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Study identifier: NCT06065748 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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)

Condition: Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer  ·  Sponsor: Hoffmann-La Roche

PhasePhase 3
Planned participants1050
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Reference Study ID Number: CO44657 https://forpatients.roche.com/ No attachments to email below.  ·  888-662-6728 (U.S. Only)  ·  global-roche-genentech-trials@gene.com

Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

Always discuss trial participation with your own doctor first.

Locations (352)

Southern Cancer CenterDaphne, Alabama, United StatesRecruiting
Sutter Auburn Faith HospitalAuburn, California, United StatesWithdrawn
La Hematology Oncology Medical GroupGlendale, California, United StatesRecruiting
Marin Cancer Care IncGreenbrae, California, United StatesRecruiting
Kaiser Permanente - Harbor CityHarbor City, California, United StatesRecruiting
USC Norris Comprehensive Cancer CenterLos Angeles, California, United StatesRecruiting
USC Norris Cancer CenterNewport Beach, California, United StatesRecruiting
Sutter Medical Group, Roseville ClinicRoseville, California, United StatesWithdrawn
Sutter Health Medical CenterSacramento, California, United StatesWithdrawn
The Lundquist Institute for BioMedical Innovation at Harbor-UCLA Medical CenteTorrance, California, United StatesRecruiting
Rocky Mountain Cancer CentersLittleton, Colorado, United StatesRecruiting
Georgetown University Medical CenterWashington D.C., District of Columbia, United StatesRecruiting

+ 340 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT06065748