DISCLAIMER
The contents of the presentation are designed for educational and scientific exchange purposes and are not promotional. They may contain information on investigational products or investigational uses of approved products. No conclusions regarding safety and/or efficacy for such investigational products or uses may be made.
SUMMARY
KANDELA-302 is an open-label, randomized, global phase 3 trial evaluating the investigational CDK4-selective inhibitor BGB-43395 plus letrozole versus investigator’s choice of CDK4/6 inhibitor (abemaciclib, palbociclib, or ribociclib) plus letrozole as first-line treatment for adults with hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2−) locally advanced or metastatic breast cancer. Eligible patients (aged ≥18 years) with ECOG performance status ≤1, measurable disease per RECIST v1.1 (including evaluable bone-only disease), adequate organ function, and histologically confirmed locally advanced/metastatic HR+/HER2− breast cancer are randomized 1:1 to BGB-43395 400 mg twice daily plus letrozole 2.5 mg once daily or investigator’s choice of CDK4/6 inhibitor plus letrozole. Approximately 1,056 patients are being enrolled across North and South America, Europe, and Asia-Pacific. The primary endpoint is progression-free survival by blinded independent central review (BICR) per RECIST v1.1. Key secondary endpoint is overall survival. Other secondary endpoints include objective response rate, duration of response and time to response by BICR, progression-free survival and progression-free survival 2 by investigator assessment, clinical benefit rate, safety, and global health status/quality of life.
ClinicalTrials.gov ID: NCT07492641
| Population | Intervention | Comparator | Outcome Measures |
|---|---|---|---|
| Adults (≥18 years) with hormone receptor-positive/human epidermal growth factor receptor 2-negative locally advanced or metastatic breast cancer, ECOG performance status ≤1, measurable disease per RECIST v1.1 (including evaluable bone-only disease), and adequate organ function | BGB-43395 plus letrozole | Investigator’s choice of CDK4/6 inhibitor (abemaciclib, palbociclib, or ribociclib) plus letrozole |
|
The objective of KANDELA-302 is to evaluate the efficacy and safety of the investigational CDK4-selective inhibitor BGB-43395 plus letrozole compared with investigator’s choice of CDK4/6 inhibitor (abemaciclib, palbociclib, or ribociclib) plus letrozole as first-line therapy for patients with hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2−) locally advanced or metastatic breast cancer.
KANDELA-302 is an open-label, randomized, global phase 3 study that randomizes patients 1:1 to BGB-43395 plus letrozole or investigator’s choice of CDK4/6 inhibitor (abemaciclib, palbociclib, or ribociclib) plus letrozole. Gonadotropin-releasing hormone agonist treatment is required for premenopausal patients. Stratification factors include visceral metastases, de novo metastatic diagnosis, and investigator’s CDK4/6i choice.
Eligible patients (aged ≥18 years) with ECOG performance status ≤1, measurable disease per RECIST v1.1 (including evaluable bone-only disease), adequate organ function, and histologically confirmed locally advanced/metastatic HR+/HER2− breast cancer.
Key exclusion criteria are prior systemic therapy for advanced/metastatic disease; early recurrence (≤12 months) after (neo)adjuvant endocrine therapy (±CDK4/6i); and prior CDK4 or CDK2 inhibitors or investigational agents except for oral selective estrogen receptor degraders.
The primary endpoint is progression-free survival by blinded independent central review (BICR) per RECIST v1.1.
Key secondary endpoint is overall survival. Other secondary endpoints include objective response rate, duration of response and time to response by BICR, progression-free survival and progression-free survival 2 by investigator assessment, clinical benefit rate, safety, and global health status/quality of life.
The study began enrollment in May 2026 and plans to enroll approximately 1,056 patients across North and South America, Europe, and Asia-Pacific.
