BGB-43395 Alone or as Part of Combination Therapies in Participants With Breast Cancer and Other Advanced Solid Tumors
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Pacjenci z zaawansowanym lub nieoperacyjnym rakiem piersi (hormonoreceptorowym, HER2-ujemnym), lub innymi nowotworami, które zależą od białka CDK4.
- •W niektórych przypadkach, pacjenci musieli wcześniej przyjmować określone leki hormonalne lub inhibitory CDK4/6.
- •Uczestnicy powinni być w dobrym ogólnym stanie zdrowia, zdolnym do codziennych czynności (stan sprawności ECOG ≤ 1).
- •Kobiety z rakiem piersi muszą być po menopauzie lub stosować leczenie hamujące czynność jajników.
- •Wystarczająca funkcja narządów bez objawów choroby w narządach wewnętrznych.
✗ Disqualifies
- •Pacjenci z rozsianym rakiem opon mózgowych lub nieleczonymi przerzutami do mózgu.
- •Inny nowotwór w ciągu ostatnich 3 lat (chyba że został całkowicie wyleczony).
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- May 27, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (63)
Sarah Cannon Research Institute (Scri) At Health One
Denver, United States
Florida Cancer Specialists and Research Institute
Lake Mary, United States
Karmanos Cancer Institute
Detroit, United States
Washington University School of Medicine
St Louis, United States
Duke Cancer Center
Durham, United States
James Cancer Hospital and Solove Research Institute
Columbus, United States
Scri Oncology Partners
Nashville, United States
The University of Texas Md Anderson Cancer Center
Houston, United States
Next Dallas
Irving, United States
Next Oncology
San Antonio, United States
Blacktown Cancer and Haematology Centre
Blacktown, Australia
Southern Highlands Private Hospital
Bowral, Australia
Concord Repatriation General Hospital
Concord, Australia
Macquarie University
North Ryde, Australia
Townsville University Hospital
Douglas, Australia
Genesiscare St Andrews
Adelaide, Australia
Austin Health
Heidelberg, Australia
Peter Maccallum Cancer Centre
Melbourne, Australia
Fundacao Pio Xii Hospital de Amor de Barretos
Barretos, Brazil
Hospital Sirio Libanes Brasilia
Brasília, Brazil
Centro de Pesquisas Oncologicas Cepon
Florianópolis, Brazil
Liga Norte Riograndene Contra O Cancer
Natal, Brazil
Fundacao Universidade de Caxias Do Sul Instituto de Pesquisas Em Saude
Petrópolis, Brazil
Hospital Sao Lucas Da Pucrs Uniao Brasileira de Educacao E Assistencia
Porto Algre, Brazil
Instituto Nacional de Cancer
Rio de Janeiro, Brazil
Instituto Dor de Pesquisa E Ensino Hospital Sao Rafael
Salvador, Brazil
Icesp Instituto Do Cancer Do Estado de Sao Paulo Octavio Frias de Oliveira
São Paulo, Brazil
Clinica de Pesquisa E Centro de Estudos Em Oncologia Ginecologica E Mamaria
São Paulo, Brazil
Hospital Israelita Albert Einstein
São Paulo, Brazil
Beijing Cancer Hospital
Beijing, China
Fujian Cancer Hospital
Fuzhou, China
Sun Yat Sen Memorial Hospital, Sun Yat Sen University (South)
Guangzhou, China
Harbin Medical University Cancer Hospital
Harbin, China
The First Affiliated Hospital of Nanchang University Branch Donghu
Nanchang, China
Liaoning Cancer Hospital and Institute
Shenyang, China
Fudan University Shanghai Cancer Centerpudong
Shanghai, China
Centre de Lutte Contre Le Cancer Institut Bergonie
Bordeaux, France
Centre Francois Baclesse
Caen, France
Centre Oscar Lambret
Lille, France
Institut Paoli Calmettes
Marseille, France
Institut Curie
Paris, France
Centre Eugene Marquis
Rennes, France
Institut de Cancerologie de Louest
Saint-Herblain, France
Institut Gustave Roussy
Villejuif, France
Nagoya University Hospital
Nagoya, Japan
National Cancer Center Hospital East
Kashiwa, Japan
Shizuoka Cancer Center
Suntogun, Japan
Pulau Pinang Hospital
George Town, Malaysia
University Malaya Medical Centre
Kuala Lumpur, Malaysia
Sarawak General Hospital
Kuching, Malaysia
National Cancer Institute (Institut Kanser Negara)
Putrajaya, Malaysia
The Institute of Oncology, Arensia Exploratory Medicine
Chisinau, Moldova
Harbour Cancer and Wellness
Auckland, New Zealand
Nzcr Christchurch
Christchurch, New Zealand
Seoul National University Bundang Hospital
Seongnam-si, South Korea
Gachon University Gil Medical Center
NamdongGu, South Korea
Samsung Medical Center
GangnamGu, South Korea
The Catholic University of Korea, Seoul St Marys Hospital
SeochoGu, South Korea
Severance Hospital Yonsei University Health System
SeodaemunGu, South Korea
Korea University Anam Hospital
SeongbukGu, South Korea
Seoul National University Hospital
Seoul, South Korea
Asan Medical Center
SongpaGu, South Korea
Srinagarind Hospital (Khon Kaen University)
Muang, Thailand
Trial contact
Study Director
Contact information from ClinicalTrials.gov. Contact in English.
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.