# 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

Source: https://onco.cc/trials/nct07492641/  
OnCo record `nct07492641` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 3 trial testing BGB-43395 in HR-positive / HER2-negative breast cancer, now recruiting.

## Summary

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 is a phase 3 interventional study registered as NCT07492641, led by BeOne Medicines, and recruiting on the registry. Official title: An Open-Label, Randomised, 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. Planned enrolment is 1056 participants (estimated). The study started in 2026-05-22 and primary completion is expected in 2029-04. No results have been posted on ClinicalTrials.gov.

## Fields

- Kind: Trial
- Status: recruiting
- Last checked: 2026-09-11
- Also known as: KANDELA-302
- Tags: ctgov-ingest
- Registry id: NCT07492641
- Phase: 3
- Setting: 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
- Sponsor: BeOne Medicines
- Enrolled: 1056

## Sources

- ClinicalTrials.gov NCT07492641: https://clinicaltrials.gov/study/NCT07492641

## Connected records

- cancers: [HR-positive / HER2-negative breast cancer](https://onco.cc/cancers/breast-hr-positive/)
- drugs: [BGB-43395](https://onco.cc/drugs/bgb-43395/)
- companies: [BeOne Medicines (formerly BeiGene)](https://onco.cc/companies/beone/)

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JSON: https://onco.cc/api/v1/entities/nct07492641.json