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
KANDELA-302
An Open-Label, Randomized, Multicenter Phase 3 Study Investigating the Efficacy and Safety of BGB-43395 Plus Letrozole Versus CDK4/6 Inhibitors (Abemaciclib, Palbociclib, Ribociclib) Plus Letrozole in Patients With Advanced or Metastatic HR+/HER2- Breast Cancer Who Have Not Received Prior Systemic Anticancer Treatment for Advanced or Metastatic Disease
3 other identifiers
interventional
1,056
16 countries
189
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2026
Longer than P75 for phase_3
189 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 20, 2026
CompletedFirst Posted
Study publicly available on registry
March 25, 2026
CompletedStudy Start
First participant enrolled
May 22, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 7, 2037
September 28, 2026
September 1, 2026
2.9 years
March 20, 2026
September 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-Free Survival (PFS) Determined by Blinded Independent Central Review (BICR)
PFS is defined as the time from first dose until first documentation of progression or death, whichever comes first, as assessed by BICR per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Up to approximately 4 years
Secondary Outcomes (9)
Overall Survival (OS)
Up to approximately 11 years
Overall Response Rate (ORR)
Up to approximately 4 years
Duration of Response (DOR)
Up to approximately 4 years
PFS Determined by Investigator
Up to approximately 4 years
Clinical Benefit Rate (CBR)
Up to approximately 4 years
- +4 more secondary outcomes
Study Arms (2)
Arm A: BGB-43395 + Letrozole
EXPERIMENTALParticipants will receive BGB-43395 in combination with letrozole.
Arm B: Cyclin-Dependent Kinase 4/6 Inhibitor + Letrozole
ACTIVE COMPARATORParticipants will receive either abemaciclib, palbociclib, or ribociclib based on the Investigator's choice in combination with letrozole.
Interventions
Administered orally.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BeOne Medicineslead
Study Sites (189)
Alabama Oncology Princeton
Birmingham, Alabama, 35211, United States
Alaska Oncology and Hematology, Llc
Anchorage, Alaska, 99508-2974, United States
Fairbanks Cancer Care Physicians Pc
Fairbanks, Alaska, 99701, United States
Pioneer Research Center
Bullhead City, Arizona, 86442, United States
Ironwood Cancer and Research Centers Chandler Ii
Chandler, Arizona, 85224-5665, United States
Genesis Cancer and Blood Institute Hot Springs (Harmony Park)
Hot Springs, Arkansas, 71913, United States
Helios Clinical Research the Oncology Institute Fountain Valley
Fountain Valley, California, 92708, United States
California Research Institute
Los Angeles, California, 90027, United States
Ventura County Hematology Oncology Specialists
Oxnard, California, 93030, United States
Brcr Coral Springs
Coral Springs, Florida, 33065, United States
Mid Florida Hematology and Oncology Center
Orange City, Florida, 32763-8316, United States
Cancer Care Centers of Brevard Palm Bay
Palm Bay, Florida, 32901, United States
Florida Clinical Trials Group Plantation
Plantation, Florida, 33322, United States
Hematology Oncology Associates of the Treasure Coast
Port Saint Lucie, Florida, 34952-7596, United States
The Oncology Institute of Hope and Innovation South Miami
South Miami, Florida, 33143, United States
Florida Clinical Trials Group Tamarac
Tamarac, Florida, 33321, United States
Moffitt Cancer Center McKinley Campus Richard M Shulze Family Foundation Outpatient Center
Tampa, Florida, 33612, United States
University Cancer and Blood Center Athens Comprehensive Cancer Center
Athens, Georgia, 30607, United States
Central Georgia Cancer Care Macon Office
Macon, Georgia, 31210, United States
Hawaii Cancer Care
Honolulu, Hawaii, 96813, United States
Hope and Healing Cancer Services
Hinsdale, Illinois, 60521-0509, United States
Cancer Care Specialists For Illinois
OFallon, Illinois, 62269, United States
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, 46804, United States
Hematology Oncology of Indiana
Indianapolis, Indiana, 46260, United States
Mercy Medical Center
Cedar Rapids, Iowa, 52403, United States
Owensboro Health Mitchell Memorial Cancer Center
Owensboro, Kentucky, 42303, United States
Karmanos Cancer Institute
Detroit, Michigan, 48201-2013, United States
Aspirus St Lukes Hospital
Duluth, Minnesota, 55805, United States
Metro Minnesota Community Oncology Research Consortium (Mmcorc)
Saint Paul, Minnesota, 55101-2502, United States
Oncology Hematology Associates
Springfield, Missouri, 65807-5288, United States
Nebraska Cancer Specialists St Francis Grand Island
Grand Island, Nebraska, 68803, United States
Cancer Partners of Nebraska April Sampson Cancer Center
Lincoln, Nebraska, 68516, United States
Nebraska Cancer Specialists
Omaha, Nebraska, 68130-2042, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169-3321, United States
Renown Regional Medical Center
Reno, Nevada, 89502, United States
Astera Cancer Care East Brunswick
East Brunswick, New Jersey, 08816-4096, United States
Summit Medical Group
Florham Park, New Jersey, 07932-1049, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901-1914, United States
Nyu Langone Health Perlmutter Cancer Center Sunset Park
Brooklyn, New York, 11220, United States
Nyu Langone Health Perlmutter Cancer Center At Nyu Langone Hospital Long Island
Mineola, New York, 11501, United States
Nyu Langone Health Perlmutter Cancer Center 34Th Street
New York, New York, 10016, United States
University of Rochester
Rochester, New York, 14642-0001, United States
New York Cancer and Blood Specialists
Shirley, New York, 11967, United States
Pardee Cancer Center
Hendersonville, North Carolina, 28739, United States
Carolina Cancer Research Center
Wilson, North Carolina, 27896, United States
Gabrail Cancer Center Research
Canton, Ohio, 44718-2566, United States
Dayton Physicians Network
Dayton, Ohio, 45409, United States
Oncology Associates of Oregon Willamette Valley Cancer Center
Eugene, Oregon, 97401, United States
Oregon Oncology Specialists
Salem, Oregon, 97301, United States
Consultants in Medical Oncology and Hematology Cancer Center At Broomall
Broomall, Pennsylvania, 19008, United States
McGlinn Cancer Institute
West Reading, Pennsylvania, 19611-2143, United States
Ballad Health Cancer Center Kingsport
Kingsport, Tennessee, 37660, United States
Texas Oncology Austin Central
Austin, Texas, 78731-4214, United States
Utah Cancer Specialists Cancer Center
Salt Lake City, Utah, 84107, United States
Oncology and Hematology Associates of Southwest Virginia, Inc (Us Oncology Research)
Blacksburg, Virginia, 24060-6325, United States
Virginia Cancer Specialists
Fairfax, Virginia, 22031-2171, United States
Virginia Cancer Institute
Richmond, Virginia, 23229-8605, United States
Vista Oncology East Olympia
Olympia, Washington, 98506, United States
Multicare Cancer Institute Deaconess Medical Office Building 1
Spokane, Washington, 99204, United States
Multicare Cancer Institute Tacoma General Hospital
Tacoma, Washington, 98405, United States
Northwest Medical Specialties
Tacoma, Washington, 98405, United States
Multicare Cancer Institute North Star Lodge
Yakima, Washington, 98902, United States
Gundersen Health System
La Crosse, Wisconsin, 54601-5467, United States
Blacktown Cancer and Haematology Centre
Blacktown, New South Wales, NSW 2148, Australia
Liverpool Hospital
Liverpool, New South Wales, NSW 2170, Australia
Wollongong Hospital
Wollongong, New South Wales, NSW 2500, Australia
Sunshine Coast University Private Hospital
Birtinya, Queensland, QLD 4575, Australia
Townsville University Hospital
Douglas, Queensland, QLD 4814, Australia
Peter Maccallum Cancer Centre
Melbourne, Victoria, VIC 3000, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, WA 6150, Australia
One Clinical Research
Nedlands, Western Australia, WA 6009, Australia
Fundacao Pio Xii Hospital de Amor de Barretos
Barretos, 14.784-400, Brazil
Hospital Brasilia
Brasília, 71681-603, Brazil
Instituto de Pesquisa Em Saude Da Universidade de Caxias Do Sul
Caxias do Sul, 95070-560, Brazil
Oncosite Centro de Pesquisa Clinica Em Oncologia
Ijuí, 98700-000, Brazil
Liga Norte Riograndene Contra O Cancer
Natal, 59062-000, Brazil
Hospital Sao Lucas Da Pucrs
Porto Alegre, 90610-000, Brazil
Instituto Sul Mineiro de Oncologia Ltda
Pouso Alegre, 37554-238, Brazil
Hospital Do Cancer de Pernambuco
Recife, 50040-000, Brazil
Instituto Nacional de Cancer
Rio de Janeiro, 20560-120, Brazil
Icesp Instituto Do Cancer Do Estado de Sao Paulo Octavio Frias de Oliveira
São Paulo, 01246-000, Brazil
The First Affiliated Hospital of Bengbu Medical University
Bengbu, Anhui, 233004, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 630014, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001, China
The Peoples Hospital Affiliated to Fujian University of Traditional Chinese Medicine
Fuzhou, Fujian, 350009, China
Fujian Cancer Hospital
Fuzhou, Fujian, 350014, China
Sun Yat Sen University Cancer Center
Guangzhou, Guangdong, 510060, China
Sun Yat Sen Memorial Hospital, Sun Yat Sen University (South)
Guangzhou, Guangdong, 510245, China
Cancer Hospital of Shantou University Medical College
Shantou, Guangdong, 515031, China
Guangxi Medical University Cancer Hospital Wuxiang Branch
Nanning, Guangxi, 530201, China
Hainan General Hospital
Haikou, Hainan, 570206, China
Affiliated Hospital of Hebei University(North Branch)
Baoding, Hebei, 71000, China
The Fourth Hospital of Hebei Medical University East Branch
Shijiazhuang, Hebei, 050035, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052, China
Union Hospital Tongji Medical College Huazhong University of Science and Technologyjinyinhu Branch
Wuhan, Hubei, 430048, China
Hubei Cancer Hospital
Wuhan, Hubei, 430079, China
The First Peoples Hospital of Changde City
Changde, Hunan, 415000, China
Xiangya Hospital of Central South University
Changsha, Hunan, 410008, China
Jiangsu Province Hospital Longjiang Branch
Nanjing, Jiangsu, 210036, China
Affiliated Hospital of Nantong University
Nantong, Jiangsu, 201203, China
Nanchang Peoples Hospitalchaoyang Branch
Nanchang, Jiangxi, 330025, China
Jiangxi Cancer Hospital
Nanchang, Jiangxi, 330029, China
The Second Affiliated Hospital of Xian Jiaotong University
Xi'an, Shaanxi, 710004, China
Weifang Peoples Hospital
Weifang, Shandong, 261000, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200000, China
Yuncheng Central Hospital West Branch
Yuncheng, Shanxi, 44099, China
Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
Chengdu, Sichuan, 610071, China
Binhai Hospital, Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300453, China
Yunnan Cancer Hospital
Kunming, Yunnan, 650100, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000, China
Centre de Lutte Contre Le Cancer Institut Bergonie
Bordeaux, 33076, France
Icm Val Daurelle
Montpellier, 34090, France
Centre Eugene Marquis
Rennes, 35043, France
Institut Gustave Roussy
Villejuif, 94800, France
Invo Institut Fur Versorgungsforschung in Der Onkologie
Koblenz, 56068, Germany
Istituto Europeo Di Oncologia
Milan, 20141, Italy
Fondazione Policlinico Universitario Agostino Gemelli
Roma, 00168, Italy
Japan Community Healthcare Organization Kurume General Hospital
Kurumeshi, Fukuoka, 830-0013, Japan
Gunma Prefectural Cancer Center
Otashi, Gunma, 373-8550, Japan
Hiroshima City Hiroshima Citizens Hospital
Hiroshima, Hiroshima, 730-8518, Japan
National Hospital Organization Hokkaido Cancer Center
Sapporo, Hokkaido, 003-0804, Japan
Hyogo Medical University Hospital
Nishinomiyashi, Hyōgo, 663-8501, Japan
Social Medical Corporation Hakuaikai Sagara Hospital
Kagoshima, Kagoshima-ken, 892-0833, Japan
Tokai University Hospital
Iseharashi, Kanagawa, 259-1193, Japan
Nippon Medical School Musashi Kosugi Hospital
Kawasakishi, Kanagawa, 211-8533, Japan
Yokohama City University Medical Center
Yokohama, Kanagawa, 232-0024, Japan
Kanagawa Cancer Center
Yokohama, Kanagawa, 241-8515, Japan
Mie University Hospital
Tsu, Mie-ken, 514-8507, Japan
National Hospital Organization Osaka National Hospital
Osakashi, Osaka, 540-0006, Japan
The University of Osaka Hospital
Suitashi, Osaka, 565-0871, Japan
Tokyo Metropolitan Komagome Hospital
Bunkyoku, Tokyo, 113-8677, Japan
Cancer Institute Hospital of Jfcr
Kotoku, Tokyo, 135-8550, Japan
Showa Medical University Hospital
Shinagawaku, Tokyo, 142-8666, Japan
Tokyo Womens Medical University Hospital
Shinjukuku, Tokyo, 162-8666, Japan
Pulau Pinang Hospital
George Town, 10450, Malaysia
Hospital Raja Permaisuri Bainun
Ipoh, 30450, Malaysia
Hospital Raja Perempuan Zainab Ii
Johor Bahru, 15586, Malaysia
Hospital Wanita Dan Kanak Kanak Sabah (Hospital Likas)
Kota Kinabalu Sabah, 88996, Malaysia
Hospital Kuala Lumpur
Kuala Lumpur, 50586, Malaysia
University Malaya Medical Centre
Kuala Lumpur, 59100, Malaysia
Sarawak General Hospital
Kuching, 93586, Malaysia
Hospital Picaso
Petaling Jaya, 46300, Malaysia
National Cancer Institute (Institut Kanser Negara)
Putrajaya, 62250, Malaysia
Bialostockie Centrum Onkologii Im M Sklodowskiej Curie W Bialymstoku
Bialystok, 15-027, Poland
Szpitale Pomorskie Spolka Z Ograniczona Odpowiedzialnoscia
Gdynia, 81-519, Poland
Pratia McM Krakow
Krakow, 30-727, Poland
Szpital Specjalistyczny Im Ludwika Rydygiera W Krakowie
Krakow, 31-826, Poland
Opolskie Centrum Onkologii
Opole, 45-061, Poland
Brcr Global Puerto Rico Hato Rey
San Juan, 00917, Puerto Rico
Inje University Haeundae Paik Hospital
HaeundaeGu, Busan Gwang'Yeogsi, 48108, South Korea
Dong A University Hospital
Seogu, Busan Gwang'Yeogsi, 49201, South Korea
Chungbuk National University Hospital
Cheongju-si, Chungcheongbukdo, 28644, South Korea
Soon Chun Hyang University Cheonan Hospital
Cheonansi, Chungcheongnam-do, 31151, South Korea
Keimyung University Dongsan Hospital
Dalseogu, Daegu Gwang'Yeogsi, 42601, South Korea
Cha Bundang Medical Center, Cha University
BundangGu SeongnamSi, Gyeonggi-do, 13496, South Korea
Korea University Ansan Hospital
DanwonGu AnsanSi, Gyeonggi-do, 15355, South Korea
National Cancer Center (Korea)
IlsandongGu GoyangSi, Gyeonggi-do, 10408, South Korea
The Catholic University of Korea, St Vincents Hospital
PaldalGu SuwonSi, Gyeonggi-do, 16247, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620, South Korea
Inha University Hospital
Jemulpogu, Incheon Gwang'Yeogsi, 22332, South Korea
Gachon University Gil Medical Center
NamdongGu, Incheon Gwang'Yeogsi, 21565, South Korea
Chonnam National University Hwasun Hospital
HwasunGun, Jeonnam-Gwangju S.M. City, 58128, South Korea
Chung Ang University Hospital
DongjakGu, Seoul Teugbyeolsi, 06973, South Korea
Samsung Medical Center
GangnamGu, Seoul Teugbyeolsi, 06351, South Korea
Korea University Guro Hospital
GuroGu, Seoul Teugbyeolsi, 08308, 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
Gangnam Severance Hospital, Yonsei University Health System
Seoul, Seoul Teugbyeolsi, 06273, South Korea
Ehwa Womans University Mokdong Hospital
Seoul, Seoul Teugbyeolsi, 07985, South Korea
Asan Medical Center
SongpaGu, Seoul Teugbyeolsi, 05505, South Korea
Ulsan University Hospital
Ulsan, Ulsan Gwang'Yeogsi, 44033, South Korea
Ajou University Hospital
Suwon, 16499, South Korea
Hospital General Universitario de Elche
Elcheelx, 03203, Spain
Hospital Universitario Clinico San Cecilio
Granada, 18016, Spain
Iob Institute of Oncology Madrid
Madrid, 28007, Spain
Complejo Hospitalario Univ de Santiago (Chus)
Santiago de Compostela, 15706, Spain
Hospital Universitario Virgen Del Rocio
Seville, 41013, Spain
Taipei Veterans General Hospital
Beitou Dist, 11217, Taiwan
China Medical University Hospital
Taichung, 40447, Taiwan
National Cheng Kung University Hospital
Tainan, 704, Taiwan
National Taiwan University Hospital
Zhongzheng Dist, 100225, Taiwan
Adana City Education and Research Hospital
Adana, 01060, Turkey (Türkiye)
Hacettepe University
Ankara, 6100, Turkey (Türkiye)
Kocaeli Universitesi Tip Fakultesi
Kocaeli, 41380, Turkey (Türkiye)
Royal Surrey County Hospital
Guildford, GU27XX, United Kingdom
Maidstone and Tunbridge Wells Nhs Trust Kent Oncology Centre Maidstone Hospital
Maidstone, ME16 9QQ, United Kingdom
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
BeOne Medicines
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 20, 2026
First Posted
March 25, 2026
Study Start
May 22, 2026
Primary Completion (Estimated)
April 1, 2029
Study Completion (Estimated)
August 7, 2037
Last Updated
September 28, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- See plan description
- Access Criteria
- See plan description
BeOne shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. BeOne shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations. Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.