{"entity":{"id":"nct04576455","kind":"trial","name":"A Study Evaluating the Efficacy and Safety of Giredestrant Compared With Physician's Choice of Endocrine Monotherapy in Participants With Previously Treated Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (acelERA Breast Cancer)","aka":[],"tldr":"A phase 2 trial of Giredestrant and Fulvestrant in HR-positive / HER2-negative breast cancer, run by Hoffmann-La Roche, active and no longer recruiting.","summary":"A Study Evaluating the Efficacy and Safety of Giredestrant Compared With Physician's Choice of Endocrine Monotherapy in Participants With Previously Treated Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (acelERA Breast Cancer) is a phase 2 interventional study registered as NCT04576455 by Hoffmann-La Roche, with 303 participants enrolled, started 2020-11-27 and due to reach its primary completion in 2022-02-18. Interventions recorded: Giredestrant, Fulvestrant or an Aromatase Inhibitor (Physician Choice) and LHRH Agonist. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04576455","url":"https://clinicaltrials.gov/study/NCT04576455"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-hr-positive"],"sections":[],"technologies":["endocrine-therapy"],"targets":[],"drugs":["giredestrant","fulvestrant"],"companies":["flatiron-health"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct04576455-j-clin-oncol-2024"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04576455","phase":"2","setting":"A Phase II, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of GDC-9545 Compared With Physician's Choice of Endocrine Monotherapy in Patients With Previously Treated Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer","sponsor":"Hoffmann-La Roche","started":"2020-11-27","startedType":"actual","yearReported":2023,"enrolled":303,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-Free Survival (PFS), as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)","primary":true,"unit":"months","arms":[{"name":"Giredestrant","n":151,"value":5.55,"note":"95% CI 4.93 to 7.36; Figures from the ClinicalTrials.gov results section (first posted 2023-03-10), not from a publication"},{"name":"Physician's Choice of Endocrine Monotherapy","n":152,"value":5.36,"note":"95% CI 3.71 to 5.55"}],"hr":0.81,"ci":[0.6,1.1],"p":"0.1757","source":"https://clinicaltrials.gov/study/NCT04576455?tab=results"},{"endpoint":"Overall Survival (OS)","unit":"months","arms":[{"name":"Giredestrant","n":151,"value":27.5,"note":"95% CI 23.20 to 32.69; Figures from the ClinicalTrials.gov results section (first posted 2023-03-10), not from a publication"},{"name":"Physician's Choice of Endocrine Monotherapy","n":152,"value":29.77,"note":"95% CI 26.78 to NA"}],"hr":1.16,"ci":[0.85,1.6],"p":"0.3446","source":"https://clinicaltrials.gov/study/NCT04576455?tab=results"}]},"route":"/trials/nct04576455/","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":"fulvestrant","kind":"drug","name":"Fulvestrant","route":"/drugs/fulvestrant/"},{"id":"giredestrant","kind":"drug","name":"Giredestrant","route":"/drugs/giredestrant/"}],"company":[{"id":"flatiron-health","kind":"company","name":"Flatiron Health (Roche)","route":"/companies/flatiron-health/"}],"paper":[{"id":"paper-nct04576455-j-clin-oncol-2024","kind":"paper","name":"Giredestrant for Estrogen Receptor-Positive, HER2-Negative, Previously Treated Advanced Breast Cancer: Results From the Randomized, Phase II acelERA Breast Cancer Study","route":"/key-papers/paper-nct04576455-j-clin-oncol-2024/"}]}}