{"entity":{"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","aka":[],"tldr":"Published report from the DAWNA-1 trial registered as NCT03927456, in Nature Medicine (2021), chosen as the most cited paper whose own text cites the registry id.","summary":"Blockade of the cyclin-dependent kinase 4 and 6 pathway has been shown to be effective in the treatment of hormone receptor-positive advanced breast cancer (ABC). We report the interim results of DAWNA-1 ( NCT03927456), a double-blind, randomized, phase 3 trial of dalpiciclib (a new cyclin-dependent kinase 4 and 6 inhibitor) plus fulvestrant in hormone receptor-positive, HER2-negative ABC with disease progression after endocrine therapy. A total of 361 patients were randomized 2:1 to receive dalpiciclib plus fulvestrant or placebo plus fulvestrant. The study met the primary end point, showing significantly prolonged investigator-assessed progression-free survival with dalpiciclib plus fulvestrant versus placebo plus fulvestrant (median = 15.7, 95% confidence interval (CI) = 11.1-not reached versus 7.2, 95% CI = 5.6-9.2 months; hazard ratio = 0.42, 95% CI = 0.31-0.58; one-sided P < 0.0001 (boundary was P ≤ 0.008)). The most common grade 3 or 4 adverse events with dalpiciclib plus fulvestrant were neutropenia (84.2%) and leukopenia (62.1%). The incidence of serious adverse events was 5.8% with dalpiciclib plus fulvestrant versus 6.7% with placebo plus fulvestrant. Our findings support dalpiciclib plus fulvestrant as a new treatment option for pretreated hormone receptor-positive, HER2-negative ABC.\n\nIndexed on Europe PMC as PubMed record 34737452 (DOI 10.1038/s41591-021-01562-9). Its abstract cites the registry id NCT03927456, which is how it was matched to this trial; no figure has been checked by an editor.","asOf":"2026-09-22","links":[{"label":"Nat Med 2021","url":"https://doi.org/10.1038/s41591-021-01562-9"},{"label":"PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/34737452/"},{"label":"Europe PMC","url":"https://europepmc.org/article/MED/34737452"},{"label":"ClinicalTrials.gov NCT03927456","url":"https://clinicaltrials.gov/study/NCT03927456"}],"tags":["europepmc-ingest"],"related":[],"cancers":[],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":["dawna-1"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":["nature-medicine"],"dependsOn":[],"notes":[],"journal":"Nature Medicine","year":2021,"doi":"10.1038/s41591-021-01562-9","pmid":"34737452","authors":"Xu B, Zhang Q, Zhang P, et al.","paperType":"rct","findings":[],"whatItMeans":"This is the paper Europe PMC returns for registry id NCT03927456 with the most citations, so it is the natural first reading for anyone following the DAWNA-1 trial. Read the abstract above alongside the trial page and the registry entry; the record was linked automatically and its figures have not been checked by hand.","caveats":["Matched to the trial by the registry id cited in the Europe PMC record; the summary reproduces the record's abstract and no figure has been verified against the full paper."]},"route":"/key-papers/paper-dawna-1-nat-med-2021/","neighbours":{"trial":[{"id":"dawna-1","kind":"trial","name":"DAWNA-1","route":"/trials/dawna-1/"}],"journal":[{"id":"nature-medicine","kind":"journal","name":"Nature Medicine","route":"/journals/nature-medicine/"}]}}