clinical trial · NCT06065748
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)
Estrogen Receptor-Positive, HER2-Negative Advanced Breast CancerGiredestrantFulvestrantAbemaciclibPalbociclibRibociclibLHRH AgonistFoundationOne Liquid CDx Assay (F1LCDx)
brief summary
This is a Phase III, randomized, open-label multicenter study that will evaluate the efficacy and safety of giredestrant compared with fulvestrant, both in combination with the investigator's choice of a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib), in participants with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer who have developed resistance to adjuvant endocrine therapy.
started
Dec 11, 2023
primary completion
Apr 20, 2028
completion
Feb 12, 2029
last updated
Sep 14, 2026
official title
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
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol