{"entity":{"id":"paper-nct05587296-n-engl-j-med-2025","kind":"paper","name":"Elinzanetant for Vasomotor Symptoms from Endocrine Therapy for Breast Cancer","aka":[],"tldr":"Published report from the OASIS-4 trial registered as NCT05587296, in New England Journal of Medicine (2025), chosen as the most cited paper whose own text cites the registry id.","summary":"Background: Women receiving endocrine therapy for hormone receptor (HR)-positive breast cancer or its prevention among those at high risk for breast cancer commonly have vasomotor symptoms. Data are lacking on the effects of elinzanetant, a neurokinin-targeted therapy shown to be effective in treating vasomotor symptoms, in this population.\n\nMethods: We performed a phase 3 trial involving women 18 to 70 years of age with moderate-to-severe vasomotor symptoms associated with endocrine therapy for HR-positive breast cancer or its prevention. Women were randomly assigned in a 2:1 ratio to receive once-daily elinzanetant at a dose of 120 mg for 52 weeks or once-daily placebo for 12 weeks followed by once-daily elinzanetant at a dose of 120 mg for 40 weeks. The primary end points were the change in the mean daily frequency of moderate-to-severe vasomotor symptoms from baseline to week 4 and to week 12.\n\nResults: A total of 316 participants were assigned to the elinzanetant group and 158 to the placebo-elinzanetant group. At baseline, the mean daily frequency of moderate-to-severe vasomotor symptoms was 11.4 episodes (95% confidence interval [CI], 10.7 to 12.2) in the elinzanetant group and 11.5 episodes (95% CI, 10.5 to 12.5) in the placebo-elinzanetant group. At week 4, the mean change from baseline in the mean daily frequency of moderate-to-severe vasomotor symptoms was -6.5 episodes (95% CI, -7.2 to -5.8) among those who were receiving elinzanetant and -3.0 episodes (95% CI, -3.9 to -2.2) among those who were receiving placebo (least-squares mean difference, -3.5 episodes; 95% CI, -4.4 to -2.6; P<0.001). At week 12, the mean change was -7.8 episodes (95% CI, -8.5 to -7.1) among those receiving elinzanetant and -4.2 episodes (95% CI, -5.2 to -3.2) among those receiving placebo (least-squares mean difference, -3.4 episodes; 95% CI, -4.2 to -2.5; P<0.001). During weeks 1 through 12, a total of 220 participants (69.8%) receiving elinzanetant and 98 (62.0%) receiving placebo reported at least one adverse event that occurred while receiving elinzanetant or placebo, with the most common being headache, fatigue, and somnolence. Serious adverse events occurred during weeks 1 through 12 in 8 participants (2.5%) receiving elinzanetant and 1 participant (0.6%) receiving placebo.\n\nConclusions: Elinzanetant led to a significantly lower frequency of vasomotor symptoms associated with endocrine therapy than placebo. (Funded by Bayer; OASIS-4 ClinicalTrials.gov number, NCT05587296.).\n\nIndexed on Europe PMC as PubMed record 40454634 (DOI 10.1056/nejmoa2415566). Its abstract cites the registry id NCT05587296, which is how it was matched to this trial; no figure has been checked by an editor.","asOf":"2026-09-22","links":[{"label":"N Engl J Med 2025","url":"https://doi.org/10.1056/nejmoa2415566"},{"label":"PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/40454634/"},{"label":"Europe PMC","url":"https://europepmc.org/article/MED/40454634"},{"label":"ClinicalTrials.gov NCT05587296","url":"https://clinicaltrials.gov/study/NCT05587296"}],"tags":["europepmc-ingest"],"related":[],"cancers":[],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":["nct05587296"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":["nejm"],"dependsOn":[],"notes":[],"journal":"New England Journal of Medicine","year":2025,"doi":"10.1056/nejmoa2415566","pmid":"40454634","authors":"Cardoso F, Parke S, Brennan DJ, et al.","paperType":"rct","findings":[],"whatItMeans":"This is the paper Europe PMC returns for registry id NCT05587296 with the most citations, so it is the natural first reading for anyone following the OASIS-4 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-nct05587296-n-engl-j-med-2025/","neighbours":{"trial":[{"id":"nct05587296","kind":"trial","name":"A Study to Learn More About How Well Elinzanetant Works and How Safe it is Compared to Placebo for the Treatment of Hot Flashes Caused by Anti-cancer Therapy in Women With, or at High Risk for Developing Hormone-receptor Positive Breast Cancer","route":"/trials/nct05587296/"}],"journal":[{"id":"nejm","kind":"journal","name":"New England Journal of Medicine","route":"/journals/nejm/"}]}}