{"entity":{"id":"nct07492641","kind":"trial","name":"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","aka":["KANDELA-302"],"tldr":"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.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07492641","url":"https://clinicaltrials.gov/study/NCT07492641"}],"tags":["ctgov-ingest"],"related":[],"cancers":["breast-hr-positive"],"sections":[],"technologies":[],"targets":[],"drugs":["bgb-43395"],"companies":["beone"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"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","participation":[{"nct":"NCT07492641","source":"https://clinicaltrials.gov/study/NCT07492641","fetchedAt":"2026-10-07T16:55:46.774Z","studySha256":"5af61c49ac28fe7b2bb2ba9be89917a19ceb7823bf9f3cde578d450817cc35f7","overallStatus":"RECRUITING","lastUpdatePosted":"2026-09-28","leadSponsor":"BeOne Medicines","collaboratorCount":0,"minimumAge":"18 Years","sex":"ALL","healthyVolunteers":false,"hasEligibility":true,"enrolment":1056,"enrolmentType":"ESTIMATED","siteCount":189,"recruitingSiteCount":189,"countries":["Australia","Brazil","China","France","Germany","Italy","Japan","Malaysia","Poland","Puerto Rico","South Korea","Spain","Taiwan","Turkey (Türkiye)","United Kingdom","United States"]}],"started":"2026-05-22","startedType":"actual","enrolled":1056,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct07492641/","neighbours":{"cancer":[{"id":"breast-hr-positive","kind":"cancer","name":"HR-positive / HER2-negative breast cancer","route":"/cancers/breast-hr-positive/"}],"drug":[{"id":"bgb-43395","kind":"drug","name":"BGB-43395","route":"/drugs/bgb-43395/"}],"company":[{"id":"beone","kind":"company","name":"BeOne Medicines (formerly BeiGene)","route":"/companies/beone/"}]}}