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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

Study acronym: KANDELA-302
StatusRecruiting
PhasePhase 3
Started2026-05-22
View on ClinicalTrials.gov ↗

Amendment history

2026-09-29
Trial sites expanded: 162 → 189 locations
2026-08-18
Study Status, Contacts/Locations v9
Trial sites expanded: 108 → 162 locations
Trial sites expanded: 90 → 108 locations
2026-08-05
Study Status, Contacts/Locations v8
Trial sites expanded: 74 → 90 locations
2026-07-22
Study Status, Contacts/Locations v7
Trial sites expanded: 62 → 74 locations
2026-07-09
Study Status, Contacts/Locations v6
Trial sites expanded: 30 → 62 locations
2026-06-17
Study Status, Contacts/Locations v5
Trial sites expanded: 13 → 30 locations
2026-06-15
Study Status v4
Start date2026-05-20→2026-05-22
2026-06-01
Study Status, Contacts/Locations v3
Trial sites expanded: 4 → 13 locations
2026-05-21
Study Status, Contacts/Locations v2
Recruitment opened
Trial sites expanded: 0 → 4 locations
Start dateestimated 2026-05-11→confirmed 2026-05-20
2026-04-22
Study Identification, Study Status, Outcome Measures, Eligibility v1
Eligibility criteria+186 characters
[...] 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 uncontr [...]
Secondary endpoints8 to 9 entries
Progression-Free Survival 2 (PFS2)
2026-03-20
Original filing
BeOne Medicines
59 trials monitored
See 7 trials at risk
Breast Cancer
5,180 trials monitored
See 256 trials at risk
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 Details
NCT Number NCT07492641
Lead Sponsor BeOne Medicines
Conditions HR+/HER2- Breast Cancer
Enrollment 1,056 participants
Start Date 2026-05-22
Primary Completion 2029-04 (estimated)
Study Completion 2037-08-07 (estimated)
Updated on ClinicalTrials.gov 2026-09-28