HR+/HER2- Breast CancerPhase 3KANDELA-302NCT07492641
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
A Phase 3 study testing BGB-43395, Letrozole and Abemaciclib in people with HR+/HER2- Breast Cancer, run by BeOne Medicines at 206 sites in 16 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HR+/HER2- Breast Cancer
- What is being tested?
- BGB-43395, Letrozole and Abemaciclib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,056 participants
- Where
- 206 sitesin 16 countries
- Study dates
- 22 May 2026to 7 Aug 2037
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
206 sites in 16 countries. Contact the study team or a site near you to ask about taking part.
206 sites in 16 countries
United States71 sites, 71 recruiting
- Recruiting
Alaska Oncology and Hematology, Llc
Anchorage, Alaska, 99508-2974
- Recruiting
University Cancer and Blood Center Athens Comprehensive Cancer Center
Athens, Georgia, 30607
- Recruiting
Texas Oncology Austin Central
Austin, Texas, 78731-4214
- Recruiting
Alabama Oncology Princeton
Birmingham, Alabama, 35211
- Recruiting
Oncology and Hematology Associates of Southwest Virginia, Inc (Us Oncology Research)
Blacksburg, Virginia, 24060-6325
- Recruiting
Nyu Langone Health Perlmutter Cancer Center Sunset Park
Brooklyn, New York, 11220
- Recruiting
Consultants in Medical Oncology and Hematology Cancer Center At Broomall
Broomall, Pennsylvania, 19008
- Recruiting
Pioneer Research Center
Bullhead City, Arizona, 86442
- Recruiting
Gabrail Cancer Center Research
Canton, Ohio, 44718-2566
- Recruiting
Mercy Medical Center
Cedar Rapids, Iowa, 52403
- Recruiting
Ironwood Cancer and Research Centers Chandler Ii
Chandler, Arizona, 85224-5665
- Recruiting
University of Virginia
Charlottesville, Virginia, 22908-0817
- Recruiting
Missouri Cancer Associates Columbia, Mo
Columbia, Missouri, 65201
- Recruiting
Brcr Coral Springs
Coral Springs, Florida, 33065
- Recruiting
Texas Oncology Baylor Charles A Sammons Cancer Center
Dallas, Texas, 75246-2003
- Recruiting
Dayton Physicians Network
Dayton, Ohio, 45409
- Recruiting
Karmanos Cancer Institute
Detroit, Michigan, 48201-2013
- Recruiting
Aspirus St Lukes Hospital
Duluth, Minnesota, 55805
- Recruiting
Astera Cancer Care East Brunswick
East Brunswick, New Jersey, 08816-4096
- Recruiting
Oncology Associates of Oregon Willamette Valley Cancer Center
Eugene, Oregon, 97401
- Recruiting
Fairbanks Cancer Care Physicians Pc
Fairbanks, Alaska, 99701
- Recruiting
Virginia Cancer Specialists
Fairfax, Virginia, 22031-2171
- Recruiting
Summit Medical Group
Florham Park, New Jersey, 07932-1049
- Recruiting
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, 46804
- Recruiting
Helios Clinical Research the Oncology Institute Fountain Valley
Fountain Valley, California, 92708
- Recruiting
Nebraska Cancer Specialists St Francis Grand Island
Grand Island, Nebraska, 68803
- Recruiting
Hattiesburg Hematology and Oncology Clinic
Hattiesburg, Mississippi, 39401-7233
- Recruiting
Pardee Cancer Center
Hendersonville, North Carolina, 28739
- Recruiting
Hope and Healing Cancer Services
Hinsdale, Illinois, 60521-0509
- Recruiting
Hawaii Cancer Care
Honolulu, Hawaii, 96813
- Recruiting
Genesis Cancer and Blood Institute Hot Springs (Harmony Park)
Hot Springs, Arkansas, 71913
- Recruiting
Hematology Oncology of Indiana
Indianapolis, Indiana, 46260
- Recruiting
Ballad Health Cancer Center Kingsport
Kingsport, Tennessee, 37660
- Recruiting
Gundersen Health System
La Crosse, Wisconsin, 54601-5467
- Recruiting
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169-3321
- Recruiting
Nebraska Hematology Oncology
Lincoln, Nebraska, 68506-7548
- Recruiting
Cancer Partners of Nebraska April Sampson Cancer Center
Lincoln, Nebraska, 68516
- Recruiting
Rocky Mountain Cancer Centers, Llp(Us Oncology Research)
Lone Tree, Colorado, 80124-5641
- Recruiting
California Research Institute
Los Angeles, California, 90027
- Recruiting
Central Georgia Cancer Care Macon Office
Macon, Georgia, 31210
- Recruiting
Nyu Langone Health Perlmutter Cancer Center At Nyu Langone Hospital Long Island
Mineola, New York, 11501
- Recruiting
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901-1914
- Recruiting
Nyu Langone Health Perlmutter Cancer Center 34Th Street
New York, New York, 10016
- Recruiting
Virginia Oncology Associates
Norfolk, Virginia, 23502-2800
- Recruiting
Cancer Care Specialists For Illinois
O'Fallon, Illinois, 62269
- Recruiting
Vista Oncology East Olympia
Olympia, Washington, 98506
- Recruiting
Nebraska Cancer Specialists
Omaha, Nebraska, 68130-2042
- Recruiting
Mid Florida Hematology and Oncology Center
Orange City, Florida, 32763-8316
- Recruiting
Owensboro Health Mitchell Memorial Cancer Center
Owensboro, Kentucky, 42303
- Recruiting
Ventura County Hematology Oncology Specialists
Oxnard, California, 93030
- Recruiting
Cancer Care Centers of Brevard Palm Bay
Palm Bay, Florida, 32901
- Recruiting
Florida Clinical Trials Group Plantation
Plantation, Florida, 33322
- Recruiting
Hematology Oncology Associates of the Treasure Coast
Port Saint Lucie, Florida, 34952-7596
- Recruiting
Renown Regional Medical Center
Reno, Nevada, 89502
- Recruiting
Virginia Cancer Institute
Richmond, Virginia, 23229-8605
- Recruiting
University of Rochester
Rochester, New York, 14642-0001
- Recruiting
Metro Minnesota Community Oncology Research Consortium (Mmcorc)
Saint Paul, Minnesota, 55101-2502
- Recruiting
Oregon Oncology Specialists
Salem, Oregon, 97301
- Recruiting
Utah Cancer Specialists Cancer Center
Salt Lake City, Utah, 84107
- Recruiting
Kaiser Permanente San Marcos Medical Offices
San Marcos, California, 92078
- Recruiting
New York Cancer and Blood Specialists
Shirley, New York, 11967
- Recruiting
The Oncology Institute of Hope and Innovation South Miami
South Miami, Florida, 33143
- Recruiting
Multicare Cancer Institute Deaconess Medical Office Building 1
Spokane, Washington, 99204
- Recruiting
Oncology Hematology Associates
Springfield, Missouri, 65807-5288
- Recruiting
Multicare Cancer Institute Tacoma General Hospital
Tacoma, Washington, 98405
- Recruiting
Northwest Medical Specialties
Tacoma, Washington, 98405
- Recruiting
Florida Clinical Trials Group Tamarac
Tamarac, Florida, 33321
- Recruiting
Moffitt Cancer Center McKinley Campus Richard M Shulze Family Foundation Outpatient Center
Tampa, Florida, 33612
- Recruiting
McGlinn Cancer Institute
West Reading, Pennsylvania, 19611-2143
- Recruiting
Carolina Cancer Research Center
Wilson, North Carolina, 27896
- Recruiting
Multicare Cancer Institute North Star Lodge
Yakima, Washington, 98902
China30 sites, 30 recruiting
- Recruiting
Affiliated Hospital of Hebei University(North Branch)
Baoding, Hebei, 71000
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
- Recruiting
The First Affiliated Hospital of Bengbu Medical University
Bengbu, Anhui, 233004
- Recruiting
The First Peoples Hospital of Changde City
Changde, Hunan, 415000
- Recruiting
Xiangya Hospital of Central South University
Changsha, Hunan, 410008
- Recruiting
Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
Chengdu, Sichuan, 610071
- Recruiting
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 630014
- Recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001
- Recruiting
The Peoples Hospital Affiliated to Fujian University of Traditional Chinese Medicine
Fuzhou, Fujian, 350009
- Recruiting
Fujian Cancer Hospital
Fuzhou, Fujian, 350014
- Recruiting
Sun Yat Sen University Cancer Center
Guangzhou, Guangdong, 510060
- Recruiting
Sun Yat Sen Memorial Hospital, Sun Yat Sen University (South)
Guangzhou, Guangdong, 510245
- Recruiting
Hainan General Hospital
Haikou, Hainan, 570206
- Recruiting
Yunnan Cancer Hospital
Kunming, Yunnan, 650100
- Recruiting
Nanchang Peoples Hospitalchaoyang Branch
Nanchang, Jiangxi, 330025
- Recruiting
Jiangxi Cancer Hospital
Nanchang, Jiangxi, 330029
- Recruiting
Jiangsu Province Hospital Longjiang Branch
Nanjing, Jiangsu, 210036
- Recruiting
Guangxi Medical University Cancer Hospital Wuxiang Branch
Nanning, Guangxi, 530201
- Recruiting
Affiliated Hospital of Nantong University
Nantong, Jiangsu, 201203
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200000
- Recruiting
Cancer Hospital of Shantou University Medical College
Shantou, Guangdong, 515031
- Recruiting
The Fourth Hospital of Hebei Medical University East Branch
Shijiazhuang, Hebei, 050035
- Recruiting
Binhai Hospital, Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300453
- Recruiting
Weifang Peoples Hospital
Weifang, Shandong, 261000
- Recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
- Recruiting
Union Hospital Tongji Medical College Huazhong University of Science and Technologyjinyinhu Branch
Wuhan, Hubei, 430048
- Recruiting
Hubei Cancer Hospital
Wuhan, Hubei, 430079
- Recruiting
The Second Affiliated Hospital of Xian Jiaotong University
Xi'an, Shaanxi, 710004
- Recruiting
Yuncheng Central Hospital West Branch
Yuncheng, Shanxi, 44099
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
South Korea25 sites, 25 recruiting
- Recruiting
Cha Bundang Medical Center, Cha University
BundangGu SeongnamSi, Gyeonggi-do, 13496
- Recruiting
Soon Chun Hyang University Cheonan Hospital
Cheonansi, Chungcheongnam-do, 31151
- Recruiting
Chungbuk National University Hospital
Cheongju-si, Chungcheongbukdo, 28644
- Recruiting
Keimyung University Dongsan Hospital
Dalseogu, Daegu Gwang'yeogsi, 42601
- Recruiting
Korea University Ansan Hospital
DanwonGu AnsanSi, Gyeonggi-do, 15355
- Recruiting
Chung Ang University Hospital
DongjakGu, Seoul Teugbyeolsi, 06973
- Recruiting
Samsung Medical Center
GangnamGu, Seoul Teugbyeolsi, 06351
- Recruiting
Korea University Guro Hospital
GuroGu, Seoul Teugbyeolsi, 08308
- Recruiting
Inje University Haeundae Paik Hospital
HaeundaeGu, Busan Gwang'yeogsi, 48108
- Recruiting
Chonnam National University Hwasun Hospital
HwasunGun, Jeonnam-Gwangju S.M. City, 58128
- Recruiting
National Cancer Center (Korea)
IlsandongGu GoyangSi, Gyeonggi-do, 10408
- Recruiting
Inha University Hospital
Jemulpogu, Incheon Gwang'yeogsi, 22332
- Recruiting
Gachon University Gil Medical Center
NamdongGu, Incheon Gwang'yeogsi, 21565
- Recruiting
The Catholic University of Korea, St Vincents Hospital
PaldalGu SuwonSi, Gyeonggi-do, 16247
- Recruiting
The Catholic University of Korea, Seoul St Marys Hospital
SeochoGu, Seoul Teugbyeolsi, 06591
- Recruiting
Severance Hospital Yonsei University Health System
SeodaemunGu, Seoul Teugbyeolsi, 03722
- Recruiting
Dong A University Hospital
Seogu, Busan Gwang'yeogsi, 49201
- Recruiting
Korea University Anam Hospital
SeongbukGu, Seoul Teugbyeolsi, 02841
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
- Recruiting
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, 03080
- Recruiting
Gangnam Severance Hospital, Yonsei University Health System
Seoul, Seoul Teugbyeolsi, 06273
- Recruiting
Ehwa Womans University Mokdong Hospital
Seoul, Seoul Teugbyeolsi, 07985
- Recruiting
Asan Medical Center
SongpaGu, Seoul Teugbyeolsi, 05505
- Recruiting
Ajou University Hospital
Suwon, 16499
- Recruiting
Ulsan University Hospital
Ulsan, Ulsan Gwang'yeogsi, 44033
Japan19 sites, 19 recruiting
- Recruiting
Tokyo Metropolitan Komagome Hospital
Bunkyoku, Tokyo, 113-8677
- Recruiting
Hiroshima City Hiroshima Citizens Hospital
Hiroshima, Hiroshima, 730-8518
- Recruiting
Tokai University Hospital
Iseharashi, Kanagawa, 259-1193
- Recruiting
Social Medical Corporation Hakuaikai Sagara Hospital
Kagoshima, Kagoshima-ken, 892-0833
- Recruiting
Nippon Medical School Musashi Kosugi Hospital
Kawasakishi, Kanagawa, 211-8533
- Recruiting
Cancer Institute Hospital of Jfcr
Kotoku, Tokyo, 135-8550
- Recruiting
Japan Community Healthcare Organization Kurume General Hospital
Kurumeshi, Fukuoka, 830-0013
- Recruiting
Hyogo Medical University Hospital
Nishinomiyashi, Hyōgo, 663-8501
- Recruiting
National Hospital Organization Osaka National Hospital
Osakashi, Osaka, 540-0006
- Recruiting
Osaka International Cancer Institute
OsakaShi, Osaka, 541-8567
- Recruiting
Gunma Prefectural Cancer Center
Otashi, Gunma, 373-8550
- Recruiting
National Hospital Organization Hokkaido Cancer Center
Sapporo, Hokkaido, 003-0804
- Recruiting
Showa Medical University Hospital
Shinagawaku, Tokyo, 142-8666
- Recruiting
Tokyo Womens Medical University Hospital
Shinjukuku, Tokyo, 162-8666
- Recruiting
The University of Osaka Hospital
Suitashi, Osaka, 565-0871
- Recruiting
Shizuoka Cancer Center
Suntogun, Shizuoka, 411-8777
- Recruiting
Mie University Hospital
Tsu, Mie-ken, 514-8507
- Recruiting
Yokohama City University Medical Center
Yokohama, Kanagawa, 232-0024
- Recruiting
Kanagawa Cancer Center
Yokohama, Kanagawa, 241-8515
Brazil11 sites, 11 recruiting
- Recruiting
Fundacao Pio Xii Hospital de Amor de Barretos
Barretos, 14.784-400
- Recruiting
Hospital Brasilia
Brasília, 71681-603
- Recruiting
Fundacao Universidade de Caxias Do Sul
Caxias do Sul, 95070-560
- Recruiting
Oncosite Centro de Pesquisa Clinica Em Oncologia
Ijuí, 98700-000
- Recruiting
Liga Norte Riograndene Contra O Cancer
Natal, 59062-000
- Recruiting
Hospital Sao Lucas Da Pucrs
Porto Alegre, 90610-000
- Recruiting
Instituto Sul Mineiro de Oncologia Ltda
Pouso Alegre, 37554-238
- Recruiting
Hospital Do Cancer de Pernambuco
Recife, 50040-000
- Recruiting
Instituto Nacional de Cancer
Rio de Janeiro, 20560-120
- Recruiting
Icesp Instituto Do Cancer Do Estado de Sao Paulo Octavio Frias de Oliveira
São Paulo, 01246-000
- Recruiting
Hospital Santa Rita de Cassia Afecc
Vitória, 29043-260
Malaysia9 sites, 9 recruiting
- Recruiting
Pulau Pinang Hospital
George Town, 10450
- Recruiting
Hospital Raja Permaisuri Bainun
Ipoh, 30450
- Recruiting
Hospital Raja Perempuan Zainab Ii
Johor Bahru, 15586
- Recruiting
Hospital Wanita Dan Kanak Kanak Sabah (Hospital Likas)
Kota Kinabalu Sabah, 88996
- Recruiting
Hospital Kuala Lumpur
Kuala Lumpur, 50586
- Recruiting
University Malaya Medical Centre
Kuala Lumpur, 59100
- Recruiting
Sarawak General Hospital
Kuching, 93586
- Recruiting
Hospital Picaso
Petaling Jaya, 46300
- Recruiting
National Cancer Institute (Institut Kanser Negara)
Putrajaya, 62250
Australia8 sites, 8 recruiting
- Recruiting
Sunshine Coast University Private Hospital
Birtinya, Queensland, QLD 4575
- Recruiting
Blacktown Cancer and Haematology Centre
Blacktown, New South Wales, NSW 2148
- Recruiting
Townsville University Hospital
Douglas, Queensland, QLD 4814
- Recruiting
Liverpool Hospital
Liverpool, New South Wales, NSW 2170
- Recruiting
Peter Maccallum Cancer Centre
Melbourne, Victoria, VIC 3000
- Recruiting
Fiona Stanley Hospital
Murdoch, Western Australia, WA 6150
- Recruiting
One Clinical Research
Nedlands, Western Australia, WA 6009
- Recruiting
Wollongong Hospital
Wollongong, New South Wales, NSW 2500
Poland6 sites, 6 recruiting
- Recruiting
Bialostockie Centrum Onkologii Im M Sklodowskiej Curie W Bialymstoku
Bialystok, 15-027
- Recruiting
Szpitale Pomorskie Spolka Z Ograniczona Odpowiedzialnoscia
Gdynia, 81-519
- Recruiting
Pratia McM Krakow
Krakow, 30-727
- Recruiting
Szpital Specjalistyczny Im Ludwika Rydygiera W Krakowie
Krakow, 31-826
- Recruiting
Opolskie Centrum Onkologii
Opole, 45-061
- Recruiting
Narodowy Instytut Onkologii Im Marii Sklodowskiej Curie W Warszawie
Warsaw, 02-781
Spain6 sites, 6 recruiting
- Recruiting
Hospital Clinic de Barcelona
Barcelona, 08036
- Recruiting
Hospital General Universitario de Elche
Elcheelx, 03203
- Recruiting
Hospital Universitario Clinico San Cecilio
Granada, 18016
- Recruiting
Iob Institute of Oncology Madrid
Madrid, 28007
- Recruiting
Complejo Hospitalario Univ de Santiago (Chus)
Santiago de Compostela, 15706
- Recruiting
Hospital Universitario Virgen Del Rocio
Seville, 41013
France5 sites, 5 recruiting
- Recruiting
Centre de Lutte Contre Le Cancer Institut Bergonie
Bordeaux, 33076
- Recruiting
Institut Paoli Calmettes
Marseille, 13009
- Recruiting
Icm Val Daurelle
Montpellier, 34090
- Recruiting
Centre Eugene Marquis
Rennes, 35043
- Recruiting
Institut Gustave Roussy
Villejuif, 94800
Italy4 sites, 4 recruiting
- Recruiting
Asst Papa Giovanni Xxiii
Bergamo, 24127
- Recruiting
Istituto Europeo Di Oncologia
Milan, 20141
- Recruiting
Azienda Socio Sanitaria Territoriale Di Monza (Presidio San Gerardo)
Monza, 20900
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli
Roma, 00168
Taiwan4 sites, 4 recruiting
- Recruiting
Taipei Veterans General Hospital
Beitou Dist, 11217
- Recruiting
China Medical University Hospital
Taichung, 40447
- Recruiting
National Cheng Kung University Hospital
Tainan, 704
- Recruiting
National Taiwan University Hospital
Zhongzheng Dist, 100225
Turkey (Türkiye)4 sites, 4 recruiting
- Recruiting
Adana City Education and Research Hospital
Adana, 01060
- Recruiting
Hacettepe University
Ankara, 6100
- Recruiting
Marmara University Pendik Research and Training Hospital
Istanbul, 34899
- Recruiting
Kocaeli Universitesi Tip Fakultesi
Kocaeli, 41380
United Kingdom2 sites, 2 recruiting
- Recruiting
Royal Surrey County Hospital
Guildford, GU27XX
- Recruiting
Maidstone and Tunbridge Wells Nhs Trust Kent Oncology Centre Maidstone Hospital
Maidstone, ME16 9QQ
Germany1 site, 1 recruiting
- Recruiting
Invo Institut Fur Versorgungsforschung in Der Onkologie
Koblenz, 56068
Puerto Rico1 site, 1 recruiting
- Recruiting
Brcr Global Puerto Rico Hato Rey
San Juan, 00917
About this study
Official title: 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
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.
- Conditions
- HR+/HER2- Breast Cancer
- Being tested
- BGB-43395, Letrozole, Abemaciclib, Palbociclib, Ribociclib
- Keywords
- CDK4 inhibitor, CDK4/6 inhibitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BGB-43395Drug
Administered orally.
LetrozoleDrug
Administered orally.
AbemaciclibDrug
Administered orally.
PalbociclibDrug
Administered orally.
RibociclibDrug
Administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Arm A: BGB-43395 + Letrozole | Experimental | Participants will receive BGB-43395 in combination with letrozole. Receives: Drug: BGB-43395; Drug: Letrozole |
| Arm B: Cyclin-Dependent Kinase 4/6 Inhibitor + Letrozole | Active comparator | Participants will receive either abemaciclib, palbociclib, or ribociclib based on the Investigator's choice in combination with letrozole. Receives: Drug: Letrozole; Drug: Abemaciclib; Drug: Palbociclib; Drug: Ribociclib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to approximately 4 years
Secondary outcomes (9)
Overall Survival (OS)
OS is defined as the time from the date of randomization until the date of death due to any cause.
Measured: Up to approximately 11 years
Overall Response Rate (ORR)
ORR is defined as the percentage of participants who had a complete response (CR) or partial response (PR), as assessed by BICR per RECIST v1.1.
Measured: Up to approximately 4 years
Duration of Response (DOR)
DOR is defined as the time from the first occurrence of a documented objective response to the time of disease progression or death from any cause, whichever occurs first, as assessed by BICR per RECIST v1.1.
Measured: Up to approximately 4 years
PFS Determined by Investigator
PFS is defined as the time from first dose until first documentation of progression or death, whichever comes first, as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Measured: Up to approximately 4 years
Clinical Benefit Rate (CBR)
CBR is defined as the percentage of participants who have a CR, PR, or stable disease maintained for ≥ 24 weeks after randomization (without subsequent anticancer treatment) per RECIST v1.1 .
Measured: Up to approximately 4 years
Time to Response (TTR)
TTR is defined as the time from treatment initiation to the first response confirmed by BICR per RECIST v1.1.
Measured: Up to approximately 4 years
Number of Participants with Adverse Events (AEs)
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including laboratory values, vital signs, physical examination findings, and electrocardiogram results.
Measured: From first dose of study drug up to 30 days after last dose, up to approximately 11 years
Change from Baseline in European Organisation for Research and Treatment of Cancer (EORTC)-Item Library (IL)454.
The EORTC-IL454 is a questionnaire that asks participants to rate their breast cancer symptoms and the impact of breast cancer on their quality of life (QoL). The EORTC-IL454 is an EORTC Item Library-derived scale set constructed using items from the validated EORTC Quality of Life Questionnaire-Core 30 (QLQ-C30) (a core measure of health-related QoL in cancer patients) and the QLQ-BR23 (its breast cancer-specific module)
The EORTC-IL454 contains 26 questions, each answered on a 4-point scale (1 = Not at all; 4 = Very much), and includes 2 functional scales (physical functioning and role functioning), 2 symptom scales (Nausea/Vomiting and Diarrhea), and 1 Global Health Status (GHS)/Quality of Life (QoL) scale, 7 systemic side effects scales, 3 arm symptom scales, and 4 breast-specific symptom scales. The recall period is the past 7 days. Higher scores in GHS and functional scales and lower scores in symptom scales indicate better QoL.
Measured: Baseline and up to approximately 4 years
Progression-Free Survival 2 (PFS2)
PFS2 is defined as the time from randomization until progression on the next line of treatment (ie, first subsequent therapy), as assessed by the investigator, or death due to any cause, whichever occurs first.
Measured: Up to approximately 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2026
- Study start22 May 2026
- Primary completionApr 2029 (estimated)
- Study completion7 Aug 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HR+/HER2- Breast CancerStudies of the same condition, open and under way.
- More trials run by BeOne MedicinesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,056 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BeOne Medicines
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, BeOne Medicines
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07492641
- Sponsor's protocol ID
- BGB-43395-302
- Other IDs
- 2025-523960-19-00, 2025
- Acronym
- KANDELA-302
- Status last verified
- Sep 2026
- First submitted
- 20 Mar 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.