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

NCT ID NCT07492641

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

First seen Jun 27, 2026 · Last updated Aug 07, 2026 · Updated 4 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.

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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

Contacts and locations

Show contact details

Study contacts

Contact

Email: •••••@•••••

Locations

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
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
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
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
Cha Bundang Medical Center, Cha University
RECRUITING

BundangGu SeongnamSi, Gyeonggi-do, 13496, South Korea
Chonnam National University Hwasun Hospital
RECRUITING

HwasunGun, Jeollanam-do, 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
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
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
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
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
Hope and Healing Cancer Services
RECRUITING

Hinsdale, Illinois, 60521-0509, United States
Hospital Kuala Lumpur
RECRUITING

Kuala Lumpur, 50586, Malaysia
Hospital Picaso
RECRUITING

Petaling Jaya, 46300, Malaysia
Hospital Wanita Dan Kanak Kanak Sabah (Hospital Likas)
RECRUITING

Kota Kinabalu Sabah, 88996, Malaysia
Hyogo Medical University Hospital
RECRUITING

Nishinomiyashi, Hyōgo, 663-8501, Japan
Inha University Hospital
RECRUITING

Jemulpogu, Incheon Gwang'Yeogsi, 22332, South Korea
Inje University Haeundae Paik Hospital
RECRUITING

HaeundaeGu, Busan Gwang'Yeogsi, 48108, South Korea
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
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
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
Mie University Hospital
RECRUITING

Tsu, Mie-ken, 514-8507, Japan
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
National Cancer Center (Korea)
RECRUITING

IlsandongGu GoyangSi, Gyeonggi-do, 10408, South Korea
National Cancer Institute (Institut Kanser Negara)
RECRUITING

Putrajaya, 62250, Malaysia
National Hospital Organization Hokkaido Cancer Center
RECRUITING

Sapporo, Hokkaido, 003-0804, 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
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
Pulau Pinang Hospital
RECRUITING

George Town, 10450, Malaysia
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
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
Sunshine Coast University Private Hospital
RECRUITING

Birtinya, Queensland, QLD 4575, Australia
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 Peoples Hospital Affiliated to Fujian University of Traditional Chinese Medicine
RECRUITING

Fuzhou, Fujian, 350009, China
Tokai University Hospital
RECRUITING

Iseharashi, Kanagawa, 259-1193, 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
University Malaya Medical Centre
RECRUITING

Kuala Lumpur, 59100, Malaysia
Virginia Cancer Institute
RECRUITING

Richmond, Virginia, 23229-8605, United States
Wollongong Hospital
RECRUITING

Wollongong, New South Wales, NSW 2500, Australia
Yokohama City University Medical Center
RECRUITING

Yokohama, Kanagawa, 232-0024, Japan

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