N
← Back to Search
Sponsored

Accelerate Your Clinical Trial Recruitment

Reach thousands of high-intent patients matching your specific inclusion criteria.

Start Campaign
RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: BeOne Medicines • ClinicalTrials.gov ID: NCT07492641

Registry updated: 2026-10-26
Ad

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Check Eligibility →

Description

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.

Interventions

  • BGB-43395 (Drug)
    Administered orally.
  • Letrozole (Drug)
    Administered orally.
  • Abemaciclib (Drug)
    Administered orally.
  • Palbociclib (Drug)
    Administered orally.
  • Ribociclib (Drug)
    Administered orally.

Eligibility criteria

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.

Conditions

HR+/HER2- Breast Cancer

Locations

  • Alabama Oncology Princeton — Birmingham, Alabama, United States
  • Alaska Oncology and Hematology, Llc — Anchorage, Alaska, United States
  • Fairbanks Cancer Care Physicians Pc — Fairbanks, Alaska, United States
  • Pioneer Research Center — Bullhead City, Arizona, United States
  • Ironwood Cancer and Research Centers Chandler Ii — Chandler, Arizona, United States
  • City of Hope Phoenix Cancer Center — Goodyear, Arizona, United States
  • Genesis Cancer and Blood Institute Hot Springs (Harmony Park) — Hot Springs, Arkansas, United States
  • City of Hope National Medical Center — Duarte, California, United States
  • Helios Clinical Research the Oncology Institute Fountain Valley — Fountain Valley, California, United States
  • California Research Institute — Los Angeles, California, United States
  • Ventura County Hematology Oncology Specialists — Oxnard, California, United States
  • Kaiser Permanente San Marcos Medical Offices — San Marcos, California, United States
  • Providence Saint Johns Health Center — Santa Monica, California, United States
  • Wellness Oncology and Hematology — West Hills, California, United States
  • Rocky Mountain Cancer Centers, Llp(Us Oncology Research) — Lone Tree, Colorado, United States
  • Danbury Hospital — Danbury, Connecticut, United States
  • Brcr Coral Springs — Coral Springs, Florida, United States
  • Mid Florida Hematology and Oncology Center — Orange City, Florida, United States
  • Cancer Care Centers of Brevard Palm Bay — Palm Bay, 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
  • The Oncology Institute of Hope and Innovation South Miami — South Miami, Florida, United States
  • Florida Clinical Trials Group Tamarac — Tamarac, Florida, United States
  • Moffitt Cancer Center McKinley Campus Richard M Shulze Family Foundation Outpatient Center — Tampa, Florida, United States
  • University Cancer and Blood Center Athens Comprehensive Cancer Center — Athens, Georgia, United States
  • Central Georgia Cancer Care Macon Office — Macon, Georgia, United States
  • Hawaii Cancer Care — Honolulu, Hawaii, United States
  • Hope and Healing Cancer Services — Hinsdale, Illinois, United States
  • Cancer Care Specialists For Illinois — O'Fallon, Illinois, United States
  • City of Hope Chicago Cancer Center — Zion, Illinois, United States
  • Fort Wayne Medical Oncology and Hematology — Fort Wayne, Indiana, United States
  • Hematology Oncology of Indiana — Indianapolis, Indiana, United States
  • Mercy Medical Center — Cedar Rapids, Iowa, United States
  • Owensboro Health Mitchell Memorial Cancer Center — Owensboro, Kentucky, United States
  • Karmanos Cancer Institute — Detroit, Michigan, United States
  • Aspirus St Lukes Hospital — Duluth, Minnesota, United States
  • Allina Health Cancer Institute Minneapolis — Minneapolis, Minnesota, United States
  • Metro Minnesota Community Oncology Research Consortium (Mmcorc) — Saint Paul, Minnesota, United States
  • Hattiesburg Hematology and Oncology Clinic — Hattiesburg, Mississippi, United States
  • Missouri Cancer Associates Columbia, Mo — Columbia, Missouri, United States
  • Oncology Hematology Associates — Springfield, Missouri, United States
  • Nebraska Cancer Specialists St Francis Grand Island — Grand Island, Nebraska, United States
  • Nebraska Hematology Oncology — Lincoln, Nebraska, United States
  • Cancer Partners of Nebraska April Sampson Cancer Center — Lincoln, Nebraska, United States
  • Nebraska Cancer Specialists — Omaha, Nebraska, United States
  • Comprehensive Cancer Centers of Nevada — Las Vegas, Nevada, United States
  • Renown Regional Medical Center — Reno, Nevada, United States
  • Astera Cancer Care East Brunswick — East Brunswick, New Jersey, United States
  • Summit Medical Group — Florham Park, New Jersey, United States
  • Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States
  • Nyu Langone Health Perlmutter Cancer Center Sunset Park — Brooklyn, New York, United States
  • Nyu Langone Health Perlmutter Cancer Center At Nyu Langone Hospital Long Island — Mineola, New York, United States
  • Nyu Langone Health Perlmutter Cancer Center 34Th Street — New York, New York, United States
  • University of Rochester — Rochester, New York, United States
  • New York Cancer and Blood Specialists — Shirley, New York, United States
  • Stony Brook Cancer Center — Stony Brook, New York, United States
  • University of North Carolina At Chapel Hill — Chapel Hill, North Carolina, 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
  • Oncology Associates of Oregon Willamette Valley Cancer Center — Eugene, Oregon, United States
  • Oregon Oncology Specialists — Salem, Oregon, United States
  • Consultants in Medical Oncology and Hematology Cancer Center At Broomall — Broomall, Pennsylvania, United States
  • McGlinn Cancer Institute — West Reading, Pennsylvania, United States
  • Avera Cancer Institute — Sioux Falls, South Dakota, United States
  • Ballad Health Cancer Center Kingsport — Kingsport, Tennessee, United States
  • Vanderbilt Ingram Cancer Center Nashville Vanderbilt Breast Center — Nashville, Tennessee, United States
  • Texas Oncology Austin Central — Austin, Texas, United States
  • Texas Oncology Baylor Charles A Sammons Cancer Center — Dallas, Texas, United States
  • Baylor Scott and White Medical Center Round Rock — Round Rock, Texas, United States
  • Utah Cancer Specialists Cancer Center — Salt Lake City, Utah, United States
  • Oncology and Hematology Associates of Southwest Virginia, Inc (Us Oncology Research) — Blacksburg, Virginia, United States
  • University of Virginia — Charlottesville, Virginia, United States
  • Virginia Cancer Specialists — Fairfax, Virginia, United States
  • Virginia Oncology Associates — Norfolk, Virginia, United States
  • Virginia Cancer Institute — Richmond, Virginia, United States
  • Vista Oncology East Olympia — Olympia, Washington, United States
  • Multicare Cancer Institute Deaconess Medical Office Building 1 — Spokane, Washington, United States
  • Multicare Cancer Institute Tacoma General Hospital — Tacoma, Washington, United States
  • Northwest Medical Specialties — Tacoma, Washington, United States
  • Multicare Cancer Institute North Star Lodge — Yakima, Washington, United States
  • Gundersen Health System — La Crosse, Wisconsin, United States
  • Medical College of Wisconsin — Milwaukee, Wisconsin, United States
  • Blacktown Cancer and Haematology Centre — Blacktown, New South Wales, Australia
  • Liverpool Hospital — Liverpool, 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
  • Fundacao Pio Xii Hospital de Amor de Barretos — Barretos, Brazil
  • Hospital Brasilia — Brasília, Brazil
  • Fundacao Universidade de Caxias Do Sul — Caxias do Sul, Brazil
  • Ictr Instituto Do Cancer E Transplante de Curitiba — Curitiba, Brazil
  • Centro Regional Integrado de Oncologia Crio — Fortaleza, Brazil
  • Oncosite Centro de Pesquisa Clinica Em Oncologia — Ijuí, Brazil
  • Liga Norte Riograndene Contra O Cancer — Natal, Brazil
  • Hospital Sao Lucas Da Pucrs — Porto Alegre, Brazil
  • Instituto Sul Mineiro de Oncologia Ltda — Pouso Alegre, Brazil
  • Hospital Do Cancer de Pernambuco — Recife, Brazil
  • Instituto Nacional de Cancer — Rio de Janeiro, Brazil
  • Icesp Instituto Do Cancer Do Estado de Sao Paulo Octavio Frias de Oliveira — São Paulo, Brazil
  • Hospital Santa Rita de Cassia Afecc — Vitória, Brazil
  • The First Affiliated Hospital of Bengbu Medical University — Bengbu, Anhui, China
  • Anhui Provincial Hospital — Hefei, Anhui, China
  • Beijing Cancer Hospital — Beijing, Beijing Municipality, China
  • The First Affiliated Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China
  • Fujian Medical University Union Hospital — Fuzhou, Fujian, China
  • The Peoples Hospital Affiliated to Fujian University of Traditional Chinese Medicine — Fuzhou, Fujian, China
  • Fujian Cancer Hospital — Fuzhou, Fujian, China
  • Sun Yat Sen University Cancer Center — Guangzhou, Guangdong, China
  • Sun Yat Sen Memorial Hospital, Sun Yat Sen University (South) — Guangzhou, Guangdong, China
  • Cancer Hospital of Shantou University Medical College — Shantou, Guangdong, China
  • Guangxi Medical University Cancer Hospital Wuxiang Branch — Nanning, Guangxi, China
  • Hainan General Hospital — Haikou, Hainan, China
  • Affiliated Hospital of Hebei University(North Branch) — Baoding, Hebei, China
  • The Fourth Hospital of Hebei Medical University East Branch — Shijiazhuang, Hebei, China
  • Harbin Medical University Cancer Hospital — Harbin, Heilongjiang, China
  • The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China
  • Union Hospital Tongji Medical College Huazhong University of Science and Technologyjinyinhu Branch — Wuhan, Hubei, China
  • Hubei Cancer Hospital — Wuhan, Hubei, China
  • The First Peoples Hospital of Changde City — Changde, Hunan, China
  • Xiangya Hospital of Central South University — Changsha, Hunan, China
  • Jiangsu Province Hospital Longjiang Branch — Nanjing, Jiangsu, China
  • Affiliated Hospital of Nantong University — Nantong, Jiangsu, China
  • Nanchang Peoples Hospitalchaoyang Branch — Nanchang, Jiangxi, China
  • Jiangxi Cancer Hospital — Nanchang, Jiangxi, China
  • The Second Affiliated Hospital of Xian Jiaotong University — Xi'an, Shaanxi, China
  • Weifang Peoples Hospital — Weifang, Shandong, China
  • Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China
  • Yuncheng Central Hospital West Branch — Yuncheng, Shanxi, China
  • Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital — Chengdu, Sichuan, China
  • Binhai Hospital, Tianjin Medical University Cancer Institute and Hospital — Tianjin, Tianjin Municipality, China
  • Yunnan Cancer Hospital — Kunming, Yunnan, China
  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China
  • The First Affiliated Hospital of Wenzhou Medical University — Wenzhou, Zhejiang, China
  • Centre de Lutte Contre Le Cancer Institut Bergonie — Bordeaux, France
  • Centre Leon Berard — Lyon, France
  • Institut Paoli Calmettes — Marseille, France
  • Icm Val Daurelle — Montpellier, France
  • Centre Eugene Marquis — Rennes, France
  • Ico Site Rene Gauducheau — SaintHerblain, France
  • Institut Gustave Roussy — Villejuif, France
  • Helios Klinikum Berlin Buch Brustzentrum — Berlin, Germany
  • Klinikum Esslingen Gmbh Klinik Fuer Frauenheilkunde Und Geburtshilfe — Esslingen am Neckar, Germany
  • Centrum Fur Haematologie Und Onkologie Bethanien — Frankfurt am Main, Germany
  • Invo Institut Fur Versorgungsforschung in Der Onkologie — Koblenz, Germany
  • Asst Papa Giovanni Xxiii — Bergamo, Italy
  • Istituto Europeo Di Oncologia — Milan, Italy
  • Azienda Socio Sanitaria Territoriale Di Monza (Presidio San Gerardo) — Monza, Italy
  • Fondazione Policlinico Universitario Agostino Gemelli — Roma, Italy
  • Japan Community Healthcare Organization Kurume General Hospital — Kurumeshi, Fukuoka, Japan
  • Gunma Prefectural Cancer Center — Otashi, Gunma, Japan
  • Hiroshima City Hiroshima Citizens Hospital — Hiroshima, Hiroshima, Japan
  • National Hospital Organization Hokkaido Cancer Center — Sapporo, Hokkaido, Japan
  • Hyogo Medical University Hospital — Nishinomiyashi, Hyōgo, 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
  • Yokohama City University Medical Center — Yokohama, Kanagawa, Japan
  • Kanagawa Cancer Center — Yokohama, Kanagawa, Japan
  • Mie University Hospital — Tsu, Mie-ken, Japan
  • National Hospital Organization Osaka National Hospital — Osakashi, Osaka, Japan
  • Osaka International Cancer Institute — OsakaShi, Osaka, Japan
  • The University of Osaka Hospital — Suitashi, Osaka, Japan
  • Shizuoka Cancer Center — Suntogun, Shizuoka, Japan
  • Tokyo Metropolitan Komagome Hospital — Bunkyoku, Tokyo, 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 Raja Permaisuri Bainun — Ipoh, Malaysia
  • Hospital Raja Perempuan Zainab Ii — Johor Bahru, 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
  • Bialostockie Centrum Onkologii Im M Sklodowskiej Curie W Bialymstoku — Bialystok, Poland
  • Szpitale Pomorskie Spolka Z Ograniczona Odpowiedzialnoscia — Gdynia, Poland
  • Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach — Kielce, Poland
  • Pratia McM Krakow — Krakow, Poland
  • Szpital Specjalistyczny Im Ludwika Rydygiera W Krakowie — Krakow, Poland
  • Opolskie Centrum Onkologii — Opole, Poland
  • Europejskie Centrum Zdrowia Otwock — Otwock, Poland
  • Narodowy Instytut Onkologii Im Marii Sklodowskiej Curie W Warszawie — Warsaw, Poland
  • 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, Jeonnam-Gwangju S.M. City, 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
  • Hospital Universitario de Badajoz — Badajoz, Spain
  • Vall D Hebron Institute of Oncology Vhio — Barcelona, Spain
  • Hospital Clinic de Barcelona — Barcelona, Spain
  • Hospital Universitario Donostia — Donostiasan Sebastian, Spain
  • Hospital General Universitario de Elche — Elcheelx, Spain
  • Hospital Universitario Clinico San Cecilio — Granada, Spain
  • Hospital General Universitario Gregorio Maranon — Madrid, Spain
  • Iob Institute of Oncology Madrid — Madrid, Spain
  • Hospital Universitario 12 de Octubre — Madrid, Spain
  • Hospital Clinico San Carlos — Madrid, Spain
  • Complejo Hospitalario Univ de Santiago (Chus) — Santiago de Compostela, Spain
  • Hospital Universitario Virgen Del Rocio — Seville, Spain
  • Taipei Veterans General Hospital — Beitou Dist, Taiwan
  • China Medical University Hospital — Taichung, Taiwan
  • National Cheng Kung University Hospital — Tainan, Taiwan
  • National Taiwan University Hospital — Zhongzheng Dist, Taiwan
  • Adana City Education and Research Hospital — Adana, Turkey (Türkiye)
  • Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital — Ankara, Turkey (Türkiye)
  • Hacettepe University — Ankara, Turkey (Türkiye)
  • Ankara City Hospital — Ankara City Hospital, Turkey (Türkiye)
  • Marmara University Pendik Research and Training Hospital — Istanbul, Turkey (Türkiye)
  • Ege University Medical Faculty — Izmir, Turkey (Türkiye)
  • Kocaeli Universitesi Tip Fakultesi — Kocaeli, Turkey (Türkiye)
  • Mersin City Hospital — Mersin City Hospital, Turkey (Türkiye)
  • Royal Surrey County Hospital — Guildford, United Kingdom
  • Maidstone and Tunbridge Wells Nhs Trust Kent Oncology Centre Maidstone Hospital — Maidstone, United Kingdom
Sponsored

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record