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
2 other identifiers
interventional
1,056
7 countries
74
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
74 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
July 24, 2026
July 1, 2026
2.9 years
March 20, 2026
July 22, 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 (74)
Alabama Oncology Princeton
Birmingham, Alabama, 35211, United States
Alaska Oncology and Hematology, Llc
Anchorage, Alaska, 99508-2974, United States
Ironwood Cancer and Research Centers Chandler Ii
Chandler, Arizona, 85224-5665, United States
Helios Clinical Research the Oncology Institute Fountain Valley
Fountain Valley, California, 92708, United States
Brcr Coral Springs
Coral Springs, Florida, 33065, 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
Florida Clinical Trials Group Tamarac
Tamarac, Florida, 33321, United States
Hope and Healing Cancer Services
Hinsdale, Illinois, 60521-0509, United States
Cancer Care Specialists For Illinois
O'Fallon, Illinois, 62269, United States
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, 46804, United States
Owensboro Health Mitchell Memorial Cancer Center
Owensboro, Kentucky, 42303, 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
Astera Cancer Care East Brunswick
East Brunswick, New Jersey, 08816-4096, United States
Summit Medical Group
Florham Park, New Jersey, 07932-1049, 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
Oregon Oncology Specialists
Salem, Oregon, 97301, United States
McGlinn Cancer Institute
West Reading, Pennsylvania, 19611-2143, United States
Virginia Cancer Institute
Richmond, Virginia, 23229-8605, United States
Northwest Medical Specialties
Tacoma, Washington, 98405, United States
Blacktown Cancer and Haematology Centre
Blacktown, New South Wales, NSW 2148, 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
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200000, China
National Hospital Organization Hokkaido Cancer Center
Sapporo, Hokkaido, 003-0804, 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
Mie University Hospital
Tsu, Mie-ken, 514-8507, 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 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
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, Jeollanam-do, 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
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
July 24, 2026
Record last verified: 2026-07
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.