picaso

Petaling Jaya, Malaysia

National Cancer Institute (Institut Kanser Negara)

Putrajaya, Malaysia

Brcr Global Puerto Rico Hato Rey

San Juan, Puerto Rico

Inje University Haeundae Paik Hospital

HaeundaeGu, Busan Gwang'yeogsi, South Korea

Dong A University Hospital

Seogu, Busan Gwang'yeogsi, South Korea

Chungbuk National University Hospital

Cheongju-si, Chungcheongbukdo, South Korea

Soon Chun Hyang University Cheonan Hospital

Cheonansi, Chungcheongnam-do, South Korea

Keimyung University Dongsan Hospital

Dalseogu, Daegu Gwang'yeogsi, South Korea

Cha Bundang Medical Center, Cha University

BundangGu SeongnamSi, Gyeonggi-do, South Korea

Korea University Ansan Hospital

DanwonGu AnsanSi, Gyeonggi-do, South Korea

National Cancer Center (Korea)

IlsandongGu GoyangSi, Gyeonggi-do, South Korea

The Catholic University of Korea, St Vincents Hospital

PaldalGu SuwonSi, Gyeonggi-do, South Korea

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Inha University Hospital

Jemulpogu, Incheon Gwang'yeogsi, South Korea

Gachon University Gil Medical Center

NamdongGu, Incheon Gwang'yeogsi, South Korea

Chonnam National University Hwasun Hospital

HwasunGun, Jeollanam-do, South Korea

Chung Ang University Hospital

DongjakGu, Seoul Teugbyeolsi, South Korea

Samsung Medical Center

GangnamGu, Seoul Teugbyeolsi, South Korea

Korea University Guro Hospital

GuroGu, Seoul Teugbyeolsi, South Korea

The Catholic University of Korea, Seoul St Marys Hospital

SeochoGu, Seoul Teugbyeolsi, South Korea

Severance Hospital Yonsei University Health System

SeodaemunGu, Seoul Teugbyeolsi, South Korea

Korea University Anam Hospital

SeongbukGu, Seoul Teugbyeolsi, South Korea

Seoul National University Hospital

Seoul, Seoul Teugbyeolsi, South Korea

Gangnam Severance Hospital, Yonsei University Health System

Seoul, Seoul Teugbyeolsi, South Korea

Ehwa Womans University Mokdong Hospital

Seoul, Seoul Teugbyeolsi, South Korea

Asan Medical Center

SongpaGu, Seoul Teugbyeolsi, South Korea

Ulsan University Hospital

Ulsan, Ulsan Gwang'yeogsi, South Korea

Ajou University Hospital

Suwon, South Korea

View Full Details on ClinicalTrials.gov

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NCT07492641

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