Phase 3 Giredestrant Trial, ER+/HER2- Early Breast Cancer, Apr 21
ClinicalTrials.gov Studies
Summary
The National Library of Medicine has registered a Phase 3 clinical trial (NCT07541079) evaluating the adherence, tolerability, and patient-reported outcomes of giredestrant in participants with ER+/HER2- early breast cancer who are intolerant to prior aromatase inhibitor therapy. The trial, designated novERA Breast Cancer, will enroll participants with Stage I-III disease across risk categories as adjuvant endocrine therapy.
What changed
This document registers a new Phase 3 clinical trial on ClinicalTrials.gov. The trial evaluates giredestrant as adjuvant endocrine therapy for early-stage breast cancer patients who cannot tolerate standard aromatase inhibitor treatment. The study focuses on adherence rates and patient-reported quality-of-life outcomes rather than efficacy endpoints.
Affected parties include clinical investigators seeking to enroll eligible breast cancer patients, pharmaceutical sponsors conducting oncology drug development, and institutional review boards reviewing human subjects protocols. Trial sites should verify giredestrant supply and confirm institutional capabilities for patient-reported outcome collection. Sponsors of competing SERD therapies may monitor enrollment milestones and trial design characteristics.
Archived snapshot
Apr 21, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
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)
Phase 3 NCT07541079 Kind: PHASE3 Apr 21, 2026
Abstract
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.
Conditions: Early Breast Cancer
Interventions: Giredestrant
Related changes
Get daily alerts for ClinicalTrials.gov Studies
Daily digest delivered to your inbox.
Free. Unsubscribe anytime.
Source
About this page
Every important government, regulator, and court update from around the world. One place. Real-time. Free. Our mission
Source document text, dates, docket IDs, and authority are extracted directly from NLM.
The summary, classification, recommended actions, deadlines, and penalty information are AI-generated from the original text and may contain errors. Always verify against the source document.
Classification
Who this affects
Taxonomy
Browse Categories
Get alerts for this source
We'll email you when ClinicalTrials.gov Studies publishes new changes.
Subscribed!
Optional. Filters your digest to exactly the updates that matter to you.