{"entity":{"id":"nct06065748","kind":"trial","name":"A Study to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a CDK4/6 Inhibitor), in Participants With ER-Positive, HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer)","aka":[],"tldr":"A phase 3 trial of Giredestrant, Fulvestrant, Abemaciclib, Palbociclib and Ribociclib in HR-positive / HER2-negative breast cancer, run by Hoffmann-La Roche, active and no longer recruiting.","summary":"A Study to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a CDK4/6 Inhibitor), in Participants With ER-Positive, HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer) is a phase 3 interventional study registered as NCT06065748 by Hoffmann-La Roche, with 1050 participants enrolled, started 2023-12-11 and due to reach its primary completion in 2028-04-20. Interventions recorded: Giredestrant, Fulvestrant, Abemaciclib, Palbociclib, Ribociclib and LHRH Agonist.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT06065748","url":"https://clinicaltrials.gov/study/NCT06065748"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-hr-positive"],"sections":[],"technologies":[],"targets":[],"drugs":["giredestrant","fulvestrant","abemaciclib","palbociclib","ribociclib"],"companies":["flatiron-health"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"notes":[],"nct":"NCT06065748","phase":"3","setting":"A Phase III Randomized, Open-Label Study Evaluating Efficacy and Safety of Giredestrant Compared With Fulvestrant, Both Combined With a CDK4/6 Inhibitor, in Patients With Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer With Resistance to Prior Adjuvant Endocrine Therapy","sponsor":"Hoffmann-La Roche","enrolled":1050,"outcomes":[]},"route":"/trials/nct06065748/","neighbours":{"cancer":[{"id":"breast-hr-positive","kind":"cancer","name":"HR-positive / HER2-negative breast cancer","route":"/cancers/breast-hr-positive/"}],"drug":[{"id":"abemaciclib","kind":"drug","name":"Abemaciclib","route":"/drugs/abemaciclib/"},{"id":"fulvestrant","kind":"drug","name":"Fulvestrant","route":"/drugs/fulvestrant/"},{"id":"giredestrant","kind":"drug","name":"Giredestrant","route":"/drugs/giredestrant/"},{"id":"palbociclib","kind":"drug","name":"Palbociclib","route":"/drugs/palbociclib/"},{"id":"ribociclib","kind":"drug","name":"Ribociclib","route":"/drugs/ribociclib/"}],"company":[{"id":"flatiron-health","kind":"company","name":"Flatiron Health (Roche)","route":"/companies/flatiron-health/"}]}}