{"entity":{"id":"nct04214288","kind":"trial","name":"A Study to Investigate Efficacy and Safety With Oral AZD9833 Compared With Intramuscular Fulvestrant in Post-menopausal Women at Least 18 Years of Age With Advanced ER-positive HER2 Negative Breast Cancer","aka":["SERENA-2"],"tldr":"A phase 2 trial of Camizestrant and Fulvestrant in HR-positive / HER2-negative breast cancer, run by AstraZeneca, active and no longer recruiting.","summary":"A Study to Investigate Efficacy and Safety With Oral AZD9833 Compared With Intramuscular Fulvestrant in Post-menopausal Women at Least 18 Years of Age With Advanced ER-positive HER2 Negative Breast Cancer is a phase 2 interventional study registered as NCT04214288 by AstraZeneca, with 240 participants enrolled, started 2020-04-22 and due to reach its primary completion in 2022-08-30. Interventions recorded: AZD9833 and Fulvestrant. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04214288","url":"https://clinicaltrials.gov/study/NCT04214288"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-hr-positive"],"sections":[],"technologies":["endocrine-therapy"],"targets":[],"drugs":["camizestrant","fulvestrant"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct04214288-lancet-oncol-2024"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04214288","phase":"2","setting":"SERENA-2: A Randomised, Open-Label, Parallel-Group, Multicentre Phase 2 Study Comparing the Efficacy and Safety of Oral AZD9833 Versus Fulvestrant in Women With Advanced ER-Positive HER2-Negative Breast Cancer","sponsor":"AstraZeneca","started":"2020-04-22","startedType":"actual","yearReported":2023,"enrolled":240,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free Survival (PFS)","primary":true,"unit":"months","arms":[{"name":"AZD9833 75mg","n":74,"value":7.2,"note":"90% CI 3.7 to 10.9; Figures from the ClinicalTrials.gov results section (first posted 2023-12-12), not from a publication"},{"name":"AZD9833 150mg","n":73,"value":7.7,"note":"90% CI 5.5 to 12.9"},{"name":"AZD9833 300mg","n":20,"value":6.3,"note":"90% CI 1.9 to NA"},{"name":"Fulvestrant 500 mg","n":73,"value":3.7,"note":"90% CI 2.0 to 6.0"}],"source":"https://clinicaltrials.gov/study/NCT04214288?tab=results"},{"endpoint":"Objective Response Rate (ORR)","unit":"%","arms":[{"name":"AZD9833 75mg","n":70,"value":15.7,"note":"Figures from the ClinicalTrials.gov results section (first posted 2023-12-12), not from a publication"},{"name":"AZD9833 150mg","n":65,"value":17.1},{"name":"AZD9833 300mg","n":19,"value":25.2},{"name":"Fulvestrant 500 mg","n":68,"value":11.6}],"source":"https://clinicaltrials.gov/study/NCT04214288?tab=results"}]},"route":"/trials/nct04214288/","neighbours":{"cancer":[{"id":"breast-hr-positive","kind":"cancer","name":"HR-positive / HER2-negative breast cancer","route":"/cancers/breast-hr-positive/"}],"technology":[{"id":"endocrine-therapy","kind":"technology","name":"Endocrine therapy (SERMs, AIs, SERDs)","route":"/technologies/endocrine-therapy/"}],"drug":[{"id":"camizestrant","kind":"drug","name":"Camizestrant","route":"/drugs/camizestrant/"},{"id":"fulvestrant","kind":"drug","name":"Fulvestrant","route":"/drugs/fulvestrant/"}],"company":[{"id":"astrazeneca","kind":"company","name":"AstraZeneca","route":"/companies/astrazeneca/"}],"paper":[{"id":"paper-nct04214288-lancet-oncol-2024","kind":"paper","name":"Camizestrant, a next-generation oral SERD, versus fulvestrant in post-menopausal women with oestrogen receptor-positive, HER2-negative advanced breast cancer (SERENA-2): a multi-dose, open-label, randomised, phase 2 trial","route":"/key-papers/paper-nct04214288-lancet-oncol-2024/"}]}}