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A Study Evaluating Adherence, Tolerability, and Patient Reported Outcomes of Giredestrant in Participants With ER+/HER2- Early Breast Cancer Who Are Intolerant to Adjuvant Aromatase Inhibitor Therapy (novERA Breast Cancer)

StatusRecruiting
PhasePhase 3
Started2026-08-25
View on ClinicalTrials.gov ↗
The purpose of this study is to understand treatment adherence and patient-reported outcomes of switching to giredestrant due to prior aromatase inhibitor (AI) intolerance. Giredestrant will be administered as adjuvant endocrine therapy for participants with low-, medium-, and high-risk, Stage I-III, histologically confirmed, estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-), early breast cancer (eBC), as defined by the investigator. Participants will enroll if considered to be intolerant to a prior adjuvant AI therapy.

Amendment history 1 change detected by DataLookout

2026-07-21
notable
Recruitment opened
Trial Details
NCT Number NCT07541079
Lead Sponsor Genentech, Inc.
Conditions Early Breast Cancer
Enrollment 300 participants
Start Date 2026-08-25
Primary Completion 2032-06-30 (estimated)
Study Completion 2034-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-09-01