Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New hope for advanced breast cancer: phase 3 trial compares experimental combo to standard care

NCT ID NCT07492641

Disease control Sponsor: BeOne Medicines Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 16, 2026 · Updated 8 times

Summary

This study tests a new drug called BGB-43395 combined with letrozole against standard CDK4/6 inhibitor drugs (abemaciclib, palbociclib, or ribociclib) plus letrozole for people with advanced or metastatic HR+/HER2- breast cancer who have not had prior treatment for advanced disease. About 1056 participants will be enrolled to see if the new combination improves progression-free survival and overall survival. The study is currently recruiting.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 1,056 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

Aug 2037

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for HR+/HER2- breast cancer are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

hormone receptor-positive breast cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HR+/HER2- breast cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    162 sites in 14 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Affiliated Hospital of Hebei University(North Branch)

    RECRUITING

    Baoding, Hebei, 71000, China

  • Affiliated Hospital of Nantong University

    RECRUITING

    Nantong, Jiangsu, 201203, China

  • Ajou University Hospital

    RECRUITING

    Suwon, 16499, South Korea

  • Alabama Oncology Princeton

    RECRUITING

    Birmingham, Alabama, 35211, United States

  • Alaska Oncology and Hematology, Llc

    RECRUITING

    Anchorage, Alaska, 99508-2974, United States

  • Asan Medical Center

    RECRUITING

    SongpaGu, Seoul Teugbyeolsi, 05505, South Korea

  • Aspirus St Lukes Hospital

    RECRUITING

    Duluth, Minnesota, 55805, United States

  • Astera Cancer Care East Brunswick

    RECRUITING

    East Brunswick, New Jersey, 08816-4096, United States

  • Ballad Health Cancer Center Kingsport

    RECRUITING

    Kingsport, Tennessee, 37660, United States

  • Beijing Cancer Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100142, China

  • Binhai Hospital, Tianjin Medical University Cancer Institute and Hospital

    RECRUITING

    Tianjin, Tianjin Municipality, 300453, China

  • Blacktown Cancer and Haematology Centre

    RECRUITING

    Blacktown, New South Wales, NSW 2148, Australia

  • Brcr Coral Springs

    RECRUITING

    Coral Springs, Florida, 33065, United States

  • Brcr Global Puerto Rico Hato Rey

    RECRUITING

    San Juan, 00917, Puerto Rico

  • California Research Institute

    RECRUITING

    Los Angeles, California, 90027, United States

  • Cancer Care Centers of Brevard Palm Bay

    RECRUITING

    Palm Bay, Florida, 32901, United States

  • Cancer Care Specialists For Illinois

    RECRUITING

    OFallon, Illinois, 62269, United States

  • Cancer Hospital of Shantou University Medical College

    RECRUITING

    Shantou, Guangdong, 515031, China

  • Cancer Institute Hospital of Jfcr

    RECRUITING

    Kotoku, Tokyo, 135-8550, Japan

  • Cancer Partners of Nebraska April Sampson Cancer Center

    RECRUITING

    Lincoln, Nebraska, 68516, United States

  • Carolina Cancer Research Center

    RECRUITING

    Wilson, North Carolina, 27896, United States

  • Central Georgia Cancer Care Macon Office

    RECRUITING

    Macon, Georgia, 31210, United States

  • Centre Eugene Marquis

    RECRUITING

    Rennes, 35043, France

  • Centre de Lutte Contre Le Cancer Institut Bergonie

    RECRUITING

    Bordeaux, 33076, France

  • Cha Bundang Medical Center, Cha University

    RECRUITING

    BundangGu SeongnamSi, Gyeonggi-do, 13496, South Korea

  • China Medical University Hospital

    RECRUITING

    Taichung, 40447, Taiwan

  • Chonnam National University Hwasun Hospital

    RECRUITING

    HwasunGun, Jeonnam-Gwangju S.M. City, 58128, South Korea

  • Chung Ang University Hospital

    RECRUITING

    DongjakGu, Seoul Teugbyeolsi, 06973, South Korea

  • Chungbuk National University Hospital

    RECRUITING

    Cheongju-si, Chungcheongbukdo, 28644, South Korea

  • Complejo Hospitalario Univ de Santiago (Chus)

    RECRUITING

    Santiago de Compostela, 15706, Spain

  • Consultants in Medical Oncology and Hematology Cancer Center At Broomall

    RECRUITING

    Broomall, Pennsylvania, 19008, United States

  • Dayton Physicians Network

    RECRUITING

    Dayton, Ohio, 45409, United States

  • Dong A University Hospital

    RECRUITING

    Seogu, Busan Gwang'Yeogsi, 49201, South Korea

  • Ehwa Womans University Mokdong Hospital

    RECRUITING

    Seoul, Seoul Teugbyeolsi, 07985, South Korea

  • Fairbanks Cancer Care Physicians Pc

    RECRUITING

    Fairbanks, Alaska, 99701, United States

  • Fiona Stanley Hospital

    RECRUITING

    Murdoch, Western Australia, WA 6150, Australia

  • Florida Clinical Trials Group Plantation

    RECRUITING

    Plantation, Florida, 33322, United States

  • Florida Clinical Trials Group Tamarac

    RECRUITING

    Tamarac, Florida, 33321, United States

  • Fort Wayne Medical Oncology and Hematology

    RECRUITING

    Fort Wayne, Indiana, 46804, United States

  • Fudan University Shanghai Cancer Center

    RECRUITING

    Shanghai, Shanghai Municipality, 200000, China

  • Fujian Cancer Hospital

    RECRUITING

    Fuzhou, Fujian, 350014, China

  • Fujian Medical University Union Hospital

    RECRUITING

    Fuzhou, Fujian, 350001, China

  • Fundacao Pio Xii Hospital de Amor de Barretos

    RECRUITING

    Barretos, 14.784-400, Brazil

  • Gabrail Cancer Center Research

    RECRUITING

    Canton, Ohio, 44718-2566, United States

  • Gachon University Gil Medical Center

    RECRUITING

    NamdongGu, Incheon Gwang'Yeogsi, 21565, South Korea

  • Gangnam Severance Hospital, Yonsei University Health System

    RECRUITING

    Seoul, Seoul Teugbyeolsi, 06273, South Korea

  • Genesis Cancer and Blood Institute Hot Springs (Harmony Park)

    RECRUITING

    Hot Springs, Arkansas, 71913, United States

  • Guangxi Medical University Cancer Hospital Wuxiang Branch

    RECRUITING

    Nanning, Guangxi, 530201, China

  • Gundersen Health System

    RECRUITING

    La Crosse, Wisconsin, 54601-5467, United States

  • Gunma Prefectural Cancer Center

    RECRUITING

    Otashi, Gunma, 373-8550, Japan

  • Hainan General Hospital

    RECRUITING

    Haikou, Hainan, 570206, China

  • Helios Clinical Research the Oncology Institute Fountain Valley

    RECRUITING

    Fountain Valley, California, 92708, United States

  • Hematology Oncology Associates of the Treasure Coast

    RECRUITING

    Port Saint Lucie, Florida, 34952-7596, United States

  • Hematology Oncology of Indiana

    RECRUITING

    Indianapolis, Indiana, 46260, United States

  • Hiroshima City Hiroshima Citizens Hospital

    RECRUITING

    Hiroshima, Hiroshima, 730-8518, Japan

  • Hope and Healing Cancer Services

    RECRUITING

    Hinsdale, Illinois, 60521-0509, United States

  • Hospital General Universitario de Elche

    RECRUITING

    Elcheelx, 03203, Spain

  • Hospital Kuala Lumpur

    RECRUITING

    Kuala Lumpur, 50586, Malaysia

  • Hospital Picaso

    RECRUITING

    Petaling Jaya, 46300, Malaysia

  • Hospital Sao Lucas Da Pucrs

    RECRUITING

    Porto Alegre, 90610-000, Brazil

  • Hospital Universitario Clinico San Cecilio

    RECRUITING

    Granada, 18016, Spain

  • Hospital Universitario Virgen Del Rocio

    RECRUITING

    Seville, 41013, Spain

  • Hospital Wanita Dan Kanak Kanak Sabah (Hospital Likas)

    RECRUITING

    Kota Kinabalu Sabah, 88996, Malaysia

  • Hyogo Medical University Hospital

    RECRUITING

    Nishinomiyashi, Hyōgo, 663-8501, Japan

  • Icesp Instituto Do Cancer Do Estado de Sao Paulo Octavio Frias de Oliveira

    RECRUITING

    São Paulo, 01246-000, Brazil

  • Inha University Hospital

    RECRUITING

    Jemulpogu, Incheon Gwang'Yeogsi, 22332, South Korea

  • Inje University Haeundae Paik Hospital

    RECRUITING

    HaeundaeGu, Busan Gwang'Yeogsi, 48108, South Korea

  • Instituto Nacional de Cancer

    RECRUITING

    Rio de Janeiro, 20560-120, Brazil

  • Instituto de Pesquisa Em Saude Da Universidade de Caxias Do Sul

    RECRUITING

    Caxias do Sul, 95070-560, Brazil

  • Invo Institut Fur Versorgungsforschung in Der Onkologie

    RECRUITING

    Koblenz, 56068, Germany

  • Ironwood Cancer and Research Centers Chandler Ii

    RECRUITING

    Chandler, Arizona, 85224-5665, United States

  • Japan Community Healthcare Organization Kurume General Hospital

    RECRUITING

    Kurumeshi, Fukuoka, 830-0013, Japan

  • Jiangsu Province Hospital Longjiang Branch

    RECRUITING

    Nanjing, Jiangsu, 210036, China

  • Keimyung University Dongsan Hospital

    RECRUITING

    Dalseogu, Daegu Gwang'Yeogsi, 42601, South Korea

  • Korea University Anam Hospital

    RECRUITING

    SeongbukGu, Seoul Teugbyeolsi, 02841, South Korea

  • Korea University Ansan Hospital

    RECRUITING

    DanwonGu AnsanSi, Gyeonggi-do, 15355, South Korea

  • Korea University Guro Hospital

    RECRUITING

    GuroGu, Seoul Teugbyeolsi, 08308, South Korea

  • Liga Norte Riograndene Contra O Cancer

    RECRUITING

    Natal, 59062-000, Brazil

  • Liverpool Hospital

    RECRUITING

    Liverpool, New South Wales, NSW 2170, Australia

  • Maidstone and Tunbridge Wells Nhs Trust Kent Oncology Centre Maidstone Hospital

    RECRUITING

    Maidstone, ME16 9QQ, United Kingdom

  • McGlinn Cancer Institute

    RECRUITING

    West Reading, Pennsylvania, 19611-2143, United States

  • Mercy Medical Center

    RECRUITING

    Cedar Rapids, Iowa, 52403, United States

  • Metro Minnesota Community Oncology Research Consortium (Mmcorc)

    RECRUITING

    Saint Paul, Minnesota, 55101-2502, United States

  • Mid Florida Hematology and Oncology Center

    RECRUITING

    Orange City, Florida, 32763-8316, United States

  • Mie University Hospital

    RECRUITING

    Tsu, Mie-ken, 514-8507, Japan

  • Moffitt Cancer Center McKinley Campus Richard M Shulze Family Foundation Outpatient Center

    RECRUITING

    Tampa, Florida, 33612, United States

  • Multicare Cancer Institute Deaconess Medical Office Building 1

    RECRUITING

    Spokane, Washington, 99204, United States

  • Multicare Cancer Institute North Star Lodge

    RECRUITING

    Yakima, Washington, 98902, United States

  • Multicare Cancer Institute Tacoma General Hospital

    RECRUITING

    Tacoma, Washington, 98405, United States

  • Nanchang Peoples Hospitalchaoyang Branch

    RECRUITING

    Nanchang, Jiangxi, 330025, China

  • National Cancer Center (Korea)

    RECRUITING

    IlsandongGu GoyangSi, Gyeonggi-do, 10408, South Korea

  • National Cancer Institute (Institut Kanser Negara)

    RECRUITING

    Putrajaya, 62250, Malaysia

  • National Cheng Kung University Hospital

    RECRUITING

    Tainan, 704, Taiwan

  • National Hospital Organization Hokkaido Cancer Center

    RECRUITING

    Sapporo, Hokkaido, 003-0804, Japan

  • National Hospital Organization Osaka National Hospital

    RECRUITING

    Osakashi, Osaka, 540-0006, Japan

  • Nebraska Cancer Specialists

    RECRUITING

    Omaha, Nebraska, 68130-2042, United States

  • Nebraska Cancer Specialists St Francis Grand Island

    RECRUITING

    Grand Island, Nebraska, 68803, United States

  • New York Cancer and Blood Specialists

    RECRUITING

    Shirley, New York, 11967, United States

  • Nippon Medical School Musashi Kosugi Hospital

    RECRUITING

    Kawasakishi, Kanagawa, 211-8533, Japan

  • Northwest Medical Specialties

    RECRUITING

    Tacoma, Washington, 98405, United States

  • Nyu Langone Health Perlmutter Cancer Center 34Th Street

    RECRUITING

    New York, New York, 10016, United States

  • Nyu Langone Health Perlmutter Cancer Center At Nyu Langone Hospital Long Island

    RECRUITING

    Mineola, New York, 11501, United States

  • Nyu Langone Health Perlmutter Cancer Center Sunset Park

    RECRUITING

    Brooklyn, New York, 11220, United States

  • Oncology Associates of Oregon Willamette Valley Cancer Center

    RECRUITING

    Eugene, Oregon, 97401, United States

  • Oncology Hematology Associates

    RECRUITING

    Springfield, Missouri, 65807-5288, United States

  • Oncology and Hematology Associates of Southwest Virginia, Inc (Us Oncology Research)

    RECRUITING

    Blacksburg, Virginia, 24060-6325, United States

  • Oncosite Centro de Pesquisa Clinica Em Oncologia

    RECRUITING

    Ijuí, 98700-000, Brazil

  • One Clinical Research

    RECRUITING

    Nedlands, Western Australia, WA 6009, Australia

  • Oregon Oncology Specialists

    RECRUITING

    Salem, Oregon, 97301, United States

  • Owensboro Health Mitchell Memorial Cancer Center

    RECRUITING

    Owensboro, Kentucky, 42303, United States

  • Pardee Cancer Center

    RECRUITING

    Hendersonville, North Carolina, 28739, United States

  • Peter Maccallum Cancer Centre

    RECRUITING

    Melbourne, Victoria, VIC 3000, Australia

  • Pioneer Research Center

    RECRUITING

    Bullhead City, Arizona, 86442, United States

  • Pratia McM Krakow

    RECRUITING

    Krakow, 30-727, Poland

  • Pulau Pinang Hospital

    RECRUITING

    George Town, 10450, Malaysia

  • Renown Regional Medical Center

    RECRUITING

    Reno, Nevada, 89502, United States

  • Royal Surrey County Hospital

    RECRUITING

    Guildford, GU27XX, United Kingdom

  • Samsung Medical Center

    RECRUITING

    GangnamGu, Seoul Teugbyeolsi, 06351, South Korea

  • Sarawak General Hospital

    RECRUITING

    Kuching, 93586, Malaysia

  • Seoul National University Bundang Hospital

    RECRUITING

    Seongnam-si, Gyeonggi-do, 13620, South Korea

  • Seoul National University Hospital

    RECRUITING

    Seoul, Seoul Teugbyeolsi, 03080, South Korea

  • Severance Hospital Yonsei University Health System

    RECRUITING

    SeodaemunGu, Seoul Teugbyeolsi, 03722, South Korea

  • Showa Medical University Hospital

    RECRUITING

    Shinagawaku, Tokyo, 142-8666, Japan

  • Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital

    RECRUITING

    Chengdu, Sichuan, 610071, China

  • Social Medical Corporation Hakuaikai Sagara Hospital

    RECRUITING

    Kagoshima, Kagoshima-ken, 892-0833, Japan

  • Soon Chun Hyang University Cheonan Hospital

    RECRUITING

    Cheonansi, Chungcheongnam-do, 31151, South Korea

  • Summit Medical Group

    RECRUITING

    Florham Park, New Jersey, 07932-1049, United States

  • Sun Yat Sen Memorial Hospital, Sun Yat Sen University (South)

    RECRUITING

    Guangzhou, Guangdong, 510245, China

  • Sun Yat Sen University Cancer Center

    RECRUITING

    Guangzhou, Guangdong, 510060, China

  • Sunshine Coast University Private Hospital

    RECRUITING

    Birtinya, Queensland, QLD 4575, Australia

  • Szpital Specjalistyczny Im Ludwika Rydygiera W Krakowie

    RECRUITING

    Krakow, 31-826, Poland

  • Szpitale Pomorskie Spolka Z Ograniczona Odpowiedzialnoscia

    RECRUITING

    Gdynia, 81-519, Poland

  • Texas Oncology Austin Central

    RECRUITING

    Austin, Texas, 78731-4214, United States

  • The Catholic University of Korea, Seoul St Marys Hospital

    RECRUITING

    SeochoGu, Seoul Teugbyeolsi, 06591, South Korea

  • The Catholic University of Korea, St Vincents Hospital

    RECRUITING

    PaldalGu SuwonSi, Gyeonggi-do, 16247, South Korea

  • The First Affiliated Hospital of Bengbu Medical University

    RECRUITING

    Bengbu, Anhui, 233004, China

  • The First Affiliated Hospital of Chongqing Medical University

    RECRUITING

    Chongqing, Chongqing Municipality, 630014, China

  • The First Affiliated Hospital of Zhengzhou University

    RECRUITING

    Zhengzhou, Henan, 450052, China

  • The First Peoples Hospital of Changde City

    RECRUITING

    Changde, Hunan, 415000, China

  • The Oncology Institute of Hope and Innovation South Miami

    RECRUITING

    South Miami, Florida, 33143, United States

  • The Peoples Hospital Affiliated to Fujian University of Traditional Chinese Medicine

    RECRUITING

    Fuzhou, Fujian, 350009, China

  • The Second Affiliated Hospital of Xian Jiaotong University

    RECRUITING

    Xi'an, Shaanxi, 710004, China

  • The University of Osaka Hospital

    RECRUITING

    Suitashi, Osaka, 565-0871, Japan

  • Tokai University Hospital

    RECRUITING

    Iseharashi, Kanagawa, 259-1193, Japan

  • Tokyo Metropolitan Komagome Hospital

    RECRUITING

    Bunkyoku, Tokyo, 113-8677, Japan

  • Tokyo Womens Medical University Hospital

    RECRUITING

    Shinjukuku, Tokyo, 162-8666, Japan

  • Townsville University Hospital

    RECRUITING

    Douglas, Queensland, QLD 4814, Australia

  • Ulsan University Hospital

    RECRUITING

    Ulsan, Ulsan Gwang'Yeogsi, 44033, South Korea

  • Union Hospital Tongji Medical College Huazhong University of Science and Technologyjinyinhu Branch

    RECRUITING

    Wuhan, Hubei, 430048, China

  • University Cancer and Blood Center Athens Comprehensive Cancer Center

    RECRUITING

    Athens, Georgia, 30607, United States

  • University Malaya Medical Centre

    RECRUITING

    Kuala Lumpur, 59100, Malaysia

  • University of Rochester

    RECRUITING

    Rochester, New York, 14642-0001, United States

  • Utah Cancer Specialists Cancer Center

    RECRUITING

    Salt Lake City, Utah, 84107, United States

  • Ventura County Hematology Oncology Specialists

    RECRUITING

    Oxnard, California, 93030, United States

  • Virginia Cancer Institute

    RECRUITING

    Richmond, Virginia, 23229-8605, United States

  • Virginia Cancer Specialists

    RECRUITING

    Fairfax, Virginia, 22031-2171, United States

  • Weifang Peoples Hospital

    RECRUITING

    Weifang, Shandong, 261000, China

  • Wollongong Hospital

    RECRUITING

    Wollongong, New South Wales, NSW 2500, Australia

  • Xiangya Hospital of Central South University

    RECRUITING

    Changsha, Hunan, 410008, China

  • Yokohama City University Medical Center

    RECRUITING

    Yokohama, Kanagawa, 232-0024, Japan

  • Yuncheng Central Hospital West Branch

    RECRUITING

    Yuncheng, Shanxi, 44099, China

  • Yunnan Cancer Hospital

    RECRUITING

    Kunming, Yunnan, 650100, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.