{"entity":{"id":"dawna-1","kind":"trial","name":"DAWNA-1","aka":[],"tldr":"The trial that made dalpiciclib the first Chinese CDK4/6 inhibitor approved, more than doubling the time before breast cancer grew when added to fulvestrant.","summary":"361 patients randomised 2:1. Median progression-free survival 15.7 versus 7.2 months (hazard ratio 0.42), published in Nature Medicine 2021, with neutropenia the main toxicity. NMPA approval December 2021; DAWNA-2 (first line with an aromatase inhibitor) followed in 2023. It reproduced the PALOMA-3 and MONALEESA-3 pattern with a domestic, reimbursed drug.","status":"positive","asOf":"2026-09-10","links":[{"label":"ClinicalTrials.gov NCT03927456","url":"https://clinicaltrials.gov/study/NCT03927456"},{"label":"Nat Med 2021","url":"https://doi.org/10.1038/s41591-021-01562-9"}],"tags":["china"],"related":[],"cancers":["breast-hr-positive"],"sections":[],"technologies":["cdk46-inhibitor"],"targets":["cdk4-6"],"drugs":["dalpiciclib","fulvestrant"],"companies":["hengrui"],"institutions":["cams-cancer-hospital"],"pathways":[],"terms":[],"trials":[],"people":["xu-binghe"],"bottlenecks":[],"keyPapers":["paper-dawna-1-nat-med-2021"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03927456","phase":"3","setting":"HR-positive, HER2-negative advanced breast cancer after progression on endocrine therapy, China: dalpiciclib or placebo plus fulvestrant","sponsor":"Jiangsu Hengrui Pharmaceuticals","result":"PFS 15.7 vs 7.2 months, HR 0.42.","started":"2019-06-13","startedType":"actual","yearReported":2021,"enrolled":361,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival","primary":true,"unit":"months","arms":[{"name":"Dalpiciclib + fulvestrant","n":241,"value":15.7},{"name":"Placebo + fulvestrant","n":120,"value":7.2}],"hr":0.42,"source":"https://doi.org/10.1038/s41591-021-01562-9"}]},"route":"/trials/dawna-1/","neighbours":{"cancer":[{"id":"breast-hr-positive","kind":"cancer","name":"HR-positive / HER2-negative breast cancer","route":"/cancers/breast-hr-positive/"}],"technology":[{"id":"cdk46-inhibitor","kind":"technology","name":"CDK4/6 inhibitors","route":"/technologies/cdk46-inhibitor/"}],"target":[{"id":"cdk4-6","kind":"target","name":"CDK4/6","route":"/targets/cdk4-6/"}],"drug":[{"id":"dalpiciclib","kind":"drug","name":"Dalpiciclib","route":"/drugs/dalpiciclib/"},{"id":"fulvestrant","kind":"drug","name":"Fulvestrant","route":"/drugs/fulvestrant/"}],"company":[{"id":"hengrui","kind":"company","name":"Jiangsu Hengrui Pharmaceuticals","route":"/companies/hengrui/"}],"institution":[{"id":"cams-cancer-hospital","kind":"institution","name":"Cancer Hospital, Chinese Academy of Medical Sciences","route":"/institutions/cams-cancer-hospital/"}],"person":[{"id":"xu-binghe","kind":"person","name":"Binghe Xu","route":"/people/xu-binghe/"}],"paper":[{"id":"paper-dawna-1-nat-med-2021","kind":"paper","name":"Dalpiciclib or placebo plus fulvestrant in hormone receptor-positive and HER2-negative advanced breast cancer: a randomized, phase 3 trial","route":"/key-papers/paper-dawna-1-nat-med-2021/"}]}}