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Life sciences · Phase 3 Trial
ClinicalTrials.gov · September 14, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Phase 3 Trial.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
The source did not state who this applies to in practice.
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Registry record from ClinicalTrials.gov (NCT06065748). This is a study registration, not published results. Lead sponsor: Hoffmann-La Roche. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 1050 participants (ESTIMATED). Conditions: Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer. Interventions: DRUG: Giredestrant; DRUG: Fulvestrant; DRUG: Abemaciclib; DRUG: Palbociclib; DRUG: Ribociclib; DRUG: LHRH Agonist; DIAGNOSTIC_TEST: FoundationOne Liquid CDx Assay (F1LCDx). Primary outcome measures: Progression-Free Survival (PFS) in the ESR1 mutation (ESR1m) Subgroup , From randomization to first occurrence of progressive disease (PD) or death (up to 5 years); PFS in the Full Analysis Set (FAS) Population , From randomization to first occurrence of PD or death (up to 5 years). 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.