drugset / Trial / NCT07541079

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)

NCT07541079

Phase 3 Recruiting 300 enrolled Genentech, Inc.
NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2026-08-15
Primary completion
2032-06-30
Completion
2034-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Giredestrant Small molecule 30 mg Oral

Indications