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.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Progression-Free Survival (PFS) in the ESR1 mutation (ESR1m) Subgroup
Timeframe: From randomization to first occurrence of progressive disease (PD) or death (up to 5 years)
PFS in the Full Analysis Set (FAS) Population
Timeframe: From randomization to first occurrence of PD or death (up to 5 years)
Reference Study ID Number: CO44657 https://forpatients.roche.com/