Trial Profile

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

Status: Recruiting

Phase of Trial: Phase III

Latest Information Update: 12 Feb 2026

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At a glance

Drugs Giredestrant (Primary) ; Abemaciclib; Fulvestrant; LHRH receptor agonists; Palbociclib; Ribociclib
Indications Adenocarcinoma; Advanced breast cancer; HER2 negative breast cancer; Male breast cancer
Focus Registrational; Therapeutic Use
Acronyms pionERA Breast Cancer
Sponsors Roche

20 Oct 2025 Planned End Date changed from 30 Dec 2028 to 12 Feb 2029.
20 Oct 2025 Planned primary completion date changed from 30 Jul 2026 to 19 Feb 2027.
04 Jun 2024 Trial design presented at the 60th Annual Meeting of the American Society of Clinical Oncology

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