BGB-43395 Alone or as Part of Combination Therapies in Participants With Breast Cancer and Other Advanced Solid Tumors
Start Date
12/1/2023
Completion Date
11/1/2028
Summary
This is a dose escalation and dose expansion study to compare how well BGB-43395, a selective cyclin-dependent kinase 4 (CDK4) inhibitor, works as monotherapy or in combination with fulvestrant, letrozole, or elacestrant in participants with hormone receptor positive (HR+) and human epidermal growth factor 2 negative (HER2-) breast cancer (BC) and other advanced solid tumors. The main purpose of this study is to explore the recommended dosing for BGB-43395.
Detailed Description
Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
BGB-43395
Fulvestrant
Letrozole
Elacestrant
Anti-Diarrheal Agent
Conditions
Locations
Sarah Cannon Research Institute (Scri) At Health One
Denver, Colorado 80218-1238
United States
Florida Cancer Specialists and Research Institute
Lake Mary, Florida 32746-2115
United States
Karmanos Cancer Institute
Detroit, Michigan 48201-2013
United States
Washington University School of Medicine
St Louis, Missouri 63110-1010
United States
Duke Cancer Center
Durham, North Carolina 27710-2000
United States
James Cancer Hospital and Solove Research Institute
Columbus, Ohio 43210-1240
United States
Scri Oncology Partners
Nashville, Tennessee 37203-1503
United States
The University of Texas Md Anderson Cancer Center
Houston, Texas 77030-4009
United States
Next Dallas
Irving, Texas 75039-2743
United States
Next Oncology
San Antonio, Texas 78229-6028
United States
Blacktown Cancer and Haematology Centre
Blacktown, New South Wales NSW 2148
Australia
Southern Highlands Private Hospital
Bowral, New South Wales NSW 2576
Australia
Concord Repatriation General Hospital
Concord, New South Wales NSW 2139
Australia
Macquarie University
North Ryde, New South Wales NSW 2109
Australia
Townsville University Hospital
Douglas, Queensland QLD 4814
Australia
Genesiscare St Andrews
Adelaide, South Australia SA 5000
Australia
Austin Health
Heidelberg, Victoria VIC 3084
Australia
Peter Maccallum Cancer Centre
Melbourne, Victoria VIC 3000
Australia
Fundacao Pio Xii Hospital de Amor de Barretos
Barretos, 14.784-400
Brazil
Hospital Sirio Libanes Brasilia
Brasília, 70200-730
Brazil
Centro de Pesquisas Oncologicas Cepon
Florianópolis, 88034-000
Brazil
Liga Norte Riograndene Contra O Cancer
Natal, 59062-000
Brazil
Fundacao Universidade de Caxias Do Sul Instituto de Pesquisas Em Saude
Petrópolis, 95070-560
Brazil
Hospital Sao Lucas Da Pucrs Uniao Brasileira de Educacao E Assistencia
Porto Algre, 90610-000
Brazil
Instituto Nacional de Cancer
Rio de Janeiro, 20560-120
Brazil
Instituto Dor de Pesquisa E Ensino Hospital Sao Rafael
Salvador, 41253-190
Brazil
Icesp Instituto Do Cancer Do Estado de Sao Paulo Octavio Frias de Oliveira
São Paulo, 01246-000
Brazil
Clinica de Pesquisa E Centro de Estudos Em Oncologia Ginecologica E Mamaria
São Paulo, 01318-001
Brazil
Hospital Israelita Albert Einstein
São Paulo, 05652-900
Brazil
Beijing Cancer Hospital
Beijing, Beijing Municipality 100142
China
Fujian Cancer Hospital
Fuzhou, Fujian 350014
China
Sun Yat Sen Memorial Hospital, Sun Yat Sen University (South)
Guangzhou, Guangdong 510245
China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang 150000
China
The First Affiliated Hospital of Nanchang University Branch Donghu
Nanchang, Jiangxi 330006
China
Liaoning Cancer Hospital and Institute
Shenyang, Liaoning 110042
China
Fudan University Shanghai Cancer Centerpudong
Shanghai, Shanghai Municipality 201321
China
Centre de Lutte Contre Le Cancer Institut Bergonie
Bordeaux, 33000
France
Centre Francois Baclesse
Caen, 14000
France
Centre Oscar Lambret
Lille, 59000
France
Institut Paoli Calmettes
Marseille, 13009
France
Institut Curie
Paris, 75005
France
Centre Eugene Marquis
Rennes, 35043
France
Institut de Cancerologie de Louest
Saint-Herblain, 44800
France
Institut Gustave Roussy
Villejuif, 94800
France
Nagoya University Hospital
Nagoya, Aichi-ken 466-8560
Japan
National Cancer Center Hospital East
Kashiwa, Chiba 277-8577
Japan
Shizuoka Cancer Center
Suntogun, Shizuoka 411-8777
Japan
Pulau Pinang Hospital
George Town, 10450
Malaysia
University Malaya Medical Centre
Kuala Lumpur, 59100
Malaysia
Sarawak General Hospital
Kuching, 93586
Malaysia
National Cancer Institute (Institut Kanser Negara)
Putrajaya, 62250
Malaysia
The Institute of Oncology, Arensia Exploratory Medicine
Chisinau, 2025
Moldova
Harbour Cancer and Wellness
Auckland, 1023
New Zealand
Nzcr Christchurch
Christchurch, 8011
New Zealand
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do 13620
South Korea
Gachon University Gil Medical Center
NamdongGu, Incheon Gwang'yeogsi 21565
South Korea
Samsung Medical Center
GangnamGu, Seoul Teugbyeolsi 06351
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
Asan Medical Center
SongpaGu, Seoul Teugbyeolsi 05505
South Korea
Srinagarind Hospital (Khon Kaen University)
Muang, 40002
Thailand